Objective: The validation and accuracy of sphygmomanometers are important issues in the home sphygmomanometer market and in clinical practice. The aims of this study are to assess the frequency of validated home sphygmomanometers and to evaluate the relationship between the validation and accuracy of the devices.
Methods: Eight hundred and ninety-six home sphygmomanometers were brought by individuals to the University Hospital Hypertension Clinic for this study, and 870 (97%) of the devices were in adequate working condition and suitable for analysis. The relationship between accuracy and validation was investigated only in automated sphygmomanometers (n = 554).
Results: Both the manufacturer and model were known in 500 devices (90%), and these devices were eligible for evaluation of validation. We found 74 devices listed in the dabl Educational Trust website. Twenty-two of the 74 (30%) devices were validated. Four hundred (72%) of the 554 automated sphygmomanometers were inaccurate. The frequency of accuracy was higher among validated devices compared with nonvalidated devices (68 vs. 15%) (P<0.01).
Conclusion: Our study showed that the frequency of accurate devices was higher among validated sphygmomanometers compared with nonvalidated sphygmomanometers. To our knowledge, our study is the first to demonstrate the relationship between accuracy and validation of home sphygmomanometers. The frequency of device-related errors can be decreased by training patients and supervising the blood pressure device market. Nonprofit organizations can help patients to overcome some of the problems in the blood pressure device market.