Monday, April 7, 2008

Medical device reuse bill shelved on Beacon Hill

By Ryan McBride

The Massachusetts medical devices industry has hit a roadblock in its campaign to limit the reuse of recycled catheters, medical scissors and other products. But one company in the state has decided not to wait for proposed legislation to ban recycled medical devices -- it has redesigned its product to stymie efforts to reprocess the device.

Though the U.S. Food and Drug Administration allows some "single-use" medical devices to be reprocessed, manufacturers of those products argue that the recycled devices can be tainted and pose health risks. U.S. hospitals have countered that they save millions annually by purchasing refurbished devices instead of new ones.

On March 18, the state Legislature's joint public health committee voted not to report favorably on bills requiring hospitals to let patients choose to be treated with recycled or new single-use devices. The bills were given a study order, which all but kills the legislation for this year, state officials said.

Radi Medical Systems Inc., a Swedish firm with U.S. headquarters in Wilmington, has decided take its fight against the reuse of its medical devices in a different direction. The company plans this month to sell a new version of its single-use FemoStop device with certain parts that would be damaged by chemicals commonly used in reprocessing, said company COO James Archetto.

"No question," Archetto said, "over the years reprocessing has cost us millions of dollars."

The FemoStop wraps around the leg and has an external pump to apply pressure to help seal surgical wounds in the femoral artery after surgery. Previous versions of the device, on the market since 1992, come with a detachable pump that is taken off while other components are sterilized. But the pump, which could be damaged in the cleaning process, is built into the latest version, Archetto said.

The redesign of single-use medical devices to prevent reprocessing has been tried before with varied success, says an advocate for the reprocessing industry.

"All they are doing is cheapening the product so the hospital is forced to buy a new one," said Daniel Vukelich, president of the Association of Medical Device Reprocessors, a Washington, D.C., industry group. He testified against the legislation in Massachusetts and opposes similar state bills pending in Rhode Island and New Jersey.

Covidien Ltd., a medical products giant based in Mansfield, makes, among other devices, single-use pulse oximeters that are reprocessed. Spokesman Bruce Farmer said that Covidien has never intentionally modified its single-use pulse oximeters to prevent them from being reprocessed. Like other medical device makers, Covidien has come out against reprocessing, stating that pathogens such as hepatitis C may remain on a device after the cleaning procedure.

The U.S. market for reprocessed medical devices was $150 million in 2007, Vukelich said, and reprocessors typically charge about half as much as manufacturers for their refurbished products. The FDA permits about 2 percent of all medical devices labeled as "single-use" to be reprocessed.

Arguments against reprocessing took a blow in January, when the U.S. Government Accountability Office issued a report to Congress that said there wasn't sufficient evidence that reprocessed, single-use devices posed greater health risks than new single-use products.

Yet officials at Smith & Nephew PLC in Andover point to a study the medical devices firm funded to compare its new arthroscopic shaver blades to reprocessed models, which found traces of human proteins and DNA on the recycled products. The study also said the recycled blades, used to remove tissue in surgeries, were less functional than new ones.

"We believe that we're fighting the good fight here, and at the end of the day the patient is the one that would benefit from (anti-reprocessing laws) being passed," said Joseph Metzger, a spokesman for Smith & Nephew, a British company with its U.S. headquarters in Massachusetts. "We're fighting very hard for it."

The Massachusetts Medical Device Industry Council, or MassMEDIC, has advocated for the now-shelved legislation that would have enabled patients to choose between new or reprocessed single-use devices. MassMEDIC has lobbied for the legislation since 2005 and hasn't decided its next step, said Thomas Sommer, president of the industry group in Boston.

"We're not clear as to whether we're going to bring it up again," said Sommer. "I've got to go to my members to see if they are interested."