Legal aspects of sourcing expired platelets for stem cell research?

[allahbaksh]

A Pvt. Ltd. Co. involved in Stem Cell Therapy has approached my blood bank to source expired platelet bags. Our managers are worried about the legal aspects. I would be very grateful for any help or pointers on this topic. Is it ethical to provide / sell these bags instead of disposing them as per guidelines? What storage facilities are necessary? Is there any problem with ownership of the products, the platelets having been donated by donors in good faith?

Pls put up anwers if anyone has any experience in these issues, since this will be helpful to all.. Thanks!

[Debbie]

I don't have experience with selling off the whole product, but we did collect samples for research ... and we had to amend our donor consent to include a phrase stating that it would be okay for us to use some of the samples collected for research.

Rather than obtaining consent for each tube - we just put in a generic clause that it MAY happen and they consent to it. You'd want to do the same thing... as for product handling, not sure I can help with an opinion there...

[allahbaksh]

Our lawyers are not too sure of the aspects too, including that of getting donor consent. Our national guidelines also have strict rules for disposal of expired blood products. So we have put the proposal on hold for the time being..

[heathervaught]

Our donor consent states "I am voluntarily donating blood...to be used in any way (organization) deems advisable." This allows us to manufacture products that are used for research or further manufacturing at our discretion. Of course, we ensure that the manufacture of these products does not interfere with our ability to provide transfusable products to our patients. We consider our it part of our mission to be a steward of the blood products that are donated to us and ensure that some good may come of it. We always entertain opportunities to sell products that expire on our shelves, rather than let it end up in our medical waste container. We sell expired platelets and lipemic plasma to a company that salvages the lipids from the plasma.

Remember that umbilical cord blood was once considered medical waste, and is now used for life-saving therapies...