Bruce A. Tampa Friedman

Validation of a conical cuff on the forearm for estimating radial artery blood pressure.

IntroductionThere has been a growing need for and interest in measuring noninvasive blood pressure (NIBP) in obese patients. In many situations, available rectangular upper arm blood pressure cuffs do not fit properly, closing in a crisscross manner or overlapping the elbow. To address this issue, GE Healthcare has designed a conically shaped cuff for use on the forearm to estimate radial arterial blood pressure. This study evaluated using this forearm cuff with an oscillometric NIBP algorithm compared with an invasive radial arterial blood pressure reference. Patients and methodsThirty-four patients were enrolled in the study with an aim to acquire a minimum of 150 paired measurements. Blood pressure was measured and recorded invasively from the radial artery of each patient, while noninvasive oscillometric measurements were acquired from the same limb using a conically shaped cuff placed on the patient’s forearm. AnalysisNIBP values were compared with the invasive blood pressure values acquired in the combined 30-s period preceding cuff inflation and the 30-s period following cuff deflation. The acceptance criteria for measurement accuracy were defined in accordance with the ANSI/AAMI/ISO 81060-2:2009 standard, which requires an absolute average error of 5 mmHg or less, with an SD of 8 mmHg or less. ResultsThe systolic mean error (−0.82 mmHg) and SD (6.08 mmHg) and the diastolic mean error (1.53 mmHg) and SD (3.83 mmHg) were within the 81060-2 acceptance criteria. ConclusionThe statistical results show that oscillometric NIBP measurements taken with the conically shaped cuff placed on the forearm give an accurate estimation of radial arterial blood pressure.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

A review of the latest guidelines for NIBP device validation.

The current ISO Standard is accepted as the National Standard in almost every industrialized nation. An overview of the most recently adopted standards is provided. Standards writing groups including the Advancement of Medical Instrumentation Sphygmomanometer Committee and ISO JWG7 are working to expand standardized evaluation methods to include the evaluation of devices intended for use in environments where motion artifact is common. An Association for the Advancement of Medical Instrumentation task group on noninvasive blood pressure measurement in the presence of motion artifact has published a technical information report containing research and standardized methods for the evaluation of blood pressure device performance in the presence of motion artifact.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.