カフレス血圧計の国際標準規格化動向─令和元年度戦略的国際標準化推進委員会報告

抄録

This article reports on the 2019 annual meeting of the Committee for Promotion of Strategic International Standardization of Non-Invasive Cardiovascular Monitors. This committee consists of mainly members from industries interested in manufacturing cuffless blood pressure monitors. The aim of the committee is to organize meetings and encourage draft standards from committee members for use by international organizations. During the meetings, advice is given by policymakers and professionals working in the digital medicine and healthcare fields. In 2019, we reviewed the Institute of Electric and Electronic Engineers (IEEE) 1708a-2019 standard for wearable, cuffless blood pressure measuring device, and the International Standards Organization Draft International Standard (ISODIS) 81060-3 for non-invasive sphygmomanometers. We discussed and evaluated these standards with committee members. The IEEE1708a-2019 standard is not accepted by Japanese regulatory body. Based on ISODIS 81060-3, a subcommittee was formed to evaluate the current embedded cuffless blood pressure monitors based on mobile devices by collection of basic accuracy data. Additionally, Pharmaceuticals and Medical Devices Agency (PMDA) and Food and Drug Administration (FDA) recommendations were evaluated, and advocacy of the importance of cuffless blood pressure monitors was conducted to regulatory bodies and academic societies. Based on these activities, we are in a position to create new standards for blood pressure monitors.