ATBF Heart Valve
Workshop -2005
AGENDA
1.
Discussion
on Heart Valve Bank Specific Standards – TGA (Trish) – discussion points
o
Discipline
specific standards – number of standards involved in the review –
o
Discuss the
current requirements and how the development of the new quality system
principles and product specific standards will take place.
o
Identify any
current standards in use by the sector
o
Identify areas of
reviewed standards currently relevant to discipline and how it applies to the
tissue sector.
o
Receive input
from sector in identifying commonalities and differences of current practices
that have not been addressed.
o
This will then
progress to the construction of a Standards document which will then be
generated for comment.
o
GTP – for the
underlying principles of donor selection, product packaging, handling,
transport, identification, traceability, etc ;
tissue driven specificity of testing, any exclusions to the testing
requirements, tissue specific packaging, handling, transport labelling etc will be identified.
2. ATBF Heart Valve Database – Update - Kurt
Trends in Heart Valve Donation & Implantation Rates - Kurt
3. Procedural Presentation – Dr. Marian Sturm
Cryopreservation – “Let Me Count the Ways”
4. Research Presentation – Dr. Lois Armiger
“Aspects
of Heart Valve Research”
5.
DISCUSSION TOPICS:
a. Valve Labelling & Information provided to surgeons
b. Cryopreservation medium (suppliers, bank requirements, sterilisation issues; RPMI vs Medium 199) – Linda
c. Staff training procedures
d. 180 day testing
e. viral infections (denge fever, West Nile Virus)
f. Microbiological testing, criteria for release and TGA recommendations – Kellie
g. Environmental testing (both physical and microbial) and clean room
housekeeping - Kurt
6.
OTHER
BUSINESS: