AAMI recently announced that the FDA has added 13 guidance documents produced by AAMI or its standards committees to its database of Recognized Consensus Standards. Of the 13, several have special relevance for the operating room or greater health care facility.
The official recognition of these documents 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.
- AAMI TIR104:2022, Guidance on transferring health care products between radiation sterilization sources
- AAMI TIR17:2017/(R)2020, Compatibility of materials subjected to sterilization
- ISO/TS 16775:2021, 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
- SO 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
Documents of Interest: TIR 104:2022 and TIR17:2017/(R)2020
Two of the newly recognized documents have special importance. 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 the 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 health care products subject to sterilization modalities like ethylene oxide, steam and radiation. The TIR provides guidance on improving quality while reducing the cost and time involved in material qualifications.
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, 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 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 medical device manufacturers and healthcare delivery organizations. Their inclusion not only raises their profile but will make it easier for manufacturers and health care delivery organizations to comply with their guidance.
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 committees that produces these guidance documents, please contact AAMI at membership@aami.org.
