Equipment process validations are becoming one of the tissue banking industry’s most pressing regulatory compliance concerns. Until recently, the tissue industry has enjoyed a comparatively less regulated environment than medical device manufacturers and other medtech service providers. But a surge of regulatory attention focused on validations begs the question; do equipment and supplies used to process tissue need cleaning, disinfection, and sterilization validations?
While the FDA does not clearly state the requirements for these validations they have started asking for them in the audit process. And although the Good Tissue Practices (GTP’s) do not specify these validation practices, there is good reason for tissue banks to acquire them. Recent trends have shown that, companies that state they adhere to the American Association of Tissue Banks (AATB) standard may be required to have a validation plan in place. AATB is the tissue industry’s gold standard – any tissue bank desiring to be seen as a legitimate facility is going to reference the AATB standard in their SOP. It is this catch 22 that has raised discussion in the tissue industry.
Regulators have already audited some tissue banks, issuing observations to facilities that did not have validation data to support the cleaning, disinfection and sterilization of their equipment. This development is a big deal for the tissue industry because prior to this year, few, if any tissue banks had validated equipment cleaning, disinfection, and sterilization processes. Based on this industry trend, it would be wise to review whether or not an equipment validation plan is in existence and take appropriate measures to ensure compliance sooner rather than later.
It is also important to note that independent of regulatory requirement, development of an equipment validation plan represents adherence to the industry’s “best practice” protocols. A validated cleaning, disinfection, and sterilization process provides data to support the absence of cross-contamination between donors during tissue processing.
To learn more visit Nelson Laboratories at the 2014 AATB Conference September 16 – 20, 2014 booth #14. And mark your calendar for the September 18th Equipment Cleaning and Disinfection Validations breakout session presented by Nelson Laboratories’ Alpa Patel and MTF’s Joel Osborne from 1:45 – 2:30 pm.
Nelson Laboratories is a leading provider of microbiology testing and consulting services for tissue products. We know that every test matters and requires solutions that improve patient outcomes and minimizes client risk. We call it “The Science of Success™.” It means working with clients to solve complex problems, providing precise test results, and delivering value through superior testing solutions and service to ensure the safety and efficacy of every product. Nelson Laboratories tissue testing services include facility monitoring, process validation, tissue screening, product validation, and consulting services. Learn more at www.nelsonlabs.com.
