March 1, 2012

Four U.S. Senators, including Oregon Sen. Jeff Merkley, have proposed a new federal law intended to enhance the safety of medical devices. The authors are chiefly concerned about product defects that come to light after devices have gone to market. Their proposal would mandate that the U.S. Food and Drug Administration exercise more oversight on the safety of medical devices after the testing and approval phases.

The move was motivated, in part, because of reports that improperly functioning medical devices have caused thousands of fatalities in the last few years. If passed, the proposed Ensuring Safe Medical Devices for Patients Act would empower the FDA to conduct stringent surveillance of the performance of medical devices after they are placed on the market and to remove products that cause avoidable injuries or deaths as soon as possible.

While the FDA does currently vet and approve medical devices and drugs for safety before they are marketed, there is some concern that the same level of care and scrutiny is not currently exercised after approval is given — and after doctors and surgeons have used the products on millions of patients. Frequently, the proponents of the legislation believe, major problems with medical devices may manifest themselves for the first time only following widespread use.

Particular concern was expressed over medical devices that are implanted in the body to treat heart problems, to replace knees and the like. In each of the last seven years, about 700 medical devices have been recalled. In 2009, defective or harmful medical devices were involved in almost 5,000 deaths. Recent major problems cited have been those involving surgical mesh, implantable programmable infusion pumps and metal-on-metal hip replacements.

A long list of consumer advocacy and health organizations has endorsed the proposal. The bill may also win bipartisan support in both the Senate and the House.

Source:, “Senators Introduce Bipartisan Effort to Make Medical Devices Safer,” Mar. 15, 2012


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