Postmarketing studies using medical device registries: reporting adverse events

2018 Fiscal Year Final Research Report

• Project/Area Number: 16K16415
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Medical engineering assessment
• Research Institution: The University of Tokyo
• Principal Investigator: Kumamaru Hiraku 東京大学, 医学部附属病院, 特任講師 (00511461)
• Research Collaborator: Kohsaka Shun ; Miyata Hiroaki
• Project Period (FY): 2016-04-01 – 2019-03-31
• Keywords: 市販後調査 / 医療機器 / 安全性

Outline of Final Research Achievements

The objective of this study was to evaluate the timing of postprocedural adverse event occurrences among cases undergoing medical device insertion using device registries, in order to build real-world evidence for registry based data collection that assessed device safety.
For transcatheter aortic valve replacement, 92% of device related and 57% of overall severe adverse events occurring within 1 year after the procedure had occurred during the first 30 days. The finding supported the importance of the first 30 days post procedure in medical device safety monitoring. Review of previous published literature on post procedure adverse events for 3 other newly introduced devices revealed that while the importance of the first 30 days had been repeatedly shown, especially for device related events, variation in its strength also suggested that assessment is required for each new device registry during its initiation phase.

Free Research Field

薬剤疫学

Academic Significance and Societal Importance of the Research Achievements

新規に市場に導入された医療機器の実臨床における安全性や有効性の評価を、症例レジストリなどを用いて実施する動きが進められている。データ登録には臨床現場への負荷がかかるため、効率的な仕組みが望まれる。今回の検証では、医療機器の例として経カテーテル大動脈弁置換術用生体弁の術後の合併症が、特に機器関連のものでは術後30日に集中しておきている事が、初めてタイミングに注目した形で報告された。術後30日間の重要性は、他の新規市販された機器の報告でも同様に見られたが、レジストリごとの評価が重要であることが示唆され、今後のレジストリと機器安全性評価の連携の設計に資する報告となった。