Validation Status of Electronic Sphygmomanometers in China: A National Survey.

Abstract

Background: Although the information on the validation status of electronic sphygmomanometer (ES) devices in use in health care institutions and households is much more clinically relevant than that of ES models available on the market, it remains insufficient.

Methods: A national survey was conducted across all administrative regions of mainland China to assess the validation status of ESs. Fifty-eight cities were selected with stratification by municipality, provincial capital, and other cities, and health care institutions and households in each city were chosen by convenience to identify ES devices in use according to the study protocol. Information on devices' model, type, was collected. The validation status of each device was ascertained through searching international online registries of its models.

Results: A total of 3230 ES devices (1924 from health care institutions and 1306 from households), encompassing 498 ES models, were actually selected. The weighted proportion of accuracy-validated devices was significantly higher in health care institutions (33.9% [95% CI, 31.8-36.0%]) compared with households (23.0% [95% CI, 20.8-25.4%]; P<0.001), and both exceeded the proportions for models (17.7% [95% CI, 13.7-22.6%] and 12.5% [95% CI, 9.5-16.3%], respectively). Regional economic development, device type, and years in use were associated with the proportion of accuracy-validated devices. Notably, 8.8% of devices used in secondary hospitals were wrist type.

Conclusions: The accuracy validation status of ESs in China in the number of devices in use shows a more favorable situation than that in the number of models but remains low and concerning. Policies are urgently needed to promote the widespread adoption of accuracy-validated models among all users.