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

Abstract：

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. COMMENTS: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.

journal_name

EBioMedicine

journal_title

EBioMedicine

authors

Handa N,Ishii K,Matsui Y,Ando Y

doi

10.1016/j.ebiom.2015.07.011

subject

Has Abstract

pub_date

2015-07-10 00:00:00

pages

1211-6

issue

9

issn

2352-3964

pii

S2352-3964(15)30066-9

journal_volume

2

pub_type

杂志文章

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