Bulletin 24-6

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Changes to Standards*

REVISED AATB STANDARDS COMING INTO EFFECT JULY 31, 2024

The Board of Governors acted on recommendations from the Standards Committee and approved changes to the 14th Edition of AATB's Standards for Tissue Banking (Standards). There are no revisions to the 2nd Edition of Standards for Non-Transplant Anatomical Donation coming into effect at this time. 

The below changes were announced in Bulletin 24-2, with a six-month preparatory period starting on January 31, 2024. A redlined copy of the Standards was disseminated at that time to all Bulletin recipients to assist in the preparation process. Members were advised to ensure that by July 31, 2024, these changes are reflected in all relevant standing operating procedures, policies, and staff training files. 

The changes to Standards coming into effect July 31, 2024, are as follows (see exact verbiage in the updated Standards): 

  • Section E2.520 Time Limits for Pre-processing, Processing and Preservation Phases 

A clean copy of each Standards containing said changes will be available to AATB members through the AATB Portal within the next few days.

 

CHANGES TO STANDARDS

ENTERING A SIX-MONTH PREPARATORY PERIOD ON JULY 31, 2024 
The 15th edition of Standards for Tissue Banking has been approved by the Board of Governors with a 6-month preparatory period starting July 31, 2024, and expiring January 31, 2025, when it will come into effect. The 15th edition is the product of the Standards Rebuild Project and represents the first new edition of Standards since 2016. Revisions resulting from the Rebuild Project are not tracked in redline, but the edition is accompanied by an updated crosswalk designed to assist users in identifying the location of 14th edition requirements in the 15th.
 
Shown in redline in this edition are changes to requirements in the following sections: 

  • A4.000 Mergers, Acquisitions, or Dissolution 
  • Appendix II and H19.600 Infection Risk Review regarding donor eligibility criteria, as described in Bulletin 24-5

Members are advised to ensure that the changes are reflected in all relevant standard operating procedures, policies, and staff training files by January 31, 2025, when the changes will come into effect. 
 

ENTERING AN EXTENDED (GREATER THAN SIX MONTHS) PREPARATORY PERIOD ON JULY 31, 2024 
The 15th edition of Standards also includes, in redline, 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 months from publication (by January 31, 2025) and full compliance with the labeling of products manufactured no later than two years later (by January 31, 2027). These requirements are not intended to be applied retroactively (i.e., to existing inventory).

Given the extended timeline for implementing these revisions, they are enclosed in red text boxes that specify their effective date. This approach is designed to retain the currently effective text while informing users of future requirements. 

There are no changes to Standards for Non-Transplant Anatomical Donation entering a 6-month preparatory period at this time. 

Redlined versions of the Standards are available by request to the Primary Establishment Contact or Management Representative for Accreditation of each AATB-accredited establishment by emailing standards@aatb.org.

If you have questions, please contact standards@aatb.org. 

*Originally published on July 29, 2024. Revised on October 22, 2024, to clarify the final effective date of revisions to H26.000 Storage Temperatures; H26.600 Storage Temperatures for Lyophilized, Dehydrated, or Desiccated Tissue; and H34.400, H34.500, and H37.700 regarding packaging from July 31, 2026 to January 31, 2027.