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Questions about Single-dose/Single-use Vials

Questions and Answers on Medical Injection Safety

1. What is the difference between a single-dose and a single-use vial?

A single-dose or single-use vial is a vial of liquid medication designed for parenteral delivery (injection or infusion) in a single patient for a single case, procedure, or injection. Manufacturers mark single-dose or single-use vials as such, and they often lack an antibacterial preservative.

2. Is it possible to use single-dose or single-use vials for more than one patient?

Single-dose or single-use vials should only be used for a single patient as part of a single case, procedure, or injection. Multiple outbreaks have occurred as a result of healthcare workers using single-dose or single-use vials for multiple patients.

Even if a single-dose or single-use vial looks to contain more doses or more medication than is required for a single patient, it should not be utilized for more than one patient or kept for future use on the same patient.

When making purchase decisions, healthcare professionals should select the smallest vial essential for their needs to avoid excessive waste or the temptation to use contents from single-dose or single-use vials for more than one patient.

Repackaging is defined by the United States Pharmacopeia as “the act of removing a sterile product or preparation from its original primary container and placing it into another primary container, usually of a smaller size without further manipulation.” Splitting a single-dose or single-use vial into multiple single-use vehicles (e.g., syringes) is considered repackaging. If the contents of a single-dose or single-use vial must be used for more than one patient, the USP Chapter 797> Pharmaceutical Compounding – Sterile Preparationsexternal icon, as well as the manufacturer’s recommendations for safe storage of that medication outside of its original container, must be followed.

3. How many times can a single patient’s single-dose or single-use vials be entered?

To avoid unintended contamination of a single-dose or single-use vial and infection transmission, it is best to enter a single-dose or single-use vial just once. For a single patient and a single case/procedure/injection, single-dose or single-use vials should be utilized. As a result, they should only need to enter the vial once.

In some cases, healthcare professionals may assume that drawing the full contents of a vial into a single syringe will prevent safe and correct dosage titration (e.g., pediatric dosing during a surgical procedure).

In these situations, healthcare workers must weigh the risk of entering a single-dose or single-use vial for that single patient/procedure multiple times.

If a single-dose or single-use vial is to be used more than once for a single patient during a single treatment, a new needle and syringe should be used each time, and the vial must be discarded after the procedure and not saved for future use.

4. Can leftover medication from single-dose or single-use vials be combined (pooled)?

No, do not combine (pool) the contents of leftover single-dose or single-use vials, or save single-dose or single-use vials for subsequent use. Single-dose or single-use vials are designed to be used on a single patient for a single surgery or case. There have been outbreaks caused by the mixing of contents from single-dose or single-use vials, as well as the storage of contents for future use.

5. When do single-dose or single-use vials need to be thrown away?

When sterility is impaired or doubtful, medication vials should always be discarded.

In addition, the following guidelines for handling single-dose or single-use vials are provided:

  • If a single-dose or single-use vial has been opened or accessible (e.g., needle-punctured), the vial should be disposed within the timeframe specified by the manufacturer for the opened vial, or at the end of the case/procedure for which it was used, whichever comes first. It shouldn’t be kept for later use.
  • If a single-dose or single-use vial has not been opened or accessed (e.g., needle-punctured), the manufacturer’s expiration date should be followed.