Joint Commission standard refers to FDA requirement regarding FFP labelling

[lab217]

FDA requires plasma to be infused withing six hours and if it is extended to our standard 24 hours a variance must be requested from the FDA.

Federal regulation 21 CFR 606.122 SUBSECTION 3.

Any thoughts...

[Dansket]

See this:

http://www.aabb.org/events/government/fdaliaison/bloodcomponents/Pages/flm041212.aspx

FDA Liaison Meeting – 4/12/12

Food and Drug Administration staff from the Center for Biologics Evaluation and Research (CBER) met with AABB's FDA Liaison Committee to discuss topics of mutual concern in the areas of donor and patient safety and product manufacturing. The committee includes liaisons from AABB, the Advanced Medical Technology Association (AdvaMed), America's Blood Centers (ABC), the American Red Cross, the Armed Services Blood Program, and the College of American Pathologists.

Effective date of new requirements vs. discontinuation of requirements no longer in effect

The final rule published January 2012, titled "Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma" (effective date July 2, 2012) includes updates to several regulations that will eliminate the need to use variances related to ISBT labels and expiration time of thawed FFP. As with any rule or guidance document, new requirements or recommendations must be implemented by the effective date and may be implemented prior to that time.

[JFRhamy]

From the Joint Commission Website:

[h=2]Quality System Assessment for Nonwaived Testing (CAMLAB / Laboratory Services)[/h]Thawed Plasma Expiration

Updated | January 19, 2012

After thawing frozen plasma, how long can it be stored before infusion?Joint Commission standards refer to the Food and Drug Administration (FDA) regulations for blood product labeling requirements. Effective July 2, 2012, the FDA regulations will allow the infusion of thawed fresh frozen plasma for up to 24 hours after thawing. The need for a variance from the FDA to transfuse plasma beyond the original six-hour limit will no longer be required. The scheduled regulation change was published in the Federal Register, Vol. 77, No. 1, Tuesday January 3, 2012/Rules and Regulations 7.

When frozen plasma is thawed, the product is still considered to be fresh frozen plasma for up to the 24 hours. After 24 hours, the product should be labeled as thawed plasma. The license number should be struck, because this is no longer a licensed product according to the FDA. For more information on product modifications, an excellent resource is found on the AABB website, www.aabb.org/development/education/material/Documents/resourceguide.pdf

[aafrin]

I have a related question.

We received blood bags with expiry of November 2013 in March 2013. If we use them and make FFP, it will have expiry date March 2014, i.e.approximately 1 year expiry. Is it OK to use these bags until March 2014 or will the FFP also expire in Nov.2013 according to Manufacturer expiry. What are your thoughts on this?

[Abdulhameed Al-Attas]

aafrin,that is a very good question.

I am afraid I have no idea but let us see what our folks say.

Edited March 9, 2013 by Abdulhameed Al-Attas

[Eman]

I have a related question.

We received blood bags with expiry of November 2013 in March 2013. If we use them and make FFP, it will have expiry date March 2014, i.e.approximately 1 year expiry. Is it OK to use these bags until March 2014 or will the FFP also expire in Nov.2013 according to Manufacturer expiry. What are your thoughts on this?

I would adivse checking the package insert very carefully for any language regarding use/fill dates and expiration dates. On the surface I would be inclined to say that if the bag expires in November 2013 the product would as well, unless there was package insert language stating that is a "fill by" deadline. Your service rep may also be able to provide a definitive answer. You may also want to ask your service rep why you're receiving bags so close to their expiration date (unless these were transferred to your facility from someone other than the vendor).

[aafrin]

Thanks for your replies. I have checked the package insert & it does not say anything about the expiry date being "fill by" deadline.