Bulletin 13-14

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Changes to Standards

Bulletin 13-14

July 16, 2013​

The Board of Governors acted on recommendations from the Standards Committee and approved changes to the 13th edition (2012) of AATB's Standards for Tissue Banking (Standards). These updates finalize the deletion to references in Standards to use of a smooth muscle relaxant (SMR) in the perfusion solution for vascular (V) tissue and in the solution used to flush (V) tissue when packaging post recovery.

These updates align with a previous announcement via AATB Bulletin No. 13-7 issued on March 1, 2013 where AATB exercised enforcement discretion regarding references to "a smooth muscle relaxant (i.e., papaverine)" within relevant (V) standards. Additionally, in mid April, the AATB-accredited processors of (V) tissue, CryoLife and LifeNet Health, were sent letters that granted approval of their submissions of requests for variance to these (V) standards where the use of a smooth muscle relaxant appears.

The deletions announced in this bulletin to the following definition and standard are effective immediately:

A2.000 DEFINITIONS OF TERMS

PERFUSION SOLUTION (V)

- A room temperature, sterile isotonic solution such as tissue culture media or PlasmaLyte utilized to gently perfuse veins at recovery. This solution is amended with an appropriate smooth muscle relaxant (i.e., papaverine) and may also contain an antithrombotic agent (i.e., sodium heparin).

D5.700 Post-Recovery Packaging

....

(V) Immediately following Recovery, vascular tissue shall be gently flushed and packaged in an isotonic Sterile solution such as tissue culture media, which has been appropriately amended with a smooth muscle relaxant (i.e., papaverine). Normal saline solution should not be used. The type, Lot number, manufacturer, and expiration date of all reagents used for Recovery and packaging shall be documented. The transport container should be fluid tight, designed to prevent contamination of the contents, and allow for aseptic delivery of the specimen at the time of Processing.

The links below provide printable updates for insertion into your Standards book:

If you have any questions, please contact Scott Brubaker at the AATB Office.