Devices & Diagnostics

Sweating 510k changes: MedCity Morning Read, Dec. 7, 2009

According to a prominent Minneapolis attorney, significant alterations to the FDA’s 510k rules could leave the region and its device makers “hurt big time.”

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Highlights of the interesting and the important from the world of health care.

Sweating 510k changes: In an interview with the Minneapolis Star Tribune, a local lawyer and medical device expert expresses nervousness about possible changes to the FDA’s 510k process. President Obama’s appointee to head up the FDA has called the agency’s device unit “troubled,” so there’s speculation that the administration will call for an overhaul of 510k rules. According to Minneapolis Attorney Mark DuVal, significant alterations to 510k rules could leave the region and its device makers “hurt big time.”

AMA top priorities: The American Medical Association lays out its five “core commitments” for 2010. The group’s CEO calls its a “broad view” of what’s good for medicine, physicians and patients. Knowing the AMA’s agenda, put a heavy emphasis on the “physicians” part of the previous sentence.

Steris questions answered:A widely used device used to sterilize flexible instruments such as endoscopes has attracted the FDA’s wrath. Hospitals and providers were left scrambling Friday when the FDA advised them to find an alternative to the device, Steris’ System 1 Processor. Now, the FDA has published a series of Q&As designed to provide guidance to health care facilities that use the System 1 Processor.

Sign of the economic times: If you have a hospital job in the Minneapolis area consider yourself lucky. After plenty of layoffs in the area, at least one major employer is hiring: Maple Grove Hospital, which is set to open its doors on Dec. 30. The only problem? The hospital has received 8,500 applications for 180 positions.