February is Heart Month, dedicated to raising awareness of cardiovascular disease and reminding everyone to assess their risk factors and take steps to help their heart. This year, the CDC's Heart Month campaign focuses on the fact that cardiovascular disease isn't just a condition for older adults - it's happening to younger adults more often. The conditions that lead to heart disease, including high blood pressure or cholesterol, obesity, and physical inactivity, can happen at any age. Lifestyle changes such as quitting smoking, eating healthier, and exercising contribute greatly to cardiovascular health, but sometimes medical interventions are necessary. Members of the American National Standards Institute (ANSI) have developed and contributed to many standards that support medical procedures for the hearts that need them.
The Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer, offers standards that provide guidelines for cardiovascular medical devices. Available as a collection through the Cardio Medical Device Package, these standards offer safety, monitoring, and performance requirements for more frequently used cardiovascular medical devices, including cardiac monitors, sphygmomanometers, electrocardiographs, ECG cables/lead wires/electrodes, blood pressure transducers, and defibrillator devices.
Another standard that guides devices for heart health was developed by ANSI member and audited designator ASTM International. ASTM F3211-17, Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices, provides an experimental methodology to assess and determine the structural fatigue of implantable cardiovascular devices. Its guidelines can be used to assess or characterize device durability during design development and for testing product specifications.
International standards support medical interventions for heart health as well, including these documents from the International Organization for Standardization (ISO) on cardiovascular implants and extracorporeal systems:
ISO/TS 17137:2014, Cardiovascular absorbable implants
ISO 5910:2018, Cardiac valve repair devices
ISO 18242:2016, Centrifugal blood pumps
These standards were developed by ISO Technical Committee (TC) 150, Implants for surgery, Subcommittee (SC) 2, Cardiovascular implants and extracorporeal systems. The Secretariat of SC 2 is held by the U.S., and AAMI serves as the delegated secretary and associated ANSI-accredited U.S. Technical Advisory Group (TAG) Administrator. ASTM is the ANSI-accredited U.S. TAG Administrator to TC 150.
When medical treatments are needed to improve the health of someone who has or is at risk of having heart disease, it's critical that the devices used are at the highest levels of safety and effectiveness. American and international standards are there to assure the quality of these instruments and support a healthier heart for everyone, young and old.