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.
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 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 has released guidance detailing best practices for sterile processing of dilators and ultrasound probes in healthcare settings.
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 and the British Standards Institute have jointly published guidance documents on performing risk management for machine learning or artificial intelligence incorporating medical devices.
Read MoreAAMI 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.
Read MoreApply 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.
Read MoreAAMI 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.
Read MoreAAMI and the Global Clinical Engineering Alliance (GCEA) have announced a partnership to jointly improve patient care experiences.
Read MoreIt’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.
Read MoreWith 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.