Determining The Accuracy of Home And Office Blood Pressure Monitors

This post is not yet complete. I am posting it now so that I can easily have access to the Resources below on my mobile devices.

Everyone wonders if the blood pressure readings from their home cuff, doctor’s office cuff, or automatic blood pressure reading at the pharmacy are accurate.

Ultimately this blog post, hopefully, will evolve into a simple and practical way to assess the continued accuracy of blood pressure monitors after purchase.

For a list of blood pressure cuffs available for purchase that have passed accuracy checks please see my post,

And there are many potential sources of inaccuracy in blood pressure measurement. A blood pressure machine that is inaccurate can be the source of measurement errors.

However, many other factors besides the blood pressure machine can lead to inaccurate blood pressure measurement.

Table 2 [p 4 of the PDF] in Resource (1) lists 29 potential sources of blood pressure measurement error. These give examples types of errors.

Table 3 below [p. 12 of the above PDF] gives the effect of the potential sources of error on the blood pressure measurement:

fig1

One way of  eliminating many of the technical errors that can cause blood pressure measurement inaccuracies is to use The SPRINT protocol for blood pressure measurement. Resource (2).

And it is critical for accurate blood pressure measurement to use the correct sized blood pressure cuff as outlined in Resource (2).

Resources (3) below gives the most current information on blood pressure measurement in the doctor’s office, home, and ambulatory measurement.

And Resource (4) are the most recent hypertension guidelines (2017) from Hypertension Canada.

But now we come to the blood pressure machine itself. How do we know that any given blood pressure device (whether home, office, or pharmacy) is giving accurate readings?

Resource (5) is a prerecorded webinar on the use of biomedical equipment to validate the accuracy and reproducibility of a noninvasive blood pressure monitor. The video is approximately 40 minutes long and would be of most interest to a physician or biomedical technician.

Fluke, who created the above webinar, manufactures three instruments that can be used in biomedical testing of noninvasive blood pressure monitors: Prosim 4, Prosim 8, and the BP Pump 2.

Two companies  that perform the biomedical testing referenced in Resource (5) are Aramark Biomedical and Crothal Healthcare.

Resources (6) and (7) below use a different method [from that used by Resource (5) above] of checking the accuracy of an automated blood pressure cuff. And both use their method to check the accuracy of the OMRON HEM-907XL oscillometric blood pressure measurement device (the device used in the groundbreaking SPRINT trial [See Resources (8) and (9) for links on the SPRINT Trial].

Resources (6)  used the Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80601:2009 & A1:2013 which is behind a paywall. Resource (7) used an earlier AAMI standard also not freely available.

See Resource (8) for a guideline on standardization of the European Society of Hypertension.

Here we will describe how to do it.

Resources:

(1) J Hypertens. 2017 Mar;35(3):421-441. doi: 10.1097/HJH.0000000000001197.
Sources of inaccuracy in the measurement of adult patients’ resting blood pressure in clinical settings: a systematic review [PubMed Abstract] [Full Text HTML] [Full Text PDF].

(2) PDF Excerpt From The SPRINT Trial Manual of Procedures detailing how to measure blood pressure for the study.

(3) Accurate Measurement of Blood Pressure DIAGNOSIS AND ASSESSMENT [Full Text HTML] [Full Text PDF] from Hypertension Canada 2017.

(4) Hypertension Canada’s 2017 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults [PubMed Abstract] [Full Test HTML] [Full Text PDF]. Can J Cardiol. 2017 May;33(5):557-576. doi: 10.1016/j.cjca.2017.03.005. Epub 2017 Mar 10.

(5) Non-Invasive Blood Pressure Monitoring and Testing: a prerecorded Webinar from Fluke Biomedical-“Trusted For Measurements That Matter.” Accessed 8-28-2017.

(6) Assessing the accuracy of the OMRON HEM-907XL oscillometric blood pressure measurement device in patients with nondialytic chronic kidney disease [PubMed Abstract] [Full text HTML] [Full Text PDF]. J Clin Hypertens (Greenwich). 2017 Mar;19(3):296-302. doi: 10.1111/jch.12961. Epub 2017 Jan 12.

(7) Assessing the validity of the Omron HEM-907XL oscillometric blood pressure measurement device in a National Survey environment [PubMed Abstract] [Full Text HTML] [Full Text PDF]. J Clin Hypertens (Greenwich). 2010 Jan;12(1):22-8. doi: 10.1111/j.1751-7176.2009.00199.x.

(8) European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults [PubMed Abstract] [Full Text HTML] [Full Text PDF]. Blood Pressure Monitoring 2010, 15:23–38.

(8) Methods of the SPRINT MIND Trial – How They Did It + Why It Matters to Primary Care Physicians Posted on November 24, 2015 by Tom Wade MD.

(9) The SPRINT Treatment Algorithm for the Intensive Treatment Group (Goal SBP < 120 mm Hg) – How They Did It Posted on November 14, 2015 by Tom Wade MD.

(10) How to Calibrate Pressure Instruments YouTube video from Mensor

(11) BP Pump 2 NIBP Blood Pressure Simulator from Flake BioMedical:

The BP Pump 2 provides dynamic blood-pressure simulations for testing adult and neonatal noninvasive blood pressure monitors, including both arm- and wrist-cuff types. The analyzer features a preset mode for simulation of most patient conditions and the capability to program user-defined simulations. BP Pump 2 tests for leaks, measures static pressure, generates pressure, and tests overpressure valves. For improved testing versatility, the analyzer’s recently upgraded waveform test suite includes additional physiological selections. BP Pump 2 comes in two models: the standard BP Pump 2L and the BP Pump 2M, which features a high-accuracy pressure transducer. BP Pump 2 also includes an optional five-lead ECG test capability.

(12) FAQs On Using the ProSim 2 to Assess the Accuracy of noninvasive blood pressure monitors [PDF accessed 8-21-2017]

(11) Calibration accuracy of hospital-based non-invasive blood pressure measuring devices [PubMed Abstract] [Full Text HTML] [Full Text PDF]. J Hum Hypertens. 2010 Jan;24(1):58-63. doi: 10.1038/jhh.2009.29.

(12) Quality Control and Validation of Oscillometric Blood Pressure Measurements Taken During an Epidemiological Investigation [PubMed Abstract] [Full Text HTML] [Full Text PDF]. Medicine (Baltimore). 2015 Sep;94(37):e1475. doi: 10.1097/MD.0000000000001475.

(13) Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z) [PubMed Abstract] [Full Text HTML] [Full Text PDF]. Vasc Health Risk Manag. 2015 Jan 9;11:49-53. doi: 10.2147/VHRM.S72438. eCollection 2015.

(14) Blood Press Monit. 2016 Feb;21(1):1-8. doi: 10.1097/MBP.0000000000000150.
Validation protocols for blood pressure-measuring devices: status quo and development needs [PubMed Abstract]. Blood Press Monit. 2016 Feb;21(1):1-8. doi: 10.1097/MBP.0000000000000150.

(15) An Assessment of the Accuracy of Home Blood Pressure Monitors When Used in Device Owners [PubMed Abstract] [Full Text HTML] [Full Text  PDF]. Am J Hypertens. 2017 Jul 1;30(7):683-689. doi: 10.1093/ajh/hpx041.

(16) Implementing Home Blood Pressure Monitoring In Your Practice: A Practical Guide [Full Text PDF]. This resource is a joint production of the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Greater Manchester and the British Hypertension Society.

(17) How Accurate Are Home Blood Pressure Devices in Use? A Cross-Sectional Study [PubMed Abstract] [Full Text HTML] [Full Text PDF]. PLoS One. 2016 Jun 1;11(6):e0155677. doi: 10.1371/journal.pone.0155677. eCollection 2016.

(18) Experts Provide a Glimpse of the New Post-SPRINT Era of Hypertension [PubMed Abstract] [Full Text HTML] [Full Text PDF]. P T. 2017 Feb;42(2):118-123.

(19) A novel and simple protocol for the validation of home blood pressure monitors in clinical practice [PubMed Abstract]. Blood Press Monit. 2012 Oct;17(5):210-3. doi: 10.1097/MBP.0b013e328356e196.

 

This entry was posted in Family Medicine, Hypertension, Internal Medicine, Medical Decision Making, Medical Equipment. Bookmark the permalink.