• 1 Department of Laboratory Medicine and Genetics, Soonchunhyang University College of Medicine, Bucheon, Korea
  • 2 Department of Medical Engineering, Dongguk University College of Medicine, Gyeongju, Korea
  • 3 Department of Medical Education, Jeju National University School of Medicine, Jeju, Korea
  • 4 Center for Medical Device Safety Monitoring, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
  • 5 Quality and Regulatory Affairs, Medtronic Korea, Seoul, Korea
  • 6 Department of Medical Devices, Clinical Trial Center, Yonsei University Health System Severance Hospital, Seoul, Korea
  • 7 Center for Medical Device Safety Monitoring, Dongguk University Ilsan Hospital, Goyang, Korea
  • 8 Technical Expert, Division of Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
  • 9 ECRI Institute, Selangor, Malaysia
J Korean Med Sci, 2019 Oct 14;34(39):e255.
PMID: 31602825 DOI: 10.3346/jkms.2019.34.e255


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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.