Current status and trends in the safety management of cardiopulmonary bypass in Japan: Insights from questionnaire surveys on incidents and accidents ─ secondary publication（complete translation）─

Over the past 46 years since its establishment in 1976, the Japanese Society of Extra Corporeal Technology in Medicine（JaSECT）has undertaken various initiatives to improve the quality of cardiopulmonary bypass（CPB）and circulatory support. As part of these efforts, a questionnaire survey on incidents, accidents, and safety measures related to CPB and circulatory support was conducted in 2021 to gather foundational data for developing appropriate safety standards and guidelines. The results were compared with a paper published in 2013 and earlier questionnaire findings. The 2021 survey targeted 656 medical institutions, with responses received from 441（response rate: 67.2%）regarding CPB and circulatory support cases from 2019 and 2020. Analysis revealed an annual accident rate of at least 0.03% for CPB cases with patient impact levels of 3b or higher. In response to past serious accidents, significant advancements in safety measures have been implemented by the Japanese government and relevant societies. This report aims to present the current status and trends in safety management while contributing to the development of global evidence and guidelines for safer CPB practices.