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FDA's GAO-Recommended Device Review Not Finished Yet

Emily Berry, April 23, 2009

Yesterday's internal Food and Drug Administration meeting was routine and not specifically focused on its troubled device review process as suspected, according to an agency spokesperson.

"[It] was a staff meeting within the Office of Device Evaluation (ODE) at the FDA's Center for Device and Radiological Health," said FDA spokesperson Peper Long. "The director of ODE holds these with her staff as many other staff directors in other agencies and businesses do from time to time."

Premonitions about a more focused meeting are not unfounded. In January, the U.S. Government Accountability Office recommended that the FDA take another look at the safety and effectiveness of a number of already approved class III devices. These devices ranged from pacemaker programmers to a spinal screw system. (A complete list of these devices is available on the FDA's Web site.)

The FDA divides medical devices into three categories; class III categories carry the most risk for patients.

Medical staffs are still waiting to see how the FDA's review process will evolve as a result of the GAO report. Critics say it's too soft, yet hospitals see FDA approval as a safety gold stamp when approving new technologies and granting practitioner privileges to use them.

Despite the current review, hospitals should remain confident that the devices they're using have been well-reviewed by the agency, says one trade group. "The FDA has an unparalleled record in the review of medical technology and that's why it's a model for other governments as they go about their process," said Wanda Moebius, vice president for policy and communication at AdvaMed [www.advamed.org], the trade association for advanced medical technology. "I think that if there are concerns to be addressed, they are concerns of resources and we support a well-resourced FDA."

In the meantime, hospitals and other facilities that use any of the devices under review should continue to report adverse events to the FDA, says Long.


Emily Berry is an associate editor for Briefings on Credentialing and Credentialing Resource Center Connection, and manages the Credentialing Resource Center. You can reach her at eberry@hcpro.com.

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