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Blood Press Monit. 2016 Aug;21(4):197-205. doi: 10.1097/MBP.0000000000000186.

The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control.

Author information

1
aDepartment of Internal Medicine III, Karl-Leisner Clinic, St Antonius Hospital, Kleve bCentre of Hypertension, St Josef Hospital cInstitute for Pharmacology and Preventive Medicine, Cloppenburg dCharité University Clinic, Helios Clinic Berlin-Buch, Berlin eDepartment of Cardiology, Heart and Diabetes Centre NRW, Bad Oeynhausen fCentre of Rehabilitation, Kerckhoff-Clinic, Bad Nauheim gDepartment of Nephrology and Dialysis, Helios Clinic, Schwerin hDepartment of Internal Medicine, Agaplesion Bethesda, Wuppertal iMedical Practice of Internal Medicine, Cuxhaven, Germany.

Abstract

OBJECTIVE:

The German Hypertension League (Deutsche Hochdruckliga) established a program to assess the accuracy and reliability of blood pressure (BP)-measuring devices in 1999 (Quality Seal Protocol). Here, we report on the results of a testing series of 105 devices designed for BP self-measurement.

METHODS:

The test protocol for the validation of upper-arm, wrist, and finger devices was developed to compare device to conventional Riva-Rocci measurements based on five criteria: mean systolic and mean diastolic differences, their standard deviations, and a point score representing the correlation of systolic and diastolic errors of individual comparisons. The results of this testing are summarized.

RESULTS:

From 1999 to 2014, a total of 105 BP devices for self-measurement were tested according to the Quality Seal Protocol. Of these, 47.6% fulfilled all five validation criteria, 55.7% of the upper-arm devices (39 of 71) and 32.4% (11 of 34) of the wrist devices. Finger devices were not offered for testing. Forty-four devices (41.9%) failed multiple test criteria of the validation procedure. A subanalysis with 51 devices tested showed that a stricter definition of the passing point score with a limit of at least 55% would slightly increase the consistency with the conventional criteria in comparison with a point score criterion of at least 50%. It was therefore introduced in 2007.

CONCLUSION:

The results indicate the importance of a rigorous testing of a BP-measuring device used for home BP measurement to prevent patients from making erroneous treatment decisions.

PMID:
26998590
DOI:
10.1097/MBP.0000000000000186
[Indexed for MEDLINE]

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