The F.D.A.’s Medical Device Problem - The New York Times

The F.D.A.’s Medical Device Problem - The New York Times

By RITA F. REDBERG and SANKET S. DHRUVAJULY 17, 2015

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).

As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.

Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.

The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

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Audio NEJM Interview: Dr. Rita Redberg on the approval process for medical devices in the United States and in Europe.

Dr. Rita Redberg is a professor of medicine at the University of California, San Francisco, and the editor of the Archives of Internal Medicine. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. S. Basu and J.C. Hassenplug. Patient Access to Medical Devices - A Comparison of U.S. and European Review Processes. N Engl J Med 2012;367:485-8.