A new white paper detailing the new scope of reusable medical device cleaning validations is available free from Microtest Laboratories at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.
"Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead," writes white paper author Patrick Kenny, manager of analytical services at Microtest Laboratories. Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.
In the new white paper, "The New Scope of Reusable Medical Device Cleaning Validations," Kenny notes that "although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples."
"An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device's submission," he notes.
In the paper, Kenny also discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. His recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.
Microtest's broad portfolio of medical device and combination product testing services include sterilization validation, reusable device studies, endotoxin and sterility testing, and package validation.