Nelson Laboratories, Inc. Alpa Patel, senior scientist in healthcare reprocessing, presented at the annual American Association of Tissue Banks (AATB) meeting last month on the topic of Equipment Cleaning and Disinfection Validations, something she calls, “the tissue industry’s compliance challenge.”
Highlighting regulatory issues and solutions for process validations at tissue banking facilities, Patel noted, “Because tissue is an emerging industry they have had less experience with validations than other MedTech service providers and may not know what to expect.” However, recent regulatory attention on the cleaning, disinfection, and sterilization validations for the equipment and supplies used to process tissue is changing that.
“While the FDA does not clearly state the requirements for these validations, 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.” said Patel. “And although the Good Tissue Practices (GTP’s) do not specify these validation practices, there is good reason for tissue banks to acquire them.”
Intimately involved in assisting some of the world’s premier tissue banks in establishing their validation plans, Patel recommends tissue banks review whether or not an equipment validation plan is in place and take appropriate measures to ensure compliance sooner rather than later since:
- Regulators have begun auditing some tissue banks.
- Facilities that did not have validation data to support the cleaning, disinfection and sterilization of their equipment have been issued observations.
Patel reminds us “The real value of a process validation for equipment used in tissue processing is that validated cleaning, disinfection, and sterilization processes help ensure the absence of cross contamination between donors during tissue processing.”
To learn more read Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!, and Importance of Cleaning and Sterilization Validations, Even When They May Not Be Required.