Can we trust automatic sphygmomanometer validations?

Abstract

Hypertension is a leading risk factor for mortality. Detecting, treating and monitoring hypertensive patients require accurate blood pressure measurements. Protocols for validation of automatic sphygmomanometers exist, but quality control of validations is limited to peer review of published reports, which has severe limitations. An extensive international measurement framework provides quality assurance, traceability and laboratory accreditation for many measurements that are important to society, including industrial, scientific and trade measurements, medical imaging and medical laboratory testing. An important part of this quality assurance is external accreditation of laboratories that perform testing and calibration to the international standard ISO 17025 General requirements for the competence of testing and calibration laboratories. Automatic sphygmomanometer validation is a form of calibration and deserves quality control at least as good as other tests and calibrations that are important to society. It is suggested that laboratories that perform automatic sphygmomanometer validations should participate in the international measurement framework and be externally accredited by accrediting agencies that are members of the International Laboratory Accreditation Cooperation.