Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices

DSpace/Manakin Repository

Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices

Citable link to this page

 

 
Title: Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices
Author: Mahomed, Nizar N; Syed, Khalid; Sledge, Clement Blount; Brennan, Troyen Anthony; Liang, Matthew Heng

Note: Order does not necessarily reflect citation order of authors.

Citation: Mahomed, Nizar N, Khalid Syed, Clement B. Sledge, Troyen A Brennan, and Matthew H Liang. 2008. Improving the postmarket surveillance of total joint arthroplasty devices. The Open Rheumatology Journal 2: 7-12.
Full Text & Related Files:
Abstract: Objective: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA’s post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Results: Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Conclusion: Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.
Published Version: doi://10.2174/1874312900802010007
Other Sources: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2577946/pdf/
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:5978728
Downloads of this work:

Show full Dublin Core record

This item appears in the following Collection(s)

 
 

Search DASH


Advanced Search
 
 

Submitters