Hypertension Leaders Call for Stronger Blood Pressure Kiosk and Home Device Regulations

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Twenty-one worldwide hypertension organizations have issued a consensus statement calling for improved regulation of consumer blood pressure devices, and pressed the private healthcare sector to carefully assess the devices they offer to patients. CEOs from the World Hypertension League and PharmaSmart® International applauded the announcement, citing its important implications for patient care and pharmacy-based clinical services.

In the largest consensus statement of its kind, twenty-one international hypertension organizations have published a joint “Position Statement” calling on the private healthcare sector and governments worldwide to address the issue of inaccurate blood pressure (BP) devices. Noting inadequate regulatory control and lack of published evidence for many devices, the authors called for immediate action to ensure accurate patient diagnosis and treatment decisions.

This guidance comes on the heels of 2015 position statements on Public-Use BP kiosks from both the American Society of Hypertension (ASH) and the World Hypertension League (WHL), warning healthcare providers against the use of pharmacy-based, recreational BP kiosks, many of which are not designed for patients with large arm sizes. In addition, the FDA has issued a consumer alert, advising the public some BP Kiosk devices, while cleared by the FDA, fail to provide accurate results for many users.    

The 2015 ASH and WHL statements both acknowledged the potential of clinically-validated public-use BP kiosks to support improved screening and management of hypertension, and noted PharmaSmart® (a BP kiosk manufacturer) for its independently validated technology and patented cuff design that ensures reliable BP measurement for the general population, including people with large arm sizes.

Many US hypertension leaders view insufficient regulatory oversight as a major impediment to improved blood pressure control rates. Because inaccurate measurement confounds the diagnosis and management of hypertension, it also undermines efforts to reduce incidences of stroke, heart attack, diabetes, and other cardiovascular conditions linked to hypertension.

Dr. Mark Niebylski, CEO of the World Hypertension League (WHL), stated, “There is a growing global consensus for improved BP device quality. New guidelines in the US 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 US, and internationally, to address this healthcare issue.”    

Asked about the role of community pharmacy, Dr. Niebylski added, “Pharmacies have an enormous opportunity to support improved BP control in the US, and to coordinate care with primary care physicians. 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.    This is unacceptable to the WHL, and the clinical community in general. 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.”    

PharmaSmart® International CEO Fred Sarkis added, “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. 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 healthcare provider status.”

Sarkis continued, “Because of our recognized validity and patented universal cuff technology, PharmaSmart® has altered the potential of an in-store biometric kiosk. Our pharmacy clients are incorporating validated patient data from PharmaSmart® devices into the patient electronic record.    We have already seen how PharmaSmart® device integration can drive new clinical services revenue for our pharmacy clients. But this opportunity starts with providing patients with valid blood pressure measurement. The reality is, pharmacies can’t use blood pressure data from recreational kiosks to contract with payers or providers for hypertension-related clinical services.”

Sarkis concluded, “This global physician consensus is another wake-up call to device manufacturers and to retailers. Blood pressure measurement is not a recreational activity, it is a clinical service that has major implications on clinical decisions and health outcomes.”    

References:

http://onlinelibrary.wiley.com/doi/10.1111/jch.12782/abstract
https://www.ash-us.org/documents/files/2015/150422-DOCUMENT-Guide-Public-Use-BP-Kiosks-%283%29.pdf
http://onlinelibrary.wiley.com/doi/10.1111/jch.12671/epdf
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm402287.htm

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Katie Miller
@PharmaSmart
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