AATB Standards for Tissue Banking 15th Edition QMS Implementation

As we start off 2025, the American Association of Tissue Banks (AATB) 15th edition (1), Standards for Tissue Banking, rolls in with a new format reorganizing and combining sections while still maintaining its focus on general and technical requirements. The crosswalk between the 14th and 15th editions helps tie in this reorganization. With the preparatory period starting from July 31, 2024, the 15th edition is the product of the Standards Rebuild Project, and represents the first new edition of Standards since 2016. This reorganization also provides a risk-based approach to maintaining compliance and support the novel and evolving products and technologies in tissue banking. To learn more about the Standards Rebuild Project, check out this link: Standards Rebuild Project

The main areas of focus for this edition of the Standards are:

- A4.000 Mergers, Acquisitions, or Dissolution

- Appendix II, and

- H19.600 Infection Risk Review regarding donor eligibility criteria, previously described in

Bulletin 24-5 (with implementation of updated and new forms - Revised Uniform Donor

Risk Assessment Interview - Donor >12 years old, Revised Uniform Donor Risk

Assessment Interview - Child Donor ≤12 years old, New Donor Risk Assessment Interview - Birth Tissue).

The 15th edition of Standards also includes changes to the following sections, which are subject to an extended preparatory period:

- H26.000 Storage Temperatures;

- H26.600 Storage Temperatures for Lyophilized, Dehydrated, or Desiccated Tissue; and

- H34.400, H34.500, and H37.700 regarding packaging.

The implementation timeline for these changes requires development of a transition plan within six (6) months from publication (by January 31, 2025), and full compliance with the labeling of products manufactured no later than two (2) years later (by January 31, 2027). These requirements are not intended to be applied retroactively (i.e., to existing inventory). Additionally, “ambient” temperature labeling is not included in this reorganization and will be revisited at a later date. There were no changes to Standards for Non-Transplant Anatomical Donation.

2025 has started off quickly and with January 31, 2025, fast approaching for implementation, AATB’s 15 th Edition of Standards for Tissue Banking contributes to the consistent growth and evolution of the tissue banking industry!

References:

1 American Association of Tissue Banks, Standards for Tissue Banking, 15 th Edition