Objectives
1. To provide an overview of the background of the reuse issue.
2. To explain the various viewpoints of the reprocessing debate.
3. To discuss the FDA's Final Guidance document on reuse of single-use
devices.
Amid all
of the other controversies and confusion involving healthcare in the
United States, the practice of reusing single-use devices (SUD) is one
of the more complex. The practice of reprocessing and reusing single-use
devices has been occurring in this country since the 1970s.2
The arguments, both for and against it, involve the manufacturers of
devices, third party reprocessing businesses, hospitals, healthcare
networks, accrediting agencies, professional organizations and a host
of federal agencies. The diverse and conflicting viewpoints from legal
advisors, regulatory bodies, economists, ethicists and clinicians make
the issues surrounding the practice a major patient safety concern.
A thorough understanding of the background of the reuse issue, the various
viewpoints, and the U.S. Food and Drug Administration's (FDA) Final
Guidance document are necessary for healthcare workers (HCWs) to address
the issues. Persons working in frontline positions such as operating
rooms, invasive procedure areas, central sterilization and supplies
have a particular need to understand the concerns.
Hospitals
have reprocessed devices and used them for multiple patient procedures
for decades. In fact, prior to the 1970s, most medical devices were
considered to be reusable. The materials they were manufactured from
and the sterilization technologies at the time allowed this practice
to occur. With the development of new plastics, the use of ethylene
oxide sterilization and the market demand, manufacturers of medical
devices began labeling their products as "single-use only."2
When cost constraints began to appear in the early 1970s, hospitals
began looking at ways to save money. Reprocessing single-use devices
was one method. The hospitals that chose this cost-saving method did
their own reprocessing, usually of low-risk equipment. This evolved
into reprocessing of more complex equipment by third party reprocessors
as a response to the reprocessing needs of hospitals.
Currently,
approximately 20-30 percent of American hospitals report that they reuse
at least one type of single-use device and at least one-third of the
hospitals that do so contract with third party reprocessing companies.2
The expansion of this practice and the types of single-use products
being reprocessed raised the concerns regarding patient safety, informed
consent, ethics of this practice and equitable regulation of Original
Equipment Manufacturers (OEM's) and reprocessing firms. The growth of
the commercial reprocessing industry, the increase in the number of
devices labeled for single-use only and the economics of the situation
was a major driving force that got the federal government involved.
The cleaning,
disinfecting and sterilization of medical devices are highly regulated
by the government and private sector. The various agencies and organizations
publish their guidelines to ensure that standards are met consistently
nationally. Common methods of sterilization include both physical and
chemical methods. Physical methods include: dry heat, steam, radiation
and plasmas. Radiation sterilization may be: gamma radiation electron
beam, X-ray, ultraviolet, microwave and white (broad-spectrum) light.
Chemicals used to sterilize include: ethylene oxide, propylene oxide,
chlorine dioxide, ozone gases and a variety of liquid and vapor chemicals
such as glutaraldehyde. Devices made with superior performance characteristics,
such as polymer, adhesives and coatings many times cannot withstand
some common cleaning and sterilization processes, or multiple reprocessing.3
As instruments have become more intricate, less able to be broken down
and have cavities, they are more difficult to reprocess. The FDA, device
manufacturers and third party reprocessors generally agree many safely
cleaned and sterilized.1 Yet, there are
many devices that can and are effectively reprocessed and reused. In
fact, manufacturers of single-use devices have provided directions on
how to reprocess their products. The need here is for more research
into what devices can and cannot be safely reused because of cleaning,
disinfecting and sterilizing problems.
Although
reprocessing of single-use devices poses theoretical health risks to
patients, clinical evidence from both the FDA's medical device reporting
system and CDC's nosocomial infection surveillance system do not show
that this is actually happening to the extent that it poses a public
health risk. This country does an excellent job of tracking infections
and monitoring manufacturers. However, while the systems and processes
are in place to do this, the reporting of problems with single-use devices
is only as good as the frontline staff who knows about the problems
and makes the report. Most medical errors are underreported and error
involving medical devices is no exception. Therefore, the fact that
there is little literature to support the failure rate of single-use
devices that were reused needs to be evaluated with caution. The inspection
of manufacturing facilities by the government is not 100 percent and
is plagued with the same problems and issues all regulatory and accrediting
groups have -- namely, consistency in the application of the standards.
Infections can and do get transmitted from instruments to patients even
when the device is original,4 but this can
be for a variety of reasons. Instruments may not have been properly
cleaned, disinfected or sterilized. The automated reprocessing machine
may be the source of the contamination. Breaks in infection control
practices can occur. These things can occur in equipment, instruments
and other devices designed to be reprocessed as well as those labeled
single-use. It is the ability to thoroughly and properly clean, disinfect
and sterilize the instrument without breaching the functionality of
the device that determines whether or not the practice of reuse is a
healthcare risk for patients.
The Joint
Commission issued Sentinel Event Alert Issue 20 titled "Exposure
to variant Creutzfeldt-Jakob Disease" dated June 2001.5
In the incidents described by the commission, two separate hospitals
reported 14 patients may have been exposed to vCJD through instruments
used during brain surgeries. Richard T. Johnson, MD, consultant to the
National Institutes of Health (NIH) on transmissable spongiform encepalopathies
(TSEs) states the usual disinfection methods are not effective for these
pathogens.5 What does work is high-pressure
disinfection in sodium hydroxide for one hour, which, for the stereostatic
electrodes used during the surgery, renders them useless. They cannot
be reused. The recommendations that need to be reviewed by healthcare
facilities that perform brain surgeries and adapted are to: 1) establish
policies for the disinfection or disposal of instruments used in neurosurgery
in general and when vCJD is suspected or confirmed, and 2) quarantine
surgical instruments until an unclear diagnosis or biopsy is clarified.5
The fact that this adverse event occurred does not mean that hospitals
stop reprocessing of all instruments. vCJD is known to be iatrogenically
transmitted via procedures such as administration of human cadaver-derived
growth or pituitary hormones, cornea transplants, dura mater grafts
or other neurosurgery. Knowing this hasn't stopped these procedures
from occurring in healthcare facilities. They have had to adapt different
practices and procedures to reduce the likelihood that the incident
will occur in the future.
What does the risk
of exposing patients to infections mean for the reprocessing controversy?
For one, the public is concerned for its safety as are all of us as
potential consumers of healthcare in this country. During the past 20
years, the public has been exposed by the media to all sorts of healthcare
horror stories most accusing the industry of delivering poor healthcare
because of economic issues. This means that we need more research to
develop new technologies and materials that can be reused safely. This
means that we need to use the scientific knowledge we have about surveillance,
monitoring and control of infectious diseases and apply it consistently
to our procedures. This means that sometime in the future, another problem
will occur that threatens patient safety that the industry had no idea
was out there. Controversial issues require a calm, realistic approach
based on good science.
Do you
notify the patients exposed to vCJD that 20 years down the line they
may develop a disease that, at present, we have no cure for? What are
the legal and ethical issues that have come about because of the practice
of reprocessing single-use items? For one, there is the issue of informed
consent. The debate has always been, how much do you tell the patient
about the risks and benefits of the procedure/surgery they are going
to have? What do patients really understand of what they are being told?
Can they truly assess the risk to their health? For those who have been
in healthcare for a while, it is known that information is misunderstood
routinely by patients and family members alike. Yet, there are groups
of people who have an excellent knowledge base or know where to get
the information they need. Sometimes this information is scientifically
based; sometimes it is from computer chat rooms or neighbors' experiences.
To obtain appropriate informed consent, the patient must be informed
of the nature and purpose of the procedure; be informed of the material
risks and benefits of the procedure; be informed of the alternatives
to the proposed treatment, including the possibility of forgoing treatment
and the risks and benefits of forgoing treatment; be given the opportunity
to ask questions and receive understandable answers; and, be free to
make the decision without duress or coercion.6
In general, if there is no increase in the level of risk, there is no
need to obtain specific informed consent. If there is an increase in
the level of risk, the practice of reusing single-use devices on another
patient is prohibited.6 In addition to Joint
Commission's standards on informed consent and patient rights, each
state has confidentiality and disclosure statues. So, too, does the
Health Care Finance Administration (HCFA). Risk managers, the facility's
legal counsel or the compliance officer are all individuals that need
to be brought into the discussion of reprocessing of single-use items.
The issue of who is liable for an adverse event that involves a reprocessed
single-use device needs to be understood by the persons in the healthcare
facility. Generally speaking, a facility's employees need not be concerned
about their personal liability. However, physicians need to thoroughly
understand their liability as they can be sued for device failure during
a procedure.6 The hospitals that experienced
this adverse event notified the patients. They believed it was the right
thing to do.
In a 1998
US District court case, the judge found that the manufacturer's only
purposes in labeling a device for single-use were to comply with FDA
requirements and limit liability from reuse, not to prevent a hospital
from using it more than once.7 So, if it's
not illegal to reuse single-use devices, is it ethical? Medical ethics
is based on the principles of beneficence (a duty to promote good and
act in the best interest of the patient and the health of society) and
nonmaleficence (the duty to do no harm to patients).8
Also included is respect for patient autonomy, the duty to protect and
foster a patient's free, uncoerced choices, from which are derived the
rules for truth-telling, disclosure and informed consent.8
Information should be disclosed whenever it is considered to be material
to the patient's understanding of his or her situation. In addition,
disclosure to patients about procedural or judgment errors made in the
course of care, if such information is material to the patient's well-being,
is also encouraged.7
Remember, error does not mean improper, unethical or negligent behavior
-- failure to disclose them might. The physician is required to act
in the best interest of the patient regardless of financial issues.
It includes management of the conflicts of interest and multiple commitments
that arise in any healthcare environment, especially in an era of cost
concerns.8 Therefore, a discussion with
the organization's ethics committee/group is essential in documenting
the issues the organization and providers face with this controversy.
As all healthcare organizations are required to have an organizational
ethics policy, it needs to be reviewed to determine if changes need
to be made.
If just
1 or 2 percent of all disposable devices used in the United States today
were reprocessed, the healthcare industry would save a billion dollars
every year.9 Prices of disposables have
been known to drop when a hospital informs their suppliers that they
are looking into reprocessing.1 Hospitals
can decide to reprocess their single-use items in-house or contract
with a reprocessing firm. Independent reprocessing firms charge hospitals
approximately one-half the price of a new device, while in-house costs
of reprocessing some devices can be approximately 10 percent the cost
of a new device.1 This is cost savings can
be further expanded to the cost of disposal of medical waste by the
industry and ultimately to the cleanliness of the environment. There
is no question that reuse of disposables saves money and the environment.
The only downside to the money issue is if an organization were to incur
a lawsuit based on an adverse event to a patient that was related to
the reuse of a single-use device.
The debate surrounding
the reprocessing issue is complex because it touches on many aspects
of healthcare. Patients need to be assured and feel confident that they
are receiving good care. Healthcare providers need to trust that what
they use is safe and works properly. The legal, ethical and regulatory
issues affect the healthcare industry, the patients and third party
reprocessors. The economics of reprocessing both for dollars saved and
environmental concerns is important to all parties. Into the controversy,
the FDA introduced their final guidance on reuse of single-use medical
devices.
The FDA has alternatively
been urged to regulate the process of reusing single-use devices and
then criticized for issuing too stringent regulations. Professional
healthcare associations, private sector businesses, hospitals and even
other federal agencies have both praised and argued with the guidance
provided by the FDA. With the state of the art and science reprocessing
technologies and device technologies are at, the lack of good research
on the efficacy of the practice, it is difficult to write regulations
that at once must protect the public, allow for cost savings to occur
and satisfy private industry. The FDA's Final Guidance has many proponents
and opponents.
What the FDA basically
did was to require hospitals and third-party reprocessors to follow
the same regulations that manufacturers of the devices did. This added
a burden to hospitals and reprocessing businesses, but assured the same
level of control throughout the country. There are seven requirements
that the FDA lists. These are:
- All facilities
are required to register initially and annually thereafter with the
FDA providing them with a comprehensive list of all medical devices
they reprocess.
- All organizations
that are engaged in reprocessing must use the Medical Device reporting
(MDR) and report all patient injuries related to device failures and
malfunctions.
- All organizations
must be able to identify all patients with a device that the FDA orders
tracked.
- A formal procedure
must exist for recalling or correcting defective products.
- A Quality System
Regulation (QSR) must be established and maintained for all aspect
of the reprocessing operation.
- Labeling of devices
must follow the same regulations as the original manufacturer of the
equipment had to use.
- Premarket
requirements based on the FDA's classification of a device. There
are two types of submissions. Unless the classification regulation
specifically exempts a device, a premarket notification 510K(k) is
needed for a class I and class II device. If a class III device is
submitted, a premarket notification or a premarket approval (PMA)
may be needed.1 The FDA then lists the
single-use devices known to be reprocessed, whether they are exempt
or not, and if not exempt, their classification.
Examples of devices
that fall into classification I are orthopedic chisels, general use
surgical scissors and orthopedic saw blades. Examples of Class II devices
are drills and burrs, recording and diagnostic EP catheters and sequential
compression devices. Class III devices examples are implanted infusion
pumps, transluminal coronary catheters and percutaneous and conduction
ablation electrodes.
A great deal of
time, effort and money goes into meeting these regulations. This has
forced many hospitals to contract with third-party reprocessors even
when they have been doing their own reprocessing for years with no infections
or malfunctions. Many OEM's readily state that they label devices for
single-use only as a marketing strategy realizing that the device could
be reused.
Change
in healthcare is never easy. New technologies and products have their
champions and critics. Some of the arguments are solidly based in research
and experience, others may never get to be researched and are forever
unknown to the provider and patient. In viewing this controversy, several
areas of healthcare need to be considered. Those touched on here are
legal, ethical, financial, political and, most important, the need to
provide and promote safety in the care of our patients. Cost reduction
must be balanced with patient safety issues. Although the society may
reap the benefits of reusing single-use devices through cost reduction,
environmental protection and judicious use of resources, the individual
patient may not. As with other areas of healthcare, research and emerging
technologies, the balance of the safety of the single patient and the
promise of future benefits needs to move toward a balance.
References
1. US Department of Health and Human Services Food and Drug Administration
Center of Devices and Radiological Health. Enforcement priorities for
single-use devices reprocessed by third parties and hospitals. August
14, 2000.
2. FDA's proposed strategy on reuse of single-use devices. August 24,
2001. www.ffda.gov/cdrh/reuse/singleuse/html.
3. Harbrecht, Doug. Sterilization A to Z. Infection Control Today. June
2001.
4. Centers for Disease Control and Prevention. Nosocomial infection
and pseudoinfection from contaminated endoscopes and bronchoscopes.
Wisconsin and Missouri. October 4, 1991.
5. Joint Commission on the Accreditation of Healthcare Organizations.
Inside Perspectives. "Exposure to Creutzfeldt-Jakob Disease. Issue
20, June, 2001.
6. West, John C. "Risk Management Issues in the Reuse of Single
Use Devices: American Society for Healthcare Risk Managers. Summer,
2000.
7. United States Surgical Corp. v. Orris, Inc. 5 F. Supp. 2nd 1201 aat
1207.
8. Annals of Internal Medicine. Position paper. Ethics Manual, 4th edition.
April 1998.
9. Selvey, Don. Medical device reprocessing: is it good for your organization?
Infection Control Today. January 2001.
10. APIC. Responding to Safer Sharps Legislation. January 21, 2001.
11. AORN. Reuse of Single Use Disposable Devices. AORN Online.
12. Walker, E.D. Reuse of disposable medical devices. American Society
of Healthcare Risk Managers. Fall 1984.
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