Abstract
PurposeRecent safety issues involving medical devices have highlighted the need for better postmarket surveillance (PMS) evaluation. This article aims to describe and to assess the quality of the PMS data for a medical device and, finally, to provide recommendations to improve the data gathering process.MethodsA descriptive analysis of medical device reports (MDRs) on the use of MRA, a specific type of hip implant replacement submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience database from 1 January 2008 to 31 December 2017. The number of reports was described as the number of MDRs per unique MDR number and stratified by different variables. The quality was assessed by the level of completeness of the collected PMS data.ResultsThe total number of reports related to MRA was 2377, and the number of MDRs per year ranged between 84 in 2009 and 452 in 2017. Most of the reports were reported by manufacturer Depuy Johnson & Johnson and were reported by a physician. In 44.9% of the reports, the device problem was reported as “Unknown.” When the device problem was known, in the majority of cases, it was related to an implant fracture. The quality of the collected data was assessed as low due to missing information.ConclusionThe underlying data should meet high quality standards to generate more evidence and to ensure a timely signal generation. This case study shows that the completeness and quality of the MDRs can be improved. The authors propose the development of tools to ensure a more dynamic complaint data collection to contribute to this enhancement.
Highlights
An implantable medical device is a device that is partly or totally inserted into the human body or a natural orifice or is used to replace the surface of the body and is expected to stay in use for 30 days or more
A total of 2377 unique Food and Drug Administration (FDA)-reportable complaints for MRA hip implants were received by the FDA from the manufacturer between 1 January 2008 and 31 December 2017, mostly originating in the United States (1807 reports, 76.0%)
The proportion of reports with information on the type of device problem was 55.1%
Summary
An implantable medical device is a device that is partly or totally inserted into the human body or a natural orifice or is used to replace the surface of the body and is expected to stay in use for 30 days or more. The chromium and cobalt ions from the MoM hip implants could enter into the tissues of patients with this type of hip implants, leading to reactions that damaged the muscle and bone, and led to revision procedures or left some patients with long-term disability.[4,5,6,7] This safety issue was only identified by the Australian Health Authorities upon review of the Australian Orthopaedic Association National Joint Replacement Registry, and this finding was confirmed by the National Joint Replacement Registry of England, Wales, and Northern Ireland and the New Zealand Registry. The manufacturers did not effectively review post-market clinical data (including device registries containing postmarket surveillance information) and failed to identify and report this risk to the health authorities.[8]
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