Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis

Objectives We evaluated two new Welch Allyn automated blood pressure (BP) algorithms. The first, SureBP, estimates BP during cuff inflation; the second, StepBP, does so during deflation. We followed the American National Standards Institute/Association for the Advancement of Medical Instrumentation SP10:2006 standard for testing and data analysis. The data were also analyzed using the British Hypertension Society analysis strategy. Methods We tested children, adolescents, and adults. The requirements of the American National Standards Institute/Association for the Advancement of Medical Instrumentation SP10: 2006 standard were fulfilled with respect to BP levels, arm sizes, and ages. Association for the Advancement of Medical Instrumentation SP10 Method 1 data analysis was used. Results The mean +/- standard deviation for the device readings compared with auscultation by paired, trained, blinded observers in the SureBP mode were -2.14 +/- 7.44mmHg for systolic BP (SBP) and -0.55 +/- 5.98mmHg for diastolic BP (DBP). In the StepBP mode, the differences were -3.61 +/- 6.30mmHg for SBP and -2.03 +/- 5.30mmHg for DBP. Both algorithms achieved an A grade for both SBP and DBP by British Hypertension Society analysis. Conclusion The SureBP inflation-based algorithm will be available in many new-generation Welch Allyn monitors. Its use will reduce the time it takes to estimate BP in critical patient care circumstances. The device will not need to inflate to excessive suprasystolic BPs to obtain the SBP values. Deflation is rapid once SBP has been determined, thus reducing the total time of cuff inflation and reducing patient discomfort. If the SureBP fails to obtain a BP value, the StepBP algorithm is activated to estimate BP by traditional deflation methodology. Blood Press Monit 16:96-98 (C) 2011 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.