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When in doubt, you can ask them at BP_Deviations@fda.hhs.gov. They're very helpful and usually respond the same day.

We use 80700.

AABB Standard 3.7.3 is "Activation of the alarm shall initiate a process for immediate investigation and appropriate correctve action." Being staffed 24/7 would allow you to take immediate action.

John V, AABB Standard 3.7 for Alarm Systems reads "Storage devices for blood, blood components, tissue, and derivatives shall have alarms...". RhIG is a derivative, so this is a valid finding.

We also treat them as therapeutic patients who require a physician's order instead of a donor. On the FDA website's list of Exceptions and Alternatives, it does show that someone has been given a 'variance' to 21 CFR 640.3 to "Allow individuals on prescription testosterone to donate blood and blood components more frequently than every eight weeks without examination or certification of health by physician at time of donation and to be exempt from placing special labeling about the donor’s disorder on the blood components."

There is nothing on our donor history questionnaire that asks about history of convulsions. However, if that information is given we accept if seizure free the past 6 months, with or without medication.

Our state Bureau of Radiological Health requires the badge by the irradiator. Since they don't ever detect anything, we only have to change them every other month.

The only reason I can recall is if there was no Radsure on the product.

Is there any current documentation that FDA won't allow it? The only place I ever recall seeing it in writing was in a Guidance for Industry regarding a pilot licensing program for irradiated products. Unfortunately, I believe that guidance has been removed from use. I appreciate the help!

The AABB Technical Manual states "Irradiation dose to the center of irradiation field must be at least 25 Gy and no more than 50 Gy." Is there any regulation that prohibits a dose of more than 50 Gy? I'm asking because I'm concerned that if we irradiate a product more than once, it will have a cumulative dose of slightly over 50 Gy since our initial dose is about 27 Gy. Basically, I'm looking for information to back up my opinion that we shouldn't re-irradiate a product. Any suggestions?

We have pregnant techs wear a fetal dosimeter while at work.

I'm O-, CMV- and a mom. I like to think that my red cells might help some other mom's baby. And my platelet count is generally around 400,000. They can collect a double platelet from me quickly. I've had several close friends and family members who've needed platelets during surgery or because of cancer treatment. Ok, it sounds like I'm doing it to help others, but to be honest, it's probably because it makes me feel important.

Johannesburg itself does not need a deferral. The problem would be if the donor had travelled to one of the provinces in the surrounding area that is at risk for malaria. If he did, the deferral would be for one year after he left the area at risk. The CDC has a link to a very helpful tool on their website: http://www.cdc.gov/malaria/map/index.html

I had an OB doctor send someone to pick up FFP "Now, no excuses" before they had even ordered any. I couldn't bring myself to hand her the bags straight out of the freezer; I had to make an excuse.

I believe it would be covered by the short supply agreement. I also agree that your FDA contact should be able to provide that reference for you. Have you asked the plasma manufacturer as well? I would think they'd be eager to help!