Response to ‘Regarding: validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2 with two novel cuffs
The Association for the Advancement of Medical Instrumentation (AAMI) Sphygmomanometer Committee has the responsibility to write the United States Standard for the validation testing of automated blood pressure (BP) devices. The current USA National Standard is the American National Standards Institute (ANSI)/AAMI/International Organization for Standardization (ISO) publication 1. I have served on the Committee for over 30 years, and held the position of co-chair for a decade. The Committee has been extremely active during the past years. Recently, sections relating to 24-h ambulatory BP monitoring and stress testing were written by Dr David Gallick and myself. I have been an active participant in the long and complex process of developing specialized testing for BP estimation during patient transport by ground ambulance, fixed-wing, and rotary-wing ambulance. We hope to have the proposal ready for discussion and acceptance at the next ISO Sphygmomanometer Committee in Japan in January 2018. I had organized a meeting in February 2016 at which the leadership of the European Society of Hypertension (ESH), with Dr George Stergiou in charge, met with the ISO Committee to discuss the withdrawal of the ESH International Protocol 2. A manuscript from ESH, AAMI, and ISO representatives has been accepted for joint publication in the USA and Europe, accomplishing this goal. I have been active on the subcommittee tasked with the development of the statistical approach for the study of special populations, with the expert input from Dr Colin Wu of the National Institutes of Health. Populations under consideration include pregnant women, children, patients with dysrhythmias (especially atrial fibrillation), and patients with large arms.
Currently a very active subcommittee has been developing special requirements for testing of wide-range cuffs, so common in kiosk and self-measurement environments. Dr Padwal, author of the commentary in response to which this is written, has played an active role, as have Bruce Friedman, David Quinn, Josh Sarkis, Colin Wu, and myself. There are several draft proposals to be considered for the AAMI Sphygmomanometer meeting held on 8 September 2017 with, hopefully, final acceptance of the draft at the January 2018 ISO meeting in Japan.
Dr Padwal’s comments are timely and critical. With the acceptance of home (self-measurement) and kiosk BP estimations performed on validated (by ANSI/AAMI/ISO Standard) devices as part of clinical care, the rigorous testing of all cuffs that do not comply with the recommended sizing (∼40% width and 80–100% length 3) is paramount. I thank Dr Padwal for allowing me to highlight the significant improvements that have already occurred and are in the process of development/acceptance worldwide.