Received: 24 March 2018 | Accepted: 26 March 2018

DOI: 10.1111/jch.13294

SPECIAL ISSUE

Validation protocols for blood pressure measuring devices in

the 21st century

George S. Stergiou MD, PhD, FRCP1 | Bruce S. Alpert MD2 | Stephan Mieke PhD3 |
Jiguang Wang MD, PhD4 | Eoin O’Brien MD, DSc, FRCP5

1
Hypertension Center STRIDE-7, School
of Medicine, Third Department of Blood pressure (BP) is a vital sign and the essential measurement for the diagnosis of
Medicine, Sotiria Hospital, National and hypertension. Therefore, its accurate measurement is a key element for the evalua-
Kapodistrian University of Athens, Athens,
Greece tion of many medical conditions and for the reliable diagnosis and efficient treatment
2
Department of Pediatrics, University of of hypertension. In the last 3 decades prestigious organizations, such as the US
Tennessee Health Science Center (Retired), Association for the Advancement of Medical Instrumentation (AAMI), the British
Memphis, TN, USA
3 Hypertension Society, the European Society of Hypertension (ESH) Working Group
Physikalisch-Technische Bundesanstalt,
Convener of ISO/IEC Joint Working on BP Monitoring, and the International Organization for Standardization (ISO), have
Group, Non-invasive blood pressure
developed protocols for clinical validation of BP measuring devices. All these initia-
monitoring equipment, Berlin, Germany
4
Shanghai Institute of Hypertension,
tives aim to standardize validation procedures and establish minimum accuracy
Department of Hypertension, Centre standards for BP monitors. Unfortunately, only a few of the BP measuring devices
for Epidemiological Studies and Clinical
Trials, Ruijin Hospital, Shanghai Jiaotong
available on the market have been subjected to independent validation using one of
University School of Medicine, Shanghai, these protocols. Recently, the AAMI, ESH, and ISO experts agreed to develop a single
China
5
universally acceptable standard (AAMI/ESH/ISO), which will replace all previous pro-
The Conway Institute, University College
Dublin, Dublin, Ireland tocols. This major international initiative has been undertaken to best serve the
needs of patients with hypertension, a public interested in cardiovascular health,
Correspondence
George S. Stergiou, MD, FRCP, Hypertension practicing physicians, scientific researchers, regulatory bodies, and manufacturers.
Center STRIDE-7, School of Medicine, Third There is an urgent need to influence regulatory authorities throughout the world to
Department of Medicine, Sotiria Hospital,
National and Kapodistrian University of make it mandatory for all BP measuring devices to have undergone independent vali-
Athens, Athens, Greece. dation before approval for marketing. Efforts need to be intensified to improve the
Email: gstergi@med.uoa.gr
accuracy of BP measuring devices, further optimize the validation procedure, and
ensure that objective and unbiased validation data become available.

1 | H I S TO RY O F VA LI DATI O N PROTO CO L S
Blood pressure (BP) is a hemodynamically variable phenomenon and
a vital sign, and it is also the essential estimation for the identification
of patients with hypertension; its accurate measurement is, there-
fore, a key element for the evaluation of many medical conditions and
for the reliable diagnosis and efficient treatment of hypertension. 1 Validation of BP monitors was started with ad hoc protocols in the
Noninvasive auscultatory and oscillometric devices provide an “es-
timation” of BP rather than a true “measurement,” which can be ob-
tained only using a direct intra-­arterial method. However, in this article
intended for practicing clinicians we use the term “measurement,” in
Bruce Alpert retired.
order to be in line with the wording used in current guidelines for
the management of hypertension in clinical practice. Unfortunately,
at the present time formal clinical validation is not mandatory in all
countries for BP measuring devices to be put on the market, and
there is evidence that fewer than 20% of the devices available have
been subjected to validation using an established protocol.1,2
1980s,1 and since then several procedures have been developed by
prestigious organizations (Table 1). In 1987 the US Association for the
Advancement of Medical Instrumentation (AAMI) introduced a standard
including a procedure for clinical validation of an automated BP monitor.3
The British Hypertension Society presented a similar clinical validation

1096 | ©2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/jch J Clin Hypertens. 2018;20:1096–1099.


STERGIOU et al.
protocol in 1990.4 Revised versions of both protocols have been pub-
lished.5,6 The German Hypertension League developed another protocol
in 1999.7 In 2002, the European Society of Hypertension Working Group
on BP Monitoring developed the ESH-­International Protocol (ESH-­IP),8
which was revised with more stringent criteria in 2010.9 The European
10
Committee for Standardization (CEN) published a standard in 2004.
In 2009 the International Organization for Standardization (ISO)11 de-
veloped another standard, which was largely based on the AAMI and
CEN standard and has been adopted by the AAMI Sphygmomanometer
Committee12 and other national committees worldwide. A revised version
of the American National Standards Institute (ANSI)/AAMI/ISO standard
was developed in 2013.13 With the expanding use of out-­of-­office BP
monitoring (ambulatory and home) in clinical practice, which is almost
exclusively performed using electronic devices, and the progressive re-
placement of office or clinic auscultatory devices with electronic ones, the
need for formal clinical validation has now become more crucial than ever.
2 | CO M PA R I S O N O F VA LI DATI O N
PRO C E D U R E S
The aforementioned validation procedures have many similarities
but also several methodological and technical differences. The
main differences between the ESH-­IP 9 and the ANSI/AAMI/ISO
standard,13 which currently are the most widely accepted and used,
may be summarized as follows:
Efficacy measure
The two protocols require a similar level of device accuracy in
BP measurement with estimated probability of a tolerable error
(≤ 10 mm Hg) at 85%. This is not an ideal level of accuracy but a real-
istic one, taking into account the performance of currently available
technology and the patient’s physiologic BP variability within the
validation procedure. Further technological development aiming to
a higher level of accuracy is desirable.
TA B L E 1 History of validation
Publication
protocols
1987, 1992, 2002
1990, 1993
1999
2002, 2010
2004
2009
2009, 2013
2018
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| 1097
Sample size
The ESH-­IP requires 33 participants compared to 85 for the ANSI/
AAMI/ISO. The larger sample size of the latter protocol results in
greater study power and sensitivity and allows the evaluation of sub-
groups, eg, per cuff size, but requires considerably greater invest-
ment in terms of resources and costs.14
General and special populations
The ESH-­IP has been developed for a general population of
adults aged ≥ 25 years and requires separate studies for special
populations (eg, in pregnancy). The ANSI/AAMI/ISO for gen-
eral population studies requires participants aged > 12 years
and additional 35-­p articipant subgroups for special populations
(apart from pregnancy, which requires 45 women). Thus, for
special populations the sample size is similar in the ESH-­IP and
the ANSI/AAMI/ISO (33 vs 35 participants respectively). Both
protocols consider participants aged ≤ 12 years as a special
population.
Reference BP measurement
The ESH-­IP recommends the use of a mercury sphygmomanometer,
whereas the ANSI/AAMI/ISO accepts any manometer with maxi-
mum error ±1 mm Hg. The ANSI/AAMI/ISO also provides require-
ments for reference invasive BP measurements.
Methods for comparison
For the comparison of the test device BP measurements with
the reference method measurements, a same-­a rm sequential BP
measurement procedure is recommended in the two protocols.
The ANSI/AAMI/ISO also permits a simultaneous (same or oppo-
site arm) BP measurement procedure.
Organization
US Association for the Advancement of Medical Instrumentation
(AAMI)3,5
British Hypertension Society (BHS) 4,6
German Hypertension League (Deutsche Hochdruckliga) (DHL)7
European Society of Hypertension International Protocol (ESH-­IP) 8,9
European Committee for Standardization (CEN)10
International Organization for Standardization (ISO)11
American National Standards Institute/Association for the Advancement
of Medical Instrumentation/International Organization for
Standardization (ANSI/AAMI/ISO)12,13
Association for the Advancement of Medical Instrumentation/European
Society of Hypertension/International Organization for Standardization
(AAMI/ESH/ISO)14
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1098 | STERGIOU et al.

accuracy for BP measuring devices.1 The small sample size of the

Limb size and cuffs
The ANSI/AAMI/ISO has requirements for the minimum number of
participants per cuff size, whereas the ESH-­IP, because of its smaller
sample size, does not allow subgroup analyses (eg, per cuff size) but
only as special groups (eg, obese).
Ambulatory monitors and stress testing
Only the ANSI/AAMI/ISO presents additional requirements for am-
bulatory BP monitors and devices for exercise stress testing.
Pass criteria
The ESH-­IP has pass/fail criteria for individual BP readings (Part 1)
and individual participants (Part 2), which are based on the number of
readings with absolute test-­reference BP difference ≤ 5, 10, 15 mm
Hg. The ANSI/AAMI/ISO also has criteria for individual BP readings
(Criterion 1) and individual participants (Criterion 2) but based on
mean BP differences and their standard deviations. Interestingly, the
two approaches are statistically interchangeable with the two pro-
tocols allowing similar maximum levels of probability for tolerable
error of ≤ 10 mm Hg in BP measurement.14
ESH-­IP9 reduced the time, resources, and cost for validation stud-
ies and thereby allowed widespread application and considerable
increase in the number of devices subjected to independent valida-
tion.15 Thus, awareness of the importance of using appropriately val-
idated BP monitors was increased. However, this came at the cost of
lower study power and accuracy and inability to evaluate subgroups
(eg, for cuff sizes, or special populations).15-18
In 2017 the AAMI, ESH, and ISO committees have reexamined
all the major aspects of the validation procedures aiming to develop
a single universally acceptable standard.14 The AAMI/ESH/ISO uni-
versal standard is based on the collective experience from all previ-
ous standards and protocols and will replace previous protocols.14
This major international initiative has been undertaken to best
serve the needs of patients with hypertension, a public interested
in cardiovascular health, practicing physicians, scientific researchers,
regulatory bodies, and manufacturers and to strengthen the case for
independent clinical validation to become mandatory in all countries
for BP measuring devices before they are put on the market. The
key aspects of the agreed AAMI/ESH/ISO universal validation pro-
cedure are presented in Table 2.14
4 | TH E FU T U R E

3 | A A M I/E S H/I S O U N I V E R S A L S TA N DA R D At the present time, about 1 in 5 BP measuring devices availa-

ble on the market has been subjected to independent validation
Despite their differences, all the established validation protocols using an established protocol.1,2 Thus, there is an urgent need to
(Table 1) have a common objective, which is to standardize the expand validation procedures worldwide and eventually succeed
validation procedures and establish uniform minimum standards of in making it mandatory for all devices to be put on the market.

TA B L E 2 Key aspects of the AAMI/

Aspect Requirement
ESH/ISO universal validation standard14
Efficacy measure Threshold for BP measurement accuracy acceptance at estimated
probability of tolerable error (≤ 10 mm Hg) ≥85%.
Sample size ≥ 85 participants
General/special A general population study includes participants > 12 years.
populations Special populations: age < 3 years; pregnancy; arm > 42 cm; atrial
fibrillation; others may be added.
Special population studies include ≥ 35 participants (after successful
general population study).
Pregnancy: N = 45 (15 normotensive, 15 gestational hypertension, 15
preeclampsia). Korotkoff K5 for reference diastolic BP:
Children: N = 35 aged 3-­12 years can be included and analyzed together
with 50 older participants. Results also reported separately for children
(not a pass/fail criterion). Korotkoff K5 for reference diastolic BP.
Cuff sizes There is a minimum number of participants per cuff depending on number
of test device cuffs.
Requirements for arm circumference distribution according to range of
use of the test device.
Reference BP Mercury sphygmomanometers or accurate non-mercury devices.
Data collection Same-­arm sequential BP measurement is preferred.
Pass criteria Average BP difference and SD criteria 1 and 2 of ANSI/AAMI/ISO.
Absolute BP differences ≤ 5, 10, 15 mm Hg and scatterplots to be
presented.

STERGIOU et al.
The AAMI/ESH/ISO universal standard14 is a landmark initiative
towards achieving these goals. International efforts need to be
intensified to improve the clinical validation process by ensuring
that the proposed protocols are feasible for wide use and that pro-
tective measures are implemented to prevent protocol violations
and conflicts of interest.18-20
CONFLICT OF INTEREST
GS, EOB, and BA have conducted validation studies for various
manufacturers and advised manufacturers on device development.
JW conducted validation studies for various manufacturers. SM has
nothing to declare.
ORCID
George S. Stergiou http://orcid.org/0000-0002-6132-0038
Jiguang Wang http://orcid.org/0000-0001-8511-1524
Eoin O’Brien http://orcid.org/0000-0001-5417-7977
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How to cite this article: Stergiou GS, Alpert BS, Mieke S,
Wang J, O’Brien E. Validation protocols for blood pressure
measuring devices in the 21st century. J Clin Hypertens.
2018;20:1096–1099. https://doi.org/10.1111/jch.13294