J Korean Med Sci.
2019 Oct;34(39):e255. 10.3346/jkms.2019.34.e255.
Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases
- Affiliations
-
- 1Department of Laboratory Medicine and Genetics, Soonchunhyang University College of Medicine, Bucheon, Korea. cecilia@schmc.ac.kr
- 2Center for Medical Device Safety Monitoring, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
- 3Department of Medical Engineering, Dongguk University College of Medicine, Gyeongju, Korea.
- 4Center for Medical Device Safety Monitoring, Dongguk University Ilsan Hospital, Goyang, Korea.
- 5Department of Medical Education, Jeju National University School of Medicine, Jeju, Korea.
- 6Center for Medical Device Safety Monitoring, Jeju National University Hospital, Jeju, Korea.
- 7Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.
- 8Quality and Regulatory Affairs, Medtronic Korea, Seoul, Korea.
- 9Department of Medical Devices, Clinical Trial Center, Yonsei University Health System Severance Hospital, Seoul, Korea.
- 10Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
- 11Technical Expert, Division of Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
- 12ECRI Institute, Selangor, Malaysia.
- KMID: 2459424
- DOI: http://doi.org/10.3346/jkms.2019.34.e255
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.
Keyword
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Nursing Students' Experiences of Virtual and Hybrid Simulation in Gerontological Nursing: A Mixed-Methods Study
- Case Report of Anomalous Head Posture Correction with Low Vision Aid Using Virtual Reality
- Adverse Events Associated with the Use of Leukocyte Reduction Filters and Blood Transfusion Sets: Experience of a Single Institute in Korea and Status of Adverse Event Reporting in Korea and the United States
- Effects of Spatial Training Paradigms on Auditory Spatial Refinement in Normal-Hearing Listeners: A Comparative Study
- Effectiveness of Cognitive Training based on Virtual Reality for the Elderly
