Why the study?
End-users need access to reliable validated device listings to identify accurate automated blood pressure devices, motivating a detailed description of the Hypertension Canada Recommended BP Device Listing.
Key points are not available for this paper at this time.
Population
67 distinct BP device models from 13 different manufacturers
Design
Descriptive report of a national device listing registry
May help clinicians and patients identify validated automated monitors; leaves open whether the listing has increased uptake in Canada.
Automated blood pressure (BP) devices promote standardization of the BP measurement process and enable performance of unattended and out-of-office measurements.1 Consequently, authors of hypertension clinical practice guidelines and BP measurement consensus statements have strongly endorsed use of automated BP devices proven accurate in a clinical validation study in place of manual auscultation.2-4 However, resistance to automated BP measurement is widespread among clinicians (especially in developing countries)—partly, due to the proliferation of low-quality, inaccurate devices, which has eroded health care provider confidence in the accuracy of all automated BP measurement.5 Less than 15% of automated devices sold internationally are validated, underscoring the importance making device validation a pre-requisite to marketing.2 To encourage appropriate use of automated BP measurement, end-users must have ready access to a reliable validated device listing so that accurate devices can be easily identified. Several such online listings currently exist, each possessing unique characteristics (Table 1). In a previous introductory paper authored by members of the Accuracy in Measurement of Blood Pressure (AIM-BP) Collaborative, the need to provide further description of these different device listings, including their design, rationale, and unique characteristics, was identified.6 As creators of the Hypertension Canada Recommended BP Device Listing, we herein detail the rationale for its creation, operational process, areas of uncertainty, and future plans. British and Irish Hypertension Society https://bihsoc.org/bp-monitors/ Hypertension Canada https://hypertension.ca/bpdevices Validated Device Listing (VDL) for United States Blood Pressure Devices Validatebp.org Japanese Society of Hypertension http://www.jpnsh.jp/com_ac_wg1.html German Hypertension League Quality Seal Protocol https://www.hochdruckliga.de/messgeraete-mit-pruefsiegel.html dabl Educational Trust http://www.dableducational.org STRIDE BP https://stridebp.org/bp-monitors MEDAVAL https://medaval.ie As of end-2019, the listing contained 67 distinct BP device models from 13 different manufacturers, of which 48% were gold status (ie, validated by AAMI/ISO or British Hypertension Society standards). This includes 57 home monitoring devices, four in-pharmacy kiosks, three automated office devices, and three ambulatory monitors. Since its relaunch, the device listing website has been accessed 55 837 times as of December 31, 2019. Although not empirically substantiated, we estimate that the vast majority of home BP devices sold in Canadian pharmacies are included in the listing. However, additional research is needed to verify this and examine the impact of the listing on the availability of validated devices in Canada. The Hypertension Canada Recommended BP Device Listing serves as an important repository of validated automated devices sold on the Canadian market, assisting consumers, patients, and care providers in choosing or recommending a validated BP device. It helps to optimize automated BP measurement in this country and provides useful information specific to Canada. It is hoped that the information provided herein will prove useful to stakeholders in other countries or regions that are considering establishing a similar device listing. We view the establishment of a national device listing as an essential step to implementing national and international clinical practice recommendations emphasizing the importance of using automated BP measurement. This manuscript was produced as part of the Accuracy in Measurement of Blood Pressure (AIM-BP) Collaborative, an initiative advocating for best measurement practices globally. AIM-BP members and their affiliations can be found on the World Hypertension League web site. The contents of this paper reflect the opinions of its authors and not necessarily all members of AIM-BP. The Hypertension Canada Device Recommendation Listing is funded and administered by Hypertension Canada. RP and JR are Co-Founders of mmHg Inc, a University of Alberta based start-up creating software and hardware solutions to improve blood pressure measurement. AB is CEO of Hypertension Canada. The remaining authors have no conflicts to declare.
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Padwal et al. (2020) studied this question.
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