[닫기]
잠시만 기다려 주세요. 로딩중입니다.

Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases

Journal of Korean Medical Science 2019년 34권 39호 p.255 ~ 255
 ( Yoon Chi-Ho ) - Soonchunhyang University College of Medicine Department of Laboratory Medicine and Genetics

 ( Nam Ki-Chang ) - Dongguk University College of Medicine Department of Medical Engineering
 ( Lee You-Kyoung ) - Soonchunhyang University College of Medicine Department of Laboratory Medicine and Genetics
 ( Kang Young-Joon ) - Jeju National University School of Medicine Department of Medical Education
 ( Choi Soo-Jeong ) - Soonchunhyang University College of Medicine Department of Internal Medicine
 ( Shin Hye-Mi ) - Medtronic Korea Ltd.
 ( Jang Hye-Jung ) - Yonsei University Health System Severance Hospital Department of Clinical Trials for Medical Devices
 ( Kim Jin-Kuk ) - Soonchunhyang University College of Medicine Department of Internal Medicine
 ( Kwon Bum-Sun ) - Dongguk University Ilsan Hospital Department of Physical Medicine and Rehabilitation
 ( Ishikawa Hiroshi ) - Pharmaceuticals and Medical Devices Agency Division of Standards for Medical Devices
 ( Woo Eric ) - ECRI Institute

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.

키워드

Medical Device Vigilance; National Competent Authority Report; NCAR; Incidents; Regulatory Harmonization; Center of Excellence
원문 및 링크아웃 정보
  
등재저널 정보
SCI(E)
MEDLINE
KCI
KoreaMed
KAMS