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Device Makers Fight Reuse of Surgical Tools

Posted on: Wednesday, 19 October 2005, 12:01 CDT

By Ross Kerber, The Boston Globe

Oct. 19--Medical-device companies say an increasing number of doctors are treating patients with improperly sterilized surgical tools, catheters, and other instruments that are contaminated with blood or bacteria.

The companies are pushing for a state law that would require patients to consent before being treated with reprocessed instruments. A State House hearing on the bill, sponsored by State Senator Susan C. Tucker, Democrat of Andover, is scheduled for today.

To bolster their case, manufacturers have distributed to legislators photos of fouled or damaged instruments they say were shipped for reuse by reprocessors.

For example, a photo provided by Boston Scientific Corp. shows dried blood on a forceps it manufactured, the Natick company said. Boston Scientific said the forceps was going to be used to obtain a gastrointestinal tract tissue sample until doctors noticed the stains.

Another photo, from Smith & Nephew PLC's endoscopy unit in Andover, shows unidentified matter on a supposedly sterilized blade that was going to be used to trim torn tissue during knee surgery.

"It's medicine's dirty little secret," said Nigel Wilkinson, vice president of quality assurance for Smith & Nephew, which makes surgical instruments. In addition to the increased risk of infection, the instruments aren't designed for the stress of reuse, he said.

Tucker said Smith & Nephew proposed the idea of legislation. "To me it's a consumer protection issue, and it deserves to be brought to attention," she said. Though the proposal is likely to boost sales of the manufacturers' single-use devices, Wilkinson and other executives say they're mainly motivated by health concerns.

The devices were designed to be thrown away after single use, but sterilizing them for resale to hospitals at discount prices has become a $125 million business in the United States. Some organizations, including the Massachusetts Hospital Association and the American College of Cardiology, say reuse is safe, and manufacturers can only document a few instances of patients being put at risk. Used instruments can save a medium-sized hospital tens of thousands of dollars a year, according to the Massachusetts Hospital Association.

Reprocessing industry officials discount the manufacturers' photos because the companies refuse to identify the hospitals that supplied them. The companies say their sources fear being sued.

"We've seen these [photos] before, and we just don't know the chain of custody," said Mark Salomon, senior vice president of Vanguard Medical Concepts Inc. in Florida, one of the largest reprocessing companies.

Smith & Nephew said the fouled blade it photographed was reprocessed by Alliance Medical Corp. of Phoenix. Don Selvey, Alliance vice president of quality, said its tests showed the substance on the blade was a common surgical lubricant.

Still, Dan Vukelich, deputy executive director of a reprocessors' trade group, worries that such photos might have an impact. "The biggest single problem we have is the 'yuck' factor," he said.

The regulation of single-use devices has long been a hot issue among manufacturers of medical devices, an $80 billion industry in the United States. Traditionally there were sharp distinctions between devices meant to be thrown away after one procedure, and those such as clamps that hospitals were allowed sterilize for reuse. But since 1995 more single-use devices have been introduced. Manufacturers say they are often more appropriate for complicated procedures.

Doctors and hospitals began re-sterilizing devices to save money. Eventually, that gave rise to the reprocessing industry, which resells millions of used instruments, often for half their list price. A 2002 Food and Drug Administration survey found 24 percent of all US hospitals re-use devices intended for single use, including compression sleeves, drill bits and saw blades, and endoscopic instruments. At hospitals with more than 250 beds, the figure was 45 percent, the FDA found.

The savings can be significant. For instance, a Boston Scientific single-use biopsy forceps for sampling digestive tract tissue cost about $25, compared to $125 for a similar device that can be sterilized 30 times.

At the urging of manufacturers, the FDA in 2002 began requiring reprocessors to submit more data to prove their operations were safe. Device makers said that wasn't stringent enough.

But it is hard to find evidence of patient injuries caused by reprocessed devices.

The FDA's database for reporting adverse events from medical devices shows 18 incidents tied to the three large reprocessing companies since 2004, a small number relative to the total output. In one case, a doctor noticed metal filings and chips during a procedure using a shaver reprocessed by Vanguard Medical Concepts, but the patient wasn't harmed. Vanguard says it has reprocessed 17 million devices with no patient injuries, lawsuits, or settlements.

Despite the safety record, some doctors remain concerned. A study conducted at Loma Linda University in California and funded by Smith & Nephew found that of 16 shaver blades reprocessed for arthroscopic surgery, eight contained detectable levels of nucleic acids, presumably from human cells, and four had traces of proteins. Many also had damaged teeth.

In Pinellas Park, Fla., surgeon Phil Davidson, a consultant to Smith & Nephew, said he stopped using reprocessed arthroscopic surgical blades three years ago after he found one that contained "a gunky black material, presumably from a previous usage."

He said he also has seen MRIs that show metal flakes on joints that were treated with reprocessed blades. "I wouldn't ask a patient of mine to sign a consent to be treated with one of them," Davidson said.

At North Shore Medical Center in Salem, orthopedic surgeon Douglas Halsted said he and other surgeons refused to use reprocessed arthroscopic shaver blades the hospital bought from Alliance Medical. Halsted said that under a microscope the edges didn't appear as sharp as new ones. The hospital's chief medical officer, Mitchell Rein, said it stopped buying the blades in 2004 at the surgeons' request.

Reprocessing companies have plenty of supporters as well. Emerson Hospital in Concord saved $90,000 in a year by purchasing instruments from Alliance, according to a press release issued by VHA Inc., a buying group for nonprofit healthcare organizations.

At Massachusetts General Hospital, materials-management director Ed Raeke said the hospital has used reprocessed compression sleeves, which stop blood clots from forming in limbs, and had no concerns about quality.

But the hospital doesn't use many reprocessed surgical tools, Raeke said. "I think the clinicians would want more information before they would use the more invasive devices," he said.

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Source: The Boston Globe

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