Friday, February 25, 2011

4/5ths of Medical Devices recalled by FDA were not approved using standard procedures/ Archives of Internal Medicine

Steve Nissen et al. hit another homer; the authors examine why bad medical devices (those eventually recalled) were initially approved by FDA, and learn it was due to skirting the standard review process.  Does abbreviated review of products benefit the public in any way?  Shouldn't this abbreviated approval process be eliminated for all but emergency use?

Medical Device Recalls and the FDA Approval Process

Arch Intern Med. Published online February 14, 2011. doi:10.1001/archinternmed.2011.30

Background  Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. Methods  We analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009. Using FDA data, we determined whether the recalled devices were approved by the more rigorous (PMA) process, the 510(k) process, or were exempt from FDA review.
Results  There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death. Only 21 of the 113 devices had been approved through the PMA process (19%). Eighty were cleared through the 510(k) process (71%), and an additional 8 were exempt from any FDA regulation (7%). Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n = 23). Fifty-one percent of the high-risk recalls were in 5 other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology.
Conclusions  Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.

1 comment:

tal said...

Please see the further implications of this at

"...And so this suggests something of a conundrum for patients. If harm is alleged by a device that was endorsed under the more rigorous PMA process, the patient can not file a lawsuit under state law - and state courts are, generally, believed to be more sympathetic venues for product-liability litigation. Yet if a device was not reviewed under PMA, a patient can file a state lawsuit. In other words, if more devices are eventually reviewed under the PMA process, patients who allegedly suffer harm may have less recourse."