AAMI Adopts Sphygmomanometer Standard, Revises Electrocardiograph Standard

The Association for the Advancement of Medical Instrumentation’s (AAMI) Sphygmomanometer Committee has adopted an international standard that establishes minimum safety requirements for the safe and effective manufacture of non-invasive, non-automated sphygmomanometers. Examples of these requirements include proper labeling and adequate testing of the devices for accuracy prior to distribution.

The new document defines a non-automated sphygmomanometer (also known as a blood pressure meter) as an “instrument used for the non-invasive measurement of the blood pressure by utilizing an inflatable cuff with a pressure-sensing element, a valve for deflation, and a display used in conjunction with a stethoscope or other manual methods for estimating blood pressure.”

This standard would therefore not address automated blood pressure meters, such as those often used without supervision by customers in grocery stores and pharmacies.

The objective of this newly adopted standard, known as ANSI/AAMI/ISO 81060-1:2007, Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type, is to provide minimum performance and safety requirements for these devices before the devices leave the manufacturer.

The standard also provides guidance on the printed materials a manufacturer should include along with such a device, such as instructions for use and other disclaimers and warnings.

Additionally, AAMI’s Electrocardiograph Committee has revised its guidance on ambulatory electrocardiographs (ECGs)—devices worn or carried by a patient that record the patient’s heart activity.

The primary objective of the standard is to provide manufacturers of ambulatory heart monitoring systems with minimum labeling, performance, and safety specifications that, if met will help ensure a reasonable level of clinical efficacy and patient safety in the use of ECGs.

The standard will also be useful to those who use or maintain ambulatory monitoring equipment, because knowledge of the standard can give the user a more precise understanding of the characteristics and limitations of the equipment. Such understanding is conducive to a safer and more effective use of the device.