Question of the Month with Comment
MedSun: Newsletter #20, January 2008

Question:
What are the obligations of a hospital relating to a recall and disclosure to patients affected by a recall? In response to a recent defibrillator leads recall, I am asking physicians whose patients were affected by the recall to provide documentation affirming that patients were advised of the recall. I am seeking the reference to the regulation indicating the obligation of the physicians relating to disclosure.

Comment:
From FDA: While there are no FDA regulations that require hospitals or any other healthcare providers to advise patients of recalls, it is suggested that they do so. By regulation, a recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall and where appropriate, the direct accounts should in turn notify their customers. A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: “drug [or food, biologic, etc.] recall [or correction].”

Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees.

Additional Information:

The specific regulations regarding recalls can be found in 21 CFR Part 7 and additional guidance is located at
http://www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm


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