February is National Heart Month, a time to raise awareness about the prevention of heart disease, the leading cause of death for men and women in the United States. For prevention, The U.S. Department of Health and Human Services has released a toolkit with resources to help lower the risk of heart disease and heart attacks, including techniques to manage stress, a daily food and activity tracker, and a healthy heart shopping list. American National Standards Institute (ANSI) members and accredited standards developers also support healthy hearts through various standards related to heart disease prevention and treatment tools, from blood pressure monitors to implants.
The Centers for Disease Control and Prevention (CDC) advises Americans to make "control a goal" by monitoring blood pressure—the leading culprit of heart disease and strokes. Although high blood pressure shows no signs or symptoms, tracking it over time could decrease the chances of potentially dangerous medical consequences other than heart ailments, such as vision loss and stroke.
One element to effective blood pressure monitoring is interoperability with other systems. The standard ISO/IEEE 11073-10407:2010 Health informatics—Personal health device communication—Part 10407: Device specialization—Blood pressure monitor establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer engines (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. The standard was jointly developed by the Institute of Electrical and Electronics Engineers (IEEE), an ANSI member and accredited standards developer, and International Organization for Standardization (ISO) Technical Committee (TC) 215, Health informatics. The ANSI-accredited U.S. Technical Advisory Group (TAG) to ISO TC 215 is administered by American Health Information Management Association (AHIMA).
The IEEE also developed IEEE 1708-2014, IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices, which provides guidelines for manufacturers to qualify and validate their products, for potential purchasers or users to evaluate and select prospective products, and for health care professionals to understand the manufacturing processes on wearable BP devices. This standard also reflects the change in the health industry, as existing standards for evaluating blood-pressure meters were created for traditional devices.
The International Electrotechnical Commission, (IEC) has developed IEC 80601-2-30 Ed. 1.1 b:2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, a standard that covers safety and performance for a method of measuring blood pressure that does not require puncturing an artery. The standard, which was developed by IEC Technical Committee (TC) 62, Electrical equipment in medical practice, Subcommittee (SC) 62D, Electromedical equipment, applies to automated, electrically powered sphygmomanometers used by medical professionals and in the home healthcare environment.
IEC TC 62 is chaired by Dr. Rodolfo Godinez of the United States, and ANSI member and accredited standards developer the Association for the Advancement of Medical Instrumentation (AAMI) serves as the United States National Committee (USNC)-approved U.S. Technical Advisory Group (TAG) Administrator for the committee. The USNC has delegated secretariat duties for SC 62D to the AAMI; AAMI also serves as the USNC-approved U.S. TAG Administrator to SC 62D.
IEC 80601-2-30 is part of a suite of international standards for sphygmomanometers that have been adopted as American National Standards by AAMI, and were developed by IEC TC 62/SC 62D working jointly with ISO TC 121, Anaesthetic and respiratory equipment, SC 3, Lung ventilators and related equipment. The U.S. also plays a leadership role in this ISO activity, with ANSI holding the secretariat for both ISO TC 121 (delegated to AAMI), and SC 3 (delegated to Philips). AAMI is the ANSI-accredited U.S. TAG Administrator for both TC 121 and SC 3.
Statistics show that exercise is an important component of heart attack recovery, and an essential for people who have heart disease. ASTM International - an ANSI member and audited designator - has developed ASTM F2106-12, Standard Test Methods for Evaluating Design and Performance Characteristics of Motorized Treadmills, which provides guidelines for treadmills based on stability, exterior design, endurance, static loading overheating, adjustable incline system function, user interface parameters, motorized drive system operation, warning label compliance, and documentation.
ISO 14708-2:2012 Implants for surgery-Active implantable medical devices-Part 2: Cardiac pacemakers specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias. The standard was developed by ISO Technical Committee (TC) 150, Active implants Subcommitee (SC) 6, to which Dr. Raymond Yee of the U.S. holds the chair through 2017. The standard is also applicable to some non-implantable parts and accessories of the devices. AAMI serves as the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to the committee.
ANSI is committed to healthier lifestyles through continued efforts with standard developer organizations during this National Heart Month and for years to come. Read more about National Heart Month here.