On March 17, 2015, FDA published new guidance describing testing and labeling requirements for reusable medical devices. The updated guidance is timely, since recent outbreaks of CRE from endoscopes exposed several missing validation studies from implicated manufacturers. FDA's historical guidance pertaining to cleaning and disinfection of reusable medical devices was...
Microbial Ingress testing is the evaluation of the ability of a medical device to resist or inhibit the transfer of infectious microorganisms under repeated simulated use conditions. Many medical devices have features that could potentially allow microorganisms a point of entry directly into a patient or into sterile fluids...
Microchem Laboratory is one of the few laboratories in the United States qualified and prepared to help hospitals comply with the CDC interim duodenoscope surveillance protocol and the CDC interim duodenoscope sampling method. If your hospital is interested in discussing the costs and logistics associated with routine microbiological sampling...