Dear colleagues,

 

 

I need your opinion about one query situation; could we extend the expiry date of empty blood collection bag, in line with the separated blood component inside?

 

In other words, would we be able to use blood component inside bag after bag expiration date of collecting bag itself (i.e. PRBC will be expired at 30/3/2014 but the expired date of bag itself - even empty - is 20/3/2014).

 

Also, I will be so glade if you attach here any documentation about my question…

 

Thanks a lot for your cooperation

I would think you should not use an expired bag, so now the sooner expiration date (20/3/2014) is the one that you are going to have to use for that unit.

The only reason that we use expired bags is for the rare therapeutic phlebotomy that we perform.

As long as the product was collected within the expiration date of the collection set, the products manufactured can be dated and used through their normal expiration period. If the product was collected on March 20, 2014, the Red Blood Cells produced can be dated and used for the standard expiration period based on the anticoagulant and method of preparation, e.g, 42 days for an additive unit prepared in a closed system, Fresh Frozen Plasma for one year, etc.

As a separate note, it would not be advisable to use expired bags even for therapeutic phlebotomies. Doing an invasive procedure on a patient using an expired product for which sterility can no longer be assured could be a risk management nightmare.

As long as the product was collected within the expiration date of the collection set, the products manufactured can be dated and used through their normal expiration period. If the product was collected on March 20, 2014, the Red Blood Cells produced can be dated and used for the standard expiration period based on the anticoagulant and method of preparation, e.g, 42 days for an additive unit prepared in a closed system, Fresh Frozen Plasma for one year, etc.As a separate note, it would not be advisable to use expired bags even for therapeutic phlebotomies. Doing an invasive procedure on a patient using an expired product for which sterility can no longer be assured could be a risk management nightmare.

Thanks a lot for you but you have any reference.

Check the manufacturer's package insert for the dating period specified for the products collected using that particular product.

 

For US, also see the FDA Code of Federal Regulations 21CFR610.53: Dating periods for licensed biological products.

21CFR610.53( "When the dating period begins. The dating period for a product shall begin on the date of manufacture, as prescribed in 610.50...". 

The date collected would be the date of manufacture.

Check the manufacturer's package insert for the dating period specified for the products collected using that particular product.

For US, also see the FDA Code of Federal Regulations 21CFR610.53: Dating periods for licensed biological products.

21CFR610.53( "When the dating period begins. The dating period for a product shall begin on the date of manufacture, as prescribed in 610.50...".

The date collected would be the date of manufacture.

I appreciated for you, lot of thanks SMW