Since 1987 the US Association for the Advancement of Medical Instrumentation (AAMI) has published protocols for blood pressure (BP) monitor validation, and recently in collaboration with the International Organization for Standardization (ISO). A review of published validation studies using these protocols was performed, to evaluate the level of adherence with the protocol requirements.Design and method:
Published validation studies using the AAMI, ISO, or ANSI/AAMI/ISO protocols from 2010 until Dec. 2015 were identified. All the protocol procedures were scrutinized using a standard checklist adjusted according to the protocol used.Results:
Twenty-six studies were identified. The number of publications per year were 4/5/2/1/2/12 for years 2010/11/12/13/14/15 respectively. Six different revisions of the protocols were applied. The most used protocol was the ANSI/AAMI/ISO-2009 (9 studies), whereas the ANSI/AAMI/ISO-2013, ANSI/AAMI/ISO-2006, ANSI/AAMI-2003, ANSI/AAMI-2002 and ANSI/AAMI-1996 were used in 6/2/1/5/1 studies respectively (2 studies did not report the protocol version). 20 studies tested oscillometric devices, 21 upper-arm devices, 16 clinic, 2 ambulatory, 5 home, and 3 hospital monitors. 23 studies reported a ‘pass’ result. 17 used same-arm sequential method, and 8 opposite-arm simultaneous method (one did not report the method used). Samples ranging from 30 (specific population) to 509 subjects (epidemiological study) were included. Seven studies included special populations (obese, pregnant, pre-eclampsia, neonatal/infant, intensive care unit, arrhythmia,cardiac catheterization), while 8 included mixed populations (i.e. adults and children and/or obese). Several protocol violations were identified in 9 studies, involving failure to assess devices according to stipulated criteria, BP ranges, cuff size distribution, sample size, and number of test measurements per participant. Information on cuffs used, precise BP measurement procedure and BP ranges was omitted in 11 studies.Conclusions:
The AAMI/ISO protocols are mainly used in special or mixed populations, probably because, compared to other protocols, this is permitted by the large sample required and specific relevant recommendations are provided. The peer review process of scientific journals often misses important deficiencies of validation studies. The large number of AAMI/ISO revisions makes peer review and comparison among devices difficult.