Pan American Health Organization · 1st edition, 2021
Guidance for regulatory authorities on ensuring only clinically validated automated blood pressure devices enter primary health care facilities.
- Issuer
- Pan American Health Organization
- Edition
- 1st edition, 2021
- Audience
- Regulatory authorities, legal metrology departments, procurement officials, ministries of health, primary health care facility managers
- Evidence
- Expert consensus based on international validation standards and regulatory best practices
- Reviewed
- 19 Oct 2026 · GMJ
What this guideline says
GMJ summary
This PAHO technical document provides a practical framework for governments in the Americas to strengthen national regulatory systems governing blood pressure measuring devices (BPMDs). The core recommendation is that only automated BPMDs validated for accuracy through independent clinical testing according to internationally accepted protocols should receive pre-market approval and be procured for primary health care facilities.
The document addresses a critical gap: most countries in the Region lack regulatory frameworks requiring accuracy validation as a criterion for BPMD approval, meaning inaccurate devices are widely available. Since hypertension affects one in four adults in the Americas and is the leading risk factor for cardiovascular disease, accurate BP measurement is foundational to diagnosis and control. The publication outlines key regulatory elements including conflict-of-interest requirements for validation studies, labeling standards, enforcement mechanisms, and links regulation to procurement specifications.
The guidance supports the HEARTS in the Americas initiative goal of exclusive use of validated automated BPMDs in primary health care by 2025, recognizing that measurement errors of even 10/5 mm Hg can dramatically distort population hypertension prevalence estimates and lead to incorrect individual diagnosis and treatment.
Key points
For clinicians — doses and thresholds as stated in the guideline
- Regulatory frameworks must require evidence that BPMDs have passed the ISO 81060-2:2018 universal validation standard (or most recent equivalent) before pre-market approval
- Until January 2024, devices validated using older protocols (2013 AAMI, 2010 ESH, or 1993 BHS) are acceptable; after 2024, only ISO 81060-2:2018 or newer standards should be accepted
- Validation studies must be conducted by independent investigators without conflict of interest with manufacturers or distributors
- Validated devices should be confirmed through reputable online registries (STRIDE BP, Medaval) or peer-reviewed published validation studies
- Clearance by regulatory agencies of other countries does not constitute proof of accuracy validation unless that country requires independent clinical validation for pre-market approval
- Labeling must include validation status and standard used in a clearly visible manner on both packaging and the device itself
- Calibration and preventative maintenance should be performed at least annually, with more frequent checks for devices used in busy clinics
- Procurement specifications must require validated automated upper-arm cuff BPMDs with multiple cuff sizes, AC/rechargeable battery power, and at least 2-year warranty
Requirements for various parameters of the universal validation standard (ISO 81060-2)
Table extracted from the guideline
| Parameter | Requirement |
|---|---|
| Efficacy measure | Threshold for accepting accuracy of BP measurement at estimated probability of tolerable error (≤ 10 mm Hg) ≥ 85% |
| Sample size | ≥ 85 participants |
| Participating populations | General population: aged ≥ 12 years. Special populations: age < 3 years; age 3-11 years; pregnant women (N=45: 15 normotensive, 15 gestational hypertension, 15 pre-eclampsia); arm circumference > 42 cm; atrial fibrillation |
| Cuff sizes | Minimum number of participants per cuff size, depending on number of test device cuffs. Requirement for arm circumference distribution according to range of use of test device |
| Reference BP | Mercury sphygmomanometer or accurate non-mercury devices |
| Data collection | Sequential BP measurements on the same arm are preferred |
| Pass criteria | Average difference in BP and standard deviation criteria 1 and 2 of universal method. Absolute difference in BP ≤ 5, 10, and 15 mm Hg and scatterplots presented |
Source: Pan American Health Organization, HEARTS in the Americas: Regulatory Pathway to the Exclusive Use of Validated Blood Pressure Measuring Devices. Reproduced in summary form.
From the guideline
Verbatim
“Inaccurate measurement of BP has important consequences for policies to address hypertension, as well as for patient safety and quality of care.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As someone who has worked extensively with WHO on health systems strengthening in our region, I recognize that this guidance addresses a critical yet often overlooked aspect of cardiovascular disease control in Georgia and neighboring countries. While we have made progress in expanding access to antihypertensive medications through our UHC programme, the accuracy of the devices we use to diagnose and monitor hypertension has not received adequate attention. The recommendation I would emphasize to Georgian clinicians and policymakers is the requirement that all newly procured automated blood pressure devices for primary health care facilities must have undergone independent validation according to ISO 81060-2:2018, verified through international registries like STRIDE BP. The realistic implementation caveat is that our current procurement system may not yet include validation status as a mandatory criterion, and our national regulatory framework for medical devices will require strengthening to enforce pre-market validation requirements, which will need coordination between the Ministry of Health, the National Center for Disease Control and Public Health, and procurement authorities.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 19 Oct 2026
Applicability
Georgia and the South Caucasus
This guidance is highly relevant for Georgia and the South Caucasus region, where cardiovascular disease remains the leading cause of mortality and hypertension control rates are suboptimal. Georgia’s Universal Health Care programme, established in 2013, covers primary care services where accurate BP measurement is foundational to hypertension diagnosis and management. National programmes should assess current regulatory frameworks governing medical devices to determine if accuracy validation is required for BPMD pre-market approval, review procurement specifications for primary health care facilities to ensure only validated devices are acquired, and consider establishing collaboration with existing international BPMD validation registries or developing regional capacity for device verification. The transition period allowing older validation protocols until 2024 provides a realistic timeframe for regulatory updates and device replacement cycles without excessive immediate costs.
Questions this guideline answers
Quick answers
What is the difference between a validated and non-validated blood pressure device?
A validated BPMD has undergone rigorous independent clinical testing against a gold standard reference and met accuracy requirements of a scientifically accepted protocol (ISO 81060-2:2018 or equivalent). Studies show validated devices are accurate 65% of the time versus only 15% for non-validated devices. Most BPMDs available for purchase have not been validated because validation testing is not required by most regulatory authorities.
How can I verify if a specific blood pressure device has been validated?
Search for the manufacturer name and model number on reputable online registries such as STRIDE BP (www.stridebp.org) or Medaval (medaval.ie). Country-specific listings exist for Canada, Germany, Japan, UK/Ireland, and USA. If not found on registries, manufacturers should provide peer-reviewed published validation studies or proof the device is equivalent to a previously validated model (same measurement apparatus and algorithms).
Why shouldn't we accept regulatory approval from other countries as proof of accuracy?
Most countries' regulatory frameworks do not require accuracy validation testing for BPMD pre-market approval, even among International Medical Device Regulators Forum members. Relying on another country's approval is only appropriate if that country specifically requires independent clinical validation according to internationally accepted standards and all other regulatory requirements are met. Harmonization of validation requirements across countries would enable and strengthen regulatory reliance.
What maintenance is needed to keep automated blood pressure devices accurate over time?
Preventative maintenance including calibration should be performed at least every 1-2 years by technical staff or clinical engineers, with more frequent checks for devices used in busy clinics. Calibration checks should include examination of cuffs and tubing; damaged components must be repaired or replaced. Always use manufacturer-recommended cuffs, not generic replacements, as validation studies are conducted with specific cuff types. Formal records of all maintenance must be kept.
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- Issuer
- Pan American Health Organization
- Type
- Procedures, manuals, guidelines
- Edition
- 1st edition, 2021
- Status
- Current
- Published
- 2021-01-01
- Languages
- English
- Scope
- Regulatory and procurement frameworks for automated and semi-automated upper-arm cuff blood pressure measuring devices; accuracy validation requirements for pre-market approval
- Audience
- Regulatory authorities, legal metrology departments, procurement officials, ministries of health, primary health care facility managers
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-75-12485-7 (print versi
- Evidence
- Expert consensus based on international validation standards and regulatory best practices
- Record history
- Created 19 Oct 2026 · updated 19 Oct 2026 · next check Apr 2027
Pan American Health Organization. HEARTS in the Americas: Regulatory Pathway to the Exclusive Use of Validated Blood Pressure Measuring Devices. Washington, D.C.: PAHO; 2021. Licence: CC BY-NC-SA 3.0 IGO.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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