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Experts weigh in on hypertension testing devices

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ROCHESTER, N.Y. — Blood pressure kiosks in retail pharmacies are a key focus of an international effort by hypertension organizations to tighten the regulation of consumer BP devices.

PharmaSmart International reported that 21 international hypertension organizations have published a joint statement urging the private health care sector and governments to address the issue of inaccurate BP devices. Pointing to inadequate regulatory control and a 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 organizations said.
The Food and Drug Administration also has issued an alert to consumers that some BP stations — despite being cleared by the agency — fail to provide accurate results for many users.

“There is a growing global consensus for improved BP device quality,” Mark Niebylski, chief executive officer of WHL, said in a statement. “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.”

Niebylski noted that pharmacies “have an enormous opportunity” to help improve BP control in the United States 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,” Niebylski 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, which is 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?” stated PharmaSmart chief executive officer Fred Sarkis.

Millions of pharmacy customers use recreational blood pressure kiosks “off-label,” meaning that the cuff isn’t designed to properly accommodate large arms, he noted. “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.”


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