PMID- 26501120
OWN - NLM
STAT- MEDLINE
DCOM- 20160912
LR  - 20181113
IS  - 2352-3964 (Print)
IS  - 2352-3964 (Electronic)
IS  - 2352-3964 (Linking)
VI  - 2
IP  - 9
DP  - 2015 Sep
TI  - Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and 
      Medical Devices Agency, Japan.
PG  - 1211-6
LID - 10.1016/j.ebiom.2015.07.011 [doi]
AB  - 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.
FAU - Handa, Nobuhiro
AU  - Handa N
AD  - Pharmaceutical and Medical Device Agency, Tokyo, Japan.
FAU - Ishii, Kensuke
AU  - Ishii K
AD  - Pharmaceutical and Medical Device Agency, Tokyo, Japan.
FAU - Matsui, Yutaka
AU  - Matsui Y
AD  - Pharmaceutical and Medical Device Agency, Tokyo, Japan.
FAU - Ando, Yuki
AU  - Ando Y
AD  - Pharmaceutical and Medical Device Agency, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150710
PL  - Netherlands
TA  - EBioMedicine
JT  - EBioMedicine
JID - 101647039
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Cardiovascular System/*metabolism
MH  - Equipment and Supplies/*adverse effects
MH  - Humans
MH  - Japan
MH  - Logistic Models
MH  - *Organizations
MH  - Pharmaceutical Preparations
MH  - *Research Report
PMC - PMC4588369
OTO - NOTNLM
OT  - Adverse event report
OT  - Cardiovascular device
OT  - Pharmaceuticals and Medical Devices Agency
OT  - Registry
EDAT- 2015/10/27 06:00
MHDA- 2015/10/27 06:01
PMCR- 2015/07/10
CRDT- 2015/10/27 06:00
PHST- 2015/05/21 00:00 [received]
PHST- 2015/07/07 00:00 [revised]
PHST- 2015/07/07 00:00 [accepted]
PHST- 2015/10/27 06:00 [entrez]
PHST- 2015/10/27 06:00 [pubmed]
PHST- 2015/10/27 06:01 [medline]
PHST- 2015/07/10 00:00 [pmc-release]
AID - S2352-3964(15)30066-9 [pii]
AID - 10.1016/j.ebiom.2015.07.011 [doi]
PST - epublish
SO  - EBioMedicine. 2015 Jul 10;2(9):1211-6. doi: 10.1016/j.ebiom.2015.07.011. 
      eCollection 2015 Sep.