MFDS Establishes Guideline for Clinical Accuracy Evaluation of Automatic Blood Pressure Monitors

[Financial News] The Institute of Food and Drug Safety Evaluation under the Ministry of Food and Drug Safety has established the "Guideline for Clinical Accuracy Evaluation of Non-invasive Automatic Blood Pressure Monitors," which sets out methods and criteria for assessing the clinical accuracy of automatic electronic blood pressure monitors.
According to the Ministry of Food and Drug Safety on the 31st, the guideline is a follow-up measure to changes in the clinical accuracy requirements for automatic electronic blood pressure monitors following a revision of the "Medical Device Standards and Specifications" notice. An automatic electronic blood pressure monitor is a medical device that estimates blood pressure non-invasively using an inflatable cuff, a pressure transducer, an exhaust valve and a display unit.
The guideline was prepared to align with international harmonization efforts. The ministry presented two reference blood pressure methods for clinical accuracy evaluation — auscultatory blood pressure and invasive blood pressure — allowing the industry to choose its clinical trial method. Auscultatory blood pressure is measured by a trained observer listening to Korotkoff sounds through a stethoscope placed over the brachial artery while cuff pressure is lowered. Invasive blood pressure refers to values measured in real time by directly inserting a catheter into the radial or femoral artery.
The detailed provisions include requirements for clinical trials using auscultatory blood pressure as the reference standard, such as the number of participants, sex, age, cuff and blood pressure conditions, as well as testing and analysis methods. They also cover requirements and testing and analysis methods for clinical trials using invasive blood pressure as the reference standard, along with trial methods for pregnant women, including those with preeclampsia. In particular, the ministry separately set out evaluation methods for cases involving special groups such as pregnant women to improve accuracy.
A ministry official said, "By clearly presenting clinical trial design methods and testing standards that comply with the international standard (ISO 81060-2:2018 Non-invasive sphygmomanometers — Part 2), we expect to reduce the trial-and-error companies face during the preparation process for clinical studies," adding, "We also expect it to help ensure the accuracy of automatic blood pressure monitors sold in Korea and improve product quality."
[email protected] Jung Sang-hee Reporter