Infection Control

Multidose vials: Follow the 28-day rule

Briefings on Infection Control, September 1, 2010

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Multidose vials run the risk for infections and citations if they aren?t used appropriately

In one respect, multidose vials are a great way to get more for your money with expensive medications. On the other hand, they can cause multiple complications if staff members are not following very precise procedures.

One of the primary concerns of multidose vials is the fact that multiple staff members enter the vial with a syringe, creating multiple opportunities to spread infection, says Peggy Prinz-Luebbert, MS, MT(ASCP), CIC, CHSP, owner and consultant for Healthcare Interventions, Inc., in Omaha, NE. In fact, the best solution for multidose vial complications is not to use them.

?A lot of the risk occurs when you go in and out of that vial,? Luebbert says.

But healthcare facilities don?t always have that option, and as a result they may have multiple multidose vials available for clinicians. This brings up the second problem: expiration dates. 

Multidose vials have a limit on how long they can be stored after being opened or punctured; typically that limit is around 28 days. Your multidose vial may have an expiration date on the label, but that does not take into consideration the date the vial is first used, which is when the 28-day rule takes effect. 

In addition, not all medications are alike?some must be used soon after being opened, which requires the manufacturer?s specific recommendations.

?The issues are that the preservatives in them may be a short-acting preservative, and so it might not be maintaining sterility for a longer period of time because if the preservation breaks down, then the bugs or the chemicals in there could be starting to take over,? Luebbert says. ?So you need to worry about the shelf life based upon the sterility and stability of the agent in the vial.?


Current guidelines

There are a few current guidelines that address expiration dates for multidose vials. The US Pharmacopeia (USP 2008), A General Chapter <797> Pharmaceutical Compounding ? Sterile Preparations, requires multidose vials to be discarded 28 days after initial stopper penetration unless the manufacturer specifies otherwise. The vial should be labeled to reflect the penetration date or the beyond-use date.

However, the CDC indicates that multidose vials can be used until the expiration date, unless there are concerns with sterility. 

APIC takes a stance between the two. In its document APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care, it recommends that facilities develop policies based on one guideline or the other, then follow through with those policies. 

?There are varying recommendations on when the used multidose vials should be discarded, which is why our position paper noted it as an unresolved issue,? says Susan A. Dolan, RN, MS, CIC, director of the Department of Epidemiology at Children?s Hospital in Aurora, CO, and lead author of APIC?s position paper. ?Everyone would agree that it should be discarded if the sterility of the vial is in question. Prior to discarding it, though, contact your infection preventionist, as they may want the vial to culture it for microorganisms. It would be helpful to have one evidence-based recommendation for discarding used multidose vials that healthcare personnel and surveyors can both utilize.?

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