State Looks at Practice of Reusing Medical Tools Some Say Lack of Laws Leaves Patients in the Dark

Article excerpt

Byline: Don Thompson Daily Herald State Government Writer

SPRINGFIELD - Imagine undergoing a heart angioplasty or arthroscopic knee surgery and finding out what were intended as single-use surgical devices had in fact been used in someone else's surgery.

A new state law allows such disposable devices to be sterilized for reuse by anyone registered with and licensed by the U.S. Food and Drug Administration, or any licensed hospital.

But the FDA isn't doing any regulation beyond requiring processors to provide a name and address, say the Health Industry Manufacturers Association and the ECRI independent research laboratory. And the hospital licensing requirements don't include being able to adequately sterilize disposable devices.

"We are concerned that the law, as currently written, will ... allow unsafe reprocessed single-use devices to be used on unsuspecting patients," warned HIMA special counsel Nancy Singer before the Illinois law took effect Jan. 1. HIMA's members include the makers of much of the disposable tools hospitals are now reusing.

The law contains enough protections to make sure that doesn't happen, countered Dr. M. LeRoy Sprang, chairman of the board of the 18,000-member Illinois State Medical Society, and Karen Porter, spokeswoman for the Illinois Hospital and HealthSystems Association.

The law's sponsor, state Sen. Evelyn Bowles, said she was so shocked when she first heard of the practice that she tried to ban it entirely. But opposition from providers prompted her to amend her bill instead to make Illinois the first state to regulate those who reprocess such equipment.

"It just seemed to me an awful thing, but they're apparently doing it with (orthodontic) braces and everything else now," said Bowles, a Republican from Edwardsville. "I'm very, very anxious for the department (of Public Health) to get on the stick and write these regulations."

The department was ready to issue those regulations in December. But then it ran into so much opposition from both sides that it withdrew them and is now trying to round up enough scientific research to determine who's right.

That leaves the practice still substantially unregulated, said Bowles and department spokesman Tony Sanders. And the revised regulations are expected no time soon.

"It's a cottage industry that has grown from the ground up, and there are probably good reprocessors and bad reprocessors out there," said David Valestin, director of materials management at Christ Hospital in Oak Lawn. He and others say even disposable medical items are usually manufactured to such exacting standards that they can stand up to repeated surgeries.

Many hospitals send out items to be sterilized, so they are eager for the state to set standards for those reprocessing companies, said Valestin, who testified at the Department of Public Health hearing in December. …