Joint Commission releases FAQs on multidose vials
The Joint Commission has released an FAQ on multidose vials, including requirements for expiration dates after vials are punctured, specific labeling requirements, and the specific standards that support each requirement.
Included in the FAQs was the requirement that multidose vials must be discarded after 28 days of the first use, unless the manufacturer specifies otherwise.
Additionally, Standard MM.03.01.01, EP 7 requires facilities to appropriately label vials with the expiration date. The manufacturer’s expiration date is based on the fact that the vial has not been opened. Once punctured, the vial needs to be relabeled to reflect the new expiration date (28 days later, or whatever the manufacturer specifies). Of course, if the manufacturer’s expiration date is shorter than the 28 days, the manufacturer’s date must be used. Labeling the vial the the date it was opened will not meet the requirements of the standard, according to the FAQ.
As always, a vial should be discarded if sterility is compromised.
The FAQs also note that vaccines are currently exempt from the 28-day rule since the CDC states vaccines should be discarded according to the manufacturer’s expiration date.
For more FAQ’s on multidose vials, you can read our own Q&A with Susan A. Dolan, RN, MS, CIC, from the Department of Epidemiology at Children’s Hospital in Aurora, CO, and lead author of “APIC position paper: Safe injection, infusion, and medication vial practices in health care.”
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