Cardiovascular Tissue - Metro South Hospital and Health Service T/A Queensland Tissue Bank, Metro South Hospital and Health Service T/A Queensland Tissue Bank , CON-1472
Product name
Cardiovascular Tissue - Metro South Hospital and Health Service T/A Queensland Tissue Bank
Sponsor name
Metro South Hospital and Health Service T/A Queensland Tissue Bank
ARTG details
Consent start
Consent no.
CON-1472
Duration
The consent is effective from 29 April 2026 until 1 October 2031.
Standard
Schedule 1 Item 10 of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products will not comply with the requirement of deferral periods for blood
borne infection risk, applicable to tissue donors who have received a tattoo and
tests negative for HCV using NAT when a four-month deferral is applied, or in
all other circumstances a six-month deferral from the event is applied.
Conditions imposed
Tissue donors who have received a tattoo as part of a medical procedure will not
be deferred for potential blood borne infection risk when the medical procedure
was performed under the following conditions: with sterile items/instruments,
under the guidance of a medical practitioner, for a specific medical purpose
(e.g., radiation therapy, colonoscopy/polyp removal) and at a hospital or
medical clinic performed under controlled conditions.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals