Question of the Month with Comment
MedSun: Newsletter #20, January 2008
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.
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.
The specific regulations regarding recalls can be found in 21 CFR Part 7 and additional guidance is located at