We recognize the needs are changing for clinical engineers across the world to ensure the smooth operation of devices that are fundamental to patient care. Through ongoing focus groups, research, and recent conversations at the AAMI eXchange 2024, we understand the hurdles, challenges, and trends are impacting you the most. In this session, we’ll discuss the insights that are driving change at GE HealthCare within Patient Care Solutions as we support you and your teams in keeping your fleet of biomedical devices completely ready for care.

The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.

SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world.  This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.  

Join us as we go over all the major updates regarding processing (gaseous sterilization, liquid chemical sterilization, and high-level disinfectants) for reusable medical devices. The current version of AAMI ST58 was due for revision, as it was last updated in 2013. These updates will improve safety for personnel performing the processing and enhance patient outcome and experiences with the newly revised guidance.

This training program is designed to equip healthcare professionals with the knowledge and skills necessary to ensure the safe and effective processing of dilators, transesophageal and ultrasound probes, in accordance with the guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 99.