Assessment of cardiovascular and noncardiovascular medical device recalls.
Medical device recalls have called attention to the device approval process in the United States. The premarket approval (PMA) process requires clinical trials to evaluate safety and effectiveness, whereas the expedited 510(k) process does not. The 510(k) process has been considered a source of increased recalls. This study aimed to assess the relative safety of medical device approval pathways based on the numbers of approvals and recalls. Data on recalls in the United States from January 2005 to December 2012 were collected from the Food and Drug Administration Web site. Over 8 years, 30,002 devices were approved, 5,728 by PMA (19%) and 24,274 (81%) by 510(k). There were 249 recalls due to serious risks, 0.45% of PMA approvals, and 0.92% of 510(k)-cleared devices, p <0.001. Over 1/2 of the recalls were during the first 2 years on the market. Percentage of recalled PMA devices was unchanged over the 8 years, whereas 510(k) recalls increased in 2010 to 2012 (from 0.65% to 1.39%, p <0.001). Cardiovascular devices represent the largest class of recalls (27%). The proportions of recalled PMA and 510(k) cardiovascular devices were the same as for all medical devices until 2011, but 510(k) recalls dramatically decreased in 2012 to the lowest recall rate seen (0.73%). In conclusion, recall rates were the same for 510(k)- and PMA-approved devices in 2005 to 2009 and increased for 510(k) devices subsequently. Modifying the 510(k) process with more rigorous performance testing, a conditional 2-year approval and a mandatory registry may be an approach to reduce recalls.
Department of Medicine and Clinical Pharmacology, Rush University, Chicago, Illinois. Electronic address: John_Somberg@rush.edu.
John C
JC
Somberg
Department of Medicine and Clinical Pharmacology, Rush University, Chicago, Illinois.
Pauline
P
McEwen
American Institute of Therapeutics, Lake Bluff, Illinois.
Janos
J
Molnar
D002318:Cardiovascular Diseases / Q000628:therapy*; D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D057052:Medical Device Recalls / Q000331:legislation & jurisprudence*; D011785:Quality Assurance, Health Care; D012189:Retrospective Studies; D018570:Risk Assessment; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration