Editor's Note: The following article was received as a letter to the editor of Drug Store News. The opinions and views expressed here are those of the authors and do not reflect the views or opinions of the editors and publishers of Drug Store News.
We were pleased to see the recently published CDC pharmacy practice guide titled “Using the Pharmacists’ Patient Care Process to Manage High BP; A Resource Guide for Pharmacists,“ which, among other things, outlined best practices for using blood pressure (BP) kiosk devices in the management of hypertension. This is an important guideline advancement, and we also wish to commend the CDC, as well as the AMA and APhA, who collaborated on the guide. The CDC publication includes guidance on pharmacy BP kiosks, instructing pharmacists to “use only clinically validated blood pressure kiosks” and to “implement technology to automatically transmit data from kiosk to pharmacy computer system.”
Why is this new guideline so important? Because currently far more Americans are using unproven BP kiosks than they are validated kiosks. Even though well-validated BP kiosks are currently available on the market, an estimated 1 million BP measurements are performed every day using non-validated kiosks. In thousands of community pharmacies across the country, patients have free access to non-validated BP kiosks that promote products, offer games and contests, and collect email addresses, but have no connection to the pharmacy clinical system, and lack accuracy qualifications for use in the clinical assessment and management of BP.
To be clear, we are not against all BP Kiosks. We are for validated BP kiosks. We know that pharmacists are consistently rated among the most trusted professionals, and that pharmacists strive to provide the best possible care to all of their patients. However, as BP measurement experts, we believe there is a great deal of confusion, and misinformation, about what constitutes a “validated” BP kiosk. We would like to take this opportunity to offer some important clarifications.
It is common for BP kiosk manufacturers to imply that their 510(k) FDA-cleared status or their ISO-compliant manufacturing systems substantiate device validity. These are incorrect claims which, understandably, have misled many who are under the incorrect impression that FDA clearance equals clinical-grade accuracy. In fact, the FDA classifies BP devices as “class II”, exempting them from direct testing by the FDA. It is well understood that the FDA 510(k) clearance process for BP devices does not ensure clinical validity, and many devices are cleared by the FDA with no clinical data required. The FDA has recently warned consumers about devices that the FDA themselves have cleared for market. Unfortunately, there is no regulatory framework in the US, Canada, or worldwide, that ensures BP kiosks meet basic accuracy standards. Given these facts, it is the responsibility of the buyers to perform their due diligence, and demand independent, peer-reviewed accuracy validation from kiosk manufacturers.
Published Criteria for “Valid” BP Kiosks
As outlined by the American Society of Hypertension (ASH) in their professional guide on the topic, BP kiosks must be selected carefully based on their accuracy validation status. The acceptable criteria in selecting a valid BP kiosk are very simple: a) the device must demonstrate, through independent, peer-reviewed evidence, to meet the AAMI/ISO Standard; and b) the device must demonstrate, also with independent evidence, to be accurate and reliable on arm sizes representing 90% or more of the adult general population. The AAMI/ISO standard establishes uniform criteria for the validation of devices through clinical testing, using sufficient statistical power, to ensure such devices provide accurate and consistent results across a representative range of the intended population. The ASH guide calls on all BP kiosk manufacturers to submit their devices to independent clinical evaluation per the AAMI/ISO standard. By making such evaluations public, manufacturers are able to substantiate their BP kiosk accuracy claims.
We agree with the CDC, AMA, and APhA that there is great value to having patient BP data automatically populate into the pharmacy record to support optimal medication management. In today’s connected world, the use of only validated BP kiosks is even more important. Should non-validated BP kiosk data make its way into the patient’s electronic record at the pharmacy or at the physician’s office, the risks to the patient are greatly amplified. We would like to make it very clear that it is hazardous to use non-validated BP device data in clinical decisions.
We are very concerned by what appear to be unverifiable claims of some kiosk manufacturers. For example, a kiosk manufacturer with a large market share recently claimed, on their website, that their device “was the first and is the only station today that meets current ANSI-AAMI standards (ISO 81060-2:2013) for BP measurement. To the best of our knowledge, this claim is unverifiable. First, this manufacturer failed to provide, upon request, validation evidence to the author of a published survey of BP kiosk manufacturers in 2014.10 Further, after scrutinizing the manufacturer’s website, and performing a literature search, we were unable to find any validation data to support the manufacturer’s device accuracy claims. The manufacturer further published a statement, also on their website, that BP data from their devices are “reliable and actionable to share with pharmacists and other healthcare professionals”, implying their device delivers diagnostic-grade data, yet the company provided no evidence. This statement directly contradicts the manufacturer’s FDA 510(k) intended use statement for the BP kiosk, which says: “it is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional.” To clarify, a BP device cannot be considered validated, or the resulting data considered “reliable” or “actionable”, until the device performance is substantiated through published clinical evidence.
As hypertension experts and researchers, we recognize that blood pressure control rates are far too low, and that community pharmacists have an important role in addressing this challenge. Validated, interoperable BP kiosks will be a key tool for pharmacists looking to advance clinical service offerings. We strongly encourage all pharmacists and pharmacy industry professionals to clearly understand the term “validated BP kiosk,” and adhere to CDC and other published guidelines when selecting and deploying BP kiosks, for the sake of the patients we all serve.
Dr. Bruce Alpert. Division of Pediatric Cardiology, University of Tennessee Health Science Center, Memphis, TN, retired; former Co-Chair, ANSI-AAMI Sphygmomanometer Committee. Member, Editorial Board, Blood Pressure Monitoring.
Dr. Beverly B. Green, MPH, Associate Investigator, Kaiser Permanente Washington Health Research Institute in Seattle, Wash.; Fellow of the American Society of Hypertension.
Dr. Raymond R. Townsend, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.
Dr. Raj Padwal, MD, Raj Padwal, Professor of Medicine, University of Alberta, Edmonton, Alberta, Canada; Director, Hypertension Clinic, University of Alberta and Past Chair, Hypertension Canada Clinical Practice Guidelines.
Dr. Mark Gelfer, Clinical Assistant Professor, Department of Family Practice, University of British Columbia, Vancouver, BC, Canada; founder VSM Medtech and developer of BpTRU clinical BP device, C0-Chair of Canadian Hypertension Education Program (CHEP) Blood Pressure Measurement and Diagnosis Subgroup.