Storage container validation

[LaraT23]

In the most recent technical manual, the statement is made that it is recommended that all storage/transport containers except those from the collection to the processing facility be validated to maintain 1-6 degrees. What is everyone doing about this? We send blood in coolers to our outpatient infusion site, to the OR and to the floors for multiple unit transfusions but our coolers validate to hold 1-10 degrees as we determined them to be short term storage. I remember there being a great debate over this and it seems now a consensus is reached. Our facility simply cannot shell out 361.25 each ( what I was quoted) for validated storage containers that hold 1-6 degrees. We would be replacing 5 igloo storage coolers that hold 1-10 for 4 hours with no more than 4 units in each.

Does everyone think this might become a requirement eventually?

[L106]

Oh, I think that is the requirement now. (And the special 1-6C coolers are expensive.)

[LaraT23]

Do you know of somewhere it says required? My director won't ask for capital on those coolers until we see something that says required instead of recommended.

[David Saikin]

The FDA says that if you transport only 1-10C, if blood is stored (no time frame) 1-6C. I called and spoke with them and rec'd an email to that effect also . . . The feds do not care about the cost of compliance - so - - - are you willing to file a Biologic Product Deviation everytime you "store" your transported red cells in your 1-10 coolers?

[Auntie-D]

The pre-validated ones are well worth the money. A lot of labs validate their own using data loggers but this is a pointless exercise as it is very difficult to actually challenge the temperatures. We validate ours by exposing to extremes of temperature in summer and winter but this is actually quite difficult to do.

One thing to remember is the boxes should be revalidated annually also