- Hello Jeff -- I am very anxiously awaiting the next WABC
NY radio news report and information on the anesthesiologist being investigated
for HCV infections. I was listening last hour and the news story of the
doctor was stopped in midsentence. We were led to believe by the newscaster
that it was some sort of technical problem. I am hoping that it is not
a coverup and the information on the doctor and the case buried.
-
- The spread of HCV via medical/dental care setting is
not as rare as health officials would have us believe. In fact, there is
a very high risk, especially in the reuse of medical equipment.
-
- Although the article below is dated August 2, 1999, it
is still subject for discussion today and subject matter that health officials
don't want people to know.
-
- Patty
-
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- Hepatitis C And The Reuse Of Medical Equipment
- Risky Reuse Of Medical Equipment Is On The
Rise In Health Care
-
- Sylvia Pagan Westphal
- Times Staff Writer
-
- U.S. officials say the largely unregulated practice has
resulted in catheter tips breaking off in hearts, caused infections and
created other problems. FDA action is imminent.
-
- Millions of medical devices that come in contact with
blood or other body fluids and are supposed to be discarded after one use
are instead being reprocessed and reused, putting other patients at risk
without their knowledge, some experts fear. The U.S. Food and Drug Administration
is poised to crack down on the largely unregulated practice, which is escalating
because managed care reimbursements are not sufficient to cover the costs
of new devices. About 1 million disposable devices are reprocessed every
year in the United States. Reports stored in government files document
malfunctions related to reprocessed disposable devices, such as cases of
cardiac catheters with tips that have broken off inside a patient's heart.
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- Other incidents include infections caused by presumably
non-sterile devices, as well as adverse patient reactions to bacterial
toxins left after devices are cleaned. The situation is most critical at
hospitals, which often lack guidelines on how to reprocess a device. About
one-third of all hospitals use reprocessed disposable devices, according
to a recent survey.
-
- "It's a pretty grim scene, as far as I'm concerned,
with what's going on in the hospitals," said Anne Cofiell at a recent
meeting co-sponsored by the FDA and the Assn. for the Advancement of Medical
Instrumentation. Cofiell represents workers at hospital sterilization facilities.
"I can tell you, just in general, there's lots of reuse going on with
no protocols, no standards, no nothing," added Patty Stein of Advanced
Sterilization Products.
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- The FDA historically has not considered reprocessing
illegal, openly exercising regulatory discretion with those who reprocess
single-use medical devices. That includes hospital in-house reprocessing
facilities, as well as a rapidly growing group of "third-party"
reprocessors. At present, the agency does not require reprocessors to demonstrate
that a device is safe after it has been reprocessed. But that might not
last long. In a recent letter to the Assn. of Medical Device Reprocessors,
the FDA stated that "third-party reprocessing of devices labeled for
single use is unlawful" unless reprocessors provide documentation
that a device is safe. Manufacturers also are urging the agency to take
a stand on the issue of reprocessing.
-
- In May, the Medical Device Manufacturers Assn. requested
a ban on use of reprocessed single-use devices. And recently Sen. Richard
Durbin (D-Ill.), who is proposing legislation to force stricter regulations
on reprocessors, asked the U.S. General Accounting Office to investigate
the practice of reprocessing. Caught in the middle of the controversy is
the patient. Doctors are not required to inform patients that a reprocessed
single-use device will be used on them. Also, the patient is usually billed
the same amount, regardless of whether a device was new or reused. "It
is only a matter of time until the public becomes aware in large measure
of the reuse situation," said Lynn Sehulster of the U.S. Centers for
Disease Control and Prevention at the conference in May.
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- "Will they tolerate this practice? This remains
to be seen, but for now, reuse is largely unadvertised." The situation
sets manufacturers, who want to sell as many new devices as possible, against
the rapidly growing industry of third-party reprocessors, who cater to
hospitals striving to save health care dollars. According to the manufacturers,
reusable devices are made of durable materials, shaped so they are easy
to clean, and tested for multiple use. In contrast, says the association,
single-use devices are engineered for only one use. "These devices
are intricate, they have sharp points or tightly coiled wires, and they're
often made of materials not used to withstanding mechanical or biochemical
aspects of reprocessing," said Philip Grossman, a Miami gastroenterologist
who is a consultant for manufacturers. Widely reprocessed devices include
electrophysiology catheters--long wires guided through a blood vessel into
the heart that are used for measuring the organ's electrical activity.
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- Also on the list are angioplasty balloons--thin inflatable
devices that unclog arteries--and biopsy needles, used to take small tissue
samples. Rising Costs Drive the Practice Even as the controversy unfolds,
economic pressures are forcing hospitals to consider reuse of disposable
devices more than ever. For example, the cost of two new cardiac catheters
during a typical electrophysiology procedure can amount to about $2,000,
said Mark Salomon of Vanguard Corp., one of the biggest third-party reprocessors.
This is about 60% to 80% of the reimbursement for the entire procedure,
including personnel and surgical costs. Third-party reprocessors can save
the hospital from 30% to 50% of the cost of the devices. If reprocessing
were to be restricted, health care costs for hospitals would escalate,
many argue. According to the American Hospital Assn., restrictions on reprocessing
could "seriously affect both the quantity and the quality of health
care we offer our patients." Roger Richter, a spokesman for the California
Healthcare Assn., said he doubts that a ban on reprocessing will lead to
higher reimbursements for procedures. Reprocessors agree that not all single-use
devices are reusable. In fact, Salomon said that out of the thousands of
single-use devices, his company reprocesses only 15 types. Salomon said
Vanguard will reprocess only those devices that can be successfully cleaned
and sterilized. Reprocessing, when done well, does not pose a threat to
patients' health, reprocessors say.
-
- But FDA files on adverse outcomes from reused disposable
devices in the last few years would seem to argue the contrary. Some involve
malfunctioning devices, such as three cases of electrophysiology catheters
that broke during surgery. In one case, the tip of the catheter remains
lodged in the patient's atrium. In another, the 4-inch-long tip traveled
from the patient's heart to his stomach, leading to additional surgery
in which doctors opened the man's stomach in an attempt to remove the tip.
The device's manufacturers say they are unaware of any cases in which such
a catheter broke during its first use. Also, cardiac catheters became contaminated
with high levels of bacterial toxins in a Colorado hospital.
- "One death occurred from this particular outbreak,
and these were definitely reprocessed catheters," said Trish Perl,
an infection control practitioner at Baltimore's Johns Hopkins Hospital.
But as emotionally charged as those incidents are, FDA officials stress
that they are isolated, considering that tens of millions of devices have
been reprocessed over the years. And even then, they say, it is hard to
prove that a device malfunctioned or spread an infection because it had
been reprocessed.
-
- ****In fact, the FDA has many reports of new devices
failing during their first use. And a number of tuberculosis and hepatitis
C outbreaks have been linked to devices that were approved to be reused.
"The problem all along, and the reason why we have not exercised any
regulatory discretion, is because we have not had really good data with
which to project that a certain amount of harm was occurring to the public,"
said Larry Spears, director of the division of enforcement at the FDA's
center for devices and radiological health. The lack of adverse reports
is not hard to envision in a system where tracking of reprocessed devices
is poor, manufacturers say. Product failures are often registered as a
problem with the device itself, without mentioning that the device was
reprocessed. Health professionals know that using a reprocessed single-use
device can bring liability, a clear disincentive to report an adverse outcome.
And there is no proper follow-up on patients on whom reprocessed devices
have been used. Many participants at the recent conference agreed there
is no good tracking, by either hospitals or doctors, of which patients
have been operated on with reused devices.
-
- "So we don't really know what's happening to all
of these patients. Sometimes complications that can occur look like the
complications [that] occur from other things," Grossman said at the
conference. Few Safety Studies Have Been Undertaken Independent, peer-reviewed
studies of reused disposable devices are scarce. The few studies that have
been done, experts agree, are not substantial enough to conclude that reprocessing
disposable devices is either safe or unsafe. Other analyses abound that
tend to incriminate or absolve the practice of reprocessing--but these
are mostly sponsored by manufacturers or reprocessors, and the results
tend to support the sponsor's point of view. Manufacturers say all they
ask of the FDA is a level playing field. Health care in the United States
is based on the premise that devices and drugs need to be proven safe before
they even go to the market. If it is not known whether reprocessing is
safe, manufacturers argue, those devices should not be allowed near patients
until their safety is proven beyond doubt.
-
- Right now, if a manufacturer wants to change the label
of a device from "single use" to "reusable," the FDA
requires it to submit documentation, called pre-market notification, showing
that the change in use is safe. But the FDA does not require third-party
reprocessors to submit similar documentation, even though reprocessing
essentially changes the classification of a device from single-use to reusable.
In fact, manufacturers argue that many third-party reprocessors are not
even registered with the FDA. Of an estimated 23 such companies, only seven
are registered with the agency. The FDA is considering several options.
One is to force reprocessors to submit documentation that reprocessed devices
are safe. The agency also could request manufacturers to prove that labeling
a device as "single use" really means that it can't withstand
reprocessing."Absolutely, some simpler-looking devices labeled as
single-use can maybe be reused. But the burden will be on the person [who
wants to find out]," said Josephine Torrente, president of the Assn.
of Disposable Device Manufacturers. In fact, some of the instruments being
reprocessed, Vanguard's Salomon said, used to be marketed by manufacturers
as reusable before the labels were changed to "single-use."Others
claim that in the past, manufacturers knew that hospitals were reprocessing
their single-use devices, and it did not seem to be causing much concern."So
it appears to many of us that as long as it was just hospitals reprocessing
any device, that was not a problem. But as soon as the reprocessors stepped
on the playing field and took too much of the piece of the pie, then there
was cause for a concerted alarm," said Kay Watson, who manages sterilization
for the Texas Heart Institute. FDA officials said the agency hopes to have
an official position on reprocessing of single-use devices by October.
-
- * * * Most Frequently Reused Disposable Medical Devices
1. Anesthesia breathing circuits 2. Electrosurgical devices 3. Respiratory
therapy breathing circuits 4. Biopsy needles 5. Electrophysiology catheters
6. Hemodialyzers 7. Cardiac catheters 8. Angioplasty balloons Source: Emergency
Care Research Institution Copyright 1999 Los Angeles
- Debate on Medical Equipment Reuse Continues
-
- At hospitals across the country, millions of medical
instruments that come in contact with blood and other bodily fluids labeled
"for single-use" are being used more than once. While alarming
at first, this reality may or may not be cause for concern. Providing quality
health services at an affordable price is the essential, overarching goal
of healthcare. Involved parties must strike the appropriate balance by
exploring available options, protecting the sick and minimizing material
and financial waste.
-
- As debate on medical equipment reuse continues, it is
essential that hospitals and other health settings follow cleaning and
sterilization guidelines set forth by government health agencies, such
as the U.S. Food and Drug Administration (FDA) and Centers for Disease
Control and Prevention (CDC).
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- Regulating Single-Use Devices
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- In October 1999, the FDA issued a letter stating that
it "has been unable to find clear evidence of adverse patient outcomes
associated with the reuse of a single use device [SUD] from any source."
This year, the FDA wrote, "Despite a lack of clear data that directly
link injuries to reuse, FDA has concluded that the practice of reprocessing
SUDs merits increased regulatory oversight. We are concerned because we
do not have enough information to be certain that SUDs are being reprocessed
properly."
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- This concern may be warranted, as there is increasing
evidence that the reuse of certain medical equipment can create a risk
to patients. For example, according to an infection control practitioner
from Baltimore's Johns Hopkins Hospital, a Colorado case in which reused
cardiac catheters became contaminated with bacterial toxins resulted in
the death of a patient. And from devices that have been FDA approved for
reuse, a number of tuberculosis and hepatitis C outbreaks have occurred.
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- It is extremely difficult to prove whether or not a reprocessed
device has caused disease. While the reuse of SUDs has been linked to occasional
medical problems, the FDA acknowledges these misfortunes are isolated incidents
given the tens of millions of SUDs that have been reused over the years.
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- On many devices, the "single-use" label is
an arbitrary designation. Device manufacturers, not the FDA, choose when
to label a device as single-use. In the wake of increased disease awareness,
many devices that were previously marketed as reusable are now labeled
as "single-use only" regardless of durability and cleaning ease.
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- Why Equipment Is Reused
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- Despite the uncertainties surrounding safety, reusing
SUDs is a common practice and has a clear purpose: to control costs. The
American Gastrointestinal Association believes that so long as reused SUDs
are reprocessed safely, reuse should be allowed: "Labeling these products
as 'single-use' greatly increases the cost of care without necessarily
increasing the patients' safety." Many hospitals rely on third-party
reprocessing services instead of attempting to sterilize the devices in-house.
In addition to shifting potential liabilities from a hospital to a company,
these services provide a 50% cost savings, as compared to purchasing a
new device, according to the Association of Medical Device Reprocessors
(AMDR). AMDR also highlights that third-party reprocessors often have more
capital available than hospitals to invest in state-of-the-art cleaning,
sterilization, and testing equipment. Most reprocessing companies also
work in compliance with all applicable FDA Quality System Regulation (QSR)
requirements.
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- At this time, there is no foolproof protocol assuring
the safe reuse of SUDs. But to understand the sterilization process, healthcare
workers, particularly those charged with sterilizing or purchasing equipment,
should study the U.S. Environmental Protection Agency's (EPA) definitions
of cleansers and the hospital environmental control guidelines created
by the U.S. Centers for Disease Control and Prevention (CDC).
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- When to Use Antimicrobials
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- The EPA classifies antimicrobial agents as substances
or solutions that destroy or suppress the growth of harmful bacteria, viruses
or fungi on objects and surfaces. Different medical devices call for different
antimicrobial treatments, but disinfectants, sanitizers and sterilizers
comprise the majority of antimicrobials used in hospitals and homes. Disinfectants
are chemical-based products, such as chlorine bleach, which destroy or
irreversibly inactivate most pathogens. Sanitizers are products that reduce
the number of living microorganisms by significant numbers, but do not
destroy or eliminate all microorganisms. Sterilizers destroy all forms
of microbial life. Often in the form of pressured steam, liquid or gaseous
chemicals, or dry heat, sterilizers are crucial in a hospital environment.
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- The CDC divides patient-care equipment into three general
categories: noncritical items, semicritical items, and critical items.
Noncritical items consist of crutches, bedboards and other accessories.
A chemical-based detergent is all that is necessary to remove, rather than
kill, any of the microorganisms present. Semicritical items are exposed
to bodily fluids and tissue, but do not penetrate the body's surfaces;
examples being rigid fiberoptic endoscopes, endotracheal tubes, and anesthesia
breathing circuits. In most cases, the CDC recommends that hospitals employ
high-level disinfectants if not steam sterilization. Sterilization is imperative
for all critical items. These are the objects that are introduced directly
into the bloodstream or other sterile areas. Examples are surgical instruments,
cardiac catheters, implants, and the blood compartment for a hemodialyzer.
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- Lessons to Be Learned
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- The debate on medical equipment reuse seeks to achieve
the delicate balance between quality and affordability. Whether the risks
associated with reusing SUDs outweigh the benefits remains to be determined.
Healthcare professionals must adhere to federal guidelines that attempt
to ensure the safety of medical equipment and minimize the threat of device
contamination.
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- http://www.waterandhealth.org/newsletter/new/winter_2002/index.html
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- Patricia A. Doyle DVM, PhD
- Bus Admin, Tropical Agricultural Economics
- Univ of West Indies
-
- Please visit my "Emerging Diseases" message
board at:
- http://www.emergingdisease.org/phpbb/index.php
- Also my new website:
- http://drpdoyle.tripod.com/
- Zhan le Devlesa tai sastimasa
- Go with God and in Good Health
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