Background: Automated devices are widely available in the community for people to measure their blood pressure. We assessed the accuracy and reproducibility of a brand of community-based automated device against the standard mercury sphygmomanometer.
Methods: Same-arm pairs of blood pressure readings were obtained with the Vita-Stat 90550 automated device, a sphygmomanometer and the Omron HEM-705CP automated device in random order on volunteers in 3 community pharmacies using a modified protocol for evaluating blood pressure devices. Comparison of readings between the Omron device and the sphygmomanometer served as a positive control of how well a laboratory-validated automated device could perform in the community. Both the Association for the Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) criteria were used to assess the accuracy and reproducibility of readings.
Results: The mean blood pressure reading and standard error (SE) of the mean for the 108 volunteers (66 women and 42 men) was 133/77 (SE 2/1) mm Hg with the Vita-Stat device, 131/77 (SE 2/1) mm Hg with the Omron device and 129/76 (SE 2/1) mm Hg with the sphygmomanometer. The mean difference in readings was 4.4/1.0 (standard deviation [SD] 9.4/6.2) mm Hg between the Vita-Stat device and the sphygmomanometer and 1.6/0.6 (SD 9.3/6.4) mm Hg between the Omron device and the sphygmomanometer. Neither automated device met the AAMI accuracy criteria for the systolic readings. The BHS grades were C/A (systolic unacceptable/diastolic acceptable) for each automated device. According to the BHS analytical criterion, all devices achieved acceptable reproducibility grades.
Interpretation: Neither automated device met the AAMI or BHS criteria for accuracy while in use in the community, and neither performed as well in the community as in the laboratory.