Mr. Chairman, I am Walter Maurer, M.D., director of quality
management at the Cleveland Clinic Foundation in Cleveland,
Ohio. I am here today on behalf of the American Hospital
Association's (AHA) nearly 5,000 hospital, health system,
network, and other health care provider members. We are
pleased to have the opportunity to testify on the
long-standing practice of reprocessing medical devices.
The Cleveland Clinic Foundation, founded in 1921,
integrates clinical and hospital care with research and
education in a private, non-profit group practice. Last year
at the Cleveland Clinic and Cleveland Clinic Florida, more
than 850 physicians representing 100 medical specialties and
subspecialties provided care for more than 1 million
outpatient visits and close to 50,000 hospital admissions.
I have spent most of my career as a private practice
internal medicine specialist and anesthesiologist at the
Cleveland Clinic with a focus on outpatient, pediatric, and
ear, nose and throat anesthesia. I also have been involved in
resident education, quality assurance and preoperative
testing. Currently, I serve as the medical director of the
Office of Quality Management. The role encompasses the
hospital, its ambulatory settings including community health
centers, and a long-term care facility. With approximately
50,000 surgeries and more than 1.5 million outpatient visits
yearly, it is my responsibility to guide and direct our
quality management team in ensuring the highest level of
patient care is provided. I also chair the Quality Council,
the Safety Coordinating Committee and the Joint Commission
The term "reuse " and "reprocess" can encompass numerous
scenarios, and they take place in multiple locations, in
hospitals, ambulatory surgical centers and physician offices.
Some hospitals utilize the services of third-party
reprocessors while others reprocess within their own
facilities. In some cases, the device never touches a patient.
For example, almost every day at the Cleveland Clinic we have
a surgery cancelled or postponed, sometimes after the
operating room has been prepped for the procedure. That
preparation may include assembling customized procedure trays
that contain many open single-use devices (SUDs), such as
needles, scalpels, sponges and syringes. What becomes of these
devices when the surgery is cancelled? Most of it would be
unfortunately wasted as "medical trash", but because of
increased environmental concerns and cost reduction
initiatives, we have found that we can safely sterilize,
inspect and repackage many devices for later use.
In another scenario, often a manufacturer will ship SUDs to
hospitals with separate sterilization instructions, if the
manufacturer is experiencing a period of high demand and has
not had time to sterilize the SUDs prior to shipment.
Hospitals sterilize, inspect and repackage these devices too.
Another common scenario is the reuse of a non-critical
device -- one that does not penetrate a sterile tissue plane
or mucus membrane during use, but may contact the patient's
skin. For instance, a sequential compression device, which is
used on the patient's leg to promote circulation and avoid
deep vein thrombosis, is comprised largely of plastics and
fits like a sleeve over a patient's leg. Hospitals routinely
sterilize, inspect and repackage these types of devices.
Ironically, the most discussed reprocessing practice is
probably the least common for hospitals: that of cleaning,
sterilizing and repackaging a single-use, critical device
after it has been used on a patient so it can be used again on
REPROCESSING MAKES SENSE
Many medical products can be safely reused. The AHA is
unaware of any evidence to demonstrate a problem with
reprocessed SUDs. With constrained health care resources and a
heightened commitment to the environment, reprocessing makes
sense. I need only reiterated the slogans we now teach our
children - that's the three R's - reduce, reuse, and recycle.
AHA members are committed to being better stewards of the
environment by pledging to reduce, not increase
waste. In 1998, the AHA and the Environmental Protection
Agency initiated a joint-partnership to reduce hospitals'
total waste volume by 50 percent by 2010. Responsible
management and recent cost reduction initiatives have
resulted in the discovery that hospitals can safely sterilize,
inspect, and repackage many devices for later use.
The AHA is encouraged by the Food and Drug Administration's
(FDA) decision to provide guidance in this area to ensure and
enhance patient safety, which is the first and foremost
concern of AHA members. AHA members have a great deal of
experience with reprocessed medical devices and have been
working closely with the FDA as it refines its strategy. We
believe that the agency's Proposed Strategy represents a
thoughtful approach to a complex issue; it both echoes and
furthers the goals of patient safety, which we share.
The potential for device malfunctions, patient injuries, or
infections related to the reprocessing and reuse of single-use
devices is a matter of great concern to hospitals and health
systems. The AHA strongly supports the FDA's plan to develop a
research program to help bridge the data gap between the
perceived and actual safety risks associated with reuse of
SUDs. Such research should be directed at the more complex or
high-risk devices and be peer reviewed and published for
credibility. This will provide device-specific scientific
evidence regarding patient safety.
The AHA also is encouraged by the FDA's proposal to
categorize SUDs into risk categories, and we agree that the
level of regulation for a device correspond to the level of
risk to a patient.
Furthermore, the AHA applauds the FDA's plan to develop
consensus standards for the reprocessing of SUDs. These kinds
of standards would go a long way toward addressing the safety,
and effectiveness of reprocessing. The FDA should use a
"community best practices" approach for low-risk devices and a
more formal FDA interdisciplinary advisory panel for high-risk
devices. The FDA should include all stakeholders -
manufacturers, third-party reprocessors, health care
facilities, physicians and members of the public - in
developing the consensus standards.
OVERSIGHT OF REPROCESSING
Hospitals are subject to significant regulatory and
accreditation oversight by entities such as the Health Care
Financing Administration, the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO), state
licensing authorities, and other county and city agencies,
particularly with respect to patient safety and quality of
care. By contrast, only one outside source - the FDA,
regulates manufacturers and third-party reprocessors.
Hospital reprocessing activities are marked by a high
degree of physician involvement, supervision and control. In
many cases, a multi-disciplinary committee, such as the
infection control committee, consisting of clinical staff
(physicians and nurses) and operational staff (sterile
processing, risk management, and materials management)
oversees the reprocessing activities of health care
facilities. This committee monitors reprocessing quality
assurance and improvement activities, recommends strategies
for improving performance, and reports such findings and
recommendations to the facility's performance improvement
oversight committee, medical staff and governing body.
Through its membership, activities and reporting
structure, this type of multi-disciplinary committee meets the
requirements of numerous JCAHO standards, including those for
surveillance, prevention and control of infection, etc.
Naturally, medical professionals and the
health care facilities in which they practice have
as their primary mission quality patient care, and have in
place standards, policies and procedures for reprocessing.
At the Cleveland Clinic, for example, our cardiology
electrophysiology laboratory reprocesses both non-lumen
diagnostic electrophysiology catheters and non-lumen
radiofrequency ablation catheters. Each catheter is used five
times or less. It is tested after each use for electrical and
mechanical safety and function, and then resterilized. Each
year, standard operating procedures are reviewed and patient
outcomes are assessed. The sterilization practices are
regularly reviewed and staff competency assessed. Since 1993
our lab has had a continuous quality improvement project on
any infections caused by any procedures done in the lab.
Infection cases are then reviewed with the Infectious Disease
Reprocessing standards, policies and procedures, in
conjunction with the quality improvement program, are designed
specifically to protect the well-being of hospital patients.
Existing non-FDA regulatory oversight, which the AHA believes
includes the components necessary to address and satisfy the
FDA's concerns in this area, has resulted in the development
of these processes.
For instance, JCAHO, during its announced and unannounced
surveys, focuses heavily on patient safety. In addition to
visiting patient care and reprocessing areas to observe
infection control practices, JCAHO reviews the minutes of the
infection control committee, the medical staff executive
committee, the performance improvement oversight committee and
the governing body. The inspectors look for evidence of
sufficient reporting of performance improvement information
and for action on performance improvement recommendations.
Failure to adequately demonstrate compliance in these areas
would result in substantial findings of non-compliance for the
RESTORE MEANING TO THE TERM "SINGLE
Original equipment manufacturers have little incentive to
label devices as reusable, and, in fact, have financial
incentives to self-designate devices as "single use."
Manufacturers appear to use the term "single use only" as part
of their labeling without justifying whether, in fact, the
device can be safely reprocessed for subsequent use. In the
last two years, we have observed products that have been
historically labeled as reusable, arriving with the "single
use only" label with no observable change in the product.
We must ensure that the label "single use only" is
meaningful and not simply an attempt to increase device sales.
Currently, device manufacturers determine whether a device is
labeled "single use." However, the FDA should begin to
regulate the use of the "single use only" label and require
manufacturers to both justify labeling a device as "single
use" and provide scientific data specifying any
resterilization or reprocessing techniques that compromise the
integrity of the device. Manufacturers are the repository for
data on the functional specifications of their devices and
know the most about the ability of their devices to hold up to
repeated cleanings and sterilizations. They should share that
information with those of us who use the devices, and be
actively involved in developing consensus standards.
OPENED BUT UNUSED DEVICES DESERVE SPECIAL
As discussed earlier, it is common practice for hospitals
to reprocess open, but unused, SUDs. Many SUDs are routinely
opened prior to use and are assembled as part of customized
procedure trays that contain several devices. Sterile
processing professionals assemble, wrap and sterilize these
trays, which may consist of single-use and disposable items.
It is essential that hospitals be permitted to open single-use
devices, combine them with other devices as needed for each
medical procedure, and resterilize the entire tray. The
creation of these trays in advance of surgeries and other
procedures is designed to avoid delays in the surgical suite,
and prevent subsequent infection during the
procedure. Treating this process as a "reprocessing" activity
impedes these efforts.
As I stated earlier, any regulation should reflect the
relative risk of the device involved. Reprocessed devices that
have been opened, but not used on a patient, do not need to be
part of the FDA's guidance. Resterilization and repackaging of
such devices pose virtually no risk for patients.
There are three general areas of risk associated with
1. contamination of the device, if it is not properly
cleaned and sterilized, could lead to infection;
2. the cleaning and/or sterilization process could harm the
integrity of the device; and
3. the repeated use of the device in subsequent procedures
could harm the integrity of the device.
With respect to unused devices, the third risk is
eliminated entirely. A major component of the first risk,
patient cross-contamination, is also eliminated. The only
possible risks, therefore, are whether the device can be
adequately resterilized and if the process of resterilization
somehow harms the device. Hospitals have a great deal of
experience in sterilization of medical devices as
sterilization is routinely performed on many types of devices.
In fact, as mentioned earlier, it is not uncommon for
manufacturers to ship SUDs to hospitals with separate
sterilization instructions. Therefore, many providers suspect
that the "single use only" label and "do not resterilize"
instructions are not based on reliable scientific
Mr. Chairman, as we have already noted, patient safety is
the first and foremost concern of all hospitals and health
systems. The AHA believes that the FDA's proposed strategy on
the reuse of SUDs represents a thoughtful approach to a
complex issue, and we are pleased that the FDA has been
consulting with front-line caregivers and other experts in its
effort to make the standards even more meaningful. This is an
important step towards the goal of assuring patient safety.
For the sake of all concerned, we commend the FDA's efforts to
move forward, with all deliberate speed, to finalize its
strategy. We further believe that additional legislation is
unnecessary at this time and would only undermine the progress
that FDA has already made towards developing a balanced and
reasonable regulatory structure. We welcome the opportunity to
work with the FDA to ensure best practices are universally
This hearing document was last
edited by the Committee on Commerce on 02/11/2000 01:43:24 PM