A Q&A on best-practices for multidose vials
There has been much more attention recently on multidose vials, particularly the expiration date of these vials, especially from regulatory organizations such as CMS and The Joint Commission.
The following is an email interview 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.”
This Q&A accompanies an article published in the September issue of Briefings on Infection Control.
Q: Why have multi-dose vials been an issue in the past, and why do they continue to be problematic for some facilities?
A: Multi-dose vials have been and continue to be a confusion for healthcare personnel (HCP) because they either are not fully aware of or do not follow basic infection control practices as they pertain to vials. The term multidose seems to be confusing because it is seen by some HCP as being able to be used more than once. While this is true, there are basic infection control practices that are not followed and/or corners that are cut that put the vial at risk for viral or bacterial contamination.
Q: Where do facilities fall short with compliance when it comes to best-practices for multidose vials?
A: There are a few common themes.
- The label that indicates that a vial is intended for single or multidose is very small print. It is not overtly obvious when a vial is single or multidose. One manufacturer may make a vial multidose when another does not and yet the vials look very similar in size and label color.
- Vials are used in a variety of settings and it is difficult to find one solution to use that meets everyone’s need.
- Multidose vials should not be kept in patient care areas where direct care is provided. This can lead to it being used for multiple patients. They should also never be put into staff pockets and carried around with them.
- When using multidose vials, dedicate them to a single patient.
However, the basic principle of not entering a vial with a used needle should be mostly universal with very few exceptions such as in surgery/anesthesia but only for the same patient.
Q: How long should you keep multidose vials? How often does the 28-day rule apply? Is that commonplace for most vials at this point? The paper indicates it is an unresolved issue, why is that?
A: Most would agree that you should limit use of multidose vials whenever possible. 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. Everyone would agree that it should be discarded if the sterility of the vial is in question. Prior to discarding it though, contact your Iinfection 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 multi-dose vials that healthcare personnel and surveyors can both utilize.
Q: What will regulators or surveyors look for concerning expiration dates?
A: When we wrote our position paper, our communication indicated that staff were to follow their own hospital policy. However, that may not be the case today given conversations I had with colleagues at our recent APIC national conference. Therefore, we are currently having conversations with various organizations to help develop one consistent message for HCP. It appears that the 28 day recommendation will prevail along with assuring vials are accessed, stored and utilized properly. Some manufacturers may have expiration dates sooner than 28 days from the first access and that would take precedence over the 28 day recommendation
Q: What kind of education or intervention methods can IPs provide to ensure front-line staff are following best-practices regarding multi-dose vials?
A: Only use them when single dose vials are not an option. Use them for single patients whenever feasible. Keep them away from the immediate patient environment. Do not store them in your clothing/pockets. Never leave a needle cannula or spike device inserted in to a vial stopper. Always discard if the sterility of the vial is in question. Access the vial with a new needle and syringe each time.