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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

Tholl, Ulrich; Lüders, Stephan; Bramlage, Peter; Dechend, Ralf; Eckert, Siegfried; Mengden, Thomas; Nürnberger, Jens; Sanner, Bernd; Anlauf, Manfred

doi: 10.1097/MBP.0000000000000186
Special Article
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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.

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

Correspondence to Ulrich Tholl, MD, Department of Internal Medicine III, Karl-Leisner Clinic, St Antonius Hospital, Albersallee 5, 47533 Kleve, Germany Tel: +49 282 149 07250; fax: +49 282 149 01083; email: ulrich.tholl@kkle.de

Received October 31, 2015

Received in revised form February 2, 2016

Accepted February 4, 2016

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