In one case recently, the FDA came into a Rhode Island facility I serve looking for a recalled piece of equipment — they wanted to assure that the notice was received and find out what the facility did about it. We have always staged our facilities with survey readiness on this issue as we consider it an important safety element of performance. While there is no “law” as to how long the notices need to be retained, we feel that since controlled drug records are required to be retained technically for two years but most states want three years, and the stronger prevails. We personally like three years on the recalls but, again, that’s an opinion rather than a stipulation in regulations.
In the final analysis, two objectives must be reached: insulate your patients from recalled drugs, supplies and equipment, and administratively be able to demonstrate your procedures on this issue are effective.
Learn more about Sheldon S. Sones and Associates and www.sheldonsones.com.
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