title: 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.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Tholl
authors.forename: Stephan
authors.initials: S
authors.lastname: Lüders
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.forename: Ralf
authors.initials: R
authors.lastname: Dechend
authors.forename: Siegfried
authors.initials: S
authors.lastname: Eckert
authors.forename: Thomas
authors.initials: T
authors.lastname: Mengden
authors.forename: Jens
authors.initials: J
authors.lastname: Nürnberger
authors.forename: Bernd
authors.initials: B
authors.lastname: Sanner
authors.forename: Manfred
authors.initials: M
authors.lastname: Anlauf
mesh_terms: D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods; D015924:Blood Pressure Monitors; D005260:Female; D006801:Humans; D006973:Hypertension / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged