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.
Consensus ; Delivery of Health Care ; Education ; Humans ; Individuality ; Judgment ; Social Control, Formal

Background: The Laboratory Medicine Foundation (LMF) checklists explain the accreditation requirements of the program and reflect quality standards like those of the Clinical Laboratory Standards Institute (CLSI) or quality system essentials (QSE) of the World Health Organization (WHO). In this study, we have analyzed how the LMF checklists correlate with the 12 QSE elements of the WHO. Methods: The LMF checklists for laboratory management (LM) (version 2019) were classified into the 12 specific QSE elements by five laboratory physicians. Each checklist item was classified into specific element if four or more participants agreed, and into overlapping elements when two or more of them agreed for two different items. Any changes in checklist items and chapter structuring of the checklist since 2009 were investigated. Results: The LM checklists consisted of 183 checklist items, including 20 (10.9%) classified into overlapping QSE elements. The QSE element with the highest number of items was the facilities and safety (62, 33.9%), followed by the personnel (22, 12.0%), and the process control (17, 9.3%). In contrast, QSE elements with the lowest number of items were the customer service (4, 2.2%) and process improvement (4, 2.2%). Items belonging to the customer service and the organization elements have increased since 2017. Conclusions The LMF checklists reflect current quality goals for clinical laboratories and play a leading role in the laboratory's quality improvement. The results of our study will be of help in potentiating the quality leader role of LMF checklists, and international harmonization of our laboratory accreditation program.