Descriptive analysis of postmarket surveillance data for hip implants
Purpose: Recent 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. Methods: A 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. Results: The 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. Conclusion: The 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.
|Keywords||complaint data analysis, complaint data collection, medical devices, postmarket surveillance, spontaneous reports|
|Persistent URL||dx.doi.org/10.1002/pds.4971, hdl.handle.net/1765/125617|
|Journal||Pharmacoepidemiology and Drug Safety: an international journal|
Pane, J. (Josep), Verhamme, K.M.C, Rebollo, I. (Irene), & Sturkenboom, M.C.J.M. (2020). Descriptive analysis of postmarket surveillance data for hip implants. Pharmacoepidemiology and Drug Safety: an international journal. doi:10.1002/pds.4971