The application study of harmonization code in medical device adverse event reporting.

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The application study of harmonization code in medical device adverse event reporting.

The application study of harmonization code in medical device adverse event reporting.

アブストラクト	BACKGROUND: The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events. METHODS: An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases. RESULTS: All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders. CONCLUSIONS: We identified the diversification in terminology and code selection for reporting MDAEs.
ジャーナル名	BMC health services research
Pubmed追加日	2024/11/15
投稿者	Choi, Soo Jeong; Choi, Sooin; Park, Songhyeon; Nam, Ki Chang; Jang, Hye Jung; Kim, Jin Kuk; Lee, You Kyoung; Ishikawa, Hiroshi; Woo, Eric
組織名	Division of Nephrology, Department of Internal Medicine, Soonchunhyang University;College of Medicine, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea.;crystal@schmc.ac.kr.;Center for Medical Device Safety Information Monitoring, Soonchunhyang University;Bucheon Hospital, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea.;Department of Laboratory Medicine and Genetics, Soonchunhyang University College;of Medicine, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea.;Soonchunhyang Medical Device Clinical Research Center, Soonchunhyang University,;170, Jomaru-Ro, Bucheon, 14584, Republic of Korea.;Department of Medical Engineering, Dongguk University College of Medicine, 27,;Dongguk-Ro, Ilsandong-Gu, Goyang, 10326, Republic of Korea.;Center for Medical Device Safety Information Monitoring, Dongguk University Ilsan;Hospital, 27, Dongguk-Ro, Ilsandong-Gu, Goyang, 10326, Republic of Korea.;Department of Medical Devices, Clinical Trial Center, Yonsei University Health;System Severance Hospital, 50-1 Yonsei-Ro, Seodaemungu, Seoul, Korea.;Advanced Biomedical Research, University of Yamanashi, 4-4-37, Takeda, Kofu,;Yamanashi, 400-8510, Japan.;ECRI Institute, E-03-10, Sunway Geo Avenue, Jalan Lagoon Selatan, Bandar Sunway,;47500, Subang Jaya, Selangor, Malaysia.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/39543640/