FDA exceptions to 21CFR640 and receiving products from suppliers

[jshepherd]

Our blood is shipped to us from Omaha and St. Paul (ARC), and sometimes arrives to Denver later than the transport boxes are validated for, which is 48 hours. These units are frequently still in the acceptable transport temp range, be they platelet or red cells. Historically, we have tossed these units since they did not arrive to us within the validated time frame, but I am looking for a way to stop doing that. 

The FDA publishes exceptions to 21CFR640, which are publicly available, and has many exceptions listed where they have allowed the use and distribution of products when they were stored outside of the required temperature ranges for a specified amount of time, ranging from a few minutes to several hours. I cannot find in any FDA regulations where I would be allowed to accept the products in the situation described above, when units are in temp, but over the validated time frame of the transport container. 

Has anyone encountered this before, and what do you do about it? Is this simply a decision for the Medical Director of my hospital, or does this require an FDA exception? 

[RRay]

I'm curious to know as well, since I will likely be in the same situation sooner or later.  Switching some of my stock to ARC delivery to Cheyenne.

[AMcCord]

Have you contacted someone in Omaha or St Paul in their quality section? Should be someone there with knowledge about that process.

[jshepherd]

The response I got from ARC is that it is up to our medical director. There is no FDA exception needed, as the FDA doesn't have a regulation on shipping duration or transit time. They only care about temp, and since the temps are in range, there is nothing to seek a variance from. 

I heard from people who use other blood suppliers, and the general consensus is that if the packing is correct, ice is still present and the units are in temp range, they are acceptable, as long as there is documentation of this deviation from the hospital's normal policy. 

I ended up adding this tidbit to my SOP as an allowed deviation by our medical director, just need to fill out the deviation documentation form and have him sign, but this way, we can accept the units in immediately and not delay having them be available. Especially important for platelets!

[AMcCord]

On 9/1/2023 at 8:43 AM, jshepherd said:

The response I got from ARC is that it is up to our medical director. There is no FDA exception needed, as the FDA doesn't have a regulation on shipping duration or transit time. They only care about temp, and since the temps are in range, there is nothing to seek a variance from. 

I heard from people who use other blood suppliers, and the general consensus is that if the packing is correct, ice is still present and the units are in temp range, they are acceptable, as long as there is documentation of this deviation from the hospital's normal policy. 

I ended up adding this tidbit to my SOP as an allowed deviation by our medical director, just need to fill out the deviation documentation form and have him sign, but this way, we can accept the units in immediately and not delay having them be available. Especially important for platelets!

Good info - may have to update our SOP.

[Bet'naSBB]

I agree with the above for red cell products, but personally would be hesitant with platelets.....not so much for the temp, but because they'd have been without agitation for >24 hours......

Just my personal thoughts......

[applejw]

4 hours ago, Bet'naSBB said:

I agree with the above for red cell products, but personally would be hesitant with platelets.....not so much for the temp, but because they'd have been without agitation for >24 hours......

Just my personal thoughts......

AABB standard allows for no agitation for up to 30 hours