Weak and fragmented regulatory frameworks on the accuracy of blood pressure‐measuring devices pose a major impediment for the implementation of HEARTS in the Americas

Abstract

Global HEARTS is a WHO initiative for cardiovascular disease prevention and control. Accurate blood pressure (BP) measurement is an essential component of the initiative. This study aimed to determine the regulatory frameworks governing the accuracy of BPMDs in countries of the Americas participating in the HEARTS initiative. Quantitative and qualitative analysis of the laws and regulations relevant to ensuring the accuracy of BPMDs were determined from the Ministries of Health/Regulatory Agencies among 13 countries in Latin America and the Caribbean. Analysis included characterizing the scope of regulations (ie, pre‐market approval, sales and promotion, labeling, cuff sizes, and procurement), information systems for monitoring the models of BPMDs used in primary health care (PHC), and systems to enforce compliance with regulations. Ten of the 13 countries had medical device laws, but regulations that specifically address BPMDs only existed in three countries. Only one country (Brazil) had regulations for mandatory accuracy validation testing and only two countries regulated internet sales of BPMDs. Labeling and cuff size regulations existed in four and two countries, respectively. Less than half the countries reported having a data repository on the BPMD models being used in PHC facilities (four countries) or sold (five countries). Weak and fragmented regulatory frameworks on the accuracy of BPMDs exist among countries of the Americas. This will adversely affect the accuracy of blood pressure assessment and hence poses a major impediment for successful implementation of HEARTS initiative.

1. INTRODUCTION

Cardiovascular disease (CVD) is the leading cause of disease burden in the region of the Americas. According to the 2017 GBD Study's estimates, there were 14 million new cases of CVD, 80 million people living with this condition and, 2 million deaths attributed to CVD in the Americas. ¹ Hypertension is the major risk factor for CVD. ² Hypertension is highly prevalent, affecting 1 in 4 adults, including 40% of those over age 25 years. ¹ , ³ , ⁴ Fortunately, hypertension can be easily detected and effectively treated and controlled if there is a system in place adequately equipped with a skilled workforce, accurate blood pressure measurement devices (BPMDs), and a safe and effective core set of medicines, all together operating in the context of an accessible and organized health system. ³ , ⁴ , ⁵

To respond to these challenges, Global HEARTS, the World Health Organization (WHO) flagship initiative for CVD prevention and control, ⁶ has been implemented via the HEARTS in the Americas program thus far in 12 countries in the region of the Americas. This program is led by the Ministries of Health and supported by the Pan American Health Organization (PAHO), the US Center for Disease Prevention and Control (CDC), Resolve to Save Lives and World Hypertension League among other partners. The program envisions that by 2025, HEARTS will be the model for CVD risk management, including hypertension, diabetes, and dyslipidemia in primary health care in the Americas. ⁷ HEARTS in the Americas is upheld by six technical pillars to accelerate the full implementation of its technical package and whose titles form the HEARTS acronym (Healthy life‐style counseling, Evidence‐based treatment protocol, Access to essential medicines and technologies, Risk‐based approach, Team‐based care, and System for monitoring and evaluation) (Figure 1).

FIGURE 1.

Vision and pillars of the HEARTS in the Americas initiative for the prevention and control of cardiovascular disease

The specific pillar of “blood pressure measurement” focuses on correct blood pressure measurement technique, ⁸ use of automated BPMDs that have been validated for accuracy, ⁹ and strengthening of regulatory frameworks relevant to measurement accuracy. ¹⁰ This pillar is guided by the WHO policies on medical devices ¹¹ and it promotes the progressive implementation of the WHO Technical specifications for automated non‐invasive BPMDs with cuff. ¹² Manual blood pressure measurement has been recommended to be used only when it is not clinical feasible to assess blood pressure with a validated automated device (eg, atrial fibrillation, validation of hypertension in a child). ¹³ , ¹⁴ , ¹⁵ Currently, manual blood pressure assessment dominates clinical use and it has been challenging to implement widespread change. HEARTS and the recent WHO policies on medical devices represent important opportunities to stimulate the transition to validated automated devices. ¹² This document ¹² stresses the importance of clinical validation for accuracy and precision conducted by investigators independent of the manufacturer following a standardized international validation protocol. ¹⁶ This move toward the exclusive use of validated BPMDs has been recommended by many international experts and professional societies ¹⁷ , ¹⁸ because BPMDs that have not undergone rigorous validation are more likely to be inaccurate. ¹⁹ Importantly, most BPMDs sold worldwide have not undergone validation testing, ²⁰ but the extent to which this may affect countries participating in HEARTS is not known.

Accurate blood pressure measurement has profound implications for the effective implementation and scale‐up of hypertension control programs. Blood pressure measurement accuracy is critical as misclassification of a person as not hypertensive is a patient safety issue that could prevent that person from being treated, whereas misclassification of someone as having hypertension may result in side effects from unnecessary medication and wasted health system resources. Critically, even small errors in the prevalence of hypertension at the population level can severely influence appropriate policy development and proper allocation of resources. If population‐level error to the magnitude of 10 mm Hg occurs, this can impact the correct hypertension diagnosis in half of the adult population. ²¹ , ²²

Aligned with the strategic step abovementioned, this study aimed to determine the regulatory landscape for BPMDs in the HEARTS in the Americas implementing countries via their Ministries of Health and regulatory agencies. To address the study aim, first, we determined whether the countries had laws and regulations relevant to ensuring the accuracy of BPMDs. Second, we characterized the scope of such regulations with a focus on pre‐market approval, electronic sales and promotion, labeling, cuff sizes, and procurement. Third, we sought to understand the information systems for monitoring the models of BPMDs used, mainly in primary health care (PHC) centers; the mechanisms for the procurement of devices for use in publicly funded health care facilities; and the systems to assess and enforce compliance with regulations. The overall goal of this study was to derive evidence to inform policies and regulations both at the regional and national levels in Latin America and the Caribbean.

2. METHODS

A semi‐structured questionnaire was sent through official PAHO communication to the Ministries of Health of each country implementing HEARTS (Argentina, Barbados, Chile, Colombia, Cuba, Dominican Republic, Ecuador, Mexico, Panama, Peru, Saint Lucia, and Trinidad and Tobago) plus Brazil (a candidate country planning to implement HEARTS). Each Ministry of Health designated an appropriately qualified respondent to complete the questionnaire. Respondents were technical officers at the national health regulatory agencies or content‐experts from Ministries of Health. In completing the questionnaire, respondents were instructed, if necessary, to consult colleagues on topics not under their area of responsibility (for example, colleagues from the trade sector or managers of national primary health care programs). Respondents were also asked to include a link to the official documents mentioned within the answers to the questionnaire, or attach a file if not available online (this was for confirmatory analysis by study investigators, as per below). The questionnaire was sent in December 2019 and all respondents had completed and returned documents by February 2020.

The questionnaire was divided into the following main sections: the existence of medical devices laws and regulations, the scope of BPMD regulations, mechanisms to assess and ensure compliance with laws and regulations, data repository and surveillance, assessment and enforcement of adherence to regulations, procurement, and data repository. The structure of the questionnaire was based on review of the literature, including WHO guidance on regulation of medical devices, ²³ validation of BPMDs and regulatory frameworks applied to other areas of health, as well as on unstructured interviews with key informants (representatives of Ministries of Health working on HEARTS implementation and PAHO country officers) conducted in 2019. The Microsoft Forms software was used to collect data electronically.

For this study, laws, which may be enacted by legislative bodies or originate from the executive branch of the government, were considered the broader legal foundation for regulations. Laws grant legal authority to governing bodies (legislative bodies, regulatory agencies or specific sectors of the executive branch) to develop regulations (including the adoption of norms and standards) and enforce adherence to those. Regulations can be seen as a detailed application of laws to specific situations or areas, while laws are more generic.

The data collection was conducted prior to and in preparation for a technical meeting on regulatory frameworks relevant to BPMDs held in Ecuador in March 2020. ²⁴ This meeting was designed to raise awareness of the importance of validation of BPMDs, discuss gaps and facilitators regarding regulations, and explore feasible short‐ and long‐term actions to improve the regulatory environment. Eleven of the 13 respondents participated in the meeting and confirmation of answers provided by the remaining two respondents were completed by personal contact.

Several mechanisms were used to confirm the answers provided by respondents. Firstly, the country‐specific results were presented to respondents in a plenary session of the meeting mentioned above. Secondly, each respondent was asked to provide an overview of their countries’ regulatory frameworks (according to a proforma template addressing each component of the questionnaire). Thirdly, unstructured interviews were conducted with respondents during the meeting. Fourthly, a detailed review of official documents provided by each respondent was carried out. Fifthly, if there were any information gaps or inconsistencies between answers provided in the questionnaire, in the interviews or among the documents provided, an internet search was conducted to ascertain missing details and resolve inconsistencies. Finally, all country representatives for the BPMDs had full access to the findings of this study and validated the responses as official information from the Ministries of Health.

2.1. GREOM compliance

This study complies with the Guidelines for reporting evaluations based on observational methodology (GREOM). (See Appendix S1).

3. RESULTS

Nearly all countries had medical device laws (Table 1). However, such laws apply to all medical devices or even other products, and the agencies overseeing at least some of its aspects may be from different government sectors, including health sector such Center for the Estate Control of Medicines and Medical Devices (CECMED) in Cuba, National Center for Health Technology Excellence (CENETEC) in Mexico, or from others sector such as for example the National Institute of Metrology, Standardization and Industrial Quality, linked to the Ministry of Development, Industry and Foreign Trade, in Brazil, and the Bureau of Standards, linked to the Ministry of Commerce, in Saint Lucia. Despite the almost universal existence of medical devices laws in the region of the Americas, regulations specifically addressing BPMDs only existed in three countries (Argentina, Brazil, and Panama).

Table 1.

Existence of medical devices laws and BPMDs regulations, and scope of BPMDs regulations in 13 countries in Latin America and the Caribbean

	Does the country have…		Countries n = 13 total
Existence of laws and regulations	Medical devices laws (in general)?		10	ARG, BRA, CHL, COL, CUB, ECU, MEX, PAN, PER, STL
	Specific BPMDs regulations?		3	ARG, BRA, PAN
Scope of regulations	Pre‐market approval	Accuracy validation as requisite for approval?	1	BRA
		Validation study conducted independent from the manufacturer?	0
		Results of validation study published in a peer‐review journal?	0
	E‐commerce and promotion	Regulation of e‐commerce?	2	ARG, BRA
		Regulation of marketing and promotion?	1	ARG
		… includes claims not supported by evidence?	0
		Regulation of internet promotion?	0
	Labeling	Regulation of labeling?	2	ARG, BRA
		… says devices have been validated?	0
		… mentions independent validation	0
		… placing of information	0
	Cuff size	Regulation of cuff sizes?	2	ARG, BRA
		… requires a wide range of cuff sizes to be available?	2	ARG, BRA
		information on the range of arm circumferences for which the cuff can be used?	2	ARG, BRA
	Acquisition	Regulation of acquisition of BPMDs?	5	ARG, CUB, ECU, MEX, PAN
		… does procurement require validation data?	2	CUB, ECU
		Centralized?	7	BAR, BRA, COL, CUB, MEX, PAN, STL

The number of countries with each medical device law or regulation are summarized in each relevant row and each specific country is listed to the immediate right.

Abbreviations: ARG, Argentina; BAR, Barbados; BPMDs, blood pressure measuring devices; BRA, Brazil; CHL, Chile; COL, Colombia; CUB, Cuba; ECU, Ecuador; MEX, Mexico; PAN, Panama; PER, Peru; STL, Saint Lucia.

From those countries that have BPMD regulations, only Brazil had, as a requirement for pre‐market approval or registration, mandatory accuracy validation testing of BPMDs, performed according to a standard protocol by investigators independent of the manufacturer with the results being published in a peer‐reviewed scientific journal. In all the other countries, BPMDs were approved for sale and marketing independent of their accuracy status as determined by clinical validation testing (Table 1). Other factors, including safety and substantial equivalence, as represented by the manufacturers, to devices approved by other countries’ health regulatory agencies, such as the US Food and Drug Administration were among the requisites upon which approval and registration were granted.

Despite the ubiquity of internet sales around the world, e‐commerce (internet sales) of BPMDs was regulated in two countries only (Argentina and Brazil). Furthermore, marketing (promotion and advertising) of BPMDs was regulated in only one country (Argentina) and none of the countries prohibited marketing claims on BPMDs that were not supported by evidence. The promotion of devices on the internet was regulated in two countries as well (Colombia and Mexico).

Labeling of BPMDs was regulated in Argentina and Brazil (Table 1). Yet, none of the countries had regulations that referred to validation status and included requirements regarding the placement of such information in the device or packaging. Only two countries (Argentina and Brazil) regulated the availability of cuff sizes and stipulated that a wide range of cuff sizes must be available at clinical setting.

Processes in place for the procurement and acquisition of BPMDs for PHC facilities belonging to the national health system of each country were not centralized in five countries, and in those countries, BPMDs were acquired by the health regions, provinces, or even locally by the PHC facilities. Even though eight countries reported centralized procurement mechanisms, only Cuba, Ecuador, Peru and Trinidad and Tobago reported having information on the models of BPMDs used in PHC facilities. Nine out of 13 countries reported having a repository of data on models sold in the country (Table 2).

Table 2.

Data repository, surveillance and compliance with BPMDs regulations in 13 countries in Latin America and the Caribbean

Does the country have…	Countries n = 13 total
Data available on models used in primary health care?	4	CUB, ECU, PER, TTO
Data repository on models sold in the country?	8	BRA, CHL, COL, CUB, ECU, MEX, PAN, PER
Agency that inspects or audits adherence to regulations?	8	ARG, BRA, CUB, DOR, ECU, MEX, PER, STL
Agency responsible for enforcement of regulations?	7	ARG, BRA, COL, CUB, ECU, MEX, STL
Mechanisms to remove from market devices not in compliance with regulations?	7	ARG, BRA, COL, CUB, ECU, PER, STL
Mechanisms to impose sanctions to companies with violations?	6	ARG, BRA, COL, CUB, ECU, PER
Surveillance of online sales?	3	BAR, CUB, MEX

The number of countries that meet each of the repository, surveillance, and compliance criteria are summarized in each relevant row and each specific country is listed to the immediate right.

Abbreviations: ARG, Argentina; BAR, Barbados; BPMDs, blood pressure measuring devices; BRA, Brazil; CHL, Chile; COL, Colombia; CUB, Cuba; ECU, Ecuador; MEX, Mexico; PAN, Panama; PER, Peru; STL, Saint Lucia.

With regards to compliance, only eight countries reported having an agency that monitored adherence to regulations by manufacturers, distributors, and importers, while seven reported having a government agency responsible for the enforcement of BPMDs regulations and norms, including the use of sanctions. Having mechanisms for removing from the market those BPMDs that were not in compliance with the law, or applying sanctions to companies when violations have been identified, were reported by seven and six countries, respectively. Respondents of three countries reported mechanisms for surveillance of e‐commerce sales, although it was not clear if these mechanisms were regularly employed and how.

Overall, ten countries reported having a medical device law; however, there were no such laws in Barbados, Dominican Republic and Trinidad and Tobago. From these 10 countries, only three reported having regulations that apply specifically to BPMDs. These regulations included, among other elements, a reference to mandatory validation (one country), marketing (one country), cuff sizes (two countries), and acquisition for use in health care facilities (five countries). Less than half of the 13 countries reported having data repository on models being used in PHC (four countries) or sold in the country (four countries).

4. DISCUSSION

This study confirms that there are many challenges around accurate BP measurement for the HEARTS implementing countries. A key issue identified was that most countries in Latin American and the Caribbean lacked an appropriate regulatory framework to ensure that BPMDs approved for sale and used have been rigorously tested for accuracy. Indeed, accuracy was not used as a criterion for approval for BPMD registration such as has been recommended by WHO, ¹² the World Hypertension League ²⁵ and the Lancet Commission on Hypertension. ¹⁷ Thus, BPMDs used in PHC facilities are not guaranteed to be accurate, even if this is a critical factor for the diagnosis and treatment of hypertension.

Procurement procedures for acquiring devices for use in publicly funded health facilities contain several requisites, but currently, accuracy, as proved by clinical validation tests, was not one of them. Furthermore, the information provided by country representatives revealed that there was limited knowledge of the relevance of clinical validation, not to mention the capacity to conduct validation studies at the country level. Countries in the region do not have mechanisms to ensure the exclusive use of validated automated BPMDs in PHC facilities.

Even more problematic is the fact that pre‐market approval of devices—both for office and home measurement—is not contingent upon proof of having passed a clinical validation test for accuracy. The approval by regulatory agencies from the country where it was manufactured is often used as the main effectiveness requisite to obtain registration of an imported device. Data suggest that procurement policies are likely based largely on cost because of severe budget limitations, particularly in low‐ and middle‐income countries. Moreover, in noncentralized procurement models, county or national health authorities have limited information on the kind of devices being used and do not have access to basic information on the number and quality of BPMDs being used in PHC facilities, which is key for the implementation and monitoring of hypertension control programs. ¹⁰

A problem that faces consumers of BPMDs in general is that information on whether BPMDs are independently validated according to international protocols is not easily obtained. ²⁶ Moreover, online resources that list validated BPMDs ²⁵ often do not include BPMDs sold in the region of the Americas. An added difficulty is that device information (model, for example) may be unavailable ²⁶ or the model numbers of BPMDs used in one region may be different from those being used in other regions such as the US, Canada or European countries, which have national lists of validated BPMDs. ¹² So far, these resources have not been fully explored as source of information on BPMD validation in the Americas.

Further complicating issues is the possibility that BPMDs may be approved for sale based on “substantial equivalence” to an existing approved device already in the market, but it is difficult to access the information and clarify the connection between BPMDs. An issue compounding this problem is the fragmentation of agencies and entities responsible for the many aspects associated with registration, surveillance, and procurement, usually involving not only the health sector but also industry and trade. All of these challenges suggest that the issue of the accuracy of BPMDs has been neglected by most countries in the regions.

Compared to Latin America, countries like Canada, the United States, and Australia are often perceived to more established BPMD regulatory systems. To some extent this is true, in the sense that entities like Health Canada, the US Food and Drug Administration, and Therapeutic Goods Administration in Australia have overseen regulatory approval of BPMDs for many years and because registries of validated devices exist in these countries (eg, from Hypertension Canada and the American Medical Association). ⁹ However, numerous critical regulatory gaps exist in these countries as well, and they are not any more advanced in this field than most Latin American countries. Most importantly, an independently performed, published validation study is not a requirement for market approval. ²⁷ Manufacturers can liberally invoke the “substantial equivalence” of new devices to predicate devices, dispensing with the need to revalidate, even if major differences from the predicate device exist or major modifications to previously approved device measurement componentry have been performed. Therefore, unvalidated devices are sold in these markets, for the most part, without any ramification. Post‐approval regulation of marketing material is rarely done and requirements to provide a full complement of cuff sizes are non‐existent. Overall, the regulatory challenges identified in the present study are certainly not isolated to Latin America; rather, they exist on a global scale.

Considering the landscape provided by the study results, the political will of the health authorities, and the opportunity created around the HEARTS implementation, ⁷ it is believed that the region of the Americas can move forward to a regional regulatory framework to inform and support countries in advancing toward the establishment of their regulations ensuring exclusive use of validated BPMDs in PHC facilities. This effort could include raising awareness of the importance of accurate BP measurements including the relevance of clinical validation of BPMDs ¹⁷ among health authorities, policymakers, professional societies, manufacturers, procurement specialists, pharmacies, managers and professionals at PHC, and consumers; increasing knowledge of validation procedures, validation standards and mechanisms to find and buy validated devices; strengthening the capacity on the use of the validation standards and creation of research groups and networks; developing and implementing regulations that include clinical validation for accuracy and precision as requisite for pre‐approval and registration of devices and post‐market surveillance; requirement of different cuff sizes; monitoring and enforcement mechanisms with dedicated budgets.

This study has several strengths and limitations. To our knowledge, this is the first study to assess in a broad and detailed way the regulatory frameworks relevant to BPMDs and other aspects related to use of these devices in PHC in one of the WHO regions. The official information was provided by the regulatory agencies and Ministries of Health from 13 Latin American and Caribbean countries that have health systems with acceptable levels of development and maturity. However, the information provided by the country representatives was not evaluated or confirmed by a third party. Also, this information does not represent the entire region where there are several additional countries, and among whom the regulatory environment may be different. Furthermore, we did not analyze the particular characteristics of the regulations, nor the authority granted to regulatory agencies that would allow for including BPMD accuracy validation in the criteria for registration.

Hypertension is the leading CVD risk factor worldwide, ¹ and its prevention and control is one of the most critical interventions to reduce CVD burden and premature mortality from NCDs. ²⁸ Given that the problem of the lack of accuracy of the blood pressure measurement is a global problem, ²¹ insufficiently addressed and poorly financed, ¹⁷ that it even affects high income countries ²⁶ and that this problem could be even more serious in low and low‐middle‐income countries, the results of this study could be an important incentive to further research in other countries and regions and, to immediately adopt the policies that WHO ¹¹ and others ⁴ have been recommended.

In conclusion, the current regulatory landscape relevant to accurate blood pressure measurement is weak and fragmented in most of the countries studied. The lack of policies and regulations to encourage or require the use of validated automated devices is a major impediment to the accurate assessment of blood pressure and hence the successful implementation of HEARTS in the Americas. Along with workforce training and promotion of protocol compliance, strong political will and allocation of resources toward the development and implementation of a sound regulatory framework that progressively promotes and ensures the availability and use of validated automated BPMDs are needed. Only an international coordinated effort can accelerate the global adoption of an appropriate regulatory framework that guarantees accurate measurement of blood pressure, with validated automatic BPMDs and consequently reduce the burden attributable to CVD and improve patient safety and quality of care without leaving anyone behind.

CONFLICT OF INTEREST

RP is CEO of mmHg Inc, a digital health company creating solutions to improve cardiovascular care efficiency. JES’s University has received equipment and research funding from manufacturers of blood pressure devices including AtCor Medical, IEM and Pulsecor (Uscom), but he has no personal, financial, or commercial interests related to blood pressure device companies. NC has not had financial conflicts of interest within the last 3 years.

AUTHOR CONTRIBUTIONS

CL, JS, RP, NC, and PO conceived the idea for the study and designed it. CL, JS, and PO created the questionnaire. CL and PO collected and analyzed the data, and drafted the manuscript. All authors validated the data, interpreted the findings, and provided critical insight.

DISCLAIMER

CL, PLW, TM, VP, NV, and PO are staff members of the Pan American Health Organization. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent those of the Pan American Health Organization.

Supporting information

Appendix S1

Lombardi C, Sharman JE, Padwal R, et al. Weak and fragmented regulatory frameworks on the accuracy of blood pressure‐measuring devices pose a major impediment for the implementation of HEARTS in the Americas. J. Clin. Hypertens. 2020;22:2184–2191. 10.1111/jch.14058