Reused Medical Devices Endangering Patients, Experts Say/Managed care cause of practice

Kirsten Neilsen kirsten at
Mon Aug 2 10:35:02 PDT 1999

[and a major argument against "socialized" medicine is quality of care? what could be scarier than this example of free market medicine?]

Los Angeles Times

> 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
> numerous other patients at risk without
> their knowledge, some experts say.
> The U.S. Food and Drug Administration
> is poised to crack down on the largely
> unregulated practice, which is growing
> 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.
> 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. Also in the list are
> angioplasty balloons -- thin inflatable
> devices that unclog arteries -- and
> biopsy needles, used to take small
> tissue samples.
> 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. Other incidents include
> infections caused by presumably
> nonsterile devices, as well as adverse
> patient reactions to bacterial toxins
> left over 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 currently
> use reprocessed disposable devices,
> according to a recent survey.
> ``It's a pretty grim scene,'' said Anne
> Cofiell at a recent meeting
> co-sponsored by the FDA and the
> Association 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.
> 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 Association 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 Association
> 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.
> 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.
> Even as the controversy unfolds,
> economic pressures are forcing
> hospitals to consider reuse of
> disposable devices.
> If reprocessing were to be restricted,
> health care costs for hospitals would
> escalate, many argue. According to the
> American Hospital Association,
> restrictions on reprocessing could
> ``seriously affect both the quantity
> and the quality of health care we offer
> our patients.''
> next/ previous article in Chronicle section
> ©1999 San Francisco Chronicle Page A3

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