Toughen medical-device trials

Newer doesn't necessarily mean safer when it comes to medical devices.

A new report by the Institute of Medicine, an independent advisory group of the National Academy of Sciences, urges the Food and Drug Administration to revamp its flawed approval process for instruments ranging from tongue depressors to hip implants to artificial joints.

The FDA's outdated approval process, enacted 35 years ago, requires only that a new device be equally or more effective than the current one on the market and mandates no new studies. However, that assumes currently available devices are safe.

But many of them aren't. Several medical-device manufacturers have been forced to recall their products. Last year, 93,000 Johnson & Johnson hip implants were taken off the market because they caused inflammation and tissue damage.

Not surprisingly, the medical-device industry, with billions of dollars in profits at stake, argues the institute's recommendations are unnecessary and biased. While the findings are not binding, this recommendation from the institute makes clear that the FDA must update its standards to protect consumers from dangerous devices. After all, regulations for prescription drugs, which can also carry health risks, require extensive review and clinical trials before being released to the public.

The current system unfortunately favors expediency over safety. The FDA should make this overhaul a priority. hN