4/5ths of Medical Devices recalled by FDA were not approved using standard procedures/ Archives of Internal Medicine
Posted Feb 25 2011 1:05am
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?
Arch Intern Med. Published online February 14, 2011. doi:10.1001/archinternmed.2011.30
Background Unlike prescription drugs, medical devicesare reviewed by the US Food and Drug Administration (FDA) using2 alternative regulatory standards: (1) premarket approval (PMA),which requires clinical testing and inspections; or (2) the510(k) process, which requires that the device be similar toa device already marketed (predicate device). The second standardis intended for devices that the FDA deems to involve low ormoderate risk.Methods We analyzed the FDA's high-risk List of DeviceRecalls from 2005 through 2009. Using FDA data, we determinedwhether 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 2009that the FDA determined could cause serious health problemsor death. Only 21 of the 113 devices had been approved throughthe PMA process (19%). Eighty were cleared through the 510(k)process (71%), and an additional 8 were exempt from any FDAregulation (7%). Cardiovascular devices comprised the largestrecall category, with 35 of the high-risk recalls (31%); two-thirdswere cleared by the 510(k) process (66%; n = 23).Fifty-one percent of the high-risk recalls were in 5 other devicecategories: general hospital, anesthesiology, clinical chemistry,neurology, or ophthalmology.
Conclusions Most medical devices recalled for life-threateningor very serious hazards were originally cleared for market usingthe less stringent 510(k) process or were considered so lowrisk that they were exempt from review (78%). These findingssuggest that reform of the regulatory process is needed to ensurethe safety of medical devices.