Key result
In a nationwide survey of 78,397 cardiopulmonary bypass cases in Japan, the annual accident rate for events with patient impact levels of 3b or higher was 0.03%.
Why the study?
Foundational data were needed to develop appropriate safety standards and guidelines regarding incidents, accidents, and safety measures related to cardiopulmonary bypass and circulatory support in Japan.
Cross-Sectional (n=78,397)
Yes
This nationwide survey in Japan demonstrates a persistently low but notable rate of serious CPB-related accidents (≥0.03%), highlighting the ongoing need for rigorous safety management and standardized guidelines in extracorporeal circulation.
Answers are grounded in this paper and cite their sources.
Supports continued CPB safety vigilance; leaves open optimal national benchmarks without prospective data.
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.
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Tomisada et al. (2025) conducted a cross-sectional in Cardiopulmonary bypass (CPB) (n=78,397). Cardiopulmonary bypass (CPB) was evaluated on Accident rate for CPB cases with patient impact levels of 3b or higher. In a nationwide survey of 78,397 cardiopulmonary bypass cases in Japan, the annual accident rate for events with patient impact levels of 3b or higher was 0.03%.
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