의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이
Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting
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초록
This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.
Abstract
This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.
참고문헌 (13)
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- Ministry of Food and Drug Safety, "Guideline of medical device adverse event reporing", MFDS, ~ (2018)
- IMDRF ‘Strategic Plan 2020’, "International Medical Device Regulators Forum MC", IMDRF, ~ (2015)
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- Craig A, "The need for greater reporting of medical device incidents", EMJ Innov, 3(1), pp.56~63 (2019)
- Polisena J, "Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies : a systematic review", Syst Rev, 4(1), pp.37~ (2015)
- 윤치호, "Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases", Journal of Korean Medical Science, 34(39), pp.1~11 (2019), 대한의학회
- The Global Harmonization Task Force, Study Group 2, "Medical devices post market surveillance: global guidance for adverse event reporting for medical devices", GHTF, ~ (2006)
- Medical devices: post-market surveillance: National Competent Authority Report exchange criteria and report form, "National Competent Authority Report Working Group", IMDRF, ~ (2017)