Validation of the Lloyds Pharmacy BP11 oscillometric blood pressure monitor according to the International Protocol of the European Society of Hypertension

BACKGROUND: The BP11 is currently one of the lowest-cost blood pressure (BP) monitors available in the UK and has sold approximately 1.5 million units since its launch in 2006. As access to home-use BP monitoring increases, it is important that such devices are validated so that consumers and clinicians can be confident of their accuracy. METHODS: The device was validated using the European Society of Hypertension International Protocol. Data collection and analysis were carried out under the laboratory standard ISO17025. Adherence to the standard and protocol was audited on-site by the United Kingdom Accreditation Service. Nine sequential same-arm measurements were taken alternating between trained observers and the test device. Minor variations from the protocol are reported. RESULTS: The device passed both phases of the European Society of Hypertension International Protocol. The mean (standard deviation) of the difference between the observers and the device measurements was -1.2 (6.4) mmHg for systolic and 2.1 (6.8) mmHg for diastolic pressures, respectively. CONCLUSION: The BP11 BP monitor can be recommended for home and professional use in an adult population.