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Reprocessing of single-use medical devices: a survey investigation comparing the views of three unheard stakeholders

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Reprocessing of single-use medical devices: a survey investigation comparing the views of three unheard stakeholders

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REPROCESSING OF SINGLE-USE MEDICAL DEVICES:
A SURVEY INVESTIGATION COMPARING THE VIEWS OF THREE UNHEARD
STAKEHOLDERS

by

David M Locke

A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE

May 2016

Copyright 2016 David M Locke

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DEDICATION
To my lovely wife, Tami and my beautiful two girls, Annika and Maci, whose support of
this endeavor has been unwavering.

This dissertation is also dedicated to those pediatric patients who summon the enormous
courage to go under the knife when the circumstance arises. May you always find the
strength to Fight On!

3
ACKNOWLEDGEMENTS

“Education is not preparation for life; education is life itself.” – John Dewey

I would like to thank the many people who have supported and encouraged me
throughout this challenging yet rewarding endeavor. I am especially grateful to Dr.
Frances Richmond for her willingness to spend countless hours mentoring and
encouraging me over the past several years and for providing me with a solid foundation
from which I can perform future research in Regulatory Science. I would also like to
thank Dr. Tom Colonna, of Johns Hopkins University, for his mentorship during my early
graduate studies and for his willingness to participate in this important work.
Furthermore I would like to thank Dr. Michael Jamieson and Dr. Gerald Loeb, both of
whom provided inspiration and insights that helped to form and finalize this thesis.
Finally, I would like to thank Marcia Arentz, Randa Issa, Erin Chow and Deborah Lynn
Schroyer for providing me with outstanding support and encouragement throughout this
journey.

4
TABLE OF CONTENTS
DEDICATION .................................................................................................................... 2
ACKNOWLEDGEMENTS ................................................................................................ 3
TABLE OF CONTENTS .................................................................................................... 4
LIST OF TABLES .............................................................................................................. 8
LIST OF FIGURES ............................................................................................................ 9
ABSTRACT ...................................................................................................................... 13
CHAPTER 1: OVERVIEW ....................................................................................... 14
1.1 Introduction ................................................................................................... 14
1.2 Statement of the Problem .............................................................................. 17
1.3 Purpose of the Study ..................................................................................... 18
1.4 Importance of the Study ................................................................................ 19
1.5 Limitations, Delimitations and Assumptions ................................................ 19
1.6 Organization of Thesis .................................................................................. 22
1.7 Definitions ..................................................................................................... 22
1.8 Acronyms ...................................................................................................... 25
CHAPTER 2: LITERATURE REVIEW ................................................................... 26
2.1 Introduction ................................................................................................... 26
2.2 Reuse, Reprocessing and Refurbishing ......................................................... 31
2.3 Third Party Single-use Device Reprocessing ................................................ 33
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2.4 Single-use Device Designation ..................................................................... 36
2.5 How Common is the Practice of Reprocessing Single-use Devices ............. 37
2.6 The Growing Controversy over Reprocessing .............................................. 37
2.6.1 Benefits ......................................................................................................... 38
2.6.2 Cost Reduction .............................................................................................. 38
2.6.3 Waste Reduction ........................................................................................... 39
2.7 Risks .............................................................................................................. 40
2.8 Legislative Compromise ............................................................................... 43
2.8.1 Reprocessing and Reuse of SUDs: Review Prioritization Scheme ............... 45
2.8.2 Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals
....................................................................................................................... 48
2.8.3 Enforcement Priorities for Single-Use Devices Reprocessed by Third-Party
and Hospitals (Final SUD Guidance) ............................................................ 49
2.8.4 MDUFMA & MDUFSA ............................................................................... 49
2.8.5 Reprocessed Single-Use Device Premarket Notification Process ................. 52
2.9 International Use of Single-use Devices ....................................................... 54
2.10 The Silent Stakeholders ................................................................................. 57
2.11 What Legislation Did Not Solve ................................................................... 60
2.12 What Will Be Studied ................................................................................... 61

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CHAPTER 3: METHODOLOGY ............................................................................. 64
3.1 Overview ....................................................................................................... 64
3.2 Development of Initial Survey ...................................................................... 64
3.3 Survey Distribution ....................................................................................... 66
3.4 Survey Analysis ............................................................................................. 68
CHAPTER 4: RESULTS ........................................................................................... 69
4.1 Analysis of Survey Results ........................................................................... 69
4.2 Surgeon Survey Responses ........................................................................... 69
4.3 Regulatory Professional Survey Results ....................................................... 90
4.4 Layperson Survey Results ........................................................................... 110
4.5 Results of Merged Data from Three Respondent Groups ........................... 128
CHAPTER 5: DISCUSSION ................................................................................... 138
5.1 Introduction ................................................................................................. 138
5.2 Consideration of Delimitations, Limitations and Assumptions................... 139
5.2.1 Delimitations ............................................................................................... 139
5.2.2 Limitations .................................................................................................. 142
5.2.3 Assumptions ................................................................................................ 144
5.3 Responses of Surgeons ................................................................................ 146
5.4 Responses of Regulatory Professionals ....................................................... 150
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5.5 Responses of Lay Respondents ................................................................... 154
5.6 Conclusions and Considerations for the Future........................................... 160
REFERENCES ............................................................................................................... 163
APPENDIX A ................................................................................................................. 178
APPENDIX B ................................................................................................................. 181
APPENDIX C ................................................................................................................. 183
APPENDIX D ................................................................................................................. 194
APPENDIX E ................................................................................................................. 205
APPENDIX F.................................................................................................................. 213
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LIST OF TABLES
Table 1: Example reprocessed single-use device product categories ............................... 31
Table 2: Typical steps in SUD reprocessing lifecycle ...................................................... 34
Table 3: U.S. Active Third Party Reprocessors of Single-Use Devices ........................... 35
Table 4: Comments on surgeons views on acceptability of SUDs used on themselves .. 88
Table 5: Additional comments of surgeons regarding use of SUDs ................................. 89
Table 6: Surgeon Experience vs. Awareness .................................................................... 90
Table 7: “Other” concerns related to the reuse of SUDs by regulatory respondents ........ 96
Table 8: Further views of regulatory respondents on SUD identification ...................... 100
Table 9: Expanded views regarding the inspection of labeling by surgeons. ................. 104
Table 10: Regulatory Professional Experience vs Confidence in FDA with SUDs ....... 106
Table 11: Sampling of final comments received from regulatory professionals ............ 109
Table 12: Layperson respondent’s comments on SUD documentation expectations ..... 119
Table 13: Laypersons comments on surgeon’s willingness to use SUDs on themselves 124
Table 14: Sampling of final comments received from layperson respondents ............... 125
Table 15: Layperson Awareness of SUDs and Documentation Expectations ................ 126
Table 16: Layperson Position on Informing the Patient and Opting Out ....................... 127
Table 17: “Other” concerns related to the reuse of SUDs by regulatory respondents .... 178
Table 18: Additional final comments received from regulatory professionals............... 178
Table 19: Additional final comments received from layperson respondents ................. 180
Table 20: Studies Proposed in this Work for Future Consideration ............................... 213
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LIST OF FIGURES
Figure 1: Overview of the three primary forms of reprocessing ...................................... 32
Figure 2: Reprocessor Closed Loop System. .................................................................... 35
Figure 3: Reprocessing Legislation Timeline ................................................................... 45
Figure 4: Review Prioritization Scheme – Infection Risk ................................................ 47
Figure 5: Review Prioritization Scheme – Inadequate Performance Risk ........................ 48
Figure 6: Stakeholders relevant to policy-setting for reprocessed devices: ...................... 63
Figure 7: Surgeon Experience ........................................................................................... 70
Figure 8: Surgical specialties of surveyed surgeons ......................................................... 70
Figure 9: Views of surgeons regarding single-use device use in their practice setting .... 72
Figure 10: Previous and present use of SUDs by surgeons .............................................. 73
Figure 11: Post-operative infection ................................................................................... 74
Figure 12: Level of concern with three device problems expressed by surgeons ............ 75
Figure 13: Views of surgeons regarding the surgical consent process ............................. 77
Figure 14: Surgeon’s views on reprocessing to contain costs and reduce waste .............. 78
Figure 15: When are you made aware that reprocessed SUDs will be used..................... 80
Figure 16: Pattern of review of IFU (A) and symbols (B) for surgeons ........................... 82
Figure 17: Confidence of surgeons in FDA’s oversight of medical devices ................... 84
Figure 18: Views of surgeons on entity(ies) suited to designate a single-use device ....... 85
Figure 19: Frequency of patient questions about use of surgical devices ......................... 86
Figure 20: Predictions of surgeons regarding future use of reprocessed SUDs ............... 87
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Figure 21: Views of surgeons about acceptability of SUDs for procedures carried out on
themselves ................................................................................................. 88
Figure 22: Professional experience of regulatory respondents by class (A), years of
experience (B) and regulatory role (C) ..................................................... 92
Figure 23: General questions regarding reused single-use devices .................................. 94
Figure 24: Level of concern with three device problems expressed by regulatory
professionals ............................................................................................. 95
Figure 25: Views of regulatory professionals regarding surgical consent and
communications ........................................................................................ 97
Figure 26: Views of regulatory respondents regarding use of reprocessed SUDs to contain
costs and reduce waste .............................................................................. 98
Figure 27: Expectations regarding the identification of a reprocessed SUD on the device
itself........................................................................................................... 99
Figure 28: Confidence related to different aspects of reprocessed SUD use in surgical
procedures ............................................................................................... 101
Figure 29: Regulatory respondents views on the frequency with which they believe
surgeons will examine an IFU ................................................................ 103
Figure 30: Regulatory respondents views on the various sections of an IFU ................. 103
Figure 31: Confidence of regulatory professionals in FDA’s oversight of devices ....... 105
Figure 32: Frequency with which patients ask about surgical devices, predicted by
regulatory professionals .......................................................................... 107
Figure 33: Regulatory Professionals – would you allow an SUD in your procedure? ... 108
Figure 34: Expectations of laypersons that an SUD would only be used once .............. 110
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Figure 35: Views of laypersons on the use of reprocessed devices ................................ 112
Figure 36: Layperson views on communication regarding the use of reprocessed SUDs in
surgery..................................................................................................... 113
Figure 37: Litigation targets with reprocessed SUD complications ............................... 115
Figure 38: Willingness of laypersons to pay additionally for single-use SUDs without
reprocessing ............................................................................................ 116
Figure 39: Layperson views on the use of particular types of reprocessed SUDs .......... 117
Figure 40: Laypersons concern level with three potential reprocessed SUDs issues ..... 118
Figure 41: Laypersons expectations regarding documentation of reprocessed SUD use 119
Figure 42: Layperson views on the review of device labeling by surgeons ................... 120
Figure 43: Layperson views on why hospitals would use reprocessed SUDs ................ 121
Figure 44: Layperson confidence in FDA’s regulation of medical devices ................... 122
Figure 45: Layperson views on the willingness of surgeons to use reprocessed SUDs if
they were undergoing a procedure .......................................................... 123
Figure 46: Comparison on “Single-Use” Labeling ......................................................... 129
Figure 47: Allowing the use of a Single-Use Device ..................................................... 129
Figure 48: Comparison of views regarding information provided to patients about the use
of reprocessed SUDs ............................................................................... 130
Figure 49: Summary Feedback – Awareness of Reprocessing of SUDs ........................ 131
Figure 50: Comparison of views regarding use of reprocessed SUDs to cut costs and
reduce waste ............................................................................................ 132
Figure 51: Respondent Confidence Level in FDA ......................................................... 133
Figure 52: Tracing a Post-Operative Surgical Infection to a Specific Device ................ 135
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Figure 53: Summary Feedback – Future Increase in the Use of SUD ............................ 136
Figure 54: Summary Feedback – Should Surgeons Receive Training on SUDs ............ 137
Figure 55: Photograph to illustrate an unusually detailed reprocessed mark ................. 149

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ABSTRACT
Reprocessing of single-use medical devices (SUDs) has gained enormous traction over
the past decade as health care organizations seek to cut costs and reduce medical waste
while maintaining patient care of high quality. Although laws and regulations attempt to
assure the safety of these practices, they do not require that patients or physicians be
informed that the devices that they are using have been reprocessed, even though they
have been advertised as single-use devices. The results of the three surveys distributed
for this exploratory study provide insight into the thoughts and opinions of stakeholders
directly involved in or affected by the provision and use of these products. Survey
feedback shows that many individuals in all of the stakeholder groups have incomplete,
and at times, confused knowledge about the implementation of this growing practice.
Surveys results also suggest that all three groups have relatively low levels of confidence
and even a reluctance to accept this practice. Results of the three surveys can contribute
to future policy development around device reprocessing that balances the needs of
surgeons, laypersons and regulators with other more vocal stakeholders in the pursuit of
safe and cost-effective device use.

14
CHAPTER 1: OVERVIEW
1.1 Introduction
When manufacturers sell medical devices that are used for procedures on patients, they
must specify how the devices are to be used. In some cases, the devices are intended for
reuse, but others are identified as single-use devices. For single-use devices, the
manufacturer makes the assumption that the device is discarded after one use and another
new device is used for the patient who follows. This assumption can drive the device
design and can limit the liability of the manufacturer beyond the first use in a patient.
However, it can be very expensive and wasteful to use new devices for every
interventional procedure. Thus, single-use medical devices (SUDs) are now often
reconditioned either by the hospital or by outsourced reprocessing centers so that they
can be used in multiple patients (Selvey, 2001). Healthcare centers use reprocessing to
cut costs in a manner that they view to preserve high quality patient care. They are also
sensitive to the challenges of disposing of medical waste, so that a focus on waste
reduction and recycling play an important role in the ongoing activities at these
establishments. As stated by the Association of Medical Device Reprocessors (AMDR):
Hospitals and healthcare providers are among the largest generators of
regulated medical waste. FDA-regulated reprocessing of some single-use
devices allows for hospitals and healthcare facilities across the country to
reduce the overall volume of waste they generate. Reprocessing of
“single-use” devices has always been an environmentally friendly
practice (AMDR, 2014a)!
Companies that make single-use devices are not typically comfortable with the
reprocessing approaches of the health care facilities, for which their devices were not
designed or tested. They argue that safety issues could be introduced - parts could break
15
or debris or infectious agents could continue to contaminate the devices. However, the
trends suggest that reprocessing will become a more rather than less common practice as
health care costs rise.

Typically the challenges of reprocessing have been positioned as a disagreement between
two stakeholders, the manufacturer and the health care facility, whose opposing views
have been mediated by lawmakers and federal regulators. Attempts to find a middle
ground have resulted in the passage of two key laws, the Medical Device User Fee and
Modernization Act (MDUFMA) of 2002 and the Medical Device User Fee Stabilization
Act (MDUFSA) of 2005, which address some of the sources of concern. These omnibus
Acts were not solely directed at the management of reprocessed medical devices, and
dealt with device issues such as the reauthorization of user fees for marketing
applications of drugs and medical devices, and the use of accredited third parties to
conduct inspections (FDA, 2002; FDA, 2005). However, subparts of these two Acts
directly impacted the activities surrounding the reprocessing of single-use devices. Most
importantly to this work, they required reprocessors to treat single-use devices designated
as class II (an intermediate risk class into which essentially all impacted devices fit) as if
they were modified devices, and submit a premarket notification to show how the
reprocessing will not harm the functionality and safety of the devices. Further the
legislation imposed stricter labeling requirements on the reprocessed devices. The
legislation was followed by guidance documents that spelled out in more detail how the
reprocessors would be required to meet the terms of the new laws. Some of these needs
16
included new labeling requirements and validation data to substantiate claims in the
premarket notification submissions.

The legislation was a strong step in the direction of assuring regulators that reprocessed
products had a higher level of safety assurance. Reprocessed products are differentiated
from original devices in their first use by different labels on the outer packaging on the
modified devices. However, once a reprocessed product approaches the surgical suite it
is typically removed from that packaging; this masks the fact that the product is
reprocessed from the surgeon and patient. Concerns about the lack of transparency in the
use of reprocessed devices were raised early, during the first attempts to legislate the
control of reused devices. In the earliest bills, some form of informed consent from the
patient was prerequisite to the use of reprocessed devices (Congress.gov, 1999).
However, such provisions are not part of current law and little has been written about the
views of this fuller range of stakeholders, including end-users and patients, with regard to
the use of such devices during surgical procedures. These stakeholders play an important
role in the lifecycle of the use of reprocessed single-use devices, because they have direct
contact with these devices, or they work directly with these devices. Furthermore,
information about the knowledge and views of these stakeholders may be important for
regulatory professionals working in the medical device industry because it may shape the
way that they develop patient and physician-directed information.

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1.2 Statement of the Problem
We know much about the way that manufacturers and hospitals view the reprocessing of
single-use devices. What we do not know are the views held by other stakeholders. It is
important when policies and practices are established that the views and level of
understanding of all stakeholders be heard because failure to involve them denies the
opportunity to capture relevant feedback that might be important in policy-making
processes. Stakeholder theories suggest that appropriate policy development should be
led by examination of the views of “all” stakeholders and that the views of silent
stakeholders should also be taken into account in an effort to gather a robust appreciation
for diversity of opinion that may surround a contentious topic (Schmeer, 1999). In
today’s society, this can be deemed as important when dealing with human subjects and
the use of medical devices for medical treatment purposes. Some patients expect that they
will be made aware of all procedural risks and that they should have the opportunity to
participate in decisions involving the care they receive based on those risks through some
system of informed consent. Health-care professionals might also prefer to be fully
educated on the devices they are using. However, today it is not clear how much end-
users and patients know with respect to the reuse of single-use devices. Further we do
not know how they receive the information that they might have. Finally, we do not have
a clear understanding as to how regulatory professionals feel about reprocessed single-
use devices. Without insight regarding the views of the all stakeholders, it is not possible
to determine if all stakeholders are in agreement with each other.

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1.3 Purpose of the Study
This dissertation is designed as an exploratory study to examine the views and level of
understanding of clinical users, patients and regulatory professionals with regard to the
reuse of single-use medical devices. Literature relating to reprocessing of single-use
devices was first analyzed to identify historical trends and the nature of current
regulations with respect to reprocessing. A series of survey tools was developed for three
panels of survey recipients using a framework based on the Kipling Method to capture
feedback. The surveys were disseminated using a web-based platform
(www.qualtrics.com). The first panel, whose responses were expected to provide
information on the views of end-users, was composed by surgeons who use, or in the
future might use, reprocessed single-use devices. The second panel explored the views of
one subpopulation of potential patients, drawn from a sample of faculty and staff
members who work for the University of Southern California. The third panel consisted
of regulatory professionals who currently work with Class II and/or Class III medical
devices, or have worked with Class II and/or Class III medical devices in the recent past.
Survey questions explored the awareness, understanding, perceptions and expectations of
each panel with respect to the reprocessing of single-use devices. It probed whether
current approaches to inform and involve patients and end-users were considered by each
group to be adequate and appropriate. The survey further attempted to identify if the
views of the three groups were aligned with each other, and how these views fit with
current views of manufacturers and health care facilities whose views are already well
documented.
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1.4 Importance of the Study
The use of reprocessed single-use devices is a common practice throughout the United
States (Robby, Fischer & Swiontkowski, 2005) and it continues to increase globally.
Thus, it is important that federal regulators who drive the implementation of the
regulatory requirements surrounding single-use device reprocessing are aligned with all
of the stakeholders, and particularly with end-users and patients. Further, it is important
that regulatory professionals working directly with these devices know how end-users
and patients feel about this form of reprocessing, and how their devices may be affected
by reprocessing, as they seek to demonstrate their safety and effectiveness to federal
regulators. The extent to which the instructions for use and labeling are developed
depends on taking the physicians and consumers into account. Failure to anticipate their
level of knowledge can result in labeling that is inappropriate or insufficient to guide the
safe and optimized use of the product.
1.5 Limitations, Delimitations and Assumptions
This dissertation was delimited to the study of views regarding reprocessing of single-use
devices in the U.S. It did not investigate practices outside of the U.S. where reprocessing
of single-use devices can differ significantly, and further, it did not consider reprocessing
of devices that are designed for such repeated use and marketed for this expanded
purpose. Additionally, opinions were only captured from proxy groups of survey
recipients representing specific stakeholders, those being end-users, laypersons and
regulatory professionals. The three subpopulations included surgeons practicing surgery
in the United States, faculty and staff working at the University of Southern California
20
and regulatory professionals that had in the past, or currently work with Class II and/or
Class III medical devices. The delimitation was considered to be useful in order to assure
some level of homogeneity in the survey samples which are necessarily small in this
exploratory study. There was the expectation that this population will serve as a baseline
for comparative studies that might be broader and put into place based on areas of
particular interest elucidated through survey results. Information gathered within this
study did not focus on opinions from other relevant stakeholders including other
departments working in device manufacturing companies, device purchasers, federal
regulators or lawmakers.

As expected, there were limitations in the rate and depth of responses from some
respondent groups. It was understood that recipients such as surgeons and regulatory
professionals can be busy and lack motivation to see a survey as a priority amongst other
jobs with which they must deal. The study was also seen as somewhat limited by the
potential sources of bias that were thought to be present within this study. One source of
bias related to the nature of the individuals who were surveyed. For example, it was
understood that regulatory professionals who work with medical devices may also have
strong feelings about the appropriateness of reprocessing single-use devices if they
worked, or are currently working, for a company that could derive added revenue if such
devices could not be reprocessed. It was also assumed that some level of bias existed in
the investigators involved in executing the study. For example, I (lead investigator) had
prior experience working in the operating room environment and now work with a
21
medical device company that makes single-use devices. Thus it was anticipated that
some of my views could unintentionally creep into the survey.

Perhaps one of the biggest limitations for a small, exploratory study is the external
validity of the chosen respondent groups. When attempting to probe the views of end-
users, issues of external validity may be related to using surgeons as a proxy for the end-
user population, and further studies may be needed to see if different opinions exist
amongst others users such as nurses or other types of physicians or medical practitioners.
When attempting to study laypersons responses, it is especially difficult to find a small
group to represent those laypersons in whose treatments the devices will be used. This
group could potentially include every person living in the US. The U.S. population has
significant heterogeneity in race, culture and socioeconomic status and all of these
differences can cause the subpopulations to have different views. I chose one population
that consists of individuals who are working for an academic institution in California, but
acknowledge that the insights gained from this group has to be compared to responses to
other types of potential layperson groups if we are to assume any type of external validity
in their response patterns. However, for an exploratory study it is important to control
certain variables in order to understand the nature of the respondents in one subgroup.
Results may very well differ if they were captured from a different population of
individuals, located at a different location with different and varying backgrounds.
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1.6 Organization of Thesis
This study contains multiple chapters. Chapter 1 provides an overview and background
of the research question. Chapter 2 focuses more on the state of knowledge with respect
to the literature as it pertains to reprocessing of single-use devices. Chapter 3 outlines the
methods used in the survey that will explore end-users, patients and regulatory
professional’s opinions and knowledge on this topic. Chapter 4 contains an analysis of
the survey results. Chapter 5 contains an overall summary of the survey.
1.7 Definitions
Medical Device: The term ‘medical device’ means an instrument, apparatus, in vitro
reagent, or similar or related article that is used to diagnose, treat or prevent disease or
other conditions, and does not achieve its purposes through chemical action within or on
the body (which would make it a drug).
Original device: The term ‘original device’ means a new, unused single-use device.
Single-use device: The term ‘single-use device’ means a device that is intended for one
use or on a single patient during a single procedure.
Reuse Device: The term ‘reuse device’ means devices that are intended to be use multiple
times – more than one time.
Reprocessed Single-Use Device: The term ‘reprocessed’, with respect to a single-use
device, means an original device that has previously been used on a patient and has been
subjected to additional processing and manufacturing for the purpose of an additional
single use on a patient. The subsequent processing and manufacture of a reprocessed
23
single-use device shall result in a device that is reprocessed within the meaning of this
definition.
Reprocessed Reuse Device: The term ‘reprocessed reuse device’ means devices that
health care providers can reuse to diagnose and treat multiple patients. Examples of
reusable medical devices include surgical forceps, endoscopes and stethoscopes.
Refurbished Reuse Device: Refurbishing of medical device refers to restoring used
equipment or systems into a condition of safety and effectiveness comparable to new
including actions such as repair, rework, update and replacement of worn parts with
original parts.
Third-party Reprocessor: Any FDA-regulated entity that, at the request of a provider
customer, inspects, refurbishes, function tests, cleans, packages, and sterilizes medical
devices labeled as “single-use” in such a manner that:
• The quality, physical characteristics, and functionality of the devices are not
adversely affected, or such characteristics are improved;
• The devices remain safe and effective for an additional single-use; and
• The devices are reprocessed in full compliance with FDA regulations.
Premarket Notification: Section 510(k) of the Food, Drug and Cosmetic Act requires
device manufacturers who must register, to notify FDA of their intent to market a
medical device at least 90 days in advance. This is known as Premarket Notification -
also called 510(k).
Substantially Equivalent: A device is substantially equivalent if, in comparison to a
predicate it:
24
• has the same intended use and has the same technological characteristics
as the predicate or
• has the same intended use and has the same technological characteristics
and the information submitted to FDA does not raise new questions of
safety and effectiveness and demonstrates that the device is at least as safe
and effective as the legally marketed device.
Food, Drug and Cosmetic Act: The United States Federal Food, Drug, and Cosmetic Act
(FD&C Act) is a set of laws passed by Congress that gives authority to the U.S. Food and
Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. It
regulates contaminants in food including pesticides.

25
1.8 Acronyms
Term Definition
AAMI Association for the Advancement of Medical Instrumentation
AMDR Association of Medical Device Reprocessors
AHA American Hospital Association
AST Association of Surgical Technologists
CJD Creutzfeldt - Jakob disease
CDC Center for Disease Control
CFR Code of Federal Regulation
EC European Commission
EU European Union
FDA Food and Drug Administration
FD&C Food Drug and Cosmetic Act
GAO Government Accountability Office
HAI Health care-Associated Infections
HIV Human Immunodeficiency Virus
IFU Instructions for Use
IRB Institutional Review Board
MDUFMA Medical Device User Fee Modernization Act
MDUFSA Medical Device User Fee Stabilization Act
OEM Original Equipment Manufacturer
QSR Quality System Regulations
RPS Review Prioritization Scheme
SOP Standard Operating Procedure
SUD Single-use Device
US United States
WHO World Health Organization
UCLA University of California Los Angeles
USC University of Southern California
MAUDE Manufacturer and User Facility Device Experience

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CHAPTER 2: LITERATURE REVIEW
2.1 Introduction
Medical devices and instruments have played an important role in medical therapy for
almost as long as records have been kept. Some of the earliest surgical devices were
knives and saws made of flint or obsidian for use in circumcisions. Trepans, devices
designed to create holes in the skull for treatment of neurological disorders, appear to
have been used as far back as Neolithic times (Brothwell, 1963). The common use of
sophisticated surgical approaches and tools in the Indian Hindu culture is documented in
the surgical textbook, Sushruta Samhita, which is thought to date back to the 6
th
century
B.C. It describes over 120 surgical instruments made of steel, such as forceps, trocars
and cauterizing devices (Advameg, 2014). Greeks used surgical devices similar to those
used by the Hindus in order to hold, grab, puncture and cut tissue for various procedures.
Although the range of early devices lacked the breadth and complexity of devices that are
in use today, they were remarkably versatile for the medical practices of the time. They
were typically all reused from one patient to another and, without a good knowledge of
infection control, were undoubtedly cleaned between uses in ways that would be deemed
unacceptable today.

In Western medicine, clinical practices became more sophisticated through the nineteenth
and early parts of the twentieth century. They drove the development of more advanced
medical devices that often were made up of multiple parts and components needed for
more targeted operations. Some relevant examples of these more modern devices
27
included the ophthalmoscope used to visualize the retina, the tonometer used to
determine pressure within the eye, the kymograph used to measure blood pressure, the
laryngoscope used to view the larynx, the x-ray to image internal structures and more
advanced microscopes to visualize microscopic organisms. New surgical options
associated with the use of anesthesia in the 1840s also drove specialized device
development. Surgeons were able to perform more sophisticated procedures in addition
to the traditional amputations that had been common prior to that time (Marsh, 2014).
However, with this increase in surgical procedures came more surgically-related
infections and complications. Ultimately these problems were controlled, at least to a
large extent, by the introduction of “antiseptic”, and then “aseptic” surgical procedures
based on the practical applications of research by Louis Pasteur and Joseph Lister
(Marsh, 2014; Schlich, 2012).

It has been within the past fifty years that we have seen the most significant advances in
medical devices. As suggested by Nguyen, “the growth of medical technology in the past
50 years alone has exceeded all advances made during the previous 2000 years” (Nguyen,
2009). Today’s medical devices now include such highly complex devices as surgical
robots and pacemakers, many of which gain their specialized capabilities from
sophisticated electronic or computer-based technologies. This complexity is captured in
the Food and Drug Administration’s definition of a medical device which describes a
medical device as:

28
An instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component
part, or accessory which is: recognized in the official National Formulary,
or the United States Pharmacopoeia, or any supplement to them, intended
for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purpose through
chemical actions within or on the body of man or other animals and which
is not dependent upon being metabolized for the achievement of any of its
primary intended purposes (FDA, 2009b).
The growth in device complexity has been paralleled by the recognition that such devices
could be damaging unless designed and used appropriately. These challenges are
reflected in unsafe practices, such as inappropriate labeling, fraudulent claims and the
sale of defective or dangerous devices (McCoy, 2000). They have led U.S. federal
regulators to differentiate devices from drugs and challenged them to focus on addressing
public concern over the safety of medical devices as a stand-alone product.

Medical devices were initially brought under the oversight of U.S. regulators with the
passage of the Food, Drug and Cosmetic Act of 1938 (FD&C). The FD&C Act of 1938
defined drugs and medical devices as a specific, regulated sector. However, regulations
to deepen the interpretation of the Act, and more specifically medical devices, were not
developed until well after the Second World War. Protecting the public from defective
devices and irresponsible marketing practices depended on FDA’s interpretation of the
limited provisions in the FD&C Act, as well as judicial interpretations that extended
FDA’s regulatory authority over devices (Rados, 2006; Pina & Pines, 2008).

29
It was not until the FD&C Act was modified by the Medical Device Amendments of
1976 that new regulations solidified FDA’s statutory authority over medical devices. The
1976 amendments differentiated drugs from devices by stressing that a drug exerted its
effect by causing a “chemical reaction” in the body, whereas the device did not (Rados,
2006). The Medical Device Amendments established requirements that manufacturers
submit the more risky of the devices for premarket review, the depth of which was related
to the assignment of the device in a new risk-based classification system that had three
classes - Class I, Class II and Class III - organized from low risk to high risk. This three
tiered classification system based on device risk is still in use today in the U.S; this
approach is similar to many international regulatory bodies that also use a tiered device
classification system. The Amendments also introduced requirements for manufacturers
to register with FDA and to follow quality practices that were more explicitly stated in
ensuing regulations.

The Medical Device Amendments permitted FDA to use a more focused and aggressive
approach. However, with the passage of time, advances in device technology introduced
new challenges that were not foreseen at the time of the Medical Device Amendments of
1976. Some of these challenges included the procurement, storage, use and disposal of
certain types of medical devices, and it is with these challenges that the current research
is concerned.

The physician of 2015 is presented with a wide array of devices that vary greatly in
sophistication. The device catalogues of today include relatively inexpensive, reusable
30
manual tools that can be cleaned and sterilized by a hospital or clinic for reuse over many
years (e.g. scissors, dental tools, forceps, retractors). However, many of the new devices,
and particularly devices designed to become part of a patient’s body, have been
developed on the assumption that they would be used in a single patient and then
discarded when the patient died or the device lost its functionality. Such a device is
considered as a “single-use” device, defined as “a device that is intended for one use on a
single patient during a single procedure” (FDA, 2014a). Although these devices are
typically costly, the costs are often justified on the basis that recipients benefit
significantly from great improvements in their quality or length of life.

Other devices occupy a more challenging and often problematic middle ground. Devices
such as certain monopolar and bipolar vessel-sealing devices, harmonic tissue transectors
and tissue coagulators, as well as specialized catheters and trocars, are also costly and
can, in principle, be used more than once if reconditioned appropriately before their next
use; table 1 provides an overview of some of the more commonly reprocessed single-use
devices. These devices are, nonetheless, commonly marketed by the manufacturer as
“single-use devices” for a number of reasons, some of which include sales-volume
considerations, quality-assurance challenges, inability to properly clean and resterilize the
devices and liability concerns. However, over the past several decades, many device
users and purchasers have ignored the single-use device designation and instead have
opted to reprocess these devices. Ultimately, the challenges associated with the
reprocessing of single-use devices were not something that could have been predicted
with the passing of the 1938 FD&C Act, nor with the passing of the Medical Device
31
Amendments of 1976. It has only been recently that regulators have put into place
regulations addressing this rapidly expanding practice.
Table 1: Example reprocessed single-use device product categories
Product Categories
Non Invasive Catheter Lab OR General OR Ortho
Pulse Oximeter Imaging Catheters Energy Devices Shavers
Compression Sleeve
Electrophysiology
Catheters
Trocars
External
Fixation
ECG Leads and
Wires
Urinary Catheters Clip Appliers Probes

2.2 Reuse, Reprocessing and Refurbishing
“Reprocessing” is a term that can encompass a variety of different approaches designed
to manage reused devices. The range of potential approaches is reflected well in the
description by FDA:
Reprocessing is “generally” regarded as the cleaning, disinfection,
sterilization, repair, reconditioning and refurbishing of medical devices,
both items labeled as reusable and single use. Reprocessing can be done
in-house by hospitals or by third-party reprocessors, and each
reprocessor is heavily regulated by the government with oversight by the
Food and Drug Administration (FDA, 2006).
This description does not specifically differentiate between two scenarios in which
reprocessing can be applied, one in which the device is designed to be reprocessed
between sequential patient exposures, and the other in which the device is designed and
labeled by the manufacturer to be discarded after use on a single patient but is
32
nonetheless reused. The concept of reprocessing single-use medical devices is thus, from
the point of view of semantics, an oxymoron because the meaning of “single-use”
technically excludes reprocessing (SCENIHR, 2010). Reprocessing must also be
differentiated from the rather different approaches that are usually considered as
“refurbishing,” processes that are often performed on capital equipment. The FDA
definition of refurbishing reads as follows:
Restoring used equipment or systems into a condition of safety and
effectiveness comparable to new and can include actions such as repair,
rework, update and replacement of worn parts with original parts for
purposes of resale or redistribution; these devices may or may not be
cosmetically enhanced (FDA, 2014b).
Although reprocessing and refurbishing have different meanings, the terms are often used
interchangeably and/or inappropriately. For purposes of this dissertation, definitions
covering the various types of reprocessing are described in Section 1.6 of Chapter 1;
these definitions are also described in Section 201 of the Act (302(d) of MDUFMA).
Additionally, Figure 1 also provides a high-level picture of these three primarily
recognized forms of reprocessing as a simple reference tool.
Figure 1: Overview of the three primary forms of reprocessing

33
2.3 Third Party Single-use Device Reprocessing
The management of reused devices has gone from a small-scale cottage industry to a
major enterprise, and this has raised both the visibility and the level of concern.
Beginning in the 1970s and continuing over the past several decades, it has been
commonplace for hospitals and other end-user facilities to take responsibility for cleaning
and sterilizing devices that they deemed to be reusable. However, as stated by medical
device reprocessing expert Marcia Arentz, “a variety of forces including costs of
adhering to regulations, convenience and liability considerations drove most health-care
facilities in the late 1990s and 2000s to outsource the reprocessing of their used devices
to a third-party, recognized as a third-party reprocessor” (M. Arentz, personal
communication, June 1, 2014). Typically, third-party reprocessing takes the form of a
closed loop system (Figure 2) which includes the steps outlined in Table 2.

34
Table 2: Typical steps in SUD reprocessing lifecycle
Steps in Reprocessing
Step 1
A device is used on a patient in a clinical or surgical setting, such as an
operating room, radiology suite, medical office or catheterization
laboratory
Step 2
The device is retrieved and sent to central sterile supply for pre-cleaning in
anticipation of reprocessing
Step 3 The device is pre-cleaned, and sorted into a designated bin that is then sealed
Step 4
The bins are collected by a designated courier and taken to a reprocessing
site
Step 5
The devices are further sorted according to standard operating procedures
(SOPs) of the reprocessing site
Step 6
Each device is further cleaned manually or ultrasonically, disinfected,
refurbished, and dried. The device is tested and designated as acceptable
Step 7
The device is relabeled with the reprocessors information, including an
identifying mark showing the number of times the device has been
reprocessed, and then packaged and shipped for sterilization
Step 8 The device is sterilized in accordance to commitment established in 510(k)
Step 9
The device is shipped to a storage facility where it is held until it is ordered
by the original purchaser (closed-loop); and open-loop system is also used in
which the devices are sold to new purchasers

Figure 2 below outlines the closed-loop system that is often employed by third-party
reprocessors. It should be noted that third-party reprocessors are not required to resell
devices back to the entity in which they retrieved it. They can in fact work in an open-
loop system, in which they sell their products to any willing purchaser. However, the
closed-loop system is the preferred method used by the third-party reprocessor – a list of
active U.S. third party reprocessors is provided in Table 3.

35
Figure 2: Reprocessor Closed Loop System.
Reprinted with permission (JNJ, 2014)

Table 3: U.S. Active Third Party Reprocessors of Single-Use Devices
U.S Active Third-Party Reprocessors
of Single-Use Devices
Name Location Website
SterilMed, Inc
Maple Grove,
MN www.sterilmed.com
Stryker Sustainability Solutions Lakeland, FL sustainability.stryker.com
ReNu Medical Everett, WA www.renumedical.com
NEScientific Waterbury, CT www.mdreprocess.com
Medline ReNewal Redmond, OR www.medlinerenewal.com
Hygia Birmingham, AL www.hygia.net

36
2.4 Single-use Device Designation
The reprocessing of devices made for reuse is to be expected, but the reprocessing of
single-use devices has been more controversial. One might question why such devices
are classified as single-use devices at all. In the US, the decision to designate a product
as a “single-use” device is made by the manufacturer rather the FDA. As stated by the
Government Accountability Office (GAO):
The decision to label a device as single-use or reusable rests with the
manufacturer. If a manufacturer intends to label a device as reusable, it
must provide data demonstrating to FDA’s satisfaction that the device can
be cleaned and sterilized without impairing its function. Thus, a device
may be labeled as single-use because the manufacturer believes that it
cannot be safely and reliably used more than once, or because the
manufacturer chooses not to conduct the studies needed to demonstrate
that the device can be labeled as reusable GAO (GAO, 2008).
The manufacturer of a device defined for single-use attempts to make it clear that the
device is not intended for reprocessing by placing information about its designation as
“single-use only” on the outer display carton that holds the product, on the Tyvek inner
package that overwraps the device and in most cases within the instructions for use (IFU)
accompanying the device.

Over the past several decades, however, many healthcare professionals and product
purchasers have disagreed with the manufacturer’s “single-use” identification of
particular devices; they have argued that many such devices remain useable if they
undergo appropriate cleaning, repair or resterilization (UC Davis, 2014). This thinking
has led to a tension between different stakeholders about the appropriateness of
37
reprocessing devices that were neither designed nor marketed for such treatment. Some
of these tensions will be covered later in this chapter.
2.5 How Common is the Practice of Reprocessing Single-use Devices?
The reprocessing of single-use devices occurs across the entire spectrum of medical
facilities, from the largest university hospitals to solo practices that are owned and
operated by an independent provider. Large hospitals appear more likely to be reusing
single-use devices; nearly half (45.2 percent) of all hospitals with more than 250 beds
reuse single-use devices, compared to only 12.3 percent of hospitals with fewer than 50
beds. Of the hospitals reusing such devices, the large majority (85 percent) use third-
party reprocessors, whereas the remaining 15 percent of hospitals reprocess at least some
single-use devices in-house (FDA, 2009a). Nevertheless, small hospitals are more
common than large hospitals in the US, so that approximately 60 percent of the hospitals
reprocessing single-use devices in-house are categorized as small (100 beds or fewer)
(FDA, 2009a). These figures suggest that the larger medical facilities are responsible for
the bulk of single-use reprocessing and that they predominately rely upon third-party
reprocessors for this activity.
2.6 The Growing Controversy over Reprocessing
By 2000, views with regard to reprocessing had become polarized. Some stakeholders,
including healthcare facilities, insurers and reprocessors, strongly advocated for the
benefits of reprocessing, whereas others, including most notably the manufacturers,
expressed strong concerns about the dangers that such reprocessing could impose,
suggesting the risks outweigh the benefits (Wang, 2001). These views increasingly led to
38
confrontative attitudes that were not helped by the policy vacuum with respect to
reprocessing that existed at the turn of the millennium (Silverman, 2007). Regulators at
that time were presented on both sides by arguments that begged for some sort of
regulatory decision-making. These arguments, explained below, all had merits.
2.6.1 Benefits
Two arguments have been most central in arguments that defended reprocessing. First is
the importance of the cost reductions that could be achieved, and second is the
importance of reprocessing to reduce medical waste.
2.6.1.1 Cost Reduction
Devices can be very expensive; using a costly device only once can be difficult to justify
in a healthcare system faced with growing health care costs and constraints on revenue.
This concern was well-enunciated by the World Health Organization (WHO), in 2003
with the following:
Medical devices cost governments a substantial amount of money. In
2000, the estimated one and a half million different medical devices
available on the market represented over US$145 billion. With innovation
and the rapid advancement of technologies, medical devices are currently
one of the fastest growing industries, and the global market figure for
2006 was estimated to exceed US$260 billion (WHO, 2003).
There is no question that reprocessing of single-use devices can reduce health care costs.
In 2012 for example, U.S. health care facilities saved approximately $290 million in
supply costs as a result of reprocessing cardiovascular, laparoscopic, arthroscopic and
gastrointestinal devices; approximately 25 percent of hospitals reprocess at least one of
these device categories (Sprovieri, 2012). Additionally, a 2009 FDA sponsored survey
indicated that 24.2 percent of all US hospitals reuse SUDs (FDA, 2009a) in what is
39
presumably a cost saving measure in most cases. Just a decade ago, it was suggested that
if just 1 - 2% of all the disposable medical devices used in the U.S. today were
reprocessed, the healthcare industry would save a billion dollars every year. Today the
savings potential is thought to be as high as $2 – 3 billion dollars annually (AMDR,
2014b). Ultimately that money could be used for patient care, research, bringing new
treatments to the bedside, and making healthcare more affordable (Selvey, 2001).
2.6.1.2 Waste Reduction
The increased public sensitivity to the growing problem of medical waste disposal has
caused many to seek methods for reducing medical waste and recycling medical
materials. Recently, WHO estimated that high-income countries generate up to 0.5 kg of
hazardous waste (e.g. infectious and pathological, sharps, chemicals and radioactive
waste) per bed per day while low-income countries generate 0.2 kg per bed per day
(WHO, 2003). To put this in perspective, it is estimated by the American Hospital
Association (AHA) that the United States has 5372 registered hospitals with a total of
920,829 beds (AHA, 2014). Therefore, based on these WHO figures, over 460,000 kg of
hazardous waste is generated per day in the U.S., equating to about 168 million kg (365
million lbs.) of waste generated per year in the U.S. Furthermore, health-care associated
waste is often not separated into hazardous and nonhazardous waste in low-income
countries making it difficult to calculate a true “per day” waste value for these countries.
However, it has been suggested that the real quantity of hazardous waste outside of the
U.S. is likely much higher than what is reported (WHO, 2003). Thus, where possible,
user facilities have looked for ways in which to avoid disposing of what otherwise seem
to be functional devices by reusing them.
40
2.7 Risks
Opposition to reprocessing stems from a different set of arguments, perhaps the most
persuasive of which concerns product safety. Manufacturers in particular have argued
that the methods used to reprocess single-use devices can have a negative impact on
device function and performance. The physical acts of disassembling, cleaning and
reassembling devices have the potential to affect their properties. For example, the
selection of an inappropriate liquid chemical germicide(s) or sterilization method may
cause damage such as pitting or cracking of delicate device components (Colonna &
Thomas, 1999).

Damage to the patient contacting materials appears to be of particular concern. When a
device is developed, the patient contacting materials undergo rigorous biocompatibility
testing (e.g. cytotoxicity, chemical, sensitization, irritation). Aggressive and repeated
treatment of vulnerable parts of single-use devices can cause them to become weakened
or brittle. Portions of the device might then fail or break during use. Smith and Berlin
(2001) reported one such case in the American Journal of Radiology, in which the tip of a
reprocessed SUD pigtail catheter broke off as the catheter was being removed during an
arteriogram (Smith & Berlin, 2001). The tip was later found lodged in the intracranial
portion of the left internal carotid artery and caused a middle cerebral artery thrombus.
Although the patient survived the procedure, he suffered an infarct in the distribution of
the middle cerebral artery which led to a 10-day hospital stay and permanent and severe
neurologic deficits (Smith & Berlin, 2001).

41
Manufacturers argue that the types of aggressive cleaning and sterilization used during
reprocessing could change the chemical nature or physical integrity of those materials,
thus rendering them to be “new” materials that should in principle be retested for
biocompatibility. Further, these patient-facing materials and components must be
sterilized appropriately. This is a particular problem in devices that have many tiny
ridges or pockets that could harbor hard-to-remove biological contaminants, such as
blood, tissue and other biological debris. This debris can harbor microbes that survive
disinfection or sterilization, which could then lead to Health-care Associated Infections
(HAIs). It is not uncommon to find reports of bacterial contamination on reprocessed
devices as the result of inadequate cleaning, disinfection, or sterilization of SUDs
(Colonna & Thomas, 1999). For example, a patient undergoing rotator cuff surgery, “a
procedure that generally requires at most a single night’s stay in the hospital, followed
by basic physical therapy” (Eaton, 2014), developed infection related wound dehiscence
and erosion that ultimately required further surgical repairs and left him unable to
perform normal daily activities. It was later found that this patient was one of at least
seven joint-surgery patients who acquired similar infections during a two-week period
after surgery at the same hospital. The problems were later attributed to arthroscopic
surgical equipment that housed “retained tissue” that should have been removed during
the initial cleaning process (Eaton, 2014). In this case, tissue was found deep inside both
a hand-arthroscopic shaver and an inflow/outflow irrigation cannula used at the surgical
sites (Eaton, 2014). Inadequate reprocessing can also result in other adverse patient
outcomes, such as tissue irritation from residual reprocessing materials such as chemical
disinfectants (FDA, 2014b). For example, some reprocessors are known to use
42
formaldehyde, a potential carcinogen for disinfection. Underdilution of sterilization
solution may leave residual formaldehyde on the reprocessed medical device, which then
may enter the patient’s body (CDC, 2009).

The concern surrounding such issues is evident considering FDA’s recent adoption of
computer modeling to study the flow of fluid and debris within devices. Such modeling
has been shown to help OEMs determine the extent to which specific design features
make a device prone to retaining debris and allow them to improve their designs prior to
production. FDA researchers are also investigating the relationship between device
design and debris accumulation and retention over multiple cycles of soiling and
cleaning. To determine if various cleaning methods are effective, FDA researchers are
developing a method to quantify particulate biological debris retained in reusable medical
devices. Conventional test methods may underestimate the presence of debris, such as
tissue, cartilage and bone. These underestimations could lead to the design of reusable
devices that are prone to retaining debris (Sprovieri, 2012). It is worth noting that even
“dead” remnants of common pathogens (e.g. bacterial, viral) left behind can have
negative patient consequences (Mazzotti, Beuttler, Zeller, Fink, Schindler, Wendel, et al.,
2007). This reality must also be considered by hospitals and manufacturers when their
devices are known to be used more than once.

According to the Center for Disease Control and Prevention (CDC) more than 51 million
surgical procedures were carried out in the U.S in 2010 (CDC, 2014). Many such
procedures use both reusable and reprocessed single-use devices, which arguably carry
43
the “potential” for injury and/or infection due to an improper cleaning and/or
revalidation. Rutala, in his article titled Disinfection and Sterilization summarizes this
concern with the following:
Each year in the United States there are 46 million procedures performed
on hospital inpatients and an estimated 53.3 million surgical and
nonsurgical procedures performed during ambulatory surgery visits. For
example, there are at least 10 million gastrointestinal endoscopies per
year. Each of these procedures involves contact by a medical device or
surgical instrument with a patient’s sterile tissue or mucous membranes. A
major risk of all such procedures is the introduction of infection. Failure
to properly disinfect or sterilize equipment carries not only the risk
associated with breach of the host barriers but the additional risk of
person-to-person transmission (e.g., hepatitis B virus) and transmission of
pathogens that contaminate the environment (e.g., Clostridium difficile).
Achieving disinfection and sterilization through the use of disinfectants
and sterilization practices is essential for ensuring that medical and
surgical instruments do not transmit infectious pathogens to patients.
Because it is unnecessary to sterilize all patient-care items, healthcare
policies must identify whether cleaning, disinfection, or sterilization is
indicated based primarily on the items’ intended use (Rutala, 2014).
2.8 Legislative Compromise
What emerged from the 20
th
century was a classic case of stakeholder dissonance.
Differences in value systems and economic pressures brought healthcare facilities and
manufacturers into direct opposition. Thus it is not surprising that a third party,
Congress, would step in to negotiate a middle ground. A first major step in this direction
was the introduction of the Reprocessed Single Use Medical Device Patient Safety
Amendments of 1999 by Senator Dick Durbin (S.1542) of the 106
th
Congress. This bill,
which focuses on transparency, included the following language:

44
…every person or establishment (entity) engaged in the reprocessing of a
medical device labeled for single use shall: (1) upon first engaging in such
reprocessing and for each year in which such entity continues to so
engage, register with the Secretary of Health and Human Services and
provide all required information; and (2) for each such year, submit to the
Secretary a list of devices labeled for single use that the entity is
reprocessing, including names of original manufacturers and specific
models (Congress.gov, 1999).
Further, the bill required those entities to disclose the reprocessing to:
…each person or establishment that uses such device and to “demonstrate
the device's safety and effectiveness”. Requires every person or
establishment that uses a class II or III reprocessed medical device for the
provision of medical care to individuals to seek informed patient consent
for such use, and to include a record of such use in the individual's
medical record (Congress.gov, 1999).
This federal bill was followed soon thereafter by the introduction of a second bill at the
state level, the Reprocessed Single Use Medical Device Patient Safety Act of 1999 (AST,
2013) by Representatives Eshoo (D-California) and Upton (R-Michigan). Through this
bill, both representatives sought to amend the Food, Drug and Cosmetic Act by asserting
that “FDA data showed that reprocessed single-use medical devices were associated with
serious injuries and have the potential to cause serious injury” (Carey, 2001).
Additionally, the overall purpose of the bill was to require device registration, device
listing and premarket controls and like Senators Durbin’s bill, require the informed
consent of patients prior to use (Carey, 2001). Ultimately, both Senator Durbin’s bill and
Representatives Eshoo and Upton’s bills were referred to committee, from which they did
not emerge for subsequent congressional action because it was felt that this topic would
be taken up in the next session of Congress (Wang, 2001). Thus, neither bill was passed
into law. However, these two initiatives did help to motivate the FDA to consider the
problem of reprocessing more carefully, and to attempt to develop what they saw as
45
appropriate practices for the industry and hospitals through the release of two companion
draft guidance documents in February of 2000; these companion documents built upon
FDA teleconferences with the Association for the Advancement of Medical
Instrumentation (AAMI) and public feedback on a single-use device proposed strategy,
both of which took place in 1999. The first guidance document was titled, Reprocessing
and Reuse of SUDs: Review Prioritization Scheme and the second guidance document
was titled Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals
(FDA, 2000b). Although not enforceable by law, both publications explained FDA
expectations for the first time.
Figure 3: Reprocessing Legislation Timeline

2.8.1 Reprocessing and Reuse of SUDs: Review Prioritization Scheme
The purpose of the first guidance, Reprocessing and Reuse of SUDs: Review
Prioritization Scheme (FDA, 2000b), instructed those who were reprocessing SUDs to
46
assess the risk of introducing infection and of modifying functionality when reprocessing
medical devices. This document addressed FDA’s proposed strategy of developing a list
of factors to determine the risk associated with reprocessing SUDs – also known as the
Review Prioritization Scheme (RPS) - under two categories of risk: 1) the risk of
infection, and 2) the risk of inadequate or unacceptable device performance following
reprocessing (Wang, 2001). These two categories were each further delineated into the
subcategories of low risk, moderate risk and high risk (see figures 4 and 5) and were
designed to be used to set FDA’s enforcement priorities for premarket submission
requirements (Wang, 2001).
47
Figure 4: Review Prioritization Scheme – Infection Risk

48
Figure 5: Review Prioritization Scheme – Inadequate Performance Risk

2.8.2 Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals
The second guidance document, Enforcement Priorities for SUDs Reprocessed by Third
Parties and Hospitals (FDA, 2000a), attempted to clarify the FDA’s enforcement
priorities and establish a timeline based on the level of risk associated with the
reprocessing (FDA, 2013). In it, FDA suggested that it intended to enforce premarket
notification and premarket application requirements, as well as non-premarket
49
requirements (e.g. registration, listing, reporting, quality system, corrections and removal,
and labeling) based on the risk associated with the reprocessed SUD as categorized by the
SUD RPS Guidance (Wang, 2001).
2.8.3 Enforcement Priorities for Single-Use Devices Reprocessed by Third-Party
and Hospitals (Final SUD Guidance)
In August of 2000, shortly following the release of the aforementioned companion
guidance documents, FDA issued a final guidance document titled Enforcement
Priorities for Single-Use Devices Reprocessed by Third-Party and Hospitals (Final SUD
Guidance) (FDA, 2000a). Several major changes were incorporated into this final
guidance document in response to public comments on the initial two guidance
documents, including FDA’s “intent” to enforce premarket submission requirements for
applicable devices in all device classifications for all hospital and third-party
reprocessors, in the same manner as was in effect for original device manufacturers.
Importantly, FDA also made the decision to abandon the RPS System to avoid
inconsistencies and confusion between the RPS System and the already employed Code
of Federal Regulation (C.R.F.) device classification system (i.e. Class I, II & III) (Wang,
2001).
2.8.4 MDUFMA & MDUFSA
The practice of reprocessing was again revisited by Congress with more legislative
success in 2002 and 2005. Congress passed two new laws, the Medical Device User Fee
and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee
Stabilization Act (MDUFSA) of 2005. Both of these Acts were omnibus statutes whose
provisions addressed many issues of medical product management apart from issues of
50
reprocessing, such as the reauthorization of user fees for premarket reviews, and the use
of accredited third parties to conduct inspections. However, both pieces of legislation
contained key clauses relating to the topic of this dissertation.

The Medical Device User Fee and Modernization Act of 2002, as its name implies,
amended the FD&C Act to authorize medical device user fees for certain applications,
reports, application supplements and submissions sent to FDA for evaluation (Pina &
Pines, 2008). As a condition for charging these fees, FDA agreed to provide feedback
and decisions to the sponsors of such submissions within certain timelines and with
specified performance goals. Importantly, a number of new regulatory requirements
related to single-use devices were also introduced. MDUFMA required that reprocessors
of single-use devices would have to operate as if they were original device
manufacturers, by submitting appropriate premarket documentation, usually in the form
of a premarket notification. In this process, the reprocessors had to demonstrate that their
reprocessed devices were substantially equivalent to original devices. For certain critical
and semi-critical reprocessed SUDs, these submissions require the inclusion of data
demonstrating cleanliness, sterility and functionality; this is discussed in more detail in
section 2.8.5.
As stated by MDUFMA:
The Secretary shall identify such devices or types of devices for which
reports under such subsection must, in order to ensure that the device is
substantially equivalent to a predicate device, include validation data, the
types of which shall be specified by the Secretary, regarding cleaning and
sterilization, and functional performance demonstrating that the single-
use device will remain substantially equivalent to its predicate device after
51
the maximum number of times the device is reprocessed as intended by the
person submitting the premarket notification (FDA, 2002).
Further, the law also mandated that reprocessors adhere to labeling, registration, and
reporting requirements much like those required of an original equipment manufacturer.
As stated by MDUFMA:
If it is a reprocessed single-use device, unless all labeling of the device
prominently and conspicuously bears the statement `Reprocessed device
for single use. Reprocessed by ____.' The name of the manufacturer of the
reprocessed device shall be placed in the space identifying the person
responsible for reprocessing (FDA, 2002).
These requirements would be applied to all reprocessed devices, regardless of whether
they entered the market before 1976, when devices were on the market without FDA
clearance, or after 1976, when they would enter the market under a premarket notification
pathway (often called the 510(k) pathway) or preapproval pathway (FDA, 2014b).
Further, device manufacturers were required to register their manufacturing site with
FDA. The 2005 Medical Device User Fee and Stabilization Act took the requirements
placed on reprocessors a step further by strengthening the labeling requirements for
reprocessed devices to facilitate tracking and adverse event reporting related to a
reprocessed device. It required that the name, abbreviation, or symbol of the reprocessor
be placed prominently on the device itself, on an attachment to the device, or on a
detachable label. The added labeling was designed to allow the end-user to identify more
easily the reprocessor that was responsible for that reprocessed device in the event that
the device malfunctioned or caused an adverse event. Thus, hospitals and third-party
reprocessors became considered by FDA as the “adoptive” legal manufacturer of the
52
reprocessed single-use devices and therefore were subjected to the same adverse event
reporting requirements as the original equipment manufacturer.

The requirements brought about by MDUFMA (2002) and MDUFSA (2005), both of
which were built upon previously introduced legislation as well as guidance documents,
changed the reprocessing landscape by adding an additional level of regulatory oversight
and by requiring a much larger burden of medical device reporting. These two statutes
caused many hospitals to transition from reprocessing in their own facilities to utilizing
third-party reprocessors in order to avoid the costs and challenges associated with
showing substantial equivalence to a predicate device. Managing the premarket
notification process, labeling and adverse event reporting requirements can be lengthy
and extremely challenging for any organization. Medical-product manufacturers employ
highly trained regulatory professionals who understand the science and engineering of the
products around which these types of submissions are built, and the legal and clinical
requirements and implications associated with those submissions. The costs associated
with employing such individuals and supporting the developmental work associated with
their submissions generally is not in the scope of a typical hospital budget.
2.8.5 Reprocessed Single-Use Device Premarket Notification Process
Most devices that are resterilized or reprocessed are in low to moderate risk categories,
Class I and II respectively. According to section 510(k) of the Food, Drug and Cosmetic
Act (FDA) device manufacturers making Class II and/or certain high-risk Class I devices
must notify FDA of their intent to market a medical device at least 90 days in advance as
53
a part of the premarket notification process. This allows FDA to determine whether the
device being reviewed is substantially equivalent to a predicate device already placed on
the market. The review process requires that the subject device be deemed to have the
same intended use as the predicate device and FDA must determine that the subject
device has either the same technological characteristics as the predicate device or the
subject device has different technological characteristics but is deemed to be as safe and
effective as the predicate device. A device that reaches market via the 510(k) process is
not considered to be “approved” by the FDA, but instead is considered to be a “cleared”
device by FDA, and permitted to be marketed in the U. S. As part of this permission, the
manufacturer must ensure that the required general controls and special controls are met.

According to the new legislation, reprocessed single-use devices must meet the same
requirements as devices leaving an original manufacturer. Thus they must be cleared
through a submission process, with particular attention paid to certain key areas of the
submission. As described in 21CFR807.87, as well as recent guidance documents,
reprocessors must report validation data, including cleaning and sterilization data, and
functional performance data demonstrating that each single-use device will perform in a
manner substantially equivalent to the predicate device. The product cannot be
reprocessed forever. A maximum number of times that the device can be reprocessed
must be set by the entity submitting the premarket notification (Robby, Fischer &
Swiontkowski, 2005); a marking of some form is often placed on the device in order to
determine the number of reprocess cycles the device has experienced. Design validation
including risk analysis is also a critical component of the submission. It identifies
54
hazards originating from the product as well as hazards from the processes used by the
manufacturer and the users of the device, both before and after reprocessing. The risk
analysis should be followed by risk estimation, risk management and finally, risk
acceptance. In this final stage, the reprocessor must defend the position that the
reprocessed device has risks equivalent to those of the original device. Process
validations, including installation qualification, operational qualification and performance
qualification of reprocessing equipment, are also critical components of a submission for
a reprocessed single-use device which must be defended. Finally, pyrogen testing
“should” be performed and submitted for all devices that come into direct or indirect
contact with blood to ensure that residual pyrogens are no longer present after the
sterilization process. A detailed description of this rather complex process of gaining
market authority as well as complying with Quality System Regulations (QSR) is beyond
the scope of this dissertation and can be found elsewhere (see: Code of Federal
Regulation, Title 21 Part 820: Quality System Regulation). However, they do play a
critical role due to their implications for reprocessed devices.
2.9 International Use of Single-use Devices
By 2000, the use of reprocessed devices, especially reprocessed single-use devices, had
expanded rapidly not only in the U.S. but also in other countries. As stated by the
Association of Medical Device Preprocessors (AMDR),
The reprocessing of SUDs is commonplace worldwide…even in
developing nations, including those that have reprocessing prohibitions in
place, hospitals routinely reuse SUDs (AMDR, 2015).
55
International opinions on the appropriate management of reprocessed single-use devices
have varied by country and region. Many underdeveloped and developing countries have
been reprocessing both reusable and single-use devices for decades (Popp, Rasslan,
Unahalekhaka, Brenner, Fischnaller, Fathy, et al., 2010). These countries presumably
also regard the reuse of medical products as an effective way to reduce costs and medical
waste. However, such practices may also be employed simply because of insufficient
knowledge of infectious diseases amongst healthcare workers. It is amplified in countries
in which patients and practitioners believe that injectable medications are more beneficial
than oral medication because it leads to chronic reuse of syringes (Popp, Rasslan,
Unahalekhaka, Brenner, Fischnaller, Fathy, et al., 2010). However, with the recent focus
on the evolving field of reprocessing of single-use devices has come increased sensitivity
of the challenges related to such practices amongst stakeholders in other countries
Predictably, attention from global regulatory bodies has followed. For example, with the
emergence of blood transmitted diseases such as hepatitis and human immunodeficiency
virus (HIV) in the 1980s, the European Union (EU) found itself under pressure from both
end-users and manufactures to clearly differentiate single-use devices and reused devices
to reduce the risk of cross contamination between patients (SCENIHR, 2010), thus
marginalizing the reuse of single-use devices to some extent. This is expressed in
Directive 93/42/EEC on medical devices, adopted on June 1993, which states the
following:

56
For medical devices intended, by the manufacturer, to be used according
to the essential requirements, the manufacturer must provide information
on the appropriate process to allow reuse including; cleaning,
disinfection, and packaging and, where appropriate, the method of
sterilization to be used, and any restriction on the number of reuses. The
decision to market a reusable or a single-use medical device is the
responsibility of the manufacturer…Medical devices intended for single-
use must bear on their label an indication that the device is for single-use
(SCENIHR, 2010).
This directive was later amended with Directive 2007/47/EC, which further clarified the
definition of the term “single-use” and introduced new requirements for single-use
devices including that if the device bears an indication for single-use, information on
characteristics and technical factors known to the manufacturer that could pose a health
risk must be provided in the instructions for use (SCENIHR, 2010). Today, EU
regulatory bodies vary significantly with regard to their stance on reprocessing because
the reprocessing practices related to single-use devices are not currently regulated at the
Community level; different national legislations regulate this practice throughout Europe
(SCENIHR, 2010). Today, reprocessing of single-use items is accepted and common
throughout countries such as Spain (80% of hospitals) and Germany (40% of hospitals)
(Collier, 2011a) but in various other European countries such as the United Kingdom,
this practice is not allowed (Eucomed, 2009).

The act of reprocessing single-use devices is also common in Japan. In a 2003 survey of
hospitals in Japan, 80–90% of the responding hospitals reused single-use devices (Koh &
Kawahara, 2005), even though the practice of reprocessing of single-use devices has not
been approved by the Japanese government. In Canada, over a quarter of hospitals reuse
single-use devices, at a rate similar to that in the United States (Collier, 2011a). Like
57
many other countries outside of the United States, however, national regulations
governing reprocessing of single-use devices have not been established in Canada.

Clearly reprocessing of medical devices is practiced globally and plays an important role
in controlling healthcare costs globally. Education, practices and regulation are all areas
that will continue to evolve as additional information around reprocessing is captured and
shared throughout the healthcare environment. However, for purposes of this
dissertation, the focus will be on reprocessing of single-use use devices within the U.S.
2.10 The Silent Stakeholders
Both MDUFMA and MDUFSA helped to ensure a predictable level of quality for
reprocessed single-use devices reentering the marketplace. However, it did not address
some key concerns voiced by certain stakeholders. One such concern was that appearing
as a principal component of the early legislative efforts by Senators Dick Durbin and
Representatives Eshoo and Upton - provisions to assure that patients were informed about
and consented to the use of reprocessed devices as part of their treatments.

Informed consent has always been a politically charged and important issue in the U.S.,
where the rights of individuals were enshrined as far back as the constitution of the
country. In a 1905 opinion, the Supreme Court declared that Americans' rights as free
citizens prohibited "a physician or surgeon, however skillful or eminent…to violate
without permission the bodily integrity of his patient…and [to operate] on him without
his voluntary consent or knowledge” (Millenson, 2012). In 1914, Supreme Court Justice
58
Benjamin Cardozo reemphasized the importance of voluntary consent when he stated that
every human being has a right to decide what shall be done with his or her body (Fleeter,
2010). However, it was not until 1955 that two cases - one in North Carolina and the
second in California - specifically held that physicians had a duty to disclose potential
surgical risks to patients (Fleeter, 2010). Today is it standard operating procedure for the
patient to sign a surgical informed consent prior to a clinical or surgical procedure.

Current literature does not make clear whether the patient is made aware of the potential
use of a reprocessed single-use device in their procedure when such devices are
purchased and used by the healthcare facility. This brings into question the patient’s
right to know when single-use devices are used in procedures. It also raises the
potentially related question of whether end-users such as surgeons should know if
reprocessed devices are being supplied for the procedures in which they are involved. If,
for example, the physician does know, what is his or her obligation and role to inform the
patient? If the physician does not know, that provider cannot inform the patient of the
benefits and risks associated with the device(s) being used. Further, if the health care
providers do know that reprocessed devices are being used, but have no information
about how the reprocessing is being done, they may not be able to provide the patient
with reliable information. Failure to understand or disclose all of the risks of a surgical
procedure may have serious medico-legal implications in a situation where a patient is
injured and sues for recompense (Fleeter, 2010).

59
The role of the physician and institution in the education of the patient about the use of
reprocessed devices would appear to benefit from better definition. Currently, the
medical community is left to determine the standard for whether reused and single-use
medical devices should be offered explicitly as alternative treatments to the patient
(Colonna & Thomas, 1999). It has been suggested that under that current standards for
patient-based consent, patients should have the right to choose between a reused medical
device and a single-use medical device if reuse in fact presents a significantly different
material risk for the patient (Colonna & Thomas, 1999). A similar opinion was echoed
by The American College of Obstetricians and Gynecologists Committee on Gynecologic
Practice in 2012 in which they stress the following three points:
• It is the operating surgeon’s ethical responsibility to make a good faith effort to
know whether reprocessed single-use devices are to be used, and to not use the
instrument if he or she has concerns about the quality and safety of the
instrument(s)
• Physicians should be informed whether the instruments used in surgery are
original or reprocessed, and adverse events should be reported to improve the
safety information about reprocessed single-use devices
• The right of the patient to be informed of the potential for use of a reprocessed
single-use device should be considered in the decision making process (ACOG,
2012).

With the lack of clarity around the consent process, concerns regarding liability follow.
Various legal theories provide a basis for compensation if a patient is injured by the reuse
of single-use devices. For example, a malpractice action alleging negligent treatment or
the failure to obtain informed consent could be brought against a healthcare organization,
physician, or other treatment provider(s) (Colonna & Thomas, 1999).

60
The U.S. healthcare system has recently become more “participatory”, by seeking to
engage the patients in their own care. A stronger patient voice is now encouraged by
professional societies, government and stakeholders and patient-centered care is now
incorporated into today’s medical school curriculum (Millenson, 2012). In such an
evolving healthcare environment, concerns about whether to inform the patient about
reprocessed devices will likely continue. However, at this time, the published literature is
surprisingly scanty regarding the issue of informed consent related to the use of single-
use devices. This is not to say that concern surrounding potential liability of physicians
has gone unnoticed by some individuals.
2.11 What Legislation Did Not Solve
To date, legislation has evolved to require that all reprocessed medical devices originally
labeled for single-use in the United States are subject to FDA manufacturing
requirements and must meet strict cleaning, functionality, and sterility specifications prior
to use (FDA, 2006). However, legislation does not currently require end-users and
patients be made aware whether the devices being used for their care have been
reprocessed. Much time has passed since Senator Dick Durbin’s 1999 senate bill 1542,
which first proposed that patients give informed consent prior to using reprocessed
single-use devices, and that such information be appended to the patient’s medical record.
In the ensuing period, no other legislation to my knowledge has addressed the right of
patients to know when reprocessed single-use devices are being used. Additionally, no
legislation has been proposed to require that health-care providers be informed when they
are being supplied with reprocessed single-use devices for their procedures. Finally, the
61
literature does not suggest that any form of follow-up data has been captured to assess if
end-users understand reprocessed single-use device labeling requirements.
2.12 What Will Be Studied
This dissertation will focus on three unheard stakeholders who are affected by the
reprocessed single-use devices process: surgeons, regulatory professionals and laypersons
(i.e. non-device experts representing a hypothetical patient population) (see Figure 6).
Stakeholder theories suggest that appropriate policy development should be led by
examination of the views of all stakeholders and that the views of silent stakeholder
should also be taken into account. As indicated by Schmeer:
Stakeholder analysis yields useful and accurate information about those
persons and organizations that have an interest in health reform. This
information can be used to provide input for other analyses; to develop
action plans to increase support for a reform policy; and to guide a
participatory, consensus-building process…. Thus even if there is an
abundance of secondary information, the working group may choose to
interview all stakeholders to gain more insight into their opinions on the
policy and other stakeholders (Schmeer, 1999).
For this dissertation I wish to study the views of surgeons and laypersons with respect to
the potential use of reprocessed single-use devices using an information-gathering
method. Moreover, I will explore several important aspects that are derived from the
literature review: whether patients (represented by the laypersons survey group) should
give explicit informed consent, whether during the consent process the opportunity exists
for the patient to choose to use an unprocessed single-use device either at no cost or at an
incremental charge, whether end-users are made aware of the purchase of reprocessed
single-use devices for use, and finally, to what extent end-users understand the
reprocessing process. I also plan to examine whether regulatory professionals who are
62
responsible for development and global registration of medical devices now understand
how and to what extent their devices might be reprocessed and whether they are able to
predict correctly the nature of information and views held by the patients and caregivers.
Finally, the research will challenge regulatory professionals in an effort to understand
their level of knowledge with regard to the down-stream use and fate of single-use
devices with respect to reprocessing.

The majority of the questions presented to the three groups will be based on the Kipling
“5 Ws” Method for exploration and information-gathering. This method consists of
developing questions in specified domains including, what, why, who, where and when,
and these questions will be applied to the information gathering section of this work.
Some questions will be general to all panels of respondents whereas others will be
constructed to be appropriate for the particular type of stakeholder being questioned. The
results of this exploratory study will be used to better appreciate and communicate the
views of end-users, laypersons and regulatory professionals with respect to this complex
process. Additionally, this exploration may help to identify the level of transparency that
is sought by each of these groups as well as areas of dissonance between the three groups.
63
Figure 6: Stakeholders relevant to policy-setting for reprocessed devices:

*Represents those stakeholders in which this dissertation will focus.

64
CHAPTER 3: METHODOLOGY
3.1 Overview
The research was divided into 3 stages. In the first stage, the history and risks associated
with single-use device reprocessing were reviewed and the evolution of relevant
regulations was described; this review is summarized in chapter 2. In the second stage, a
series of survey instruments was developed to gain exploratory insight into the views of
specified subpopulations representing three stakeholders: end-users, who were
represented by surgeons recruited throughout the United States, laypersons, who were
represented by faculty and staff members recruited from the University of Southern
California, and regulatory professionals with Class I, II and/or Class III medical device
experience, who were recruited from professional contacts and the website LinkedIn. In
the third stage, the surveys were disseminated to a sampling of stakeholders in each
group and the responses from the three groups were analyzed.
3.2 Development of Initial Survey
The purpose of the survey developed in this research was to capture feedback using the
Kipling Method for information-gathering. The Kipling method, named after author
Rudyard Kipling, draws on the 5Ws method for information gathering by asking what,
where, when, who and why; the answers to these questions can be useful in information
gathering as well as defining the current status of a given situation. A unique survey was
distributed to each of three different groups of respondents: 1) surgeons who use or could
use reprocessed single-use devices; 2) university faculty and staff members, who
represented a specific layperson population; and 3) regulatory professionals who work or
65
have worked with Class I, II and/or Class III medical devices that have the potential for
reuse. The surveys were developed and deployed using the web-based survey tool,
Qualtrics (www.qualtrics.com), a respected provider of online survey software. Each
survey had roughly 20-25 yes/no, multiple choice, Likert scale and open-ended questions
that were designed to be answered in 15-20 minutes. The survey included a progress bar
that allowed the participant to map his/her progress as they completed the survey. The
questions presented to each subpopulation were similar in structure and basic content, but
included some questions tailored for the specific audience of the survey.

The questions in the surveys were formulated in a two-step process. First, a draft survey
was prepared by me and reviewed by a small group of supervisory faculty who provided
feedback. The survey directed to surgeons was then reviewed additionally by three
surgeons who commented on the appropriateness and clarity of the questions. Moreover,
for the “surgeon” survey, brief interviews were performed with three different surgeons
who were willing to review and scrutinize the survey developed for the surgeon panel;
these surgeons did not partake in the actual survey and their results were not recorded.
The surveys directed to laypersons and regulatory professionals were separately reviewed
by two focus groups that provided feedback on the clarity, relevance and face validity of
the survey questions. The focus group for the “layperson” survey was comprised of 7
staff and faculty members who were a mix of individuals representative of the target
group; some of these individuals also had significant experience in the construct and use
of surveys. The focus group for the “regulatory professional” survey was comprised of 6
industry and research professionals who were representative of this subgroup. Web based
66
conferences were convened using the WebEx web conferencing application on March
19th, 2015 and March 26
th
, 2015, respectively for the regulatory professional and
layperson focus groups. All recommendations from the focus groups and interviews with
reviewing surgeons were carefully considered and the surveys were adjusted where
deemed appropriate.
3.3 Survey Distribution
A web-based survey link was sent by email to the three different subpopulations specified
above. The first group sampled practicing surgeons using, or potentially using, any form
of reprocessed single-use devices in a health care setting throughout the United States. It
included surgeons located in various states including California, Ohio, Maryland,
Minnesota and Texas. When necessary to assure eligibility, surgeons were contacted by
phone and email initially to determine if they were willing to participate in the study and
to ensure that they met the inclusion criteria. These criteria included the requirement that
they were practicing actively and that they were engaged or potentially engaged in
invasive procedures that might use reprocessed devices. If they agreed to participate,
they were then asked to complete the web based survey.

The second survey group consisted of faculty and staff members of the University of
Southern California who did not perform any form of surgery and who did not have
experience working with medical devices. Many of these potential participants were also
contacted by phone or email in order to determine if they meet the inclusion criteria and
to determine if they had an interest in participating in the study. If they met the criteria
67
and confirmed an interest, a web link for the survey was sent to them through an email.
Importantly, this population was not anticipated to represent the breadth of individuals
who are laypersons. However, it was viewed as a useful group from whom to gather
insights that would form a baseline, and whose responses and experience with the survey
could help to illuminate limitations of the survey before it was considered for use on a
larger scale.

The third survey group consisted of regulatory professionals with experience working
with Class I, II and/or Class III medical devices. They were selected from my personal
and professional networks and expanded using a snowball method, and through the
LinkedIn website (www.linkedin.com).

Ultimately, the goal was to receive between 30 – 50 responses from each subgroup for
analysis. No recompense was offered to the participants, but a commitment to provide a
summary of the survey results was promised to participants who took the survey. All
respondents were also assured of anonymity. Investigational Research Board (IRB)
approval through University of Southern California (see Appendix B) was sought and
granted in order to ensure compliance with applicable university protocols and research
requirements.

68
3.4 Survey Analysis
An estimated response rate was calculated by comparing the number of returned surveys
to the number of individuals to whom the emails with the Qualtrics survey links were
sent. The numbers of respondents in this exploratory survey was lower than the sample
sizes that would typically be needed to provide a robust statistical analysis for all
questions. Nevertheless, responses to yes/no and multiple choice questions were
examined using graphical techniques and simple statistical analyses such as identification
of means and variances for questions amenable to quantitative analysis. Text boxes that
allowed respondents more latitude to express opinions to open-ended questions gave
further information that was used to expand on views captured by the simpler survey
questions. Further, Qualtrics software enables cross-tabulation that allowed subgroups
comparisons to the same question within a single survey panel. The types of simple
analyses carried out by Qualtrics were verified by developing Excel tables to check
calculations.

69
CHAPTER 4: RESULTS
4.1 Analysis of Survey Results
The responses to surveys directed at surgeons, regulatory professionals and laypersons
are analyzed separately in three sections, designated Sections 4.2, 4.3, 4.4 and 4.5
respectively.
4.2 Surgeon Survey Responses
Thirty-five surgeons responded to 95 distributed surveys, yielding a response rate of
37%. Not counted as a “distributed” survey were those that bounced back from
discontinued email addresses and those that were sent mistakenly as duplicates to an
occasional respondent. Of this group, most self-identified as having more than 15 years
of experience (41%; 14/34); the smallest subgroup had 1-5 years of experience (15%;
5/34) (Figure 7). Surgical specialties varied widely but most commonly included
otolaryngology (27%; 9/33), gynecological/obstetric related surgery (24%; 8/33) and
general surgery (15%; 5/33) (Figure 8).

70
Figure 7: Surgeon Experience
How many years of surgical experience do you have (including internship and
residency)? N = 34

Figure 8: Surgical specialties of surveyed surgeons
In what surgical field do you specialize? N = 35

A series of yes/no questions explored the degree to which surgeons were aware of
practices regarding the reuse of single-use devices in their hospital. Most surgeons (66%;
23/35) were aware that invasive single-use devices were being reprocessed in some
5
8
7
14
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Years 1-5 Years 6-10 Years 11-15 Years > 15
3
1
1
1
1
1
1
2
2
5
8
9
0 2 4 6 8 10
Not Identified
Colorectal Surgery
Endocrine Surgery
Neurosurgery
Plastic Surgery
Orthopaedic Surgery
Thoracic
Ophthamology
Cardiac Surgery
General Surgery
OB/GYN
Otolaryngology
71
facilities. However, only about one-third (37%; 13/35) knew whether reprocessed single-
use devices were used at the particular health care centers in which they perform surgery.
Most (74%; 26/35) felt that patients would expect them to know if reprocessed single-use
devices were going to be used in the procedures on that patient. The large majority
(89%; 31/35) believed that a device labeled for single-use should in fact only be used in a
single procedure. When asked if they would expect an identifier on the device itself to
signify its reprocessed status, most (80%; 28/35) also responded “Yes.” Only
occasionally (6%; 2/35) did a surgeon report that he or she had been asked by a sales
representative to use a reprocessed single-use device for a surgical procedure. No
surgeon in this survey had received training related to reprocessed single-use devices, but
most (71%; 25/35) felt that training should be given regarding the way in which single-
use devices are reprocessed and reintroduced into use (Figure 9).

72
Figure 9: Views of surgeons regarding single-use device use in their practice setting
(N = 35 for all questions)

Surgeons were asked if they had ever used invasive reprocessed single-use devices in any
capacity. Of the 35 responses, 37% selected “Yes”, 23% selected “No” and 40% selected
“I don’t know”. When asked if they knew whether they “currently” use invasive
reprocessed single-use devices, 23% selected “Yes,” 34% selected “No” and 43%
selected “I don’t know” (Figure 10).

73
Figure 10: Previous and present use of SUDs by surgeons
1) Prior to this survey, had you ever used invasive reprocessed single-use devices
in any capacity? N = 35
2) Do you know whether or not you currently use invasive reprocessed single-use
devices in your procedures? N = 35

When asked if they had ever been able to trace a post-operative surgical infection back to
a specific device used in a procedure, no surgeon responded affirmatively (94%; 33/35)
although two surgeons (6%) selected the “I don’t know” option (Figure 11). A few
(11%; 4/35) acknowledged that they had “heard” of a case in which a patient acquired an
infection due to a reprocessed single-use device, but the majority (74%; 26/35) had not;
about 15% (5/35) indicated that they did not know (Figure 11). Surgeons appeared to
have relatively little confidence that they would be able to trace a post-operative surgical
site infection back to a specific device used in a procedure, as reflected by the mean value
of confidence of 38 on a scale of 0 (lowest confidence) to 100 (highest confidence) (33
responses).
13
8
14
8
12
15
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Yes No I don't know
Have you ever used SUDs
Do you currently use SUDs
74
Figure 11: Post-operative infection
1) Have you ever been able to trace a post-operative surgical infection back to a
specific device used in a procedure? N = 35
2) Have you ever heard of a case in which a patient acquired an infection due to a
reprocessed single-use device? N = 35

Surgeons were also asked to rank the level of concern from highest to lowest, associated
with three potential problems linked to the use of reprocessed single-use devices,
including: 1) infection from an improperly cleaned and/or sterilized device 2) failure of
the device to perform adequately and 3) device breakage (Figure 12). Inadequate device
performance was most commonly chosen as the primary concern from 44% of
respondents (11/25), but the potential for infection was seen as the biggest concern for
only a slightly smaller number (36%; 9/25). Device breakage was ranked more
commonly as the middle or lowest concern. A fourth choice of “Other” was also
0
33
2
4
26
5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Yes No I do not know
Had a post-op infection
Heard of a post-op
infection
75
provided and was chosen by only one respondent who identified this choice as his/her
highest concern but did not specify the nature of that concern (Figure 12).
Figure 12: Level of concern with three device problems expressed by surgeons
Rank the following in order of highest concern to lowest concern with respect to
invasive reprocessed single-use devices being used in surgical procedures: N =
25

Three questions explored the views of surgeons with regard to the surgical consent
process related to the use of reprocessed single-use devices. All three questions allowed
for responses ranging from strongly agree to strongly disagree with the additional option
of selecting “I do not know.” The first question explored whether surgeons expected
their patients to be informed prior to a surgery when an invasive reprocessed single-use
device was going to be used in a procedure. Nearly half of respondents strongly agreed
(23%; 8/35) or agreed (23%; 8/35), about one quarter (28%; 10/35) held a neutral view
9 9
7
11
6
7
4
10
11
1
0 0
0%
20%
40%
60%
80%
100%
Highest concern Mid-level concern Lowest concern
Potential for infection from improperly cleaned and/or sterilized device
Inadequate device performance
Device breaks from stress of reuse leaving parts in the patient
Other
76
and the remaining quarter either disagreed (20%; 7/35) and strongly disagreed (3%;
1/35); three percent of respondents selected “I don’t know.” The second question
explored their views on whether patients should be informed during the surgical consent
process before an invasive reprocessed single-use device was going to be used in their
procedure. About 40% of surgeons either strongly agreed (17%; 6/35) or agreed (23%;
8/35) with this position, roughly one quarter neither agreed nor disagreed (23%; 8/35),
and the remaining one-third disagreed (28%; 10/35), strongly disagreed (6%; 2/35) or
suggested that they did not know (3%; 1/35). The final question with respect to surgical
consent asked whether surgeons felt a personal responsibility to inform the patient about
the use of a reprocessed single-use device in their procedure. Nearly 30% of surgeons
indicated that they strongly agreed (12%; 4/35) or agreed (17%; 6/35), 20% of surgeons
neither agreed nor disagreed, and nearly half of surgeons disagreed (28%; 10/35),
strongly disagreed (20%; 7/35) or indicated that they did not know (3%; 1/35) (Figure
13).

77
Figure 13: Views of surgeons regarding the surgical consent process
1) I expect that patients would be informed prior to a surgery when an invasive reprocessed
single-use device is going to be used in his/her surgical procedure. N = 35
2) I expect that patients would be informed during the surgical consent process before an
invasive reprocessed single-use device was used in his/her procedure. N = 35
3) I feel that it should be the surgeon's responsibility to inform the patient that reprocessed
single-use devices will be used in a procedure. N = 35

Surgeons were asked whether the reprocessing of single-use devices represented a
reasonable method for cutting health care center costs and reducing overall medical
waste. Views from 35 respondents on the use of reprocessing to contain costs were
distributed almost equally on both sides of the neutral position; 9% (3/35) of surgeons
strongly agreed, 28% (10/35) agreed, 17% (6/35) neither agreed nor disagreed, 26%
(9/35) disagreed, 11% (4/35) strongly disagreed and 9% (3/35) of surgeons did not know
8 8
10
7
1 1
6
8 8
10
2
1
4
6
7
10
7
1
0%
5%
10%
15%
20%
25%
30%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
I do not
know
Expect patients to be informed
Informed during surgical
consent
Surgeon should inform patient
78
(Figure 14). Views on the use of such methods to reduce waste were more heavily
weighted toward agreement; more than half of surgeons strongly agreed (11%; 4/35) or
agreed (43%; 15/35). Of the remaining respondents, 20% (7/35) neither agreed nor
disagreed, 11% (4/35) disagreed, 6% (2/35) strongly disagreed and 9% (3/35) of surgeons
did not know (Figure 14).
Figure 14: Surgeon’s views on reprocessing to contain costs and reduce waste
1) I feel that the use of reprocessed single-use devices is a reasonable method for
cutting health care center costs. N = 35
2) I feel that the use of reprocessed single-use devices is a reasonable method for
reducing overall medical waste. N = 35

Questions with regard to the actual use of reprocessed single-use devices appeared
relatively hard for surgeons to answer in comparison to preceding questions. When asked
if they were required by their health care center to use reprocessed single-use devices,
over half of the surgeons did not know (60%; 21/35). About one-quarter (26%; 9/35)
3
10
6
9
4
3
4
15
7
4
2
3
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
I do not
know
Cut costs
Reduce waste
79
identified that they had the choice to reject the use of such devices and others (14%; 5/35)
were not faced with this choice because their facility did not use reprocessed devices.
None of the surgeons indicated that they were mandated to use such devices. One
surgeon also added the following comment: Rules have evolved and my hospital now
strictly forbids reuse. Amongst surgeons who used reprocessed single-use devices, only
3% (1/34) identified that he or she was notified prior to the procedure that a reprocessed
single-use device is going to be used. Moreover, 29% (10/34) selected “No,” 9% (3/34)
selected “Sometimes,” and 59% (20/34) selected “Not applicable” indicating that they do
not use these devices or they did not want to answer the options provided. Finally, when
surgeons using reprocessed single-use devices were asked when they were made aware of
that use for a specific procedure, only 6% of surgeons (2/35) indicated that they are
notified well before the procedure, 6% (2/35) that they are notified during the procedure
and 0% after the procedure. Amongst the remaining respondents, 20% (7/35) indicated
that they are not informed of their use, 46% (16/35) did not know if they used
reprocessed single-use devices and 23% indicated that they do not use reprocessed single-
use devices (Figure 15).

80
Figure 15: When are you made aware that reprocessed SUDs will be used
If you use reprocessed single-use devices, when are you made aware that they will
be used in a procedure? N = 35

Surgeons were asked whether they were familiar with the Instructions for Use (IFU)
labeling that commonly accompanies a medical device. The 35 responses were split, with
about half affirming familiarity and the other half denying it (54% versus 46%). When
asked how often they review the Instructions for Use, no surgeon selected “Every
procedure”, 29% (10/34) selected “Only on occasion”, 15% (5/34) selected “The first
time I use a device”, 24% (8/34) selected “Only when initially trained on the device” and
32% (11/34) selected “Never” (Figure 16). Very few of these surgeons were familiar
with the single-use device symbol (yes: 9%; 3/34; no: 91%; 32/34). When asked if they
review the labeling symbols found on either the box or the packaging accompanying a
medical device, respondents were able to select more than one choice of answer, so that
38 responses were provided by 35 surgeons. Most identified that they seldom (43%) or
never (40%) conducted such reviews. Only one (3%) identified that he/she conducted
such an inspection for every procedure and 23% of surgeons identified that they
2 2
0
7
16
8
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Well before
procedure
During the
procedure
After the
procedure
I'm not
informed of
this
I do not
know if I use
SUDs
I do not use
SUDs
81
inspected the labeling whenever a new device was used (Figure 16). Two respondents
provided text responses of “very rarely” and “Never see the boxes they come in”,
respectively.

82
Figure 16: Pattern of review of IFU (A) and symbols (B) for surgeons
A: How often do you find that you read/review an Instructions for Use (IFU)
document? N = 34

B: How often do you review labeling symbols found on either the box or the
packaging that the device comes in? N = 35 respondents and 38 total responses
(some surgeons provided more than one answer).

Surgeons were also asked to rate their confidence that the Food and Drug Administration
can effectively regulate the safety of medical devices in general and reprocessed single-
use devices more specifically. Respondents typically expressed more confidence in the
0
10
5
8
11
0%
5%
10%
15%
20%
25%
30%
35%
Every
procedure
Only on
occasion
The first time I
use the device
Only when
initially trained
Never
14
15
1
8
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Never Sometimes Every procedure Whenever I use a
new device
83
ability to regulate devices in general; 6% (2/35) of surgeons selected “Strongly agree”,
65% (23/35) selected “Agree”, 18% (6/35) selected “Neither agree nor disagree”, 12%
(4/35) selected “Disagree”, and 0% selected “Strongly disagree”. For reprocessed single-
use devices, 6% (2/35) of surgeons also selected “Strongly agree”, but only 43% (15/35)
selected “Agree”, 26% (9/35) selected “Neither agree nor disagree”, 22% (8/35) selected
“Disagree” and 3% (1/35) selected “Strongly disagree” (Figure 17). Surgeons were also
asked which entity(ies) should be responsible for designating the status of a device as
“single-use” only, and could select more than one option. From a total of 41 answers
provided by 35 surgeons, 31% (11/35) selected FDA, 14% (5/35) selected the device
manufacturer, 3% (1/35) selected the hospital, and 69% (24/35) selected FDA and the
device manufacturer together; the option of “none of the above” was not selected by any
respondents (Figure 18).

84
Figure 17: Confidence of surgeons in FDA’s oversight of medical devices
1) I have confidence in FDA's ability to assure the safety of all medical devices in
general. N = 35
2) I have confidence in FDA's ability to assure the safety of reprocessed single-
use medical devices. N = 35

2
23
6
4
0
2
15
9
8
1
0%
10%
20%
30%
40%
50%
60%
70%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
FDA and all devices
FDA and SUDs
85
Figure 18: Views of surgeons on entity(ies) suited to designate a single-use device
In your professional opinion, which of the following entities should be responsible
for designating a device as “single-use only”: N = 35 respondents and 41 total
responses (some surgeons selected more than one).

Respondents were questioned about the frequency of specific questions from patients
with regard to the surgical devices to be used in their surgical procedure. Responses (n =
35) suggested that such questions were infrequent (37% Never; 11% 1:1000 patients;
20% 1:100 patients; 14% 1:50 patients; 14% 1:20 patients; 0% 1:1 patients). One
responded selected “I do not know” (Figure 19).

11
5
1
24
0
0%
10%
20%
30%
40%
50%
60%
70%
80%
FDA Device
Manufacturer
Hospital FDA & Device
Manufacturer
None of the above
86
Figure 19: Frequency of patient questions about use of surgical devices
Approximately how often do your patients ask specific questions about the
surgical "devices" you will be using in a surgical procedure? N = 35

Because many surgeons routinely interact with their device purchasers at their health care
centers, they were also asked to rate their overall satisfaction with purchasers. Most
commonly, the respondents felt satisfied (satisfied: 26%; 9/35; somewhat satisfied: 34%;
12/35) or neutral (14%; 5/35). Only 2 respondents (6%) were very satisfied, and only
one respondent was somewhat dissatisfied or dissatisfied (3%; 3%). About 14% (5/35) of
surgeons could not answer because they did not work with their purchasers.

Surgeons typically expressed the view that the use of reprocessed single-use devices
would grow nationwide (79%; 27/34); fewer than a quarter of respondents did not foresee
such an increase (21%; 7/34) (Figure 20).
13
4
7
5
5
0
1
0% 5% 10% 15% 20% 25% 30% 35% 40%
Never
1:1000 patients
1:100 patients
1:50 patients
1:10 patients
1:1 patients
I do not know
87
Figure 20: Predictions of surgeons regarding future use of reprocessed SUDs
Do you foresee an overall nationwide increase in the use of reprocessed single-
use devices in the coming years? N = 34

Surgeons who responded affirmatively most commonly expressed the view that the
increase would be linked to its importance as a cost-saving measure alone (41%) or in
combination with its importance for waste reduction (41%). Its projected importance was
linked to waste reduction alone by only 12% or respondents. One respondent selected
“other” and accompanied the selection with the comment: Greed on the part of those
responsible.

Finally, surgeons were asked whether they would accept an invasive reprocessed single-
use device if they were undergoing a personal surgical procedure. Responses were
evenly split (yes: 50%; no: 50%; n = 32) (Figure 21). Six surgeons also provided
comment primarily focusing on the “type of device used” and confidence level with
respect to the safety of the device being used. These comments can be found on Table 4
below.
27
7
0%
20%
40%
60%
80%
100%
Yes No
88
Figure 21: Views of surgeons about acceptability of SUDs for procedures carried out
on themselves
If you had a surgical procedure, would you allow the surgeon to use
invasive reprocessed single-use devices in your procedure? N = 32

Table 4: Comments on surgeons views on acceptability of SUDs used on themselves
Comments
1) It really depends on the device and procedures used to ensure it is free of biologic
or other contaminants. If it is a thin piece of silicone meant to act as a template for a
cochlear implant, then I think washing and autoclaving it should be fine. We used to
do that, but JCAHO and FDA rules now forbid it
2) Depends on the device and if it can be resterilized – would make me nervous
3) Not without documenting safety
4) Depends on the device and the surgeon
5) Concern for infection
6) If the surgeon assured me that they are equally good and do not cause any harm.

16 16
0%
10%
20%
30%
40%
50%
60%
Yes No
89
An option for surgeons to provide any final comments was provided at the end of the
survey. Five surgeons provided comments suggesting both support as well as objections
to the reuse of single-use devices. The five comments can be found on Table 5 below.
Table 5: Additional comments of surgeons regarding use of SUDs
Comments
1) Single-use devices have not been engineered to be re-used and therefore should
not be.
2) Hospitals/Surgery-centers should consent patients separately from MD for use of
these reprocessed devices.
3) I can see benefits of using reprocessed single-use devices, but before this is
adopted, there needs to be high quality data confirming the safety of such use. Once
such data exits, the adjective “single-use” should be dropped, since it clearly would
no longer be applicable and clear guidelines need to be established as to how many
repeats are reasonable.
4) I was not aware that this was occurring and I do not feel that it is appropriate. If
a device is meant to be disposable, it should be disposed of and not reused.
5) Patient acquired infection due to SUD: Multiple cases in China and Africa,
especially replatelet donation, but not my hospital.

Below, Tables 6 shows the cross tabulation results comparing similarities and differences
in two different questions posed to the surgeon respondent group. Table 6 seems to
suggest a correlation between years of experience and awareness of the practice of
reprocessing of single-use devices. More specifically, none of the surgeons taking this
survey with 1-5 years of surgical experience were aware that single-use devices were
being reprocessed, but all of those with greater than 5 years of experience had heard of
this activity.

90
Table 6: Surgeon Experience vs. Awareness
Cross tabulation table showing years of surgical experience and awareness
around reprocessing of single-use devices.
Surgeon Survey
How many years of surgical experience do you
have?
1-5
years
6-10
years
11-15
years
>15
years
Total
Prior to this
survey were you
aware that
invasive single-
use devices
were being
reprocessed?
Yes 0 8 5 10 23
No 5 0 2 4 11
Total 5 8 7 14 34

4.3 Regulatory Professional Survey Results
Fifty-six regulatory professionals responded to 88 distributed surveys yielding a response
rate of 64%. Not counted as a “distributed” survey were those sent to addresses that
bounced back and those that were received for a second time by an occasional
respondent.

Almost all respondents (98%; 52/53) had Class II medical device experience, and most
also had Class I and Class III device experience (72%; 38/53, 62%; 33/53 respectively)
(Figure 23). About one-third (35%; 9/55) had 5 or fewer years of medical device
regulatory experience, a quarter (25%; 14/55) 6 – 10 years of experience, 15% (8/55) 11
– 15 years of experience and 25% had more than 15 years of experience (25%; 14/55)
(Figure 24). Primary roles of the respondents varied; 37% (20/54) self-identified as
91
working primarily in regulatory strategy, 26% (14/54) in regulatory submissions, 18%
(10/54) in regulatory operations and 18% in post-market activities (Figure 22).

92
Figure 22: Professional experience of regulatory respondents by class (A), years of
experience (B) and regulatory role (C)
A: Please indicate the device classification (U.S.) for which you have regulatory
experience (you may select more than one option): N = 53

B: How many years of medical device regulatory experience do you have? N = 55

C: Which of the following best describes your primary role in your organization? N = 54

38
52
33
0%
20%
40%
60%
80%
100%
Class I Class II Class III
19
14
8
14
0%
10%
20%
30%
40%
0 - 5 years 6 - 10 years 11 - 15 years > 15 years
10
14
20
10
0%
5%
10%
15%
20%
25%
30%
35%
40%
Regulatory
Operations
Regulatory
Submissions
Regulatory
Strategy
Post-market
Activities
93
A series of questions explored the degree to which regulatory professionals were aware
of practices regarding the reuse of single-use devices. Almost all respondents (95%;
52/55) were aware that invasive single-use devices were being reprocessed, but less than
half acknowledged any experience with reprocessed single-use devices (40%; 22/55).
Most (82%; 45/55) felt that a device labeled as a single-use device should only be used in
a single procedure for a single patient. When asked whether surgeons should receive
training from the reprocessed device manufacturer on how reprocessed single-use devices
are brought back into service, 74% (40/54) agreed. When asked if they had ever been
able to trace a post-operative surgical infection back to a specific device used in a
procedure as a part of their surveillance programs, only 9% responded “Yes” (5/55)
(Figure 23).

94
Figure 23: General questions regarding reused single-use devices
Regulatory professionals were asked five separate questions regarding reused
single-use devices and the total number of responses ranged from 54 – 55.

Regulatory professionals were asked to rank their level of concern, from highest concern
to lowest concern, with regard to three potential problems linked to the use of
reprocessed single-use devices, including: 1) infection from an improperly cleaned and/or
sterilized device, 2) failure of the device to perform adequately and 3) device breakage.
The potential for infection from an improperly cleaned and/or sterilized device was
chosen as the primary concern by two-thirds of the regulatory respondents (67%; 32/48),
whereas inadequate device performance was seen as the biggest concern of 19% (9/48).
3
33
10
14
50
52
22
45
40
5
0% 20% 40% 60% 80% 100%
Prior to this survey, were you aware that
single-use devices were being reprocessed
(n = 55)?
Prior to this survey, had you ever had any
regulatory experience with reprocessed
single-use devices (n = 55)?
Would you expect that an invasive single-
use device that is labeled as "single-use"
device would only be used in a single
procedure for a single patient (n = 55)?
Do you feel that surgeons should receive
training from the reprocessed device
manufacturer on how reprocessed single-
use devices are brought back to the…
Have you ever been able to trace a post-
operative surgical infection back to a
specific device used in the procedure as a
part of your surveillance program (n = 55)?
Yes
No
95
The potential for device breakage was typically ranked as the middle or lowest concern.
A fourth choice of “Other” was also provided and was chosen by one respondent as the
highest concern, two as a mid-level concern and three as a lowest concern (Figure 24).
Sixteen regulatory professionals also provided responses giving insight into their
additional concerns on this topic. A sampling of these comments can be found on Table
7 below and the remainder of the comments can be found in Appendix A. Several
themes emerged from the comments and they include the importance to limit number of
uses, the need for device traceability, consequences of inadequate instructions for use, the
need for training and liability concerns.
Figure 24: Level of concern with three device problems expressed by regulatory
professionals
Rank the following in order of highest concern to lowest concern with respect to
invasive reprocessed single-use devices used in surgical procedures: N = 48

32
10
6
9
22
13
6
14
26
1
2
3
0%
10%
20%
30%
40%
50%
60%
70%
80%
Highest concern Mid-level concern Lowest concern
Potential for infection from improperly cleaned and/or sterilized device
Inadequate device performance
Device breaks from stress of reuse leaving parts in the patient
Other
96
Table 7: “Other” concerns related to the reuse of SUDs by regulatory respondents
Comments
1) No record of how many times the reprocessing has occurred.
2) Risk related to if device is reprocessed only once and being used more than once
– can be considered off-label use.
3) Inadequate directions for use after reprocessing.
4) Problems with traceability.
5) Poor training for surgeons.
6) Inability to report to correct device manufacturer.
7) Physician/Operator training.
8) Liability in misuse.
9) Inadequate instructions for use – when reprocess of single-use devices is known
to manufacture.
10) Product liability risk.

Regulatory respondents appeared to have low confidence that they would be able to trace
a post-operative surgical site infection back to a specific device used in a procedure
through their surveillance program, as reflected by 54 responses in which the mean value
of confidence was 38 on a scale of 0 (lowest confidence) to 100 (highest confidence).

The views of regulatory professionals on the communication of device reuse to patients
were also probed. Most respondents either strongly agreed (44%; 24/54) or agreed (19%;
10/54) with the view that patients would be informed before surgery if such a device was
going to be used in their surgery. A smaller number had a neutral position (7%; 4/54),
disagreed (15%; 8/54) or strongly disagreed (13%; 7/54) with this view and a single
respondent selected “do not know” (Figure 25). Most also indicated that they either
97
strongly agreed (48%; 26/54) or agreed (24%; 13/54) with the expectation that patients
would be informed in the surgical consent process before an invasive reprocessed single-
use device was used in their procedure. A small percentage had a neutral view (6%;
3/54), disagreed (9%; 5/54) or strongly disagreed (13%; 7/54) (Figure 25).
Figure 25: Views of regulatory professionals regarding surgical consent and
communications
1) I expect that patients would be informed prior to a surgery when an invasive
reprocessed single-use device is going to be used in his/her surgical procedure.
N = 54
2) I expect that patients would be informed through the surgical consent process
before an invasive reprocessed single-use device was used in his/her procedure.
N = 54

Regulatory professionals were also asked whether the reprocessing of single-use devices
represented a reasonable method for cutting health care costs and reducing overall
medical waste. The responses to both questions were distributed widely. With regard to
24
10
4
8
7
1
26
13
3
5
7
0
0%
10%
20%
30%
40%
50%
60%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
I don't
know
Expect that patient would be
informed
Patient informed through
surgical consent
98
their usefulness to reduce health-care center costs, 4% of regulatory professionals
strongly agreed (2/54), 28% agreed (15/54), 19% neither agreed nor disagree (10/54),
19% disagreed (10/54), 26% strongly disagreed (14/54) and about 5% of regulatory
professionals did not know (3/54). With regard to its usefulness for reducing medical
waste, 4% of regulatory professionals strongly agreed (2/54), 31% agreed (17/54), 26%
neither agreed nor disagreed (14/54), 13% disagreed (7/54), 20% strongly disagreed
(11/54) and 6% of regulatory professionals (3/54) did not know (Figure 26).
Figure 26: Views of regulatory respondents regarding use of reprocessed SUDs to
contain costs and reduce waste
1) I feel that the use of reprocessed single-use devices is a reasonable method for
cutting health care center costs. N = 54
2) I feel that the use of reprocessed single-use devices is a reasonable method for
reducing overall medical waste. N = 54

Most regulatory respondents (strongly agree + agree, 46/54; 85%) expected that an
invasive reprocessed single-use device would clearly state "reprocessed single-use
2
15
10 10
14
3
2
17
14
7
11
3
0%
5%
10%
15%
20%
25%
30%
35%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
I don't know
Cut costs
Reduce waste
99
device" on the device itself as well as its packaging; the remaining 15% (8/54) either did
not agree or did not express a position (Figure 27). Fourteen respondents expanded on
their views in a text box. Some indicated that such identification on the device itself was
important but others felt that this requirement added little to no value and might even lead
to confusion (Table 8).
Figure 27: Expectations regarding the identification of a reprocessed SUD on the
device itself
I would expect that an invasive reprocessed single-use device would clearly state
"reprocessed single-use device" on the device itself in addition to being on the
packaging? N = 54

36
10
2
3
2
1
0%
10%
20%
30%
40%
50%
60%
70%
80%
Strongly agree Agree Neither agree
nor disagree
Disagree Strongly
disagree
I don't know
100
Table 8: Further views of regulatory respondents on SUD identification
Comments
Strongly agree:
1) To meet adequate directions for use regulations; is required in the US; doctors
do not know that the device that they are using is reprocessed
2) This should be mandatory and should include a warning
3) The device was not tested for repeat use so it is a risk to patient safety to use
reprocessed devices at all
4) The labeling of reprocessed equipment is required
5) Just “reprocessed would be sufficient
6) I don’t think single-use devices should be reprocessed at all, but if they are, the
patient and user should be informed
7) Label/shrink wrapped when opened, such an act operates as a form of
acknowledgement/knowledge – good for defense/product liability purposes
8) Adding this statement directly to the device is a great idea. Currently the
packaging must include this type of statement, but if the device does not contain a
similar statement and a complaint is reported, it would be hard to know whether
the device was in fact reprocessed or not.
Agree:
1) Still does not protect the patient since they do not see packaging; any type of
packaging should have been labeled as “reprocessed single-use device;” would
indicate to the user that the OEM had not produced the device.
Neither Agree nor Disagree:
1) If it has been reprocessed by the manufacturer and never used in a patient, this
labeling should not be required if done per SOP. If done by hospital staff, they
should let the patient know; it should, but I don’t expect it these days.
Disagree:
1) I am not sure what adding this information to the device label will add
2) Labeling the packaging seems to be a balanced approach for ensuring robust
notification, but added costs and/or added safety and effectiveness concerns with
adding on-device labeling.
Strongly Disagree:
1) I do not think this would matter to the user of the device (physician, nurse, etc.)
their assumption is that the device has been reprocessed acceptably and is safe to
use. Having that statement adds no value but incurs cost, effort and risk to the
manufacturer and reprocessor and would only cause more problems.
I do not know:
1) I would have to do some research on labeling requirements.

101
A series of questions sought to gauge the confidence of regulatory professionals with
respect to varying aspects of reprocessed SUD use with a scale of 0 (lowest confidence)
to 100 (highest confidence). Respondents had a relatively low confidence that surgeons
would know when they are using reprocessed single-use devices in their procedures (35;
n= 53) or would be given a choice regarding the use reprocessed single-use devices, (33;
n = 50). Even lower confidence was expressed that surgeons would be notified prior to a
surgical procedure that an invasive reprocessed device is going to be used (27; n=51).
Respondents were more confident that surgeons would know the meaning of the single-
use device symbol on the package or product (49; n=53), and that patients want to be
informed that invasive reprocessed single-use devices were to be used in their surgical
procedure (49; n=53) (Figure 28).
Figure 28: Confidence related to different aspects of reprocessed SUD use in
surgical procedures

(n = 53)
(n = 50)
(n = 51)
(n = 53)
(n = 53)
0 10 20 30 40 50 60 70 80 90 100
Please indicate your level of confidence that surgeons
know when they are using reprocessing single-use
devices in their procedures? N = 53
Please indicate your level of confidence that surgeons
are given a choice about whether or not they use
reprocessed single-use device? N = 50
Please indicate your level of confidence that surgeons
are notified prior to a surgical procedure that an
invasive reprocessed single-use device is going to be…
What is your level of confidence that surgeons know
the meaning of the single-use device symbol on the
package or product? N = 53
Please indicate your level of confidence that patients
want to be informed that invasive reprocessed single-
use devices are going to be used in their surgical…
102
Several questions were posed to regulatory professionals to explore their beliefs about the
way that surgeons use documentation and labeling of SUDs. Asked how often surgeons
read/review the IFU that accompanies medical devices, most held the view that this
happened “only when initially trained on the device” (65%; 36/55). Fewer believed that
the review occurred “only on occasion” (15%; 8/55), “only when using the device for the
first time” (13%; 7/55) or never (7%; 4/55). No respondent believed that the surgeon
would review the IFU at every procedure (Figure 29). Regulatory professionals were
then asked to rank four sections of the IFU including 1) indications for use 2) directions
for use 3) device description and 4) warnings and symbols, in order of importance. The
Indications for Use section was identified as most important by 45% of respondents and
none identified it as least important (25/55), whereas the Warnings and Precautions
section was seen as most important by 31% (17/55) and only one person least important
(1/55). The Directions for Use section was identified by 11% (6/55) as the most
important section and one person identified it as the least important. The Device
Description section was considered most important by 11% (6/55) and least important by
9% (5/55). Finally, the Symbols found within the IFU were identified by 2% (1/55) of
respondents as the most important part of the IFU and least important by 87% (48/55)
(Figure 30). Respondents were asked their views on how frequently surgeons review
labeling symbols found on either the box or packaging in which it comes. A spectrum of
views included choices that surgeons never reviewed the labeling (28%; 15/54) or did so
only on occasion (20%; 11/54), at the time of first use (19%; 10/54) or when initially
trained on the device (31%; 17/54). Four short responses were added in a provided text
box suggesting varying opinions on this activity, shown in Table 9 below.
103
Figure 29: Regulatory respondents views on the frequency with which they believe
surgeons will examine an IFU
How often do you think that a surgeon reads or reviews the Instructions for Use
(IFU) that accompanies medical devices? N = 55

Figure 30: Regulatory respondents views on the various sections of an IFU
Please rank the following in order of most important (1) to least important (5) for
the sections found within the IFU: N = 55

0
8
7
36
4
0%
10%
20%
30%
40%
50%
60%
70%
Every
procedure
Only on
occasion
First time When
trained
Never
25
15
12
3
0
6
19
20
9
1
6
4
6
34
5
17
16
15
6
1 1 1
2
3
48
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Most important Important Neutral Not important Least important
Indication for Use Directions for Use Device description Warnings and Precautions Symbols
104
Table 9: Expanded views regarding the inspection of labeling by surgeons.
Comments
1) Never – the surgeon never sees the packaging; the device is handed to them; I
believe they almost never come in contact with the labeling.
2) Every procedure – at least as often as every procedure.
3) At the first time of use – and if they do not use regularly.
4) Only when initially trained to use the device – do surgeons handle the box or is
that handled by support staff?

Regulatory professionals were also asked to rate their confidence regarding the ability of
the Food and Drug Administration to regulate the safety of medical devices in general
and reprocessed single-use devices more specifically. Regulatory respondents typically
expressed confidence in the ability to regulate devices in general (strongly agree: 5%;
3/55; agree: 56%; 31/55; neither agree nor disagree: 24%; 13/55). Only 13% (7/55)
selected “Disagree” and 2% (1/55) selected “Strongly disagree.” Less confidence
appeared present in FDA’s ability to regulate reprocessed single-use devices these
devices. Less than half of the respondents strongly agreed or agreed (0% and 26%,
respectively; 14/54), whereas 31 % (17/54) had a neutral view, 31% (17/54) disagreed
and 11% (6/54) strongly disagreed (Figure 31). Regulatory professionals were also asked
which entity should be responsible for designating a device as “single-use” only. Of the
55 responses, 11% (6/55) selected FDA, 44% (24/55) selected the device manufacturer,
43% (23/55) selected device manufacturer and FDA jointly and 2% (1/55) selected
hospital. A single individual selected the “Other” option and added the following
105
comment: It’s not as simple as the original manufacturer or the FDA. If the reprocessor
is registered as a manufacturer they may have some input as well.
Figure 31: Confidence of regulatory professionals in FDA’s oversight of devices
1) I have confidence in FDA's ability to assure the safety of all medical devices in
general. N = 55
2) I have confidence in FDA's ability to assure the safety of reprocessed single-
use medical devices. N = 54

Using the cross-tabulation tool it was possible to compare the levels of confidence in
FDA’s ability to assure the safety of reprocessed single-use devices between respondents
with different amounts of regulatory experience. More experienced respondents were
less positive than less experienced respondents. Few regulatory professionals with over
five years of experience expressed any level of confidence in the ability of FDA to assure
safety of these devices (13%; n = 7) whereas 37% (7/19) of those with up to 5 years of
experience expressed such confidence (Table 10).
3
31
13
7
1
0
14
17 17
6
0%
10%
20%
30%
40%
50%
60%
Strongly
agree
Agree Neither agree
nor disagree
Disagree Strongly
disagree
FDA and all devices
FDA and SUDs
106
Table 10: Regulatory Professional Experience vs Confidence in FDA with SUDs
Cross tabulation table showing years of regulatory experience and confidence in
FDA’s ability to assure the safety of SUDs.

Regulatory Professional
Survey
How many years of medical device regulatory
experience do you have?
0-5
years
6-10
years
11-15
years
>15
years
Total
I have confidence
in FDA's ability to
assure the safety
of all reprocessed
single-use
devices?
Strongly
Agree
0 0 0 0 0
Agree 7 4 1 2 14
Neither
Agree nor
Disagree
6 4 4 3 17
Disagree 4 4 3 6 17
Strongly
Disagree
2 1 0 3 6
Total 19 13 8 14 54

Regulatory professionals were also asked to predict how often patients ask specific
questions about the surgical devices that will be used in their surgical procedure. Most
selected 1:1000 patients (45%; 25/55); no regulatory professional selected the option of a
1:1 ratio. The other five options that fell between these extremes were each selected by
approximately 5 -15% of respondents (Figure 32).

107
Figure 32: Frequency with which patients ask about surgical devices, predicted by
regulatory professionals
Approximately how often do you think patients ask specific questions about the
surgical devices that will be used in a surgical procedure? N = 55

When asked if they foresee an overall nationwide increase in the use of reprocessed
single-use devices in the coming years, most regulatory respondents (88%; 46/52)
indicated that they did foresee such an increase whereas a small minority (12%; 6/52) did
not foresee an increase.

The final question posed to the regulatory professional population asked whether or not
they would allow for an invasive reprocessed single-use device to be used in their own
procedure if they were to have such a procedure. Only18% (10/55) indicated that they
would allow a reprocess single-use device to be used in their procedure. Most (82%;
45/55) indicated that they would not (Figure 33).
6
25
9
9
3
0
3
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
Never
1:1000 patients
1:100 patients
1:50 patients
1:20 patients
1:1 patients
I do not know
108
Figure 33: Regulatory Professionals – would you allow an SUD in your procedure?
If you had a surgical procedure, would you allow the surgeon to use
invasive reprocessed single-use devices in your procedure? N = 55

An option for providing final comments was provided at the end of the survey. A total of
twenty-one comments were recorded. These comments ranged from support for the use
of reprocessed single-use devices as long as the proper quality systems and regulatory
oversight is in place, to a lack of support for such approaches with a clear indication that
they would not want such a device used in their procedure. One common theme
throughout the comments was the sense that this practice will increase in coming years
because of the continued cost pressures that hospitals and health care centers are facing.
A sampling of these comments is shown in Table 11 below and the remainder of the
comments can be found in Appendix A.

10
45
0%
20%
40%
60%
80%
100%
Yes No
109
Table 11: Sampling of final comments received from regulatory professionals
Comments
1) I think it is important to note that FDA views establishments that reprocess single-
use devices as manufacturers. They still have to follow quality system requirements,
register, and list etc. I think it is more important that hospitals are using appropriate
reprocessors that are following the regs. and QSRs. This is more important than any
labeling that should be added to the device.
2) I think the increasing cost pressure on paying institutions will force them to strongly
consider the option of reprocessed devices. This could be a benefit depending on how
well positioned a manufacturer is to embrace this change.
3) If single-use devices are reprocessed there should be strict regulations on standards
that need to be met and how often a particular device can be reprocessed. Regulations
should be based on materials used in the device (how quickly do they break down, etc.)
and the risks associated with the device.
4) If a single-use device may be reprocessed and used again, we may need to add more
extensive stability and/or durability data in its filing.
5) Reprocessed devices are increasing as hospitals try to cut costs. There are devices
labeled as single use that could most likely be reused and do not impact safety and
efficacy. If their processors are working jointly with the OEM, then this gives more
confidence in the quality and safety of the reprocessed device.
6) I think the term “single-use device” has become bastardized over time, particularly
with respect to manufacturers who make “single-use devices” yet provide instructions
for reprocessing them. I think the FDA and the industry in general, should take a step
back and reevaluate what a single use device truly is so that the same standards apply
across the board for all devices that are meant to be multi-use, and those that are truly
“single-use only” and are not allowed to be reprocessed and reintroduced. I also have
concerns about the onus (and often blame) put on manufacturers when it comes to
issues with reprocessing of single-use devices. Often times you see the manufacturers
held responsible for creating better “single-use” devices that can be better cleaned for
re-use, or for creating better instructions for reprocessing. In actuality, it should be the
hospitals or reprocessors held accountable for ensuring acceptable cleaning practices
as they are using the device beyond the intended use.
7) As a patient, I would not want reprocessed devices used on me. I do not want a
“used” device; I prefer my insurance to pay for the “new” device. As a regulatory
professional though, I know this practice is becoming common. I feel that reprocessors
have the responsibility to validate the reprocessing activities and ensure that the device
still performs as originally intended and to label the device in such a way that the user,
and someone investigating later should there be a complaint, are able to easily
determine that a device is reprocessed.

110
4.4 Layperson Survey Results
The survey developed for laypersons was sent to faculty and staff members employed at
the University of Southern California. Forty faculty and staff members responded to the
42 distributed surveys, yielding a response rate of 95%. Not counted as a “distributed”
survey were those sent to addresses that bounced back and those that were received for a
second time by an occasional respondent.

The layperson respondents were asked if they had ever heard that single-use medical
devices were being reprocessed. Less than one-third (30%; 12/40) had known previously
of this practice. The majority of respondents (90%; 36/40) expressed the view that
a surgical device that is labeled as a "single-use" device would only be used in a single
procedure on a single patient; only a few (10%; 4/40) disagreed (Figure 34).
Figure 34: Expectations of laypersons that an SUD would only be used once
Would you expect that a surgical device that is labeled as a "single-use" device
would only be used in a single procedure on a single patient? N = 40

Three questions explored how layperson respondents would feel about the use of
reprocessed devices. Most either strongly agreed or agreed (60%; 24/40) when asked if
they would have less respect for their surgeon if they knew that they used invasive
36
4
0%
20%
40%
60%
80%
100%
Yes No
111
reprocessed single-use devices; 28% percent (11/40) had a neutral view and the
remaining respondents either disagreed (10%; 4/40) or strongly disagreed (1/40) (Figure
35). Most also strongly agreed or agreed that they would consider using a different
surgeon if they found that their surgeon used invasive reprocessed single-use devices
(60%; 24/40); 23% (9/40) neither agreed nor disagreed and the remaining 17% either
disagreed (6/40) or strongly disagreed (1/40) (Figure 35). Most also agreed or strongly
agreed (65%; 26/40) that they would consider using a different hospital if they knew that
the hospital used invasive reprocessed single-use devices; 20% (8/40) neither agreed nor
disagreed and the remaining 15% indicated that they either disagreed or disagreed
strongly (6/40) (Figure 35).

112
Figure 35: Views of laypersons on the use of reprocessed devices
1) I would have less respect for my surgeon if I knew he/she used invasive
reprocessed single-use devices. N = 40
2) I would consider using a different surgeon if I knew he/she used invasive
reprocessed single-use devices. N = 40
3) I would consider using a different hospital if I knew they used invasive
reprocessed single-use devices. N = 40

The majority of respondents agreed or strongly agreed with the expectation that a patient
would be informed prior to the surgery if an invasive reprocessed single-use device was
going to be used (88%; 35/40) and that this information would be presented in the
surgical consent process (91%; 36/40). Five percent of respondents had a neutral view
and another 5 % of respondents either disagreed or strongly disagreed with these
expectations. All respondents expected that the surgeon would know if an invasive
reprocessed single-use device was going to be used in their procedure (100% 40/40).
12 12
11
4
1
16
8
9
6
1
17
9
8
5
1
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
Less respect for surgeon
Use a different surgeon
Consider using a different
hospital
113
When asked if they felt that an invasive reprocessed single-use device should clearly state
“reprocessed single-use device” on the device itself, 93% of respondents (37/40) either
strongly agreed or agreed, roughly 2% (1/40) neither agreed nor disagreed and 5% of
respondents disagreed (2/40). Most (73%; 29/40) identified that they would always
choose an option to exclude the use of an invasive reprocessed single-use device during
their surgical procedure but 12% (5/40) held a neutral position and 15% (6/40) either
disagreed or strongly disagreed with this statement (Figure 36).
Figure 36: Layperson views on communication regarding the use of reprocessed
SUDs in surgery
Please indicate your position on the following statements: N = 40

Respondents were asked, If you experienced complications following a procedure in
which a "reprocessed" single-use device was used, would you consider suing any of the
following.” The four options to this question included: 1) the company that originally
manufactured the device, 2) the company that reprocessed the device, 3) the hospital
29
31
35
28
19
6
5
5
9
10
2 2
0
1
5
2
1
0
2
5
1 1
0 0
1
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Informed
prior to
surgery
Informed
through
surgical
consent
Expect
surgeon to
know
Clearly
state
reprocessed
SUD on
device
Exclude the
use of
reprocessed
SUDs
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
114
where you had the procedure and 4) the surgeon who performed the procedure. The
highest percentage of “Yes” responses identified “the hospital where you had the
procedure” (65%; 26/40); the other respondents in this group selected “Maybe” (30%;
12/40) or “No” (5%; 2/40). A majority of layperson respondents (60%; 24/40) also
suggested that they would consider suing the company that reprocessed the device; 25%
(10/40) selected “Maybe” and 15% (6/40) selected “No”. Forty–three percent (17/40)
suggested that they might sue the surgeon that performed the surgery; 40% (16/40)
selected “Maybe” and 18% (7/40) selected “No”. Relatively few (18%; 7/39) suggested
that they would sue the company that originally manufactured the device; 46% (18/39)
selected “Maybe” and 36% (14/39) selected “No” (Figure 37).

115
Figure 37: Litigation targets with reprocessed SUD complications
If you experienced complications following a procedure in which a "reprocessed"
single-use device was used, would you consider suing any of the following:
1) The company that originally manufactured the device? N = 39
2) The company that reprocessed the device? N = 40
3) The hospital where you had the procedure? N = 40
4) The surgeon that performed the surgery? N = 40

Asked if they would pay more to ensure that invasive reprocessed devices were not used
in their procedure, many (34%; 13/38) identified that they would not pay extra, 21%
(8/38) selected “$101-500,” 13% (5/38) selected “$501-1000,” 11% (4/38) percent
selected “$51-100”, 8% (3/38) selected “$1-50”, 5% (2/38) selected “$2000-10,000”, 5%
(2/38) selected “Any amount” and 3% (1/38) selected “$1001-2000” (Figure 38).
7
24
26
17
18
10
12
16
14
6
2
7
0%
10%
20%
30%
40%
50%
60%
70%
The company that
originally
manufactured the
device.
The company that
reprocessed the device.
The hospital where you
had the procedure.
The surgeon that
performed the
procedure.
1 2 3 4
Yes Maybe No
116
Figure 38: Willingness of laypersons to pay additionally for single-use SUDs without
reprocessing
If there was an additional cost for insuring that invasive reprocessed devices were
not used in your procedure, how much would you be willing to pay? N = 38

Respondents were asked to identify their comfort level with the reuse of five devices
(urinary catheters, devices used to cut tissue and seal blood vessels, bone shavers, cardiac
catheters, and biopsy forceps) on a scale of very uncomfortable to very comfortable. The
most common response to the reprocessing of any of these devices was “very
uncomfortable”. Urinary and cardiac catheters received the highest number of “very
uncomfortable” selections (65%; 26/40 and 68%; 27/40 respectively), followed closely
by devices used to cut tissue and seal blood vessels (58%; 23/40), bone shavers (53%;
21/40), and biopsy forceps (45%; 18/40). Only one respondent suggested that he/she was
“very comfortable” with any of the devices being reprocessed (Figure 39).
13
3
4
8
5
1
2 2
0%
5%
10%
15%
20%
25%
30%
35%
40%
117
Figure 39: Layperson views on the use of particular types of reprocessed SUDs
Please indicate your comfort level with respect to the use of the following
invasive reprocessed single-use devices being used in a procedure: N = 40

Layperson respondents were also asked about their level of concern regarding certain
failure modes of reprocessed devices: 1) potential for infection from improperly cleaned
and/or sterilized device, 2) inadequate device performance and 3) device breaks from
stress of reuse leaving part(s) in patient. Most respondents (80%; 32/40) identified the
“potential for infection from improperly cleaned and/or sterilized devices” as their
highest concern; 5% (2/40) identified it as a mid-level concern and 15% (6/40) as their
lowest concern. Fewer identified the possibility that a “device breaks from stress of reuse
leaving parts in the patient” (43%; 17/40) as cause for highest concern; 33% (13/40)
identified this as a mid-level concern and 25% (10/40) identified this as lowest concern.
For the option of “inadequate device performance”, 35% (14/40) of respondents
identified this as their highest concern, 40% (16/40) identified this as a mid-level
concern, and 25% (10/40) identified this as their lowest concern (Figure 40).
26
23
21
27
18
9
8
6
9
7
2 2
5
2
5
3
7
8
2
8
0 0 0 0
2
0%
10%
20%
30%
40%
50%
60%
70%
80%
Urinary
catheter
Devices used to
cut tissue
Bone shaver Cardiac
catheter
Biopsy forceps
Very uncomfortable Somewhat uncomfortable Neutral
Somewhat comfortable Very comfortable
118
Figure 40: Laypersons concern level with three potential reprocessed SUD issues
Rank the following in order of highest concern (1) to lowest concern (3) with
respect to reprocessed single-use device performance in a surgical procedure;
please select just one number for each option and only use each number once. N
= 40

Most respondents (93%; 37/40) expected that information about the device would
be documented in the medical record if a reprocessed single-use device was in fact used
in their surgical procedure (Figure 41). Eight comments were also recorded (Table 12);
most expressed support for documentation of SUDs in the medical record but two
expressed less support or lacked confidence that it would happen properly.
32
2
6
14
16
10
17
13
10
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Highest concern (1) Mid-level concern (2) Lowest concern (3)
Potential for infection from improperly cleaned and/or sterilized device
Inadequate device performance
Device breaks from stress of reuse leaving parts in the patient
119
Figure 41: Laypersons expectations regarding documentation of reprocessed SUD
use
If a reprocessed single-use device was used in your surgical procedure, would
you expect that information about the device would be documented in your
medical record? You may add comments if you wish to do so. N = 40

Table 12: Layperson respondent’s comments on SUD documentation expectations
Comments
Yes:
1) I have no issues with a single-use device used during a surgery and as long as I
was informed and the proper documentation was presented that the item is as safe as
a never previously used device
2) Essential
3) To keep supporting documents for potential claims
4) Information needed for tracking purposes – all surgical instruments should be
coded for tracking purposes
5) There are numerous things I expect from my health care providers that never
happen; failure to do so would be malpractice
6) It seems only appropriate in case any future complications arise.
No:
1) I wouldn’t expect it, since it’s not recommended. I expect that it would be
performed without knowledge or consent of the patient
2) I would hope for this but, realistically, I would assume that it would not be
documented sufficiently, if at all.

37
3
0%
20%
40%
60%
80%
100%
Yes No
120
Layperson respondents seemed to have low confidence when asked if they felt that it is
possible to trace a post-operative surgical site infection back to a specific reprocessed
single-use device used in a procedure. From 40 responses, the mean value of confidence
was 35 on a scale of 0 (lowest confidence) to 100 (highest confidence). When asked how
often they feel that surgeons review device labeling before using a device in a procedure,
five percent (2/40) felt that this happened at very procedure, and a further 5% felt that it
happened at every few procedures. More respondents felt that it happened “Once in a
while” (17%; 7/40) or “Only when using a new device” (30%; 12/40). A small number of
respondents felt that surgeons would never review the labeling (15%; 6/40) and 28%
(11/40) selected “I do not know” (Figure 42).
Figure 42: Layperson views on the review of device labeling by surgeons
How often do you feel that surgeons review device labeling before using a device
in a procedure? N = 40

When layperson respondents were asked if the use of reprocessing single-use devices was
a reasonable method for cutting health care center costs, views varied widely; 13% (5/40)
2 2
7
12
6
11
0%
5%
10%
15%
20%
25%
30%
35%
Every
procedure
Every few
procedures
Once in a
while
Only when
using a new
device
Never I do not know
121
strongly agreed, 33% (13/40) agreed, 10% (4/40) neither agreed nor disagreed, 28%
(11/40) disagreed, and 18% (7/40) strongly disagreed. When asked if they felt that the
use of reprocessed single-use devices was a reasonable method for reducing overall
medical waste, 18% (7/40) strongly agreed, 35% (14/40) agreed, 13% (5/40) neither
agreed nor disagreed, 23% (9/40) disagreed, and 13% (5/40) strongly disagreed. When
asked if they felt that the use of reprocessed single-use devices was acceptable “since
other hospitals are doing it”, most respondents disagreed to a greater or lesser extent.
Three percent (1/40) strongly agreed, 9% (3/40) agreed, 6% (2/40) neither agreed nor
disagreed, 35%, (14/40) disagreed and 50% (20/40) strongly disagreed (Figure 43).
Figure 43: Layperson views on why hospitals would use reprocessed SUDs
Would you consider the following to be reasonable arguments for hospitals to use
reprocessed single-use devices: N = 40

5
13
4
11
7 7
14
5
9
5
1
3
2
14
20
0%
10%
20%
30%
40%
50%
60%
Strongly Agree Agree Neither Agree nor
Disagree
Disagree Strongly Disagree
Cut health care center costs Reduce overall medical waste Other hospitals are doing it
122
When respondents were asked about their confidence that FDA could assure the safety of
all medical devices, responses ranged widely from 45% strongly agreeing or agreeing
(1/40; 17/40 respectively), 23% (9/40) neither agreeing nor disagreeing, and 32% either
disagreeing or strongly disagreeing (11/40; 2/40 respectively). Confidence in FDA’s
ability to assure the safety of reprocessed single-use devices was ranked lower. Only 2%
(1/40) selected “Strongly agree,” 17% (7/40) selected “Agree,” 23% (9/40) selected
“Neither agree nor disagree,” 43% (17/40) selected “Disagree,” and 15% (6/40) selected
“Strongly disagree” (Figure 44).
Figure 44: Layperson confidence in FDA’s regulation of medical devices
1) I have confidence in the Food and Drug Administration's ability to assure the
safety of all medical devices. N = 40
2) I have confidence in the Food and Drug Administration's ability to assure the
safety of reprocessed single-use devices. N = 40

1
17
9
11
2
1
7
9
17
6
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Strongly
agree
Agree Neither agree
nor disagree
Disagree Strongly
disagree
FDA and all devices
FDA and SUDs
123
Finally, layperson respondents were asked if they felt that surgeons would allow
reprocessed single-use devices to be used in their procedure if they (the surgeon) were
having surgery. Three quarters of respondents (75%; 30/40) felt that they would not,
whereas the remaining quarter felt that they would (Figure 45). A total of seven
comments were also recorded from the respondents; some felt that surgeons would allow
a reprocessed single-use device to be used in their own procedure with conditions added,
while others suggested that surgeons would not allow these devices in their procedure
(Table 13):
Figure 45: Layperson views on the willingness of surgeons to use reprocessed SUDs
if they were undergoing a procedure
Do you feel that surgeons would allow reprocessed single-use devices to be used
in their procedure if they were having surgery? N = 40

10
30
0%
10%
20%
30%
40%
50%
60%
70%
80%
Yes No
124
Table 13: Laypersons comments on surgeon’s willingness to use SUDs on themselves
Comments
Yes:
1) If given full disclosure, most would be reasonable about it. That is, those that
tended to use the devices on others would probably also use the device on
themselves
2) Depends on the particular surgeon; possibly, but would vary according to device
type and procedure
3) Assuming the practice is legal and deemed safe, I would expect them to receive
the same treatment as any other patient.
No:
1) Depends on how smart they are
2) I really have no idea
3) I doubt most surgeons would even have a procedure done where they work
4) I don’t think surgeons would take that risk because I don’t think they would have
the confidence that they would work or be completely sterile.

An option for final comments was provided and a total of fifteen final comments were
received. Several of the responses acknowledged that they did not know about the use of
such a practice. A few linked their concerns to the recent deaths that stem from
improperly cleaned and reused device at the University of California, Los Angeles
(UCLA). Further, the comments strongly promoted a “right to know” when these devices
are going to be used in their procedure. Finally, a sense that this practice will continue
due to a push to reduce health care center costs was also evident. A sampling of these
comments is provided below in Table 14 and the remainder of the comments can be
found in Appendix A.

125
Table 14: Sampling of final comments received from layperson respondents
Comments
1) Interesting topic. An uninformed public would be very much against reusing a
single-use device. Education is key.
2) As someone who knows little about this issue, my reactions are strongly opposed
because the reprocessing sounds overly risky. I would need better and more
information about reprocessing to provide better informed (and not knee jerk)
reactions. Question 6 is too hard to answer; I’d need to know the procedure, the
overall costs, more about the risks etc. Question 10 needs clarification – does zero
mean least confident and 100 means most? I assume that but would like assurance.
3) The recent deaths and illnesses that resulted from reuse of medical device
equipment at UCLA completely colored my answers. These incidents clearly showed
the risks and the inadequate procedures in today’s medical continuum for handling
them effectively and safeguarding patients.
4) As long as the information is disclosed to all parties and their consents have been
obtained, there should not be an issue in using reprocessed single-use devices.
5) I think patients should have a right to know if the medical devices involved in their
treatment have been reconditioned. However, I don’t really have anything against the
practice so long as it is regulated and one safely and to standards where the
reprocessed device is deemed as safe as the original.
6) I just had surgery and I wish I would have known prior to my surgery that during
some procedures, if not all procedures, hospitals are using reprocessed single-use
devices. After taking this survey, I feel like inquiring about it if I have another
procedure done.

When a cross tabulation was performed to examine whether laypersons who expected or
did not expect that the use of SUDs to be recorded in their medical records would also
have heard of this practice, over 90% (n = 37/40) of respondents in both subgroups
indicated that they would have this expectation whether knowledgeable of this practice or
not (Table 15).
126
Table 15: Layperson Awareness of SUDs and Documentation Expectations
Cross tabulation table showing layperson feedback on their awareness of the
practice of reprocessing along with their expectations around documenting the
use of SUDs in their medical record.
Layperson Survey
If a reprocessed single-use device was used in
your surgical procedure, would you expect
that information about the device would be
documented in your medical record?
Yes No Total
Prior to this
survey, had you
ever heard that
single-use
devices were
being
reprocessed?
Yes 11 1 12
No 26 2 28
Total 37 3 40

A second cross tabulation suggested that individuals who would always reject the use a
reprocessed single-use device had a strong expectation that they would be informed prior
to a procedure if one of these devices was planned to be used. However, this same view
was also expressed by those with more moderate views regarding the use of such devices;
only 3 of 40 participants indicated that they would not expect to be informed about such
use (Table 16).

127
Table 16: Layperson Position on Informing the Patient and Opting Out
Cross tabulation table showing feedback on laypersons positon on informed
consent with the use of reprocessed single-use device and if they would choose to
opt out if given the option to select the type of device(s) used in their procedure.
Layperson Survey
I expect that patients would be informed prior to a procedure
when an invasive reprocessed single-use device is going to be
used in his/her procedure.
Strongly
Agree
Agree
Neither
Agree
nor
Disagree
Disagree
Strongly
Disagree
Total
If given the
option, I
would
always
choose to
exclude the
use of an
invasive
reprocessed
single-use
device
during my
surgical
procedure.
Strongly
Agree
17 0 0 2 0 19
Agree 3 5 2 0 0 10
Neither
Agree
nor
Disagree
4 0 0 0 1 5
Disagree 4 1 0 0 0 5
Strongly
Disagree
1 0 0 0 0 1
Total 29 6 2 2 1 40

128

4.5 Results of Merged Data from Three Respondent Groups
The fact that several identical or similar questions were posed to different survey groups
gave the opportunity to compare the responses of different stakeholders. Results of such
comparisons, shown in figures 46 – 54 (n values vary between groups), showed that
surgeons often had a higher sense of confidence in the ability of the current system to
manage the safe use of reprocessed SUDs. In contrast those in the more general public
appeared less well informed, less confident, and less enthusiastic about the use of
reprocessed SUDs.

This dissonance is apparent in certain questions concerning the use of SUDs in surgical
procedures as shown in Figures 46 and 47. The large majority of individuals were similar
in their expectations that an invasive surgical device labeled as an SUD would only be
used in a single procedure for a single patient; however, 50% of surgeons appeared
comfortable with the use of reprocessed SUDs in personal procedures whereas both
regulatory professionals and laypersons typically identified that they would not be in
favor of such use (Figure 46, Figure 47). Further laypersons expected much more
commonly than regulatory professionals or surgeons that patients would be informed
about the use of reprocessed SUDs and that this would be part of a surgical consent
process (Figure 48).
129
Figure 46: Comparison on “Single-Use” Labeling
Would you expect that an invasive surgical device that is labeled as a "single-use"
device would only be used in a single procedure for a single patient?

Figure 47: Allowing the use of a Single-Use Device
If you had a surgical procedure, would you allow the surgeon to use
invasive reprocessed single-use devices in your procedure?

31
45
36
4
10
4
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Surgeons Regulatory
Professionals
Laypersons
Yes
No
16
10
6
16
45
29
5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Surgeons Regulatory
Professionals
Laypersons
Yes
No
Neutral
130
Figure 48: Comparison of views regarding information provided to patients about
the use of reprocessed SUDs
A: I expect that patients would be informed prior to a surgery when an invasive
reprocessed single-use device is going to be used in his/her surgical procedure.

B: I expect that patients would be informed during the surgical consent process
before an invasive reprocessed single-use device was used in his/her procedure.

8 8
10
7
1 1
24
10
4
8
7
1
29
6
2 2
1
0%
10%
20%
30%
40%
50%
60%
70%
80%
Strongly
agree
Agree Neither
agree
nor
disagree
Disagree Strongly
disagree
I do not
know
Surgeons
Regulatory Professionals
Laypersons
6
8 8
10
2
1
26
13
3
5
7
0
31
5
2
1 1
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Strongly
agree
Agree Neither
agree
nor
disagree
Disagree Strongly
disagree
I do not
know
Surgeons
Regulatory Professionals
Laypersons
131
Comparisons also show a difference in the level of awareness regarding the reprocessing
of SUDs amongst the three groups. Almost all of the regulatory professionals appeared
aware that reprocessing of single-use devices is taking place, but a little over half of
surgeons and roughly one-third of laypersons appeared aware of the practice (Figure 49).
Figure 49: Summary Feedback – Awareness of Reprocessing of SUDs
Prior to this survey, were you aware that invasive single-use devices were being
reprocessed?

When asked if they felt that reprocessing of single-use devices was a reasonable method
for cutting health care center costs the responses from the three groups were relatively
evenly distributed between those that agree and those that don’t agree with this reasoning.
However, when asked if this practice was a reasonable method for reducing medical
waste, more respondents from the three groups seemed to agree with this goal rather than
that of reducing costs (Figure 50).

23
52
12
12
3
28
0%
20%
40%
60%
80%
100%
Surgeons Regulatory
Professionals
Laypersons
Yes
No
132
Figure 50: Comparison of views regarding use of reprocessed SUDs to cut costs and
reduce waste
A: I feel that the use of reprocessed single-use devices is a reasonable method for
cutting health care center costs.

B: I feel that the use of reprocessed single-use devices is a reasonable method for
reducing overall medical waste.

Survey results showed that surgeons often had a higher sense of confidence in the ability
of the FDA, to manage the use of reprocessed SUDs (Figure 51) than did regulatory
3
10
6
9
4
3
2
15
10 10
14
3
5
13
4
11
7
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
I do not
know
Surgeons
Regulatory Professionals
Laypersons
4
15
7
4
2
3
2
17
14
7
11
3
7
14
5
9
5
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
I do not
know
Surgeons
Regulatory Professionals
Laypersons
133
professionals and laypersons. However, the results also clearly indicate that all three
respondent groups have more confidence in FDA’s ability to regulate non-reprocessed
single-use devices than they do to manage reprocessed single-use devices.
Figure 51: Respondent Confidence Level in FDA
A: I have confidence in FDA's ability to assure the safety of all medical devices in
general.

B: I have confidence in FDA's ability to assure the safety of reprocessed single-
use medical devices.

2
23
6
4
0
3
31
13
7
1 1
17
9
11
2
0%
10%
20%
30%
40%
50%
60%
70%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
Surgeons
Regulatory Professionals
Laypersons
2
15
9
8
1
0
14
17 17
6
1
7
9
17
6
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Strongly
agree
Agree Neither
agree nor
disagree
Disagree Strongly
disagree
Surgeons
Regulatory Professionals
Laypersons
134
Importantly, when regulatory professionals and surgeons were asked if they have ever
been able to trace a post-operative surgical infection back to a specific device used in a
procedure, no surgeon indicated that he/she had, but 10 percent of regulatory
professionals suggested that they had. Further, when all three groups were asked to
provide a confidence level value (0 being no confidence and 100 being complete
confidence) that a post-operative surgical site infection could be traced back to a specific
medical device used in a procedure, all had similar mean values of roughly 35 (Figure
52).

135
Figure 52: Tracing a Post-Operative Surgical Infection to a Specific Device
A: Have you ever been able to trace a post-operative surgical infection back to a
specific device used in a procedure?

B: What is your confidence level that a post-operative infection can be traced
back to the specific device used in a procedure (0 = no confidence & 100= total
confidence)?

Both surgeons and regulatory professionals seemed aligned in their agreement that they
do foresee an overall increase in the use of reprocessed single-use devices in the coming
years (Figure 53).
0
33
2
5
50
0
0%
20%
40%
60%
80%
100%
Yes No I do not know
Surgeons Regulatory Professionals
33 54
39
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Surgeons Regulatory
Professionals
Laypersons
Confidence level
136
Figure 53: Summary Feedback – Future Increase in the Use of SUD
Do you foresee an overall nationwide increase in the use of reprocessed single-
use devices in the coming years?

Nearly three quarters of surgeons and regulatory professionals indicated that surgeons
should receive training from the reprocessed device manufacturer on how these devices
are brought back to the market (Figure 54).

27
48
7
6
0%
20%
40%
60%
80%
100%
Surgeons Regulatory Professionals
Yes No
137
Figure 54: Summary Feedback – Should Surgeons Receive Training on SUDs
Do you feel that surgeons should receive training from the reprocessed device
manufacturer on how reprocessed single-use devices are brought back to the
market (e.g. disassembly, cleaning, sterilization)?

25
40
10
14
0%
20%
40%
60%
80%
Surgeon Regulatory Professional
Yes No
138
CHAPTER 5: DISCUSSION
5.1 Introduction
This research explored the thoughts and opinions of three key stakeholder groups -
surgeons, regulatory professionals and laypersons - who are affected by the practice of
reprocessing of single-use devices. A review of the literature in Chapter 2 demonstrated
that health care centers have been reluctant to dispose of single-use devices that appear to
function normally after they have been used in a single procedure. In part, this reluctance
appears to stem from increasing pressure on user facilities and hospitals to cut health care
center costs and reduce medical waste. Understandably however, safety, ethical and legal
questions can arise when such devices, originally designed and labelled for single-use,
are reprocessed, repackaged and reused for the economic benefit of the user institution
(Eucomed, 2009). Furthermore, when those issues and concerns have the potential to
impact patient confidence and safety, feedback from all stakeholders affected should be
considered. The results of the three surveys distributed for this exploratory study provide
insight into the thoughts and opinions of stakeholders directly involved in or affected by
the provision and use of these products. Survey feedback shows that many individuals in
all of the stakeholder groups have incomplete, and at times, confused knowledge about
the implementation of this growing practice. Further, the surveys suggest that all three
groups have relatively low levels of confidence and even a reluctance to accept this
practice.
139
5.2 Consideration of Delimitations, Limitations and Assumptions
5.2.1 Delimitations
A number of delimitations and trade-offs were accepted as a part of this study in an
attempt to focus the three sets of survey questions in a way that would not produce
blurred results from too many uncontrolled variables. A key consideration was the
selection of survey recipients. Because researchers usually cannot make direct
observations of every individual in the population that they are studying, they must
collect data from a subpopulation (i.e. a sample) and use those observations to make
inferences about the entire population (Herek, 2012). Thus, when deciding on that
subpopulation, it is important to weigh the advantages of a randomized selection from the
whole group of interest - that can introduce significant diversity into the outcome - with a
narrowed selection process that would ensure some level of homogeneity in the survey
samples. In such a case, the narrowed and purposefully selected subpopulation can then
serve as a baseline for later comparative studies that might be broader and put into place
after the initial survey identifies topics that might be particularly important to explore and
compare. Here, three groups of respondents, practicing surgeons in the United States,
faculty and staff members employed by the University of Southern California and
regulatory professionals working with medical devices throughout the United States,
were chosen as proxies for the larger populations of stakeholders most affected by the
practices of single-use device reuse.

Of the three respondent groups, that representing the lay public was considered to be least
likely to represent its umbrella population of individuals who might eventually be
140
patients in whose procedure a reprocessed single-use device might be used. The sample
that was chosen was considered to be sufficiently homogeneous to provide the views of
one defined subsector of this population, but is unlikely to represent the overall
population of 50 million+ potential patients in the US (CDC, 2015b) who could be
considered potential “patients” undergoing a surgical procedure. Individuals employed at
a university such as the University of Southern California, with on-site hospitals and
good health benefits as part of their employment packages, are likely to have higher
expectations of a health care system and to receive a higher quality of care than a large
percentage of the US population. Further, the sample presumably is composed of
individuals who have at least a high school education and good English skills. However,
the broader U.S. population has significant heterogeneity in race, culture and
socioeconomic status and all of these differences can cause the subpopulations to have
differing views (Poston & Bouvier, 2010). It would be interesting in the future to repeat
the survey with other subpopulations that have different economic, cultural and/or
educational attributes in order to understand to what extent the subgroup queried here
represents other parts of the lay population.

Inclusion and exclusion criteria for each group further delimited the subpopulations in
ways that might potentially have implications for external validity. For example, the
decision to survey only actively practicing surgeons excludes other healthcare
professionals who work with reprocessed devices, including clinical physicians who do
not perform surgery, nurses, physicians’ assistants and even technicians. These
stakeholders may be more familiar with lower risk reprocessed single-use devices used in
141
office or bedside settings (e.g. pulse oximeters, blood pressure cuffs) than with higher-
risk devices (e.g. cardiac catheters, biopsy forceps, vessel sealers) used in surgical
procedures. As a result, they might not consider the negative outcomes associated with
reprocessed single-use devices to be as serious as might the surgeons using these devices
in invasive procedures.

Considerations of external validity must also take into account differences in
geographical location. This study was delimited to the US, and it is important not to
generalize to other parts of the world in which surgical practices are known to be affected
by greater resource constraints, varying degrees of access to care and differing health
practice standards (Deloitte, 2014). However, even surgeons practicing at different sites
in the United States might be influenced by differing regional standards and professional
behaviors that are typical in an industry that is heavily influenced by state rather than
national licensure and practice requirements.

Finally, the views captured by the three respondent groups were restricted to a particular
time point during which it is known that the use of reprocessed SUDs is evolving and
expanding rapidly (Healthcare, 2013). Thus views can change in response to events such
as safety issues that become public knowledge, as discussed below. It is conceivable that
opinions on this topic could be very different if the surveys were to be distributed in five
years’ time, as consequences of the recent incidents of contaminated reuse
duodenoscopes (CDC, 2015a), for example, attract more attention and cause practices to
change in health care facilities.
142
5.2.2 Limitations
A number of limitations also must be considered when attempting to determine the
strength of the observations here. Clearly important amongst these concerns are
limitations associated with the use of an electronic survey method to collect results.
Obtaining results using electronic surveys is well-known to be challenging; in research
complied by Watt and colleagues, the overall response rate for online surveys was ~ 30%
(Watt, Simpson, McKillop & Nunn, 2002).

In this study the ability to obtain a reasonable rate of response from the surgeon group
was recognized to be potentially most challenging. Surgeons have busy lives and
practices, and may have no reason to respond to a survey such as this where no
compensation is given (Flanigan, McFarlane & Cook, 2008). Further, surgeons might
also be concerned about the confidentiality of their answers, even though anonymity was
assured. However, the fact that thirty-five surgeons responded to 95 distributed surveys,
yielding a response rate of 37%, was very encouraging and was considered to be
sufficient for saturation, so that expansion of this group was not felt to be required for
this exploratory study.

Less concern was initially felt regarding the ability to achieve adequate response rates for
the regulatory professional group. Nevertheless, willingness to participate in this survey
also had the potential to be limited if respondents lacked interest or experienced “survey
fatigue”. Survey fatigue is becoming an important problem for social science research
generally. For example, Pike in 2007 identified that about 60 percent of recently
143
published research articles in major journals of higher education report some form of
survey data (Pike, 2007). A growing increase in survey fatigue appears to be supported
by the observations of the National Research Council, a US based organization which
seeks to shape policy and inform the public on scientific and medical issues, which
recently suggested that a gradual decline in survey participation has been occurring over
time (NRC, 2013). Importantly however, recent research suggests that even low response
rates can generate reliable data. Fosnacht and colleagues, for example, concluded from
studies of surveys with less than 250 participants that results are generally reliable once
responses from about 50 respondents have been attained. Interestingly, they also
concluded the following:
Survey administrators wanting to increase their response rate to an arbitrary
number to satisfy external constituents should question whether their extra effort
is warranted. This study did not find that a 5% response rate or even a 75%
response rate provides unbiased population estimates under all circumstances,
but rather that additional effort to move response rates marginally higher will
frequently only shift survey results in trivial ways. Once survey administrators
consider these results, we hope they will spend less time worrying about low
response rates and more time evaluating and using the data they collect
(Fosnacht, Sarraf, Howe & Peck, 2013).

For the regulatory group, 56 responses and a response rate of 64% seemed sufficient to
assure saturation. Similarly, the responses of 40 lay participants representing a 95%
response rate was felt to be adequate to extract a set of baseline observations for one
particular subsector of the lay population upon which further research could be built.

As with most surveys, limitations exist on the number of questions that can be asked in a
survey of this type. Busy respondents might fail to complete the survey if it is too long.
Based on experience of others with similar populations and with the feedback of the
144
focus groups developed to provide advice on the survey method, about twenty five
questions was considered to be a reasonable target number that would allow recipients to
complete the survey in 15- 20 minutes. However, in this study, the selection of questions
was further limited by the intention to provide different subgroups with some of the same
questions in order to compare their answers. Certainly many more questions on this topic
could be asked that would have to be explored in follow-on studies, perhaps using
interview methods, to elaborate on those observations that seem to warrant more
examination in depth.
5.2.3 Assumptions
Leedy and Ormrod posited, “Assumptions are so basic that, without them, the research
problem itself could not exist” (Leedy & Ormrod, 2014). For this work, several key
assumptions were made at the onset of survey development. First was the assumption that
the respondents would answer the survey questions truthfully. Three primary factors
contributed to a high level of confidence that answers provided by respondents for all
three surveys were provided honestly: 1) the survey was voluntary, 2) the respondents
were assured of anonymity and 3) the study provided IRB oversight with contact
information if respondents had any concerns. These three study attributes were thought
to provide a level of confidence for participants that was important due to the sensitivity
of some of the questions posed. For example, questions focused on patient infections,
understanding of device labeling and direct questions probing personal opinions on this
practice were asked. Therefore it was imperative that respondents felt that they could
answer honestly without threat of future recourse.

145
The second assumption was that the respondents would be able to understand how
reprocessed single-use devices differed from non-reprocessed single-use devices and
from reprocessed reusable devices. When developing this work I observed that most
documentation and literature covering this topic included a section that defined the
similar but different activities linked to reprocessing (e.g. reprocess, reuse,
remanufacture, refurbish). For this reason, I attempted to emphasize in the both the email
and the introduction to the survey that the focus of the research was on reprocessed
single-use devices. In addition, the term “invasive” preceded “reprocessed single-use
devices” throughout the survey. This was intentionally added due to the fact that this
survey was focused on more advanced reprocessed single-use devices used in higher risk
procedures performed by trained surgeons. The topic covered in this dissertation can be
complex and therefore an emphasis was placed on reducing confusion as much as
possible.

A final assumption concerns the reliability of the web-based survey tool, Qualtrics.
Qualtrics is a respected provider of online software that is used for survey creation and
quantitative statistical analysis. This software is routinely used by other doctoral students
nationwide and is often cited in academic and industry research (Qualtrics, 2015).
However its validity for the types of simple analyses carried out here were checked by
using a second method of developing excel tables to check calculations, and no errors
were found.
146
5.3 Responses of Surgeons
It would seem intuitive that surgeons would be well informed about the state of their
surgical tools. Thus, one of the more interesting findings in the responses from surgeons
was the limited knowledge that they appeared to have with regard to the use of
reprocessed SUDs in their practice setting. Particularly striking was the fact that about
one-third of surgeons did not know that single-use devices were being reprocessed and
two-thirds did not know whether or not these devices were being used in the health care
settings in which they practiced surgery. The finding is of concern because such
practices are so common; millions of these devices are being used daily in health care
facilities across the country (Jayanthi, 2014). As stated on the website of Stryker
Sustainability Solutions, a leading US based company that engages in reprocessing of
single use devices,
Most major hospitals are reprocessing/remanufacturing single use medical
devices (SUDs), and the majority of these use Stryker Sustainability Solutions for
their reprocessing/remanufacturing activities. Stryker Sustainability Solutions’
more than 2,000 customers include most of the U.S. News & World Report
“Honor Roll” hospitals. Many smaller hospitals rely on the supply cost benefits
of reprocessing/remanufacturing to sustain operations and to improve overall
quality of care by freeing supply costs to cover investments in technology and
staff. Stryker Sustainability Solutions has agreements with all leading national
group purchasing organizations as well as numerous nationally recognized
hospital integrated delivery networks (Stryker, 2015).

The fact that surgeons are not apprised fully about the use of reprocessed SUDs in their
facilities does not reflect the fact that the surgeons see this as a non-issue. Notably, most
expressed the view that a device labeled as a “single-use device” should only be used
once. Given that belief, the further observation that nearly half of the surgeons did not
know whether they used reprocessed single-use devices now or in the past would seem to
147
be problematic. It suggests that current practices of device labeling are insufficient to
communicate the reprocessed status of a single-use device to the end-user. Since 2004,
when FDA issued the Medical Device Technical Corrections Act (FDA, 2004),
reprocessed SUD labeling has required the use of the statement “reprocessed device for
single-use”. In addition, reprocessors of SUDs must identify themselves as the
manufacturer by using a “mark” placed in a “prominent and conspicuous” manner such
that it is apparent to the user under ordinary conditions of use. Typically reprocessors
have relied on the “labeling” that accompanies the product to inform the end-users of the
status of the product. However, this practice seems to be inadequate. When a device is
removed by the surgical assistant from its packaging and then handed to a surgeon during
a procedure, the surgeon may not notice and/or recognize markings on the device itself
designed to communicate its reprocessed status. We might anticipate then that other
methods would be in place to communicate with users about the use of reprocessed
devices in their operations. However, such communication appears to be minimal at best,
as reflected in data gathered here that no surgeon had ever received training related to
reprocessed single-use devices and only two surgeons had been approached by a sales
representative to discuss such devices.

Findings of this study raise more general questions about the usefulness of device
labeling as a means to communicate information about reprocessed SUDs. Typically
regulators and manufacturers look to the “Instructions for Use” (IFU) that accompanies
the product to communicate information about risks and other considerations that might
affect the way that surgeons interact with the product. However, the responses in this
148
study suggest that most surgeons seldom read the IFU, and when they do it is commonly
at the time of first use, before the product has been reprocessed. Further, IFUs do not
always accompany each medical device; sometimes one IFU accompanies a sales unit
consisting of multiple boxes of devices. Therefore, an individual device that is pulled for
a surgical case is commonly separated from its IFU, so that end-users are even less likely
to be informed about the reuse background and current status of the product. Further,
industry and regulators are considering the option of placing IFUs on websites rather than
in device packages (FDA, 2014c). Such a move further divorces end-users from the
package labeling, because surgeon are unlikely to inspect such websites when gowned
and gloved for a surgical procedure.

Would it help if reprocessors were required to place a “reprocessed” identifying mark on
the physical devices themselves? Surgeons appeared to believe that such a signifier
should be present, but current practice is variable. Some reprocessors have previously
labeled the device with both a name and the word “reprocessed”, and a few have even
gone so far as to identify that their device is not affiliated with the original manufacturer
(Figure 55). However, this extra level of transparency seems to be the exception rather
than the rule; it is worth noting that the two largest device reprocessors in the U.S.,
Stryker and Sterilmed, currently do not place a “reprocessing” mark on the reprocessed
device, although Stryker does put its name on the device and Sterilmed does label the
device with the acronym SM and some devices also spell out Sterilmed. Interpreting
these labels to understand that the device has been reprocessed would require that the
surgeon understand the significance of these marks. In a future study it would be worth
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exploring just how widespread that knowledge is amongst a much larger sample of
healthcare professionals. One simple potential solution to this issue would be for
regulators to mandate that reprocessors clearly print or laser etch the words “reprocessed
single-use device” on the physical device itself as has been shown to be done before
(Figure 55); this could be problematic however if multiple reprocessors reprocess the
device over time. Another possible solution would be to tag (e.g. a plastic ring attached
to the handle) the device in some manner such that it would come permanently attached
to the sterile device and force the end-user to question the reason for the tag.
Figure 55: Photograph to illustrate an unusually detailed reprocessed mark
This device bears the reprocessed device label of the Ascent, that shows the
reprocessing information, name of reprocessor and lack of affiliation with
original manufacturer. Acent was acquired by Stryker Sustainability Solutions in
2009 (Locke, 2015).

Even if physicians were to know that they were using a reprocessed device, it is unclear
whether they would be comfortable to communicate that knowledge to patients. Two
principal opportunities exist to inform the patient about the use of a reprocessed device.
The first would occur when the surgeon discusses the procedure with his/her patient. The
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second happens just prior to having the surgical procedure when the patient is asked to
sign a surgical consent form to signify his/her understanding of the nature and risks of the
procedure. When surgeons were asked if they felt that the patient should be informed of
the plan to use reprocessed single use-devices, most agreed, at least to some extent, but
the mixed responses to using the surgical consent process suggests some ambivalence
about assuming this responsibility. In part this may come from the fact that surgeons are
typically unclear about whether such devices are in fact to be employed. Ultimately, this
could be problematic for surgeons, as is later described in further detail in section 5.5.
5.4 Responses of Regulatory Professionals
The views of regulatory professionals were expected to be mixed, given the range of
experience amongst respondents and the possibility that they might represent both
original manufacturers of single-use devices and reprocessors of such devices. It was
nevertheless anticipated that regulatory professionals would add useful views given their
higher level of familiarity with the common practice of reprocessing, a presumption that
was confirmed by their responses.

Of the three groups of respondents polled here, regulatory respondents appeared to be
particularly concerned about the potential risks of patient infection from reprocessed
SUDs. In part this may derive from a knowledge gained through their professional work
that surgical infections are a common problem. According to a recent study by Magill
and colleagues, health care-associated infections in U.S. acute care hospitals seem to
occur in about 4% of admissions, of which about one-quarter (~1%) are directly linked to
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device related surgical-site infections (Magill, Edwards, Stat, Bamberg, Beldavs,
Dumyati, et al., 2014). Their findings are consistent with data derived from the National
Healthcare Safety Network (NHSN) showing an overall national surgical-site infection
rate of 1.9% from 2006-2008 (Mu, Edwards, Horan, Berrios-Torres, & Fridkin, 2011).
The heightened sensitivity of regulatory professionals to device-related infections seems
also to be reflected in the finding that several respondents appeared to know of situations
in which reprocessed single-use devices had been linked back to a post-operative surgical
infection. Further, compared to Magill’s 1% surgical site rate, the 10% rate that was
typically estimated by the regulatory professional group may reflect an exaggerated
perception of risk in line with the greater sensitivity shown by this group to infection as a
potential adverse event.

Curiously, information on the infection rates associated with SUDs is difficult to find.
This may reflect inadequacies in the surveillance programs now in place for device-
related adverse events. Passive surveillance systems such as the US Manufacturer and
User Facility Device Experience (MAUDE) database system depend on end-users to
report device-related adverse events. They further require only the reporting of adverse
events that result in deaths, serious injuries requiring hospitalization or medical
intervention, or product malfunctions (FDA, 2015a). This limitation excludes most
adverse events such as infections that could be treated without admission to the hospital.
Further, it excludes the roughly 85% of the 1.1 million serious patient incidents related to
medical devices that FDA has estimated to occur without being reported (Langreth,
2013). In part this may relate to the poor understanding of end-users about how to report.
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For example, the American Academy of Orthopedic Surgeons (AAOS) Biomedical
Engineering and Biologic Implants Committee found that only about 10% of AAOS
fellows knew how to utilize the FDA MedWatch program (Goodman, Mihalko, Robb,
Bozic & Goldberg, 2013). Some critics have gone so far as to suggest that the current
device surveillance program is completely broken. David Challoner, vice president
emeritus for health affairs at the University of Florida, recently stated that “the adverse
event reporting system is a disaster” and that “every link in the chain has a reason not to
report” (Langreth, 2013).

Failure to obtain accurate and timely reports from end-users is even more likely in a
situation where microbial contamination of a device might be difficult to link causally to
an infection. This challenge was particularly evident from the slow pace with which the
adverse events associated with contaminated reused duodenoscopes were recognized at
UCLA, even when the bacterial species was unusual and the problems occurred in patient
clusters (CDC, 2015a). Interestingly, Stryker Sustainable Solutions cite on their website
a report from the Association of Medical Device Reprocessors (AMDR) concluding that
none of the 6500 recorded deaths on FDA’s adverse event database were attributed to
reprocessed single-use devices (Stryker, 2015). If this statement were still to be true, one
might regard reliance on FDA’s adverse event database as a poor way to understand the
extent and seriousness of infections from sterile and non-sterile instruments in the face of
our current awareness of several infection-related serious adverse events that have been
reported in the media, and from academic literature showing that reprocessing often fails
to clean and disinfect product completely (ACOG, 2012). In order to instill a greater
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sense of public confidence that these devices are free of infectious pathogens, including
lethal agents such as the prion that causes Creutzfeldt-Jakob Disease (CJD) in humans, a
large scale study should be considered which would evaluate various different invasive
reprocessed SUDs. The study should include spectrophotometer analysis of any residual
nucleic acids and/or proteins, examination of key components under magnification and a
sterility evaluation of all patient contacting components including the hardest to reach
areas within the device. The reprocessed devices should be compared to new devices and
the results of the study should be published for the public to review.

Prion diseases such as CJD constitute a unique infection control problem because prions
exhibit unusual resistance to conventional chemical and physical decontamination
methods (Rutala & Weber, 2001). Moreover, CJD has been shown to spread via
contaminated neurosurgical instruments previously used on an infected patient (Thomas,
2013). Interestingly, during this research it was observed that neither of the two major
device reprocessors reprocessed neurosurgical instruments. The reason for this is not
clear, but it might very well be due to public concerns over the transmission of this lethal
disease. However, the appropriate segregation of “neurosurgical devices” may be
problematic. For example, many surgical procedures often involve more than one region
of the body (planned or unplanned) and are carried out by surgeons from varying surgical
specialties. For example, a procedure such as an ethmoidectomy or a frontal sinus
osteotomy is generally performed by an ENT surgeon, but can require the assistance of a
neurosurgeon at times (Freeman & Winston, 2015). This is due to the fact that the bones
involved in these procedures are easily punctured, thus introducing surgical devices
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generally designated for ENT procedures (e.g. sinus shavers) to cerebral spinal fluid, dura
mater and/or brain tissue. All devices used in the procedure can also be exposed to one
another and further, some can conceivably be disposed of in the “reprocessed devices”
bin located in the operating room suite. This then might contaminate other devices
within the bin with fluids and/or tissue from the central nervous system. Perhaps a future
study designed to record how often incorrect devices inadvertently find their way into the
“reprocessed devices” bin might shed some light on how often such an error occurs and
how effective are the current controls used to collect reprocessed single-use devices.

Regulatory professionals, like surgeons, commonly expressed the view that reprocessed
single-use devices should make the reprocessed status clearly apparent on the device as
well as the packaging. It is clear from these results that a gap exists in the labeling
process and that labeling the device itself as “reprocessed” is desired not only by
surgeons – as was previously discussed - but also by regulatory professionals.
Information presented here may help to inform those who develop labeling requirements
for reprocessed SUDs to recognize that current rules do not provide sufficient visibility
regarding the reprocessed status of these devices. A future study might be developed to
examine the comparative views of other stakeholders such as reprocessors with respect to
this topic.
5.5 Responses of Lay Respondents
Ultimately, it is neither the regulatory professional nor the surgeon who bears the
consequences of using a reprocessed SUD. Therefore, it seems important also to listen to
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the views of the layperson or patient. The relevance of hearing directly from patients
about their health conditions and their health care products is evidenced in FDA’s
recently initiated patient-focused program in which they obtain patient perspectives on
certain diseases and treatments. As suggested by FDA, patient feedback serves as an
important vehicle for views on healthcare and product decisions that patients prioritize
(FDA, 2014a).

The lay population sampled here appeared to hold particularly strong views on the use of
reprocessed SUDs. Notable, for example, was the finding that nearly three-quarters
(75%) of lay respondents said that they would reject the use of a reprocessed single-use
device in their procedure if “given the option”. Perhaps the text response that seemed to
crystallize such opinions succinctly was that of one respondent stating that he/she “had
just had surgery and he/she had wished he/she had known beforehand that these devices
were being used, and he/she will in the future inquire about these devices before having
another procedure”. These results are similar to the responses of regulatory professionals
for the same question but are more extreme than the responses of surgeons, perhaps
indicating that unknown risks are often perceived as more threatening than those that
seem more familiar or controllable (Cemile, 2015). The strength of these opinions is
more remarkable given that most of these individuals had not yet become aware of the
problems with contaminated reused duodenoscopes that were only beginning to receive
much media attention at the time of the survey. It would be interesting to know if the
recent public disclosures of contamination at several endoscopy centers have since
hardened their already strong opinions.
156

Another compelling observation from the responses of the lay sample was the finding
that nearly 90% of the respondents expected to be informed, typically through the
surgical consent procedure, that a reprocessed SUD might be used in their surgeries. A
clear disconnect therefore exists between their views and the current system which
requires neither disclosure through informed consent nor an option for patient input
concerning the types of tools to be used in their procedures. The views of lay
respondents are also at odds with the position of U.S. device reprocessors, two of which
have stated on their websites that “there is no need to ask patients whether they are
willing to have a reprocessed/remanufactured device used for their procedure” (Stryker,
2015) and “general patient consent for a procedure covers the facility’s prerogative to
select devices as they see fit” (Sterilmed, 2015). Why would hospitals and reprocessors
seem to discourage informing the patient about the use of these devices? Certainly no
harm would come from informing patients of the intent to use these devices in a
procedure. However, procedures to do so might involve a secondary step of allowing
patients to make choices, a path that could be complicated. Would the surgical
preparation for those who approve such use differ from that for patients who reject it?
Would patients rejecting the use of reprocessed SUD(s) have to pay extra for this choice?
In addition, hospitals and reprocessors would likely resist the move to mark reprocessed
devices to avoid the added cost of the additional marking step after reprocessing.

In the future, the debate about transparency regarding the use of reprocessed SUDs may
well reopen, as part of a more general concern identified by regulators and analysts that
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adverse events are difficult to link to specific devices under the current reporting system
(Matheny, Arora, Ohno-Machado & Resnic, 2007). Generally the use of surgical devices
from different manufacturers can be difficult to track because they are not billed
separately. This stems from a system in which devices tend to be included in an omnibus
package billed as a Diagnosis-related group (DRG) code (Newman, 2013). Thus, no
reason has existed to keep track of the source and model of the particular device that was
used, even for some implanted devices and certainly for the tools used to do the surgery.
However, this practice has made it difficult for the FDA to use billing records as part of a
more proactive pharmacovigilance program known as the Sentinel program to identify
adverse event clusters that can be related back to specific products. Further, the currently
disjointed nature of the medical records system in the US has made it unlikely that those
records could be used effectively as a pharmacovigilence tool (Schroeder, 2015) even if
the reprocessed status of a device were to be recorded. However, as electronic records
are introduced, electronic systems are standardized, and unique device identifiers (UDI)
are required on all devices as mandated by September of 2018, (FDA, 2015b) it will
become possible to document the use of specific devices, including reprocessed devices
which have UDI marking compliance dates in 2016 (Class III), 2018 (Class II) and 2020
(Class I), and hence to recognize device-associated adverse events more quickly from
electronic trend analysis.

Results of the layperson survey also produced another interesting finding, that laypersons
expected their surgeons to know when they were using SUDs and thus would be able to
share that information. However, it was clear from the survey of surgeons that many do
158
not have access to this information. As stated by one of the surgeons “I was not aware
that this was occurring and I do not feel that it’s appropriate…if a device is meant to be
disposable, it should be disposed of, not reprocessed.” The dissonance between
stakeholder expectations and current practices raise ethical questions related to the nature
of the doctor-patient relationship. The doctor–patient relationship is considered a
keystone of care (Lipkin, Putnam & Lazare, 1995). It is therefore of concern that most
laypersons felt that their respect for the surgeon would diminish and they might consider
using a different surgeon and health care center, based on the knowledge that the surgeon
was using a reprocessed SUD. The further finding that most respondents would consider
legal action against both the reprocessor and the health care center if they experienced a
device-related complication might be viewed as an important message to providers. If for
example, the hospital used such devices without informing the patient, its actions might
be viewed as a form of “hidden rationing” that disrespects the autonomy of patients to
make their own health-care decisions (Collier, 2011b). This was clearly the thinking of
one of the layperson respondents who characterized the failure to inform the patient as
“malpractice”. Colonna (1999) has gone so far as to predict that a litigant might accuse
the surgeon and health-care facility of violating reasonable standards of medical practice
by permitting reuse of a single-use device. Furthermore, under the “Captain of the Ship”
doctrine, physicians may be held liable also for the actions of employees under their
supervision (Colonna & Thomas, 1999). The term “Captain of the Ship” was first
introduced in the case of McConnell v. Williams, wherein the Pennsylvania Supreme
Court stated that:
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It can be readily understood that in the course of an operation in the operating
room of a hospital, and until the surgeon leaves that room at the conclusion of the
operation…he is in the same complete charge of those who are present and
assisting him as is a captain of a ship over all on board, and that such supreme
control is indeed essential in view of the high degree of protection to which an
anesthetized, unconscious patient is entitled (Capule, 2011).

Although over the past several decades the viability of the “Captain of the Ship” doctrine
has diminished, there are currently two key instances where a physician can be held liable
for a non-employee’s negligent actions: 1) when the physician discovers a non-
employee’s negligence during the course of ordinary care and fails to correct or otherwise
prevent the ill effects of the negligent act; and 2) when the non-employee is under the
physician’s supervision and control such that a “master and servant” relationship exists
(Souther, 2007). One recent example of an attempt to invoke this doctrine comes from
the 2006, Willis v. Bender case in which the plaintiff (Willis) requested a “Captain of the
Ship” jury instruction in an attempt to hold the surgeon liable for his assistant’s
negligence (Willis, 2010) following a laparoscopic cholecystectomy in which the plaintiff
sued the surgeon for lack of informed consent and malpractice. Although the doctrine
was ultimately dismissed by the U.S. Tenth Circuit Court of Appeals in this case, it is
worth observing that this doctrine is still a legal path pursued by those seeking legal
action against surgeons and surgical team members. To this date, few lawsuits appear to
have been pursued over the use of reprocessed SUDs but it is difficult to know how many
settlements have been made out of court for situations in which a reprocessed SUD has
failed to perform according to expectations.

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5.6 Conclusions and Considerations for the Future
To market a reprocessed SUD in the US, the reprocessor makes the argument that the
device is “substantially equivalent” to the SUD marketed by its original manufacturer.
Thus, in principle, all stakeholders, including those surveyed here, should feel confident
that such devices will provide the same benefits, as demonstrated through equivalent
performance testing, and pose no additional safety risks. Two questions therefore seem
to be raised by the results discussed above. Why are so many survey respondents
uncomfortable with the idea that an SUD is reprocessed and then reused, and why are
some of the key stakeholders so ill informed of this practice? Presumably they have been
comfortable for many years with the reuse of other devices and supplies, from bed-sheets
to surgical tools to capital equipment that they have accepted as acceptable practice.
Results presented here however suggest that three types of concerns may have to be more
fully explored and addressed if these stakeholders are to be convinced that it is
appropriate to use reprocessed SUDs.

First, stakeholders need to be convinced that such reprocessing is safe and will result in a
product that has not deteriorated in its performance. Currently the evidence seems
unconvincing, given the difficulties inherent in tracking the use of reprocessed SUDs and
associating them with adverse events. The case for equivalence with a previously used
single-use device is further challenged by experimental studies showing the presence of
residual debris or material degradation after use and reprocessing (Eucomed, 2009; King,
et. al., 2006; Kobayashi, et. al, 2009; Hambrick, 2001). In the future, such evidence
might be gained by specific research, in which records are kept regarding the use of
161
specific types of potentially problematic reprocessed SUDs and then the patient records
are examined retrospectively for evidence of post-surgical infections, particularly with
infectious pathogens such as Staphylococcus aureus and Escherichia coli, which are
routinely linked to medical devices (Darouiche & Weinstein, 2001).

Second, and more fundamentally, stakeholders may need to understand why a device that
is able to be cleaned and refurbished effectively is called a single-use device. It is
obvious why an original manufacturer might not want to take responsibility for a reused
device that has been reprocessed elsewhere and out of its control. However, for the end-
users, the single-use device designation is confusing. Consumers have been educated
about the dangers of reusing single-use devices such as syringes and needles, and would
probably react strongly to using an implanted device like a pacemaker or hip implant that
had been in the body of another person. It is possible that some end-users regard the
designation as a single-use device as a caution that reuse is not appropriate or
recommended because safety cannot be guaranteed. Why else would such a designation
be placed on a product and why else would the FDA support such a designation? It
would be interesting to explore further whether the use of the term “single-use only” is
appropriate on certain types of high risk devices if it is well known that those devices will
be and can be successfully reused. Thus it also might be wise in the future to look not
only at the rules governing use and disclosure of reprocessed devices, but also at the use
of the “single-use only” designation.

162
What does seem clear from this study is that most end-users have a relatively poor
understanding of practices in the surgical suite. Considering the large number of
reprocessed single-use devices on the market today, greater emphasis on education and
training might alleviate at least some of the confusion and possibly even some the
trepidation surrounding the use of these devices. As health care costs continue to mount
in the coming years and as health care centers continue to reduce their medical waste, it is
likely that hospitals will continue to advocate in favor of reprocessing and will resist
attempts to curtail its use. It is further likely that the strong efforts of federal legislators
to support programs that decrease healthcare costs will involve measures that reduce the
unnecessary purchase of surgical supplies. Therefore, in light of the results of this study,
a logical next step would be for federal regulators and the manufactures of these devices
to develop tools to better inform and educate “all” stakeholders of the processes
surrounding this practice in order to build confidence that the public is safe when
reprocessed single-use devices are used on patients. At the same time, efforts should be
made to ensure that mechanisms are available and research is conducted to be sure that
such confidence is in fact justifiable.

163
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178
APPENDIX A
Table 17: “Other” concerns related to the reuse of SUDs by regulatory respondents
Comments (continued)
11) Hospitals presumption that re-used device is as good as a new device.
12) Reprocessed too many times.
13) Product liability risk.
14) HCPs should follow the labeled use – single use is single use.
15) Proprietary and reimbursement, the original company is not getting paid for the
reused device.
16) Introduction of degraded products from cleaning and resterilization.

Table 18: Additional final comments received from regulatory professionals
Comments (continued)
8) Responses vary based on the country in which the procedure occurs. In developing
nations my confidence is very low. I have used a global average in my responses.
9) I think that FDA should be involved in reprocessing of single-use devices to ensure
safety and efficacy.
10) I handle a product line that is highly reprocessed. The hospital will often complain
to us instead of the reprocessor.
11) Q22: answer depends on type of device as to whether I’d “allow” a reprocessed
device to be used during my surgery.
12) Q6. I have high confidence that traceback can be achieved, but this may require a
great deal of time; Q7. I would not expect being a patient to be informed prior to an
emergency surgical procedure; Q8. I am not sure how much waste is produced in
reprocessing; Q11,Q12. I believe this depends on the surgeons relationship with the
surgical institution; Q14. More importantly, I would like to know how many times it
has been reused.
13) There’s a higher prevalence of use in under developed countries due to economic
constraints.
14) I feel that as long as the reprocessor understands the function of the device, their
performance window and good decontamination and sterilization practices, it could be
an economic alternative.
179
15) Most of my knowledge on this topic is from the European debate on revising the
MDD where this was discussed. I am strongly opposed to reprocessing of single-use
medical devices as they are designated “single-use” for a reason! I believe
reprocessing of single-use devices will jeopardize public health overall and I do not
believe individual patients are aware of the risk.
16) Q22. Knowingly – having had surgical procedures – I have never asked nor been
told the status of new or reprocessed devices to be used; you trust the surgeon/hospital
to follow laws and protect the patient, as they are subject to malpractice liability which
is incentive financially to manage such. Am wondering what defense and plaintiff
attorneys for medical devices would think about the questions in the survey – they
would definitely have opinions.
17) What should be considered is if the patient or the healthcare insurance is in fact
paying for the medical device being used. If they pay for new devices, then it would be
unethical if the hospital reprocessed devices and still billed for new devices. There
may also be legal liability at play here for re-using devices labeled to be “single-use.”
18) I think the FTC should also weigh in. It is not right that a third party can capitalize
on technology that they didn’t pay to develop. There should at least be a period of
exclusivity for device companies like there is in pharma. This lets the company recap
their cost of developing the device. If it’s not profitable to invent new devices, then
innovation will decrease.
19) I’ve had a lot of experience with re-sposable devices and there are issues of
cleaning and resterilization present even when designed in. It is not reasonable for a
third party to presume they can do this themselves.
20) The greatest danger with the use of reprocessed single-use is the risk associated
with the potential failure in the reprocessing/sterilization process.
21) With the current regulations/guidance, I have little confidence in reprocessing
single-use devices. If there were additional requirements for reprocessors, I think this
would be a valuable stream to reduce cost/waste and would feel more comfortable with
the use of a reprocessed device.

180
Table 19: Additional final comments received from layperson respondents
Comments (continued)
7) You haven’t distinguished between the complexity of various devices and that is
crucial in evaluating reprocessing risks.
8) As stated in question 14, I really have no idea what surgeons think about reusing
single-use devices, but it seems to me that even though manufacturers may be driving
up demand for their products by requiring they only be used once, as long as they offer
equivalent devices designed for multiple uses, the consumer has the choice of which to
use. Ideally, the free market would drive the best solution.
9) Considering the recent safety issues with virgin duodenoscopes and CRE, there
would be considerable pushback on recycled instruments used in invasive procedures.
However, the use of recycled surgical instruments is quite common in many countries,
especially where medical services are limited.
10) Until I took this survey, I thought repurposing or reused devices were being reused
secretly but it seems that this is more common than I expected.
11) I do believe that there is too much waste being generated by hospitals and research
facilities and welcome ideas to reduce it.
12) I had no idea this was being done – seems irresponsible.
13) Due to the number of infections, I would not do this.
14) I am sure it happens often. Staff is overworked and underpaid and lazy. Hospitals
also want to save money. I’m sure there are work-arounds created by surgeons to
reuse devices.
15) Once a device is deemed to be a single-use device, it should remain so without
exception. Reasonable cases can be made to “not” label certain devices from the get-
go. Otherwise, so-called single-use devices get FDA approval and become reused
devices that would not and arguably should not be reused.

181
APPENDIX B
IRB APPROVAL
Proposal #HS-15-00175
University of Southern California Health Sciences Campus
Institutional Review Board
LAC+USC Medical Center, General Hospital Suite 4700
1200 North State Street, Los Angeles, CA 90033
(323) 223-2340 phone
(323) 224-8389 fax
irb@usc.edu
Date: Apr 08, 2015, 03:39pm
To: David Locke, MS
Doctoral Student
SCHOOL OF PHARMACY

From: Health Sciences Institutional Review Board

TITLE OF PROPOSAL:
REPROCESSING OF SINGLE-USE MEDICAL DEVICES: A SURVEY INVESTIGATION
COMPARING THE VIEWS OF THREE UNHEARD STAKEHOLDERS (REPROCESSING OF
SINGLE-USE MEDICAL DEVICES SURVEY)

Action Date: 4/8/2015 Action Taken: Approve
Committee: Institutional Review Board
Note: Your iStar application and attachments were reviewed by
the IRB on April 8, 2015.

The project was APPROVED.

The material/s submitted and considered for review of this project
182
included:
1. Revised iStar Application, dated 4/8/15
2. Survey Forms (Regulatory Professionals, Surgeons,
Faculty/Staff)
3. Revised Consent Script, dated 10/10/14

Based on the information submitted for review, this study is exempt
from 45 CFR 46 according to §46.101(b) as category 2.

As research which is considered exempt according to §46.101(b),
this project is not subject to requirements for continuing review.
You are authorized to conduct this research as approved.

The Recruitment/Verbal Consent Script, modified by the IRB on
4/8/15, was APPROVED.

Please refer to the strikethrough copy of the recruitment/verbal
consent script for changes made by the IRB. You must utilize this
document approved by the IRB for obtaining informed consent. A
clean copy of the document has been uploaded at 24.2. Note that
this document is not stamped.

The HIPAA Privacy Rule will not apply to this research. The
investigator certifies that he/she is not accessing, using or
obtaining protected (i.e., identifiable) health information held by: a)
a health care provider (e.g., physician or other health care
practitioner, hospital, clinic, nursing home); b) health plan (e.g.,
group health plan, insurance company, (HMO); or c) health care
clearinghouse (e.g., billing service) that is governed by the HIPAA
privacy federal regulations.

183
APPENDIX C
Surgeon Survey:
The following survey is designed specifically for surgeons. Please read the following
paragraph before completing the survey: When manufacturers sell medical devices that
are used for procedures on patients, they must specify how the devices are to be used. In
some cases, the devices are intended for reuse. However, other devices are sold as
“single-use devices” and are used for one patient. For single-use devices, the
original manufacturer makes the assumption that the device is discarded after one use and
another new device is used for the patient that follows. However, these single-use
medical devices are now often reprocessed either by the hospital or a specialized
reprocessing center so that they can be used for another patient, and this might happen
once or more than once. This survey has been developed in order to gain better insight
into your views and understanding of this practice with particular attention being paid
to "invasive" reprocessed single-use devices (i.e. those being introduced into the body or
body cavities, such as catheters, bone shavers and tissue cutters). We would appreciate
your candid comments, but give you the option not to answer questions if you prefer. All
answers provided are completely anonymous and they cannot be linked back to the
individual taking the survey.

184
Q1 How many years of surgical experience do you have (including internship and
residency)?
 1 - 5 years (1)
 6 - 10 years (2)
 11 - 15 years (3)
 > 15 years (4)

Q2 In what surgical field do you specialize?

185
Q3 Please answer the following questions:
Yes (1) No (2)
Prior to this survey, were you aware that invasive
single-use devices were being reprocessed? (1)
 
Do you know if invasive reprocessed single-use devices
are used at any health care center in which you
perform surgery? (2)
 
Do you think a patient would expect his/her surgeon to
know if an invasive reprocessed single-use device was
going to be used in their procedure? (3)
 
Would you expect that an invasive surgical device that
is labeled as a "single-use" device would only be used in
a single procedure for a single patient? (4)
 
Whether you use reprocessed single-use devices or not,
would you expect that some identifier on the device
itself, and not just the packaging, would clearly indicate
that the device was a reprocessed single-use device?
(5)
 
Have you ever been approached by a Sales
Representative and asked to use any reprocessed
single-use device in a surgery? (6)
 
Have you ever received any form of training on
reprocessed single-use devices? (7)
 
Do you feel that surgeons should receive training from
the reprocessed device manufacturer on how
reprocessed single-use devices are brought back to the
market (e.g. disassembly, cleaning, sterilization)? (8)
 

186

Q4 Please provide an answer to the following questions:
Yes (1) No (2) I don't know (3)
Prior to this survey,
had you ever used
invasive reprocessed
single-use devices in
any capacity? (1)
  
Do you know
whether or not you
currently use
invasive reprocessed
single-use devices in
your procedures? (2)
  

Q5 Have you ever been able to trace a post-operative surgical infection back to a specific
device used in a procedure? You may add comments if you wish to do so.
 Yes (1)
 No (2)
 I do not know (3)
 Comment (4) ____________________

Q6 Have you ever heard of a case in which a patient acquired an infection due to a
reprocessed single-use device? You may add comments if you wish to do so.
 Yes (1)
 No (2)
 I do not know (3)
 Comment (4) ____________________

187
Q7 What is your confidence level that it is possible to trace a post-operative surgical
site infection back to a specific medical device used in a procedure:
______ Confidence Level

Q8 Rank the following in order of highest concern (1) to lowest concern (4) with respect
to invasive reprocessed single-use devices being used in surgical procedures:
______ Potential for patient infection from improperly cleaned or sterilized device (1)
______ Inadequate device performance (2)
______ Device breaks from stress of reuse leaving part(s) in patient (3)
______ Other (4)

188
Q9 Please indicate your position on the following statements:
Strongly
Agree
(1)
Agree (2) Neither
Agree nor
Disagree
(3)
Disagree
(4)
Strongly
Disagree
(5)
I do not
know (6)
I expect that
patients would
be informed
prior to a
surgery when an
invasive
reprocessed
single-use
device is going
to be used in
his/her surgical
procedure. (1)
     
I expect that
patients would
be informed
during the
surgical consent
process before
an invasive
reprocessed
single-use
device was used
in his/her
procedure. (2)
     
I feel that it
should be the
surgeon's
responsibility to
inform the
patient that
reprocessed
single-use
devices will be
used in a
procedure. (3)
     

189
Q10 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree
(3)
Disagree
(4)
Strongly
Disagree
(5)
I do not
know (6)
I feel that
the use of
reprocessed
single-use
devices is a
reasonable
method for
cutting
health care
center
costs. (1)
     
I feel that
the use of
reprocessed
single-use
devices is a
reasonable
method for
reducing
overall
medical
waste. (2)
     

Q11 If you use invasive reprocessed single-use devices in your surgical procedures, is it
mandated by the health care center that you do so? You may add comments if you wish
to do so.
 No, I can choose not to use them (1)
 Yes, it is mandatory that I use them (2)
 I do not know if I use reprocessed single-use devices (3)
 Reprocessed single-use devices are not used at the site(s) where I perform surgery (4)
 Comment (5) ____________________

190
Q12 If you use invasive reprocessed single-use devices, are you notified prior to a
procedure that they will be used?
 Yes (1)
 No (2)
 Sometimes (3)
 Not applicable (4)

Q13 If you use reprocessed single-use devices, when are you made aware that they will
be used in a procedure?
 Well before the procedure (1)
 During the procedure (2)
 After the procedure (3)
 I'm not informed of this (4)
 I do not know if I use reprocessed single-use devices (5)
 I do not use reprocessed single-use devices (6)

Q14 Are you familiar with the Instructions for Use (IFU) document that comes with
medical devices?
 Yes (1)
 No (2)

Q15 How often do you find that you read/review an Instructions for Use (IFU)
document?
 Every procedure (1)
 Only on occasion (2)
 The first time I use a device (3)
 Only when initially trained on the device (4)
 Never (5)

191
Q16 Are you familiar with the following symbol that is often found on medical device
packaging?
 Yes (1)
 No (2)

Q17 How often do you review labeling symbols found on either the box or the packaging
that the device comes in?
 Never (1)
 Sometimes (2)
 Every procedure (3)
 Whenever I use a new device (4)
 Comments (5) ____________________

Q18 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree (3)
Disagree (4) Strongly
Disagree (5)
I have
confidence in
FDA's ability
to assure the
safety of all
medical
devices in
general. (1)
    
I have
confidence in
FDA's ability
to assure the
safety of
reprocessed
single-use
medical
devices. (2)
    

192

Q19 In your professional opinion, which of the following entities should be responsible
for designating a device as "single-use" only:
 FDA (1)
 Device Manufacturer (2)
 Hospital (3)
 FDA and Device Manufacturer jointly (4)
 None of the above (5)
 Other (6) ____________________

Q20 Approximately how often do your patients ask specific questions about the surgical
"devices" you will be using in a surgical procedure?
 Never (1)
 1:1000 patients (2)
 1:100 patients (3)
 1:50 patients (4)
 1:20 patients (5)
 1:1 patients (6)
 I do not know (7)

Q21 Please rate your overall level of satisfaction with respect to working with device
purchasers at the health care center in which you work.
 Very Satisfied (1)
 Satisfied (2)
 Somewhat Satisfied (3)
 Neutral (4)
 Somewhat Dissatisfied (5)
 Dissatisfied (6)
 Very Dissatisfied (7)
 I do not work with this person (8)

193
Q22 Do you foresee an overall nationwide increase in the use of reprocessed single-use
devices in the coming years?
 Yes (1)
 No (2)

Q23 If you answered "yes" to the previous question, why did you answer yes?
 Cost savings (1)
 Reduction in medical waste (2)
 Both (3)
 I did not answer yes (4)
 Other (5) ____________________

Q24 If you had a surgical procedure, would you allow the surgeon to use
invasive reprocessed single-use devices in your procedure? You may add comments if
you wish to do so.
 Yes (1)
 No (2)
 Comments (3) ____________________

Q25 Please add any comments that you might want to make with respect to this survey
and/or reprocessed single-use devices:

194
APPENDIX D
Regulatory Professional Survey:
The following survey has been developed specifically for regulatory professionals.
Please read the following paragraph prior to completing the survey: When manufacturers
sell medical devices that are used for procedures on patients, they must specify how the
devices are to be used. In some cases, the devices are intended for reuse. However, other
devices are sold as “single-use devices” and are used for one patient. For single-use
devices, the original manufacturer makes the assumption that the device is discarded after
one use and another new device is used for the patient that follows. However, these
single-use medical devices are now often reprocessed either by the hospital or a
specialized reprocessing center so that they can be used for another patient, and this
might happen once or more than once. This survey has been developed in order to gain
better insight into your views and understanding of this practice with particular attention
being paid to "invasive" reprocessed single-use devices (i.e. those being introduced into
the body or body cavities, such as catheters, bone shavers and tissue cutters). We would
appreciate your candid comments, but give you the option not to answer questions if you
prefer. All answers provided are completely anonymous and they cannot be linked back
to the individual taking the survey.

195
Q1 Please indicate the device classification (U.S.) for which you have regulatory
experience (you may select more than one option):
 Class I (1)
 Class II (2)
 Class III (3)

Q2 How many years of medical device regulatory experience do you have?
 0-5 (1)
 6-10 (2)
 11-15 (3)
 > 15 (4)

Q3 Which of the following best describes your primary role in your organization:
 Regulatory operations (1)
 Regulatory submissions (2)
 Regulatory strategy (3)
 Post-market activities (4)

196
Q4 Please respond to the following questions:
Yes (1) No (2)
Prior to this survey, were you
aware that single-use devices
were being reprocessed? (1)
 
Prior to this survey, had you
ever had any regulatory
experience with reprocessed
single-use devices? (2)
 
Would you expect that an
invasive surgical device that is
labeled as a "single-use"
device would only be used in a
single procedure for a single
patient? (3)
 
Have you ever been able to
trace a post-operative surgical
infection back to a specific
device used in the procedure
as a part of your surveillance
program? (4)
 
Do you feel that surgeons
should receive training from
the reprocessed device
manufacturer on how
reprocessed single-use devices
are brought back to the
market (e.g. disassembly,
cleaning, sterilization)? (5)
 

197
Q5 Rank the following in order of your highest concern (1) to lowest concern (4) with
respect to invasive reprocesses single-use devices being used in surgical procedures:
______ Potential for patient infection from improperly cleaned or sterilized device (1)
______ Inadequate device performance (2)
______ Device breaks from stress of reuse leaving parts in patient (3)
______ Other (4)

Q6 What is your confidence level that it is possible to trace a post-operative surgical
site infection back to a specific medical device used in the procedure:
______ Confidence Level

198
Q7 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree
(3)
Disagree
(4)
Strongly
Disagree
(5)
I do not
know (6)
I expect that
patients
would be
informed
prior to a
surgery
when an
invasive
reprocessed
single-use
device is
going to be
used in
his/her
surgical
procedure.
(1)
     
I expect that
patients
would be
informed
through the
surgical
consent
process
before an
invasive
reprocessed
single-use
device was
used in
his/her
procedure.
(2)
     

199
Q8 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree
(3)
Disagree
(4)
Strongly
Disagree
(5)
I do not
know (6)
I feel that
the use of
reprocessed
single-use
devices is a
reasonable
method for
cutting
health care
center
costs. (1)
     
I feel that
the use of
reprocessed
single-use
devices is a
reasonable
method for
reducing
overall
medical
waste. (2)
     

200
Q9 Please indicate your position on the following statement: "I would expect that an
invasive reprocessed single-use device would clearly state "reprocessed single-use
device" on the device itself in addition to being on the packaging? You are welcome to
add comments if you wish to do so.
 Strongly Agree (1) ____________________
 Agree (2) ____________________
 Neither Agree nor Disagree (3) ____________________
 Disagree (4) ____________________
 Strongly Disagree (5) ____________________
 I do not know (6) ____________________

Q10 Please indicate your level of confidence that surgeons know when they are using
reprocessing single-use devices in their procedures?
______ Confidence Level

Q11 Please indicate your level of confidence that surgeons are given a choice about
whether or not they use reprocessed single-use device?
______ Confidence Level

Q12 Please indicate your level of confidence that surgeons are notified prior to a surgical
procedure that an invasive reprocessed single-use device is going to be used?
______ Confidence Level

201
Q13 What is your level of confidence that surgeons know the meaning of the single-use
device symbol on the package or product?
______ Confidence Level

Q14 Please indicate your level of confidence that patients want to be informed that
invasive reprocessed single-use devices are going to be used in their surgical procedure?
______ Confidence Level

Q15 How often do you think that a surgeon reads or reviews the Instructions for Use
(IFU) that accompanies medical devices?
 Every procedure (1)
 Only on occasion (2)
 Only when using the device for the first time (3)
 Only when initially trained on the device (4)
 Never (5)

Q16 Please rank the following in order of most important (1) to least important (5) for the
sections found within the Instructions For Use:
______ Indications for Use (1)
______ Directions for Use (2)
______ Device description (3)
______ Warnings and Precautions (4)
______ List of device symbols (5)

202
Q17 How often do you think surgeons review labeling symbols found on either the box
or the packaging in which it comes? You may add comments if you wish to do so.
 Never (1) ____________________
 Sometimes (2) ____________________
 Every procedure (3) ____________________
 At the time of first use (4) ____________________
 Only when initially trained to use the device (5) ____________________

Q18 Please provide your position on the following questions:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree (3)
Disagree (4) Strongly
Disagree (5)
I have
confidence in
FDA's ability
to assure the
safety of all
medical
devices. (1)
    
I have
confidence in
FDA's ability
to assure the
safety of all
reprocessed
single-use
devices. (2)
    

203
Q19 In your professional opinion, which of the following entities should be responsible
for designating a device as "single-use" only:
 FDA (1)
 Device Manufacturer (2)
 Device Manufacturer and FDA jointly (3)
 Hospital (4)
 Other (5) ____________________

Q20 Approximately how often do you think patients ask specific questions about the
surgical devices that will be used in a surgical procedure?
 Never (1)
 1:1000 patients (2)
 1:100 patients (3)
 1:50 patients (4)
 1:20 patients (5)
 1:1 patients (6)
 I do not know (7)

Q21 Do you foresee an overall nationwide increase in the use of reprocessed single-use
devices in the coming years?
 Yes (1)
 No (2)

Q22 If you had a surgical procedure, would you allow the surgeon to use
invasive reprocessed single-use devices in your procedure?
 Yes (1)
 No (2)

204
Q23 Please add any comments that you might want to make with respect to this survey
and/or reprocessed single-use devices:

205
APPENDIX E
Layperson Survey:
Please read the paragraph below before completing the survey: When manufacturers sell
medical devices that are used for procedures on patients, they must specify how the
devices are to be used. In some cases, the devices are intended for reuse. However, other
devices are sold as “single-use devices” and are used for one patient. For single-use
devices, the original manufacturer makes the assumption that the device is discarded after
one use and another new device is used for the patient that follows. However, these
single-use medical devices are now often reprocessed (i.e. taken apart, cleaned,
resterilized and resold) either by the hospital or a specialized reprocessing center so that
they can be used for another patient, and this might happen once or more than once. This
survey has been developed in order to gain better insight into your views and
understanding of this practice with particular attention being paid
to "invasive" reprocessed single-use devices (i.e. those being introduced into the body or
body cavities, such as catheters, bone shavers and tissue cutters). We would appreciate
your candid comments, but give you the option not to answer questions if you prefer. All
answers provided are completely anonymous and they cannot be linked back to the
individual taking the survey.

Q1 Prior to this survey, had you ever heard that single-use devices are being reprocessed?
 Yes (1)
 No (2)

206
Q2 Would you expect that a surgical device that is labeled as a "single-use" device would
only be used in a single procedure on a single patient? You are welcome to add
comments if you wish to do so.
 Yes (1) ____________________
 No (2) ____________________

Q3 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree (3)
Disagree (4) Strongly
Disagree (5)
I would have
less respect
for my
surgeon if I
knew he/she
used invasive
reprocessed
single-use
devices. (1)
    
I would
consider using
a different
surgeon if I
knew he/she
used invasive
reprocessed
single-use
devices. (2)
    
I would
consider using
a different
hospital if I
knew they
used invasive
reprocessed
single-use
devices. (3)
    

207

Q4 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree (3)
Disagree (4) Strongly
Disagree (5)
I expect that patients
would be informed
prior to a procedure
when an invasive
reprocessed single-use
device is going to be
used in his/her surgical
procedure. (1)
    
I expect that patients
would be informed
through the
surgical consent process
before an invasive
reprocessed single-use
device was used in
his/her procedure. (2)
    
I would expect a
surgeon to know if an
invasive reprocessed
single-use device was to
be used in my surgical
procedure. (3)
    
I would expect that an
invasive reprocessed
single-use device would
clearly state
"reprocessed single-use
device" on the device
itself. (4)
    
If given the option, I
would always choose to
exclude the use of an
invasive reprocessed
single-use device during
my surgical procedure.
(5)
    

208

Q5 If you experienced complications following a procedure in which a "reprocessed"
single-use device was used, would you consider suing any of the following:
Yes (1) Maybe (2) No (3)
The company that
originally
manufactured the
device. (1)
  
The company that
reprocessed the
device. (2)
  
The hospital where
you had the
procedure. (3)
  
The surgeon that
performed the
procedure. (4)
  

Q6 If there was an additional cost for insuring that invasive reprocessed devices were not
used in your procedure, how much would you be willing to pay?
 I would not pay extra (1)
 $1-50 (2)
 $51-100 (3)
 $101-500 (4)
 $501-1000 (5)
 $1001-2000 (6)
 $2000-10,000 (7)
 Any amount (8)

209
Q7 Please indicate your comfort level with respect to the use of the following
invasive reprocessed single-use devices being used in a procedure:
Very
uncomfortable
(1)
Somewhat
uncomfortable
(2)
Neutral (3) Somewhat
comfortable
(4)
Very
comfortable
(5)
Urinary
catheter (1)
    
Device used
to cut tissue
and seal
blood
vessels (2)
    
Bone shaver
(3)
    
Cardiac
catheter (4)
    
Biopsy
forceps (5)
    

Q8 Rank the following in order of highest concern (1) to lowest concern (3) with respect
to reprocessed single-use device performance in a surgical procedure; please select just
one number for each option and only use each number once.
1 (1) 2 (2) 3 (3)
Potential for patient
infection from
improperly cleaned
and/or sterilized
device (1)
  
Inadequate device
performance (2)
  
Device breaks from
stress of reuse leaving
parts in patients (3)
  

210
Q9 If a reprocessed single-use device was used in your surgical procedure, would you
expect that information about the device would be documented in your medical record?
You may add comments if you wish to do so.
 Yes (1) ____________________
 No (2) ____________________

Q10 What is your confidence level that it is possible to trace a post-operative surgical
site infection back to a specific reprocessed single-use device used in a procedure:
______ Confidence level

Q11 How often do you feel that surgeons review device labeling before using a device in
a procedure?
 Every procedure (1)
 Every few procedures (2)
 Once in a while (3)
 Only when he/she uses a new device (4)
 Never (5)
 I do not know (6)

211
Q12 Would you consider the following to be reasonable arguments for hospitals to use
reprocessed single-use devices:
Strongly
Agree (1)
Agree (2) Neither Agree
nor Disagree
(3)
Disagree (4) Strongly
Disagree (5)
Cut health
care center
costs (1)
    
Reduce
overall
medical
waste (2)
    
Other
hospitals are
doing it (3)
    

212
Q13 Please indicate your position on the following statements:
Strongly
Agree (1)
Agree (2) Neither
Agree nor
Disagree (3)
Disagree (4) Strongly
Disagree (5)
I have
confidence in
the Food and
Drug
Administration's
ability to assure
the safety of all
medical
devices. (1)
    
I have
confidence in
the Food and
Drug
Administration's
ability to assure
the safety of
reprocessed
single-use
devices. (2)
    

Q14 Do you feel that surgeons would allow reprocessed single-use devices to be used in
their procedure if they were having surgery? You are welcome to add comments if you
wish to do so.
 Yes (1) ____________________
 No (2) ____________________

Q15 Please add any comments that you might want to make with respect to this survey
and/or reprocessed single-use devices:

213
APPENDIX F
Table 20: Studies Proposed in this Work for Future Consideration
Proposed Studies
A study investigating other subpopulations that are of different economic, cultural
and/or educational attributes to better understand to what extent the subgroup queried
here represents other parts of the lay population should be considered.
A study should be considered which would evaluate various different invasive
reprocessed SUDs for any residual pathogens and structural integrity following
reprocessing. The study should include spectrophotometer analysis of any residual
nucleic acids and/or proteins, examination of key components under magnification and
a sterility evaluation of all patient contacting components including the hardest to
reach areas within the device. The reprocessed devices should be compared to new
devices and the results of the study should be published for the public to review.
A broad study to determine whether it would help communicate the status of the device
if reprocessors were required to place a “reprocessed” identifying mark on the
physical devices themselves should be considered.
A study examining how “reprocessors” feel about insuring that the reprocessed status
is clearly apparent on the device as well as the packaging should be considered.
A study designed to record how often incorrect devices inadvertently find their way
into the “reprocessed devices” bin along with an evaluation of the controls used to
collect reprocessed single-use devices should be considered.
A study examining if the recent public disclosures of contamination at several
endoscopy centers have since hardened laypersons’ opinions on the topic of
reprocessed single-use devices should be considered.
A study to evaluate if hospitals and reprocessors seem to discourage informing the
patient about the use of these devices should be considered.
A study to better understand how many settlements have been made out of court for
situations in which a reprocessed SUD has failed to perform according to expectations
should be considered.
A study in which records that are kept regarding the use of specific types of potentially
problematic reprocessed SUDs, which includes a retrospective examination of the
records for evidence of post-surgical infections should be considered.
A study investigating further whether the use of the term “single-use only” is
appropriate on certain types of high risk devices if it is well known that those devices
will be and can be successfully reused should be considered.

Abstract (if available)

Abstract Reprocessing of single-use medical devices (SUDs) has gained enormous traction over the past decade as health care organizations seek to cut costs and reduce medical waste while maintaining patient care of high quality. Although laws and regulations attempt to assure the safety of these practices, they do not require that patients or physicians be informed that the devices that they are using have been reprocessed, even though they have been advertised as single-use devices. The results of the three surveys distributed for this exploratory study provide insight into the thoughts and opinions of stakeholders directly involved in or affected by the provision and use of these products. Survey feedback shows that many individuals in all of the stakeholder groups have incomplete, and at times, confused knowledge about the implementation of this growing practice. Surveys results also suggest that all three groups have relatively low levels of confidence and even a reluctance to accept this practice. Results of the three surveys can contribute to future policy development around device reprocessing that balances the needs of surgeons, laypersons and regulators with other more vocal stakeholders in the pursuit of safe and cost-effective device use.

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Asset Metadata

Creator Locke, David M. (author)

Core Title Reprocessing of single-use medical devices: a survey investigation comparing the views of three unheard stakeholders

School School of Pharmacy

Degree Doctor of Regulatory Science

Degree Program Regulatory Science

Publication Date 02/09/2016

Defense Date 11/21/2015

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag Food and Drug Administration,OAI-PMH Harvest,reprocessing,single-use device,survey

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Richmond, Frances J. (committee chair), Church, Terry (committee member), Colonna, Thomas (committee member), Jamieson, Michael (committee member), Loeb, Jerry (committee member)

Creator Email dlocke@usc.edu

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c40-207357

Unique identifier UC11279334

Identifier etd-LockeDavid-4093.pdf (filename),usctheses-c40-207357 (legacy record id)

Legacy Identifier etd-LockeDavid-4093.pdf

Dmrecord 207357

Document Type Dissertation

Format application/pdf (imt)

Rights Locke, David M.

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...

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