Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan

Abstract

BackgroundMarketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15days (some cases 30days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. MethodsTo analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC>15days (DOC15) and delayed reports (DCR>15 or 30days) were also calculated. ResultsAEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30. CommentsAlthough Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential.