Lancet Commission: Mandatory validation, specific standards needed to improve accuracy of BP devices
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).
“[T]he global marketplace has been inundated with BP devices that are either known to be inaccurate or are of unknown accuracy,” the authors say. “This can have serious implications for being able to achieve best-practice care of people related to BP control.”
In addition, the widespread introduction of novel technologies claiming to measure BP appears to worsen this problem. The Commission, however, states that most identified problems can be sorted by the mandatory requirement for independent validation of BP devices in line with the recently developed ISO standard. [J Hypertens 2020;38:21-29]
Apart from external validation, the development of specific standards for the validation of new BP technologies and accredited online lists of BP devices that are accessible to both consumers and healthcare professionals could substantially help in addressing these challenges.
In greater detail, the Commission presents these three recommendations in their position statement:
Recommendation 1: Convergence toward the global regulatory requirement for mandatory independent validation of BP devices according to the universally accepted ISO Standard (ISO 81060-2:2018) with publication preferably in a peer-reviewed journal
Validated BP devices are vital for effective universal healthcare delivery, according to the World Health Organization (WHO). In fact, the WHO Global Model Regulatory Framework for Medical Devices has presented a stepwise approach to implementing and enforcing regulatory controls for medical devices. [https://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/en/; https://www.who.int/healthsystems/WHA60_29.pdf]
“The ISO Standard fulfils the urgent need for a single, universally accepted protocol for BP device validation,” the authors say. “The standard has already been adopted by the US, as well as many other countries and, if made a global mandatory regulatory requirement, will redress the majority of problems relating to BP device accuracy associated with current frameworks.”
Recommendation 2: Development of specific standards for the validation of new BP measuring technologies that cannot be tested using the ISO Standard (ISO 81060-2:2018)
Government and nongovernment organizations must develop specific standards and legislate for their mandatory use prior to approval for sale of new BP technologies, according to the Commission. They are also expected to endorse, regulate and monitor compliance with the new standards.
“Health professionals should avoid using new BP technologies to inform clinical management until the method in question can be proven to enhance clinical care,” the authors say.
Recommendation 3: Accredited online lists of BP devices detailing the published results of the validation studies
The creation of online lists of BP devices that present the results of validation studies conducted in accordance with international standards can help inform the scientific and general community as to which BP devices have been tested and found to have acceptable accuracy. [J Clin Hypertens (Greenwich) 2018;20:1084-1088]
“The lists should be developed and maintained by organizations with sufficient expertise to ensure scientific rigor and remain independent from BP device manufacturers,” the authors say.
Currently, an executive team of the Commission is working towards the implementation of these recommendations.