The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
The Association for the Advancement of Medical Instrumentation (AAMI) recently released the first cleaning validation standard for medical device manufactures, ANSI/AAMI ST98:2022 Cleaning validation of healthcare products—Requirements for development and validation of a cleaning process for medical devices. This new standard that...
Reusable medical devices need to have validated cleaning instructions to ensure patient safety and minimize health-care-acquired infections, corrective actions, recalls, and to ensure compliance with current regulatory standards. For devices that need to comply with US FDA, the requirements regarding...
The FDA guidance on reprocessing medical devices in health care settings: validation methods and labeling states, that when performing cleaning validations, the artificial test soil that is chosen should allow for at least two clinically relevant soil components to be...
The AAMI Sterilization Standards Meetings were held on 16-18 October 2017. There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance. One item of interest from USFDA/CDRH is that...
