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

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.

The Current Status and Necessity of Metabolic and Bariatric Surgery Accreditation System in Foreign Country

In United States, national facility accreditation in bariatric surgery was first implemented in 2004 by the ASMBS and by the ACS in 2005. The two programs unified to a single program in 2012: the MBSAQIP (Metabolic and Bariatric Surgery Accreditation & Quality Improvement Program). Accreditation in bariatric surgery signifies that the center has the infrastructure and equipment to care for the morbidly obese, has experienced and qualified staff and surgeons, and participates in data reporting and quality improvement initiatives. In an effort to improve the quality of service offered to bariatric patients worldwide, IFSO elected to form an international board that will advise and endorse national and regional 'centers of excellence' programs. The creation of guidelines that could be applied to different global areas and define surgeon's credentials and institutional requirements for safe and efficient management of morbidly obese patients was the main task. Substantial data have shown that the presence of bariatric facility accreditation is associated with improved outcomes. Therefore, we have to develop and establish a new metabolic and bariatric surgery accreditation system for surgeons and facilities adapted to our country to ensure the safe and effective performance of bariatric surgery.