Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan.
BACKGROUND
Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.


METHODS
To 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 > 15 days (DOC15) and delayed reports (DCR > 15 or 30 days) were also calculated.


RESULTS
AEs 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 30 days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30.


CONCLUSIONS
Although 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.
Pharmaceutical and Medical Device Agency, Tokyo, Japan.
Nobuhiro
N
Handa
Pharmaceutical and Medical Device Agency, Tokyo, Japan.
Kensuke
K
Ishii
Pharmaceutical and Medical Device Agency, Tokyo, Japan.
Yutaka
Y
Matsui
Pharmaceutical and Medical Device Agency, Tokyo, Japan.
Yuki
Y
Ando
D002319:Cardiovascular System / Q000378:metabolism*; D004864:Equipment and Supplies / Q000009:adverse effects*; D006801:Humans; D007564:Japan; D016015:Logistic Models; D009938:Organizations; D004364:Pharmaceutical Preparations; D058028:Research Report
D004364:Pharmaceutical Preparations
Adverse event report; Cardiovascular device; Pharmaceuticals and Medical Devices Agency; Registry