의료기기 산업체 관계자에서 의료기기 시판 후 조사에 대한 인식, 지식 및 실태 조사 연구

A Study on the Perception, Knowledge, and State of the Post-Market Surveillance of Medical Device Industry Officials

The medical device industry continues to grow worldwide due to the aging population and the increase in chronic diseases. Abnormal cases are also increasing alongside this growth. Although safety and effectiveness are confirmed when a medical device is licensed, they cannot be continuously verified throughout its lifespan. This is particularly challenging for newly developed and rare medical devices to verify their safety and effectiveness before they are marketed. The recently revised postmarketing survey system was conducted to gather information from individuals involved in the medical device industry. The purpose of the survey was to gain insight into participants’ perceptions, knowledge, and current circumstances. According to the survey, 82.1% of the participants were aware of post-marketing surveys, but 53.3% of them were not aware that the revised system was referred to as “re-examination” instead of “post-marketing survey”. In terms of knowledge, it has been found that they were familiar with approximately half of the terms related to post-marketing surveys. However, they encountered difficulties when it came to preparing a post-marketing survey plan. In terms of actual conditions, 25.9% of the surveys were conducted after marketing, with 20.7% being conducted independently and the majority being outsourced. Prior to the revision of the Medical Device Act, the scope of post-marketing investigations was limited and only applied to initial users. As a result, many individuals in the medical device industry had limited knowledge and experience in conducting post-marketing investigations. Additionally, there were challenges in securing funding, manpower, and expertise to effectively carry out these investigations. Through the results of this study, we have identified the current state of the industry. Additionally, we propose implementing a curriculum that includes clinical research methodology. We also recommend promoting and actively supporting regulators to address the identified issues and develop expertise in the field. It is hoped that this will be used to improve domestic medical device policies, thereby facilitating the successful implementation of the domestic post-marketing survey system in the future.