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Medical Device Loophole Puts Patients At Risk Says Consumers Union

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The U.S. Food and Drug Administration “does not have the power under current law to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems.”[1] So says the Consumers Union, Consumer Reports’ advocacy flank. In fact, they said so in a full page ad in “Politico” May 22, 2012.[2] Thus far, the medical device lobby has been able to halt this reform, in Lisa McGiffert’s view. McGiffert is director of the Consumers Union Safe Patient Project. Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, agrees that the agency does not have “the power it needs” to keep device makers from replicating safety flaws in devices similar to ones already recalled.

The Consumers Union restated its position noting that over 90 percent of medical devices are not required to be clinically tested prior to approval by the FDA due to the FDA’s use of the fast-track 510 (k) approval process which takes into account whether the new device is substantially equivalent to one previously approved.[3]

Many medical device recipients have suffered due to implantation of defective devices that have made it to the market place through the 510 (k) process, such as the vaginal mesh implant, certain hip implants (Johnson&Johnson/DePuy’s ASR) and defibrillators which have caused serious injuries in patients. “Under the current law, the FDA cannot require manufacturers to prove that the new device corrects the safety flaw of the recalled device.”[4] McGiffert would like to see the loophole closed, and the FDA also wants the loophole closed. A Consumer Reports poll says the public wants the loophole closed. The device lobby, however, likes the status quo, and it has the money to keep it.


[1] “Dangerous Medical Device Loophole Puts Patients At Risk,” Kansas City Infozine, May 22, 2012, http://www.infozine.com/news/stories/op/storiesView/sid/51908/

[2] Op. Cit.

[3] Ibid.

[4] Ibid.