FDA Officially Recognizes 13 AAMI Standards

FDA Headquarters

The Association for the Advancement of Medical Instrumentation (AAMI) is pleased to announce that the FDA has added 13 guidance documents produced by AAMI or its standards committees to its database of Recognized Consensus Standards. The official recognition of these standards, technical information reports (TIRs), and other documents both increases their visibility and will make compliance with their requirements and suggestions easier.

“The recognition of these standards affirms AAMI’s leadership in the development, management, and use of safe and effective health technology standards. Additionally, it allows industry members to submit declarations of conformity to these FDA-recognized consensus standards, that may reduce the amount of supporting testing documentation needed in a premarket submission,” said Matt Williams, vice president of standards at AAMI.

Newly Recognized Sterilization Standards

Of the 13, several have special relevance to the sterile processing of medical devices and their environment. AAMI TIR104:2022, Guidance on transferring health care products between radiation sterilization sources addresses and clarifies “the process for transferring sterilization of health care products between radiation sterilization sources.” The TIR assists sterilization facilities by quantifying acceptable methods of transferring medical devices from one radiation site to another or utilizing different sterilization modalities.

The FDA has also recognized an AAMI guidance document on managing materials compatibility. AAMI TIR17:2017/(R)2020, Compatibility of materials subjected to sterilization, addresses materials compatibility for polymers, ceramics, metals, and other materials used in healthcare products subject to sterilization modalities such as ethylene oxide, steam, and radiation. The TIR provides guidance on improving quality while reducing the costs and time involved in performing material qualifications.

Exploring a different avenue for patient safety is ANSI/AAMI PC76:2021, Active implantable medical devices – Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging. This document builds on previous guidance documents such as ANSI/AAMI/ISO TIR10974:2012. The standard applies to “transvenous pacemaker, ICD [implantable cardioverter-defibrillator], and CRT [cardiac resynchronization therapy] systems intended to be used in patients who undergo a magnetic resonance scan,” and provides testing guidelines that can be used to demonstrate that a device conforms to its MR Conditional [Magnetic Resonance Conditional] labelling.

The addition of these standards and other guidance documents to the FDA’s Recognized Consensus Standards database is a boon to both medical device manufacturers and healthcare delivery organizations. Their inclusion not only raises their profile but will make it easier for manufacturers and healthcare delivery organizations to comply with their guidance.

Full list of the newly recognized documents:

• ISO 16628:2022, Anaesthetic and respiratory equipment - Tracheobronchial tubes
• ISO 10993-2:2022, Biological Evaluation of medical devices - Part 2: Animal welfare requirements
• ISO 14708-2:2019, Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
• ISO 14708-6:2019, Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
• ISO 81060-3, Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
• ANSI/AAMI PC76:2021, Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
• ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• ISO TS16775:2021, Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
• ISO 22441:2022, Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
• AAMI TIR104:2022, Guidance on transferring health care products between radiation sterilization sources
• AAMI TIR17:2017/(R)2020, Compatibility of materials subjected to sterilization
• IEC 60601-2-52:2015, Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
• IEC 60601-2-39:2018, Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

AAMI consensus standards are developed by volunteer experts from around the world. For more information about AAMI standards and how you can participate, visit www.aami.org/standards. If you would like to contribute your expertise to one of the AAMI committees or working groups that produce these guidance documents, feel free to contact us at membership@aami.org.