The latest issue of The Joint Commission's Ambulatory Advisor includes an article providing guidance for surgery centers to meet the requirements for the use of multi-dose vials.
The Joint Commission aligns its requirements (standard MM.03.01.01 element of performance 7) with guidelines from the Association for Professionals in Infection Control and Epidemiology (APIC) and the United States Pharmacopeia.
"The Joint Commission requires organizations to re-label multi-dose vials with a revised expiration date (beyond-use date) once a multi-dose vial is opened or punctured," according to the article. "USP and APIC now recommend that opened or punctured multi-dose vials be used for no more than 28 days unless the manufacturer specifies otherwise. Therefore, The Joint Commission requires a 28-day expiration date for multi-dose vials from the date of opening or puncture, unless otherwise specified by the manufacturer. The 28-day time frame is based on the fact that manufacturers are required by law to test the effectiveness of the bacteriostatic agent used in the multi-dose vial for a period of 28 days."
The article also offers guidance from a surveyor, who suggests facilities:
- avoid use of multi-dose vials or, if usage is necessary, just use them with one patient to reduce likelihood of cross contamination;
- educate staff on importance of updating the discard date on the vial, either with the 28-day label or other if specified by the manufacturer; and
- train staff to check for outdated multi-dose vials.
View the latest issue of Ambulatory Advisor.
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