ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Sunday, January 12, 1997 TAG: 9701130127
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
The arthroscopic blades, special equipment for knee surgery, were meant to be used once, then thrown away. But in a practice becoming commonplace in American hospitals, they were resterilized to be used again - despite undetected pieces of a previous patient's tissue still stuck inside.
Medical devices are being recycled, from arthroscopic knee-surgery blades to catheters threaded into patients' hearts, and federal regulators are investigating whether this effort to save money is endangering American lives.
A preliminary Food and Drug Administration study uncovered dozens of reports of infection, chemical injuries or mechanical failures associated with reusing equipment designed to work just once.
``We don't think we have an epidemic'' of injuries, emphasized Dr. Susan Alpert, FDA's chief of device evaluation. But ``I don't mean to say there isn't a problem with refurbished devices.''
Medical device manufacturers, worried about liability but also about losing money from resterilization, are urging a crackdown. Companies brought the FDA photographs showing tissue-tainted equipment, including the arthroscopic blades at a hospital officials refused to identify, and argued that people who resterilize are under no federal oversight to ensure they do a safe job.
Proponents rebut that argument with the contention that reuse is safe and vital to bring down health-care costs.
``If a [cardiac] catheter sells for $300-$400, and we can reprocess it for less than $50, it doesn't take long to look at the finances,'' said Tom McGoldrick of Minneapolis-based MinnTech. The company sells equipment in Europe that has resterilized hundreds of balloon catheters used to clear clogged heart arteries.
MinnTech won't sell its sterilizing machines domestically because clinical trials necessary for FDA approval cost too much.
The FDA does not regulate hospitals, however, and they quietly resterilize in-house. Nor does it regulate an entirely new industry working for hospitals.
FDA scientists are meeting privately Monday with experts from the Centers for Disease Control and Prevention and the Health Care Financing Administration to compare injury reports and study whether the government should intervene.
Obvious infection risks aside, the thin plastic and delicate parts of many disposable devices weren't designed to withstand sterilizing over and over.
Recycling ``single-use'' devices has been big business overseas for years, but France recently prohibited reuse. In Canada, Quebec's health ministry last summer told hospitals to stop for fear of infection in reusing cardiac catheters. The province's hospitals estimated reusing catheters saved them $10 million a year.
``The end result is probably poorer health care,'' if hospitals do fewer surgeries because they can't afford new equipment, said Philip Neufeld of the government's Health Canada.
The first recycled devices in the United States were dialysis filters that individual patients used repeatedly. The practice was thought safe because patients never shared ``dialyzers,'' but studies in the early 1990s found clinics that reused dialyzers had more deaths.
The danger was in the resterilization method, something the government believes has been improved and is safe - just as hospitals begin reusing dozens of other devices.
``It's a situation that requires a lot more study to balance everybody's interests,'' said Jack Lord of the American Hospital Association. ``Clearly, patient safety is first.... The onus is on the hospital and doctor.''
The FDA recently hunted for injuries among a sample of 3,000 reports to its medical device database since 1991. About 600 injuries were reported for reused dialyzers, although many occurred before kidney clinics adopted safer resterilization.
But 60-100 problems - infection, injuries from sterilizing chemicals, mechanical failure - were reported with other devices, from tiny electronic tubes used in endoscopic surgery to angioplasty balloons.
The reports don't prove the reused devices were to blame. But problems may be underreported.
If ``to save a few dollars, a hospital decides to reuse a catheter and it breaks off in somebody's body, that's not a comfortable thing for them to report,'' said Larry Kessler, FDA's director of device surveillance.
Take those heart balloons. They lose strength to push aside artery blockages with each use, said Dr. Jeffrey Breall, Georgetown University Hospital's catheterization chief.
Plus, some patients get fevers, chills and other symptoms, a reaction to microscopic particles left on reused catheters, he said. They're not actual infections and don't cause long-term damage, Breall said, but it makes the patient miserable.
He says Georgetown colleagues do reuse less-delicate catheters that measure electrical activity in the heart. Mechanical failure with those tools wouldn't plunge a patient into crisis, although patients suffer similar fevers, Breall said.
A study of 90 Floridians treated with reused balloon catheters concluded the practice was safe with strict sterilization. Dr. Kevin Browne of the Watson Clinic found that only four reused balloons failed to squeeze through blocked arteries. New balloons were substituted successfully during those surgeries.
Many U.S. doctors are awaiting an imminent report by the independent health research firm ECRI that promises to help hospitals determine how to safely reuse devices. A chief recommendation will be that hospitals first perform pilot studies proving reuse won't hurt.
``There's room to say it could be accomplished safely, but it's going to depend on the device, and the skill and competency'' of the hospital or resterilizing company, ECRI vice president Ronni Solomon said.
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