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Are previously validated blood pressure self-measurement devices accepted under the Universal Standard? A systematic
Estefanie Siqueira Vigato de Oliveira1, Nila Larisse Silva de Albuquerque, Priscila Rangel Dordetto
1School of Nursing - University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.
Insights
Most oscillometric blood pressure devices meet initial Universal Standard criteria, but only 53% fully meet all requirements for self-measurement validation. This impacts the availability of approved home blood pressure monitoring devices.
Area of Science:
- Cardiovascular diagnostics
- Medical device regulation
- Hypertension management
Background:
- Accurate self-measurement of blood pressure is crucial for managing hypertension.
- Existing validation protocols for oscillometric devices vary, potentially affecting device approval.
- The Universal Standard provides criteria for validating blood pressure monitoring devices.
Approach:
- A systematic review analyzed 32 validation studies of noninvasive arm cuff devices for self-measurement.
- Searches were conducted across nine databases up to September 2023.
- Validation protocols, including the British Hypertension Society and Association for the Advancement of Medical Instrumentation, were assessed.
Key Points:
- The British Hypertension Society protocol was most common (68%), followed by the Association for the Advancement of Medical Instrumentation (40%).
- While most devices met Universal Standard criterion 1, only 53% met criterion 2.
- Limited study details on cuff selection and participant arm circumference were noted.
Conclusions:
- Significant differences in validation protocols result in only 53% of analyzed devices meeting Universal Standard criteria.
- The study expands the pool of validated self-measurement devices under the Universal Standard.
- Further standardization in validation studies is needed to ensure reliable home blood pressure monitoring devices.
Abstract:
This study aimed to analyze whether oscillometric blood pressure devices validated for the general population may be considered approved under Universal Standard criteria. A systematic review was conducted, with searches in nine databases, up to September 2023, including 32 validation studies of noninvasive arm cuff devices for self-measurement. The British Hypertension Society protocol was most common (68%), followed by the Association for the Advancement of Medical Instrumentation (40%). Most devices met Universal Standard criterion 1, but only 17 (53%) met criterion 2. Few studies contained details about the choice of cuffs, the number of participants by arm circumference, or the differences between methods by cuff subgroup. Due to the considerable differences between validation protocols, 53% of the devices analyzed were approved under the Universal Standard. The study contributes to expanding the validated pool of self-measurement devices under the Universal Standard.
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