IOM escucha se preocupa, las sugerencias para la aprobación médica del dispositivo del FDA

por Brendon Nafziger, DOTmed News Associate Editor | June 18, 2010

Consumer advocates agreed. "There needs to be a new tone," William Vaughan, of Consumers Union, which runs the magazine Consumer Reports, said. "We have no idea what we're getting when we get one of these [medical devices] in our body. We don't know how long it will last."

But Mark Leahey, head of the Medical Device Manufacturers Association, an industry lobby, observed that the 510(k) process was a "genuine success." Over 100,000 products were cleared by the process since it was instituted over 30 years ago, with few examples of adverse events, he said.

And some doctors groups also liked the status quo.

"The American Academy of Orthopedic Surgeons strongly believes the current 510(k) process combined with surveillance programs provides the most favorable balance between benefits and risks," Dr. Kent Lowry said, speaking on behalf of the group during a public comment period.

But nearly everyone agreed that the situation was difficult, in some ways tougher than regulating pharmaceuticals: The FDA employs nearly 12,000 people, but still lacks the manpower and resources needed to really tackle the hundreds of thousands of products released in the field.

"There are 750,000 different types on the Europe market, compared to no more than 10,000 active molecules in pharma, and probably less than that if you tease down," said Dr. David Jefferys, senior vice president of global regulatory affairs for Eisai Europe Ltd., a pharmaceutical company.

"Once you develop penicillin, it's penicillin," David W. Feigal Jr., an ex-FDA official who now handles regulatory affairs for the drug-maker Amgen, said. "Devices don't just stand still, and I think the development [process] has to fit that as well."

Suggestions on improvements varied, too, with some panelists bemoaning the slow rate of inspection cycles of factories, with the agency sometimes taking years to check up on foreign outfits. But the FDA has been reluctant to accept self-inspections audited by a third-party, as happens in the financial industry, because, as some of the panelists observed, it is, at heart, a law enforcement agency.

"They were not that enthusiastic about third parties and self certification, in part because of their idea they're a law enforcement agency," Feigal said. "You don't see highway patrols self-certifying speed limits. They'd just as soon chase you down themselves."

Nonetheless, as IOM digs down for months of further research -- it's planning a third public meeting on the topic for July -- not all consumers want the group to err too heavily on the side of caution.