7 Dec. 2006
FDA Announces Medical Device Plan
Matthew Herper, 11.09.06, 9:30 AM ET
The U.S. Food and Drug Administration unveiled a new plan to better track the safety and efficacy of medical gadgets embedded in millions of patients and used in procedures to do everything from treating heartburn to preventing stroke.
Medical devices, which include artificial hips and knees, stents for coronary disease and nerve stimulators for epilepsy and depression, are an $80 billion-a-year business in the U.S., generating big profits for firms like Medtronic, Boston Scientific, and Johnson & Johnson. In sharp contrast with medicines, which are vetted through gigantic clinical trials before approval but then loosely monitored, devices are scrutinized constantly after they hit the market for flaws that can result from design changes or manufacturing mix-ups.
Now, the FDA is planning an overhaul of this system in the hopes that it can catch problems sooner and communicate risks to patients more clearly. "They are pretty big changes, and very necessary," says Daniel Schultz, the head of the FDA's Center for Devices and Radiological Health.
The proposed changes come a year after a series of controversial recalls of implantable defibrillators--which can prevent patients with weak hearts from dying--made by Guidant, now a unit of Boston Scientific, and as a new potential safety controversy has cropped up surrounded the drug-coated stents made by Boston Scientific and Johnson & Johnson. Critics accuse the stents of causing heart attacks, but fans say the stents' benefit of preventing arteries from reclosing still outweighs their risk.
The most radical step being proposed by the FDA's new plan involves putting an identifying code on every single medical device to make it easier to track malfunctions and side effects. "We think it needs to be done," says Schultz. Discussions about exactly how the code will be placed on devices are still going on with device manufacturers.
An equally big step: overhauling the computer databases that the agency uses to pick up problems. Right now, reports of device malfunctions are often submitted in paper, slowing down the agency's ability to figure out when a particular device is having frequent problems. The new FDA report says that this entire process should be made digital.
A second database, which culls information from 350 hospitals on a real-time basis, would be expanded. This MedSun system, it is hoped, will be able to spot safety problems more quickly using specially trained professionals and real-time monitoring.
The report also puts a big emphasis on changing the way scientists at the FDA's device division communicate with one another, and the way they communicate with the public at large. Some doctors have criticized the agency for the way it handled the implantable defibrillator recalls, because for many patients, the risk of having the device removed was actually far greater than the risk that it would malfunction.
Some kinds of problems, however, may not be caught by this tightened safety net. The drug-coated stents, used to treat the crushing heart pain of angina, are being accused of causing heart attacks at a very low rate. But because the devices are implanted in more than 4 million people, several thousand people could still be affected.
Some experts have said that controlled experiments involving tens of thousands of patients will be necessary to really understand the risk. Looking at after-the-fact data from databases won't allow researchers to pinpoint the problem.
"We are humans," says Sanjay Kaul, a cardiologist at Cedars-Sinai Hospital who has been a critic of the drug-coated devices. "We cannot resist organizing our facts around our expectations, not the other way around."
