FDA not enforcing medical device safety standards

Jessica Smagacz

Contributor

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The Associated Press reported today that an independent watchdog group said FDA “has quietly scaled back enforcement of federal quality regulations at labs that develop medical devices.”

FDA has reduced the inspections of “good laboratory practices” considerably at facilities that conduct the earliest testing of medical devices. The inspections went from 33 in 2005 to 7 in 2007. Last year it went to one inspection.

The medical devices included range from imaging machines to pacemakers. The initial testing process is where these medical devices are tested in labs using specialized machinery or animals.

A nonpartisan group, the oversight project, said in the report, “The decision … to not enforce (lab standards) is stunning in its contempt for the protection of patients.”

The main center overlooking medical devices is called the Center for Devices and Radiological Health, a division of the FDA. Apparently, there have been complaints from FDA’s own scientists “that managers squelched debate, leading to the approval of devices that were of questionable effectiveness and perhaps not entirely safe.”

Right now, according to the oversight group, manufacturers are still required to abide by lab standards and must certify this in writing that they do abide by the standards.