Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Casesopen access
- Authors
- Yoon, Chiho; Nam, Ki Chang; Lee, You Kyoung; Kang, Youngjoon; Choi, Soo Jeong; Shin, Hye Mi; Jang, HyeJung; Kim, Jin Kuk; Kwon, Bum Sun; Ishikawa, Hiroshi; Woo, Eric
- Issue Date
- 14-Oct-2019
- Publisher
- 대한의학회
- Keywords
- Medical Device Vigilance; National Competent Authority Report; NCAR; Incidents; Regulatory Harmonization; Center of Excellence
- Citation
- Journal of Korean Medical Science, v.34, no.39
- Journal Title
- Journal of Korean Medical Science
- Volume
- 34
- Number
- 39
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/4142
- DOI
- 10.3346/jkms.2019.34.e255
- ISSN
- 1011-8934
1598-6357
- Abstract
- Background: Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events. Methods: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of 'patient use'. The phases of patient use' are divided into: 1) inspecting, 2) preparing, and 3) applying medical device. Results: As for the question on the beginning point of 'patient use,' 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups. Conclusion: From training courses using virtual cases, we found that there was no consensus on 'patient use' point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.
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Collections - College of Medicine > Department of Internal Medicine > 1. Journal Articles
- College of Medicine > Department of Clinical Pathology > 1. Journal Articles
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