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Blueprint for safer surgery

Helen Palmer Nov 9, 2006

KAI RYSSDAL: The heart has its own medical specialty. And its own set of surgeons. Those doctors use all kinds of fancy gizmos to help their patients. Things like pacemakers and defibrillators. And stents that pop clogged arteries open. Today, the FDA announced new safety guidelines for these medical devices that don’t always work as advertised. Helen Palmer reports now from the Marketplace Health Desk at WGBH.

HELEN PALMER: Today, Dan Schultz, the head of the FDA’s device safety division, announced new plans for collaboration within the agency. Take heart devices. The FDA proposes a special group.

DAN SCHULTZ: It would involve the pre-market reviewers, the people who look at adverse events, the people who do inspections of those facilities, all the different areas of expertise that impact cardiovascular devices.

The experts will all meet regularly, all the information will be gathered and shared electronically. The agency will also demand more complete information from the industry, and hopes to pick up problems sooner.

John McCamant, who edits the Medical Technology Stockletter, says this added oversight might help device makers.

JOHN MCCAMANT: Maybe we’ll find out some things about efficacy, so this could help industry, in that maybe they’ll find out some things that are positive about their devices.

McCamant says tighter monitoring will most likely mean devices get more limited approvals: this pacemaker only for patients with that particular heart problem. But Susan Foote, a health-policy expert at the University of Minnesota, sees a problem: the FDA might have trouble finding the cash for all this.

SUSAN FOOTE: Maintaining and managing databases with millions and millions of potential reports . . . that takes a lot of resources.

The FDA’s Dan Schultz says, yes, there’s a cash problem, but these are essential changes, and now he has a blueprint.

SCHULTZ: Now we can go shop that around and say, Look, we’ve got a plan. Now all we need is the resources to make it happen.

He may find a sympathetic audience now: Democrats in charge.

In Boston, I’m Helen Palmer for Marketplace.

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