Blood and blood components , Australian Red Cross Blood Service, CON-352
Product name
Blood and blood components
Sponsor name
Australian Red Cross Blood Service
ARTG
Consent start
Consent no.
CON-352
Standard
Subsection 7(1) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
The requirement for a6-month deferral period (or 4 months provided a NAT test
for hepatitis C is negative) for donors who have had an endoscopy with biopsy
(including removal of polyps), from the date of biopsy is not met.People who
have a history of endoscopy with biopsy performed in licensed facilities in
Australia that follow appropriate infection control requirements can be accepted
as blood donors with a reduced deferral period of 1 week from the date of
biopsy, if the procedure is performed in Australia, and if biopsy results
confirm donor eligibility.
Conditions imposed
Should new information become available in the future that indicates reduction
of quality and/or safety standard of the blood or plasma collected from the
donors who have a history of endoscopy with biopsy performed in licensed
facilities, Lifeblood must submit this information to the TGA and obtain
approval to continue with this consent.
Therapeutic product type
Blood, tissues, and biologicals