NEW federal rules seek to ensure medical equipment's safe recycling

Tuesday, September 4th 2001, 12:00 am
By: News On 6

WASHINGTON (AP) _ It's one of medicine's little secrets: Unknown to most patients, hospitals every day reuse equipment that was designed to be used once, then thrown in the trash.

This recycling covers everything from simple surgical clamps to hard-to-sterilize angioplasty balloons. Some doctors call it a safe way to save lots of money; others decry it as a serious risk for infecting or injuring patients.

It is hard to know who is right because no one has regulated the practice. Now, following years of complaints about the uncertainty, federal rules to ensure recycling is done safely are kicking in.

Food and Drug Administration inspections of hospitals are set to start any day, to see who is recycling and ensure that quality standards are followed.

It just became illegal for anyone _ hospitals or the $20 million industry that offers to do the recycling for them _ to recycle certain risky products such as angioplasty balloons.

More restrictions come next year. Recyclers will have to prove that nooks and crannies in numerous other devices, such as cardiac catheters, can be adequately resterilized without damaging delicate parts, to keep recycling them.

The rules are causing rancor. Makers of disposable devices _ who stand to sell more under a recycling crackdown _ complain the FDA is not tough enough. When several companies failed to finish studies proving the safety of recycled heart catheters they have been selling, the FDA gave them six more months to comply instead of stopping sales.

Recyclers argue that the FDA is requiring too much safety proof on short notice. They say it is no more risky to resterilize a disposable device than to clean similar products intended to be reused.

The FDA is frustrated that while as many as a third of hospitals are estimated to recycle in-house, not a single one registered with the government for easier quality monitoring.

Numerous hospitals say the FDA's rules are forcing them to quit recycling and instead spend millions buying new medical equipment or hiring private recyclers.

``We have totally stopped reprocessing'' because the quality standards are ``impossible to meet,'' says Richard Ketcham, president of Brooks Memorial Hospital in Dunkirk, N.Y.

He points to simple external cuffs used to squeeze bedridden patients' legs to help blood flow. ``In my mind, there is absolutely no reason they cannot be wiped off and reused,'' Ketcham said. What once cost pennies to clean in the hospital will now run $20 apiece to send those cuffs to an FDA-approved recycler for sterilization.

Hospitals and recycling companies do revamp more intricate equipment _ cardiac catheters or tiny, wired biopsy devices threaded deep into the intestines _ without first proving such products can be properly resterilized, or how often they can be reused without breaking.

What is a patient to think?

Independent experts say some devices are safely recyclable, while others are not.

The Centers for Disease Control and Prevention has found no evidence of a major infection threat. On the other hand, there is no good tracking system of hospital-caused infections so there is no way to prove recycled devices have never caused infection, congressional investigators concluded. If a surgery patient develops a fever days later nobody checks if a recycled device even was used during the operation or if something else was to blame.

Adding to the confusion are cases such as that of a Kansas woman who, FDA records show, has a piece of metal lodged in her heart after a reused catheter broke during surgery. New catheters sometimes break, too.

So the FDA's new rules strive for a middle ground.

The agency's own research found that recycling angioplasty balloons dangerously stretched them; they can no longer be recycled. The less risky the device, the less proof required to keep recycling. It is pretty easy to resterilize a simple bone saw, for instance.