AAMI Aligns With National Academy of Medicine AI Code of ConductAI Code of Conduct’s six core principles key to ensuring the safe and effective use of AI technologies
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide GuidanceNew versions of AAMI ST58, ST24, and TIR17 included in Recognized Consensus Standards database
Transporting Sterile Medical Devices – AAMI Sterilization GuidanceTIR109 applies to health care facilities and off-site reprocessing centers
HTM College Education: AAMI Sets New StandardFirst-ever standard for training biomedical, clinical engineers
AAMI, CTA to Collaborate on AI StandardsArlington, Virginia, Sept. 24, 2024 (GLOBE NEWSWIRE) -- As artificial intelligence (AI) becomes more integrated into the healthcare sector, there is a pressing need for industry standards that will protect patients and promote best practices.
AAMI Releases Alternative Guidance for Radiation SterilizationArlington, Virginia, July 29, 2024 (GLOBE NEWSWIRE) -- Right now, pharmaceutical and biopharmaceutical manufacturers often rely on outdated best practices related to radiation sterilization and routine control of single-use systems. But there is new industry guidance that will help streamline these processes.
Ethylene Oxide Sterilizer Standard Updated to Reflect Technological ChangesArlington, Virginia, June 12, 2024 (GLOBE NEWSWIRE) -- As leaders in the medical device industry seek ways to optimize the application of ethylene oxide (EO) sterilization, it is more important than ever to ensure that medical device manufacturers and healthcare facilities are following up to date practices and have state of the art technology.
New AAMI Guidance on Combination Products and FDA CGMPsArlington, Virginia, May 30, 2024 (GLOBE NEWSWIRE) -- As the breadth and scope of combination products around the world continues to ramp up, are U.S. manufacturers equipped with the best design plans possible? A brand-new guidance document released by the Association for the Advancement of Medical Instrumentation (AAMI), will assist manufacturers in aligning with the latest best practices for manufacturing combination products established by the Food and Drug Administration.
AAMI Releases Guidance on Dilator, Ultrasound DeSterilizationArlington, Virginia, April 17, 2024 (GLOBE NEWSWIRE) -- A new guidance document on the sterile processing of dilators and ultrasound probes in healthcare facilities has been published by the Association for the Advancement of Medical Instrumentation (AAMI).
AAMI Announces Ralph Basile Appointed to Philanthropic Activities for the AAMI FoundationArlington, Virginia, April 10, 2024 (GLOBE NEWSWIRE) -- AAMI is pleased to announce that Ralph Basile, standards corporate executive at Healthmark, will be stepping into a new philanthropic role with the AAMI Foundation. Basile’s responsibilities will include raising charitable donations and assisting the Foundation in awarding scholarships, research grants, and other awards to noteworthy recipients.
AAMI and FDA Co-Sponsor Medtech Conference, ‘AAMI and FDA neXus'Arlington, VA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is delighted to welcome the U.S. Food and Drug Administration as an official co-sponsor of its upcoming medical device standards conference, AAMI and FDA neXus 2024. The conference will feature a wealth of FDA experts alongside industry members and will focus on the latest information on medical device regulations and standards.
FDA Gives Full Recognition to AAMI Cybersecurity Guidance DocumentArlington, VA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is proud to announce that the U.S. Food and Drug Administration has officially extended complete recognition to AAMI’s groundbreaking guidance document on medical device cybersecurity, ANSI/AAMI SW96.
Introducing AAMI neXus, the Evolved International Standards ConferenceArlington, Virginia, Oct. 16, 2023 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is pleased to announce that it will host AAMI neXus: The Medical Device Standards Conference, the medical device sector’s leading event covering health technology standards and regulatory requirements.
Association for the Advancement of Medical Instrumentation Awards Grants to Researchers at Michigan State, Emory University, BD Medical, PAXXUS, Inc.Arlington, VA, Sept. 19, 2023 (GLOBE NEWSWIRE) -- The AAMI Foundation has awarded more than $45,000 in Kilmer Fund Committee grants to researchers at Michigan State University, Emory University and Emory University Hospital, BD Global Sterility Assurance, and PAXXUS., Inc., for various projects on improving sterilization practices and patient safety. The AAMI Foundation’s Kilmer Fund Committee awarded these grants to projects that seek to advance the science of microbiological quality and sterility assurance. They include:
Join GCEA for 5th International Clinical Engineering & HTM Congress in Visakhapatnam, IndiaArlington, Virginia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Are you interested in promoting international cooperation in clinical engineering and healthcare technology management? The Association for the Advancement of Medical Instrumentation (AAMI) is collaborating with the Global Clinical Engineering Alliance (GCEA) to bring clinical engineering experts from around the world together to collaborate and share their knowledge.
New AAMI Standard on Water Quality for Medical Device ProcessingArlington, VA, Aug. 16, 2023 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) has published a new standard that establishes requirements for the quality of water used to process medical devices. The first standard of its kind, ANSI/AAMI ST108:2023, Water for the processing of medical devices, revises and replaces AAMI TIR34:2014/(R)2021, which provided information and guidance on water quality for device reprocessing.
AAMI, BSI Join Forces to Publish Guidance on Artificial IntelligenceArlington, VA, May 31, 2023 (GLOBE NEWSWIRE) -- AAMI and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.
AAMI Releases Special Report on Artificial IntelligenceArlington, VA, April 13, 2023 (GLOBE NEWSWIRE) -- If you’re wondering how artificial intelligence (AI) will affect your healthcare institution, company, or career, the Association for the Advancement of Medical Instrumentation (AAMI) has you covered.
Standard for PPE Updated for Additional Equipment Types and Safety GuidanceArlington, VA, Jan. 18, 2023 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) has released a revised American National Standard containing new and crucial information for the manufacturers and users of personal protective equipment (PPE) in the healthcare space. The new edition of the standard, ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, accounts for a decade of new knowledge and the evolution of technologies keep our frontline healthcare workers safe.
