PharmaSmart International is among a group of hypertension organizations urging sharper regulation of consumer blood pressure devices.
The blood pressure kiosk maker reported that 21 international hypertension organizations have published a joint statement calling on the private health care sector and governments to address the issue of inaccurate BP devices. Citing inadequate regulatory control and lack of published evidence for many devices, the authors requested immediate action to ensure accurate patient diagnosis and treatment decisions.
This guidance follows 2015 position statements on public BP kiosks from the American Society of Hypertension (ASH) and the World Hypertension League (WHL), warning health care providers against the use of pharmacy-based, recreational BP kiosks, many of which aren’t designed for patients with large arms.
The Food and Drug Administration also has issued a consumer alert that some BP stations, though cleared by the FDA, fail to provide accurate results for many users.
“There is a growing global consensus for improved BP device quality. New guidelines in the U.S. call for self-measurement outside the office setting, but patients and providers are unsure what devices can be trusted. The WHL supports urgent regulatory action in the U.S. and internationally to address this health care issue,” WHL chief executive officer Mark Niebylski said in a statement.
Niebylski pointed out that pharmacies “have an enormous opportunity” to help improve BP control in the U.S. and coordinate care with doctors.
“But as the FDA and multiple clinical organizations have pointed out, recreational and ‘gamification’ blood pressure kiosks are providing inaccurate readings to millions of Americans,” he explained, adding, “We urge pharmacies to upgrade into clinically valid BP kiosk devices so that they can become an integral part of the hypertension care team. This issue goes to the core of professional trust between physicians and pharmacists.”
The 2015 ASH and WHL statements also noted PharmaSmart for its independently validated technology and patented cuff design, aimed at ensuring reliable BP measurement, including for people with large arms.
“For years, recreational kiosk companies (those with no clinical accuracy validation) have claimed that their devices generate ‘meaningful health data’. How can their blood pressure data be ‘meaningful’ when the FDA and multiple physician groups have issued warnings about their technology in order to protect patient health? Additionally, millions of pharmacy customers use recreational blood pressure kiosks ‘off-label,’ meaning the cuff is not designed to properly accommodate their large arm size, ” stated PharmaSmart CEO Fred Sarkis. “The situation is dangerous to patients, damages the reputation of the pharmacy profession and is contrary to the hard-fought efforts of pharmacists nationwide to earn health care provider status.
“This global physician consensus is another wake-up call to device manufacturers and to retailers,” Sarkis added. “Blood pressure measurement is not a recreational activity; it is a clinical service that has major implications on clinical decisions and health outcomes.”