Dating of multidose vials in hospitals
Therefore, facilities need to relabel the expiration date once the vial is punctured in order to reflect the 28-day rule.
CMS has also announced that inspectors will look at the 28-day window for multidose vials, and that requirement has been reflected in the “Surveyor Tool for Infection Control in Ambulatory Surgery Centers.” Dolan notes that although APIC’s position paper straddles the line on the 28-day issue, it seems more surveyors are using that time period as a barometer.
“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.
It would be helpful to have one evidence-based recommendation for discarding used multidose vials that healthcare personnel and surveyors can both utilize.” The regulatory perspective On June 9, Joint Commission Online published a clarification on multidose vials, reinforcing the 28-day rule.
MM., element of performance 7, requires facilities to store all medications labeled with an expiration date, which is defined as the last date the product can be used, the clarification says.
“Typically, most people will do the 28 days just because they don’t want to hassle with it, but I’ve run into some that were 10 days,” she says.
“Sometimes it depends on refrigeration, so you need to talk to the manufacturer and get it in writing.” Keep a log When Luebbert consults with facilities on how to handle multidose vials, she recommends developing a log, similar to sharps safety evaluations, so that you can track each medication and provide documentation to a surveyor to prove compliance.
This documentation will provide a strict policy and appease surveyors.
“When we wrote our position paper, our communication indicated that staff was to follow their own hospital policy,” Dolan says.
“However, that may not be the case today given conversations I had with colleagues at our recent APIC national conference.
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.
“A lot of the risk occurs when you go in and out of that vial,” Luebbert says.