Reusable Medical Device manufacturers are required by the US Food and Drug Administration to validate their reprocessing instructions. Statistics say, about one in 25 hospital patients has at least one healthcare-associated infection. With adequate reprocessing instructions, we can help reduce these statistics!
Low, Intermediate and High-Level Disinfection Validation for a Reusable Medical Device AAMI Method TIR12 AAMI TIR30 Purpose of Test The U.S. FDA requires that disinfection instructions supplied by medical device manufacturers to the end-users of reusable medical devices be validated to assure that they are appropriate for the device. AAMI Technical Information Reports (TIR) 12… Read More
Categories: Microbiology Testing
Virucidal Efficacy Validation of a Disinfectant Used to Clean and Disinfect the Exterior Surface of Blood Glucose Monitoring Devices
Utilizing Duck Hepatitis B virus as a Surrogate for Human Hepatitis B Virus Purpose of Test The purpose of this study is to validate the virucidal efficacy of a disinfectant which is used to clean and disinfect the exterior surface of blood glucose monitoring and lancing devices against duck Hepatitis B virus, to be used… Read More
Categories: Virology Testing
Purpose of Test The U.S. FDA and Health Canada require that high-level disinfectants intended to be continuously reused in a clinical setting be evaluated for efficacy after the product has been subjected to simulated re-use procedures. The purpose of this method is to generate a product which has undergone simulated use and periodic bio-burden stressing.… Read More