Many medical devices not tested for safety

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Last week, Consumer Reports released the results of a study revealing that many of the medical devices currently being marketed have never been tested for safety. In many cases, manufacturers are only required to file documents with the Food and Drug Administration (FDA) and pay a fee before marketing new devices. Under the FDA’s 510(k) approval process, medical devices that are “substantially equivalent” to another product already approved and marketed can be approved without testing.

Cardiologist Dr. Robert Hauser, a long time advocate of increased oversight of medical devices, agrees that the current system may lead to more dangerous medical products on the market.  Dr. Hauser states “The bottom line is that new devices, particularly [the most complex] lifesaving devices, need to be tested before they are put in people.”

Consumer Reports’ advocacy arm, Consumers Union, has called upon Congress to require that medical implants and “life-sustaining” devices undergo testing as strict as that required for pharmaceutical drugs, and called for an end of the practice of “grandfathering” the approval of medical implants and devices. In addition to implementing more rigorous testing prior to marketing, Consumers Union recommends that every implanted medical device be required to have a “unique identifier” so that patients can be notified about recalls and other safety issues involving their devices. Not surprisingly, some manufacturers of medical implants, devices, and other products oppose the Consumers Union recommendations.

Source: Star Tribune, “Consumer Reports slams speed of FDA’s OKs for medical devices,” James Walsh, March 28, 2012.