Mahomed Nizar N, Syed Khalid, Sledge Clement B, Brennan Troyen A, Liang Matthew H
Division of Orthopaedic Surgery, Toronto Western Hospital, University Health Network, University of Toronto, 399 Bathurst St., ECW 1-002, Toronto, Ontario, Canada M5T 2S8; Clinical Epidemiology and Health Care Research Program, Department of Health Administration, University of Toronto, Canada.
Open Rheumatol J. 2008;2:7-12. doi: 10.2174/1874312900802010007. Epub 2008 Feb 25.
To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices.
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.
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.
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.
评估美国食品药品监督管理局（FDA）对全髋关节置换（THR）器械的审批流程及上市后监测策略。
使用FDA器械与放射健康中心（CDRH）的510k可发布数据库记录已获批的THR器械。利用CDRH医疗器械报告数据文件研究FDA上市后监测系统的效率。联系制造商以获取有关其植入物的信息。检索1966年至1996年期间的医学期刊数据库（Medline），以确定有临床结果发表数据的THR器械的比例。
1976年至1996年期间，701种新型THR器械通过实质等同（SE）途径获批，34种基于上市前批准（PMA）获批。与1976年至1990年相比，1991年至1995年的获批数量翻了一番。74家不同的制造商获得了THR器械的上市批准。只有4家制造商通过PMA申请获得批准。根据强制性器械报告，所有翻修关节成形术均应报告。利用1993年我们拥有美国医院出院数据的2个独立服务机构的数据，我们估计所有翻修THR中只有3%报告给了FDA。髋关节植入物制造商未能提供有用信息。医学期刊数据库检索显示，仅15%的获批THR器械有关于结果的发表数据。
目前FDA的上市前批准和上市后监测策略未能为基于证据选择THR器械提供信息。提出了避免器械故障问题的建议。
