Product recalls and market redrawals

[tburl]

Does anyone have criteria that they use to notify the physician when a product recall or market redrawal is received from the blood supplier? The technical manual says the FDA has included recommendations on whether or not to notify the recipients physician but I can't find anything.

[SMW]

The FDA recommendations are buried in the guidance documents pertaining to each test or scenario.  There is not one guidance document that summarizes all notification recommendations. See page 6 of the HCV guidance attached as an example.

 

You may also find it helpful to review Blood component recalls and market withdrawals: frequency, reasons, and management in the United States by G. Ramsey published in Transfus Med Rev. 2013 Apr;27(2):82-90.

Abstract

In a previous article, we reviewed the management of blood component recalls and withdrawals (G. Ramsey. Transfusion Med Rev 2004;18:36-45). Since then, US rates of recall and biological product deviation for blood components have improved significantly, particularly with regard to reduced recalls for donor infectious disease risks or testing. However, analysis of the current data from the US Food and Drug Administration suggests that 1 (0.4%) in 250 blood components is involved in market withdrawals and quarantines, with 1 in 5800 components formally recalled. Most of these units, unfortunately, had already have been transfused. The U.S. Food and Drug Administration has issued several recent guidances that address transfusion service actions for dealing with specific infectious disease problems. This present article updates our 2004 recommendations as to when to notify physicians about transfused nonconforming blood components.

 

 

FDA HCV Lookback.pdf

[goodchild]

Google 42 CFR 482.27

[tburl]

Sorry I didn't write my question very well

I had found the below article for Managing Recall and Market withdrawals and then had read in the technical manual a reference to FDA blood guidances on infectious disease. Within the article it had Table 3. Suggested Approaches for Follow-up of Blood Components Discovered After Transfusion to Have Been in Nonconformance (Biological Product Deviations).

Outside of Lookback for HIV, HCV, and Chagas, is anyone contacting the physician for recalls/market withdrawals received from your blood supplier of any of the items listed like the Malaria-risk travel and if so what guidelines do you use

Managing-Recalls-and-Withdrawals.pdf

[goodchild]

Thank you for the article.

[tbostock]

Yes, we send a standard physician notification letter out with any market withdrawal or recall (the only acception is if it is N/A...for example an older male received blood and the recall is for Proscar, which only affects women/fetuses).

It's just an informational letter, we quote the exact reason given to us by the blood supplier. Our Medical Director signs the letter, providing his phone number for questions. We have never had a doctor call us, and I doubt any of them notify their patients; most of our recalls are malaria travel, tattoos, etc.

[goodchild]

tburl, there's an update to the article that you posted from 2013, same publication.

 

http://www.ncbi.nlm.nih.gov/pubmed/23375736

 

"Blood component recalls and market withdrawals: frequency, reasons, and management in the United States"

[tburl]

Thank you for the update.  I had stepped out of the field for about 5 years.  Alot changed.

[AMcCord]

We notify according to the recommendations of our blood supplier.

[carolyn swickard]

The oddballs are hard.  I get as much data on the patient and the transfusion as I can - (diagnosis, when transfused, how many other units, etc) and then take the recall/withdrawal to the Pathologist in charge of Transfusion.  We look the thing over together and decide on what to do.  Anything with a chance of an infection - we notify; most of the rest of the stuff we don't, but there is no way to anticipate all of the oddballs in a single SOP.  When there has been followup testing that eliminates any window periods - the decision to not notify is easier.  But many times, since the donor can't donate again and the blood distributors don't just retest these folks - you just have to make a hard call.  My pathologists really doesn't like the ones like that and feels that the blood distributors really should retest a donor that they are going to send out a recall/withdrawal notice on.  Fresh testing data would be the best answer for everyone.

 

I did like the one answer where they always send a copy of the notice to the attending (if findable) and a letter saying "Call us" - might be a better way to handle these.