AABB Seeking Feedback on Proposed Interim Standards Focusing on Sterile Weld

AABB is seeking public comment on proposed interim standards for the 33^rd edition of Standards for Blood Banks and Transfusion Services (BB/TS), until May 2. Under the interim revisions, the Blood Bank/Transfusion Service Standards Committee (BB/TS SC) is proposing edits to standards in the Weld section. When the 33^rd edition of BB/TS Standards was made available, the BB/TS SC received feedback from the membership that indicated that new standard 5.2.7.1.3 would be difficult to adhere to due to a lack of expiration times included in manufacturer’s instructions for certain storage containers (including but not limited to bags, transfer packs, syringes) resulting in products having to be disposed of because of the 4 hour expiration requirement that currently exists in standard 5.2.7.1.3.

Based on the feedback already received, the BB/TS SC proposes the complete removal of standard 5.2.7.1.3 from the 33^rd edition of BB/TS Standards. The BB/TS SC also intends to strengthen the language of standard 5.7.2.1.1 by including the clause, “consistent with the storage requirements for the blood or blood component.” The BB/TS SC feels that this will ensure that all storage containers meet the requirements set forth by the Food and Drug Administration or Competent Authority. The BB/TS SC also added a cross reference to standard 5.1.4 which requires that all materials are stored and used in accordance with manufacturer’s written instructions.

The standards will be out for comment by May 2. To comment on the proposed changes, please submit comments via Jotform (https://form.jotform.com/220864777829170) or via email to standards@aabb.org before the conclusion of the comment period.

While the interim standard is out for comment, AABB’s Accreditation Department will ensure that facilities assessed under the current language will not receive nonconformances if they are not in compliance with standard 5.7.2.1.3.

The interim standard revisions read as follows:

5.7.2     Weld

If a sterile connection device is used to produce sterile welds between two pieces of compatible tubing, the following requirements shall apply:

!        5.7.2.1  The weld shall be inspected for completeness.

5.7.2.1.1           If the integrity of the weld is complete, and the compo­nent is in a container approved by the FDA or Competent Authority for storage, then the original expiration date/time shall apply, consistent with the storage requirements for the blood or blood component. Standard 5.1.4 applies.

5.7.2.1.2           If the integrity of the weld is incomplete, the con­tainer shall be considered an open system and may be sealed and used with a component expiration as indicated in Reference Standard 5.1.8A, Require­ments for Storage, Transportation, and Expiration.