A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. The lab bases the advice on its performance of validations for various types of medical instruments over the years.
The brief discusses the document, FDA Draft Guidance for Industry and Staff, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, which was released in May 2011.
Even though its labeled as a draft, experience has shown that most reusable device cleaning validations are being evaluated based on this document, says Patrick Kenny, manager of analytical services at Microtest Laboratories and author of the new brief titled, Notebook Studies to Ensure Successful Reusable Device Cleaning Validations.
Kennys brief focuses on areas of the FDA guidance document that are causing difficulties in cleaning validations, and demonstrates how pre-validation laboratory work can help save time and money. It also identifies areas that can cause issues during validations if they are not thoroughly addressed prior to initiating the protocol. These include:
The use of worst-case conditions
The switch from microbial-based assays to chemical-based assays
The determination of an acceptable residual level
The validation of a reusable devices cleaning instructions
The good news is that almost all of these issues can be eliminated with some up-front work, Kenny says. And this preparatory work can best be performed by notebook studies prior to initiating GLP studies. The information obtained in these relatively quick studies often saves significant time later in the filing process. In short, we recommend the use of notebook studies prior to beginning the validation to eliminate as many unknowns as possible."
To obtain a copy of the new management brief, Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, visit http://www.microtestlabs.com/notebook-studies-brief or call 1-413-786-1680, or toll-free 1-800-631-1680.