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
Orthopedic and surgical implant device manufacturers could be spending more time and money on testing than necessary by not considering family grouping when validating the cleaning and sterilization processes that occur at healthcare facilities. Cleaning and sterilization validations help ensure...
Appropriate cleaning of cardiovascular devices is extremely important. If the device is not clean, it can lead to infection, sepsis, septic shock, blood clots, blockages, chemical impact, or toxicological repercussions. Medical device manufacturers must have an understanding of what is...
The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance. Based on the content and addition of Appendix E, this...
On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers,...
Agenda: Emily Mitzel will present on reusable medical device cleaning, disinfection and sterilization validations at the 2014 MD&M West Conference. Emily is a Laboratory Manager at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include: Standards that govern...
