Validation of the Welch Allyn Spot Vital Signs blood pressure device according to the ANSI/AAMI SP10: 2002. Accuracy and cost-efficiency successfully combined

Abstract

Objectives: To validate a significantly lower priced, new-generation blood pressure device by using the ANSI/AAMI SP10:2002 Standard evaluation.

Methods: The Spot Vital Signs device evaluation was performed using the procedure specified in the SP10: 2002 American National Standard. Both obese and hypertensive participants were overrepresented in the study population.

Results: The mean+/-standard deviation for the device readings compared with auscultation by paired, trained, blinded observers for systolic blood pressure was -1.0+/-4.1 mmHg; for diastolic blood pressure it was -0.4+/-6.1 mmHg. These passed AAMI criteria. The device, at a cost well below those of comparable professional-quality (vs. self measurement) electronic blood pressure devices, was extremely accurate.

Conclusions: The Welch Allyn Spot Vital Signs device provides a cost-effective alternative for medical-care delivery sites where accuracy and cost are both high priorities. The study population was oversampled for obese and hypertensive patients, the major target groups in whom blood pressure must be able to be recorded accurately to optimize diagnosis and management of cardiovascular disease.