Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:28
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 28
Character Range: 30460–31866

28  Tissue subjected to a bioburden reduction process
 (1) Human cardiovascular tissue that is subjected to a bioburden reduction process must be processed and treated with antimicrobial agents in accordance with subsections (2) and (3).
 (2) The processing and treatment with antimicrobial agents must commence:
 (a) in the case of a deceased donor—within 36 hours of asystole; or
 (b) in the case of a living donor—within 36 hours of collection.
 (3) The human cardiovascular tissue must be exposed, between dissection of the tissue from its surrounding tissue and the time of its cryopreservation, to conditions of antimicrobial treatment at:
 (a) 34°C to 39°C for 6 to 12 hours; or
 (b) 2°C to 8°C for 18 to 24 hours.
 (4) Following the bioburden reduction process and before the addition of cryopreservative, human cardiovascular tissue must be sampled, and tested for bioburden and, following testing, must:
 (a) demonstrate no microbial contamination; or
 (b) be rejected for therapeutic use if microbial contamination is demonstrated.
 (5) Human cardiovascular tissue that is subjected to a bioburden reduction process must be cryopreserved:
 (a) within 72 hours of asystole; or
 (b) within a longer timeframe that is validated by the manufacturer to prevent microbial proliferation and to ensure the quality, safety and efficacy of the human cardiovascular product manufactured using the tissue.