Letter to the Editor: Clarifying Multiple-Dose Vial Usage

This is a letter to the editor in response to a March 13 article by Shelden Sones, RPh, FASCP titled "Is It True You Can't Use Multiple Dose Vials Anymore?" written by Elliott S. Greene, MD, professor of anesthesiology at Albany Medical College.

To Ms. Rachel Fields, Editor-In-Chief of Becker's ASC Review:

There are several problems with the article by Sheldon S. Sones, RPh, FASCP in the March 13, 2012 Becker's Healthcare ASC Review: Clinical Quality and Infection Control Weekly: "Is It True You Can't Use Multiple Dose Vials Anymore?" Firstly, it is not consistent with the current U. S. Department of Health and Human Services' Centers for Disease Control and Prevention's (CDC) "Safe Injection Practices" recommendations. Secondly, it suggests the recommendations are solely from the AORN and the American Society of Anesthesiologists (ASA), while in fact the recommendations for use of multiple dose (or multidose vials) come from the CDC. The CDC recommendations resulted from epidemiologic investigations of multiple patient to patient outbreaks of bloodborne infections (including hepatitis B and C) which were determined to be related to improper clinical practices and lack of aseptic technique with subsequent contamination of medication vials and other injection equipment.

The CDC's "Safe Injection Practices" cover all clinical applications including recommendations include use of multiple dose vials in the operating room and other immediate patient treatment areas.

The following three recommendations are directly from the CDC's website on Safe Injection Practices:

1.    What is a multi-dose vial?

A multi-dose vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that contains more than one dose of medication. Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.

2.    Can multi-dose vials be used for more than one patient? How?
Multi-dose vials should be dedicated to a single patient whenever possible.
If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use.

3.    What are examples of the “immediate patient treatment area”?
Examples of the immediate patient treatment area include patient rooms or bays, and operating rooms.

It is clear that use of multi-dose (multiple dose) vials in an immediate patient treatment area includes all operating room areas (see #3 above). CDC recommendations are that all vials including multi-dose vials are dedicated to a single patient only and discarded after use. All medications, vials, ampules and other injection equipment are single patient use only for use in anesthesia. Only in a non-patient care area such as a satellite pharmacy under strict aseptic conditions may multiple dose vials be aliquoted into multiple doses for multiple patients.

The example cited by Mr. Sones regarding a problem with discarding 18ml out of a 20 ml labetalol vial does not explain that labetalol (and other drugs) is available in smaller vials or carpuject sizes (for labetalol a 4ml carpuject is available). Ultimately, having medications preferably in single unit dose vials and sizes appropriate for a single patient instead of large volume vials will help practitioners understand and use all vials appropriately and not persist in the dangerous habit of using medication vials for multiple patients. Most medications are available in smaller dose vials or ready to use pre-filled syringes. Future work at national levels should push to expand this type of medication dosing size availability.

Mr. Sone's assertion that the AORN or ASA recommendations and hence the CDC recommendations make it time consuming to draw up drugs from multiple dose vials in an emergent situations or for drug titration is simply not correct. The appropriate method is easy to use. Either draw up the entire vial contents into a single syringe and titrate to effect, or alternatively use a new syringe and needle each time the vial is entered so the vial is not contaminated when reentered (as the "One and Only Campaign" also recommends, along with the CDC and multiple other organizations). This results in a "two-layer" safety process as called for by the CDC: first, the vial does not become contaminated by reuse of a syringe or needle in case a vial is inadvertently left in the work area and reused, and for the second layer of protection a new vial is used for every patient in case a syringe or needle was inadvertently reused to enter the vial. In all cases restrict the vial to one patient only. It is actually quite simple and straightforward. It is simply a change in practice patterns from old risky techniques to new safe techniques. Finally, Mr. Sones' comments that "Common sense prevails" unfortunately fails to teach that propofol is a single-patient-use only vial, nor does he mention that multiple dose vials must be used consistent with the requirements called for by the CDC.

Anesthesia practitioners and other healthcare providers need to be educated about CDC's (and other national organizations') recommendations that multi-dose (multiple dose) vials are not "multiple-patient" vials”.

Additionally, for Mr. Sones to suggest it is impractical or impossible to follow the CDC recommendations is without basis: we have been doing at my hospital for the past 5 years.

Thank you,
Elliott S. Greene, MD
Professor of Anesthesiology
Department of Anesthesiology
Albany Medical College

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