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 reusable medical device industry has advanced over the last decade, which has led to an increase in new reusable devices. New devices require extensive testing that must be reviewed by the Food and Drug Administration (FDA) or other regulatory...
Dialysis machines have been used for decades to help improve the lives of people with kidney malfunctions. Developed in the 1930s, these machines have evolved to ensure the delivery of lifesaving solutions to patients who suffer from kidney complications. The...
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...
ISO17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand...
Every year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes...
