FDA Recognizes Updated AAMI Sterilization Guidance
The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
Category: AAMI
AAMI
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AAMI
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AAMI Updates Guidance on Chemical Sterilization
AAMI has updated its primary guidance on chemical sterilization and high-level disinfection in healthcare facilities, addressing safety and regulatory concerns for hospital staff using ethylene oxide (EO) for device sterilization.
AAMI
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AAMI Publishes New Sterile Processing Guidance
AAMI has released guidance detailing best practices for sterile processing of dilators and ultrasound probes in healthcare settings.
AAMI
Latest
FDA Recognizes Updated AAMI Sterilization Guidance
The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
AAMI, British Standards Institute to Publish AI Guidance
AAMI and the British Standards Institute have jointly published guidance documents on performing risk management for machine learning or artificial intelligence incorporating medical devices.
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AAMI Releases Special Report on Artificial Intelligence
AAMI has released a report, “Artificial Intelligence, the Trust Issue,” that provides insights for various stakeholders in the healthcare industry, exploring the potential of AI to revolutionize healthcare delivery, the risks and opportunities of AI, and the importance of managing the risks associated with AI.
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Apply for AAMI Foundation’s Logan Grants
Apply now for AAMI Foundation’s 2023 Mary K. Logan Research Grants program, offering up to $80,000 in funding to support research focused on improving the safe adoption and use of health technology.
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AAMI Revises Standards for PPE Use in Healthcare
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.
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AAMI, GCEA Partner to Expand Resources to Global CE/HTM Community
AAMI and the Global Clinical Engineering Alliance (GCEA) have announced a partnership to jointly improve patient care experiences.
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Grey Areas Report Offers Guidance for Medical Equipment Responsibility
It’s common for healthcare facilities to have unclearly defined medical equipment service responsibilities. AAMI’s Technology Management Council recently released a report to help HTM leaders resolve some of these grey area challenges.
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AAMI
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ST98: New Standard in Medical Device Cleaning Spotlights ‘Clean’ for Manufacturers
With the launch of ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices, manufacturers now have formalized cleaning validation methodology.
