Musculoskeletal Tissue - South Eastern Sydney Local Health District, NSW Organ and Tissue Donation Service, CON-1131
Product name
Musculoskeletal Tissue - South Eastern Sydney Local Health District
Sponsor name
NSW Organ and Tissue Donation Service
Consent start
Consent no.
CON-1131
Standard
Standard for Human Cell and Tissue Products '“ Donor Screening Requirements (TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products that do not conform to the requirements of Therapeutic Goods
(Standard for Human Cell and Tissue Products '“ Donor Screening Requirements)
(TGO 108) Order; Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c),
in that the tissue donors will not be deferred for potential environmental
exposure to vCJD for having spent a cumulative length of time of 6 months or
more in the UK between 1980 and 1996 or iatrogenic exposure in the UK at any
time on or after 1 January 1980 .
Conditions imposed
1. that the sponsor continues to monitor the literature and informs the
Therapeutic Goods Administration of any new evidence that substantively alters
the estimated risks, such that they become unacceptable.
Therapeutic product type
Blood, tissues, and biologicals