Cleaning Validation

Creating Adequate Reprocessing Instructions

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!

Categories: News and White Paper

Tags: Cleaning Validation and Reusable Device


Reusable Medical Device Disinfection Validations

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

Tags: Antimicrobial, Cleaning Validation, Medical Device, Microbial Identification, Microbiology Testing, and Test


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

Tags: Antimicrobial, Antimicrobial Liquid, Cleaning Validation, Test, and Virology Testing


Re-Use Stress Testing and Evaluation of Disinfectants

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

Categories: Liquid Anitmicrobial Efficacy Tests and Microbiology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Cleaning Validation, Medical Device, Microbial Identification, Microbiology Testing, and Test