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|Multi-Dose Vial FactFinder|
Committed to providing helpful information to International Spine Intervention Society members about key patient safety issues, the Patient Safety Committee has developed a FactFinder series. FactFinders will explore and debunk myths surrounding patient safety issues. The intent of this FactFinder is to address questions that have been raised by our members in response to the Single Dose Vial / Repackaging FactFinder. There have been several enquiries seeking guidance about the appropriate use of multi-dose vials for multiple patients. This preliminary version of the FactFinder will summarize the CDC recommendations about reuse of multi-dose vials. Additional myths will be added to the piece in the coming weeks, so stay tuned…
Myth: "During injection procedures, we currently use multi-dose vials for multiple patients. In order to comply with CDC guidelines, we must discontinue this practice.”
Fact: The current CDC guidelines discourage, but do not prohibit, the use of multi-dose vials for multiple patients; rather they provide guidance regarding the importance of following safe injection practices to prevent contamination.1
Multi-dose vials are labeled as such by the manufacturer and typically
contain an antimicrobial preservative that inhibits 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. CDC indicates that although multi-dose vials should be
dedicated to a single patient whenever possible, if multi-dose vials must be
used for more than one patient, the vial should not be kept or accessed in the
immediate patient treatment area, and both the needle or cannula and syringe
used to access the multi-dose vial must be sterile. 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.
Myth: The use of a multi-dose vial protects patients from infection or a potential outbreak.
Fact: While the multi-dose vial contains an antimicrobial preservative that inhibits the growth of bacteria, if there is a breach in sterile technique and the contents become contaminated, patients are at risk for developing a bacterial infection. In the event of viral or fungal contamination, there is no protection offered from a multi-dose vial and patients are at significant risk for infection.2-4
The investigation of four large outbreaks of Hepatitis B (HBV) and Hepatitis C (HCV) among patients in ambulatory care facilities in the United States (which included a pain clinic) found breaches in safe injection practices.2 The primary breaches that contributed to these outbreaks were reinsertion of used needles into a multi-dose vial or solution containers, and use of a single needle or syringe to administer intravenous medication to multiple patients. In one of these outbreaks, the sharp container was in the same workspace where the preparation of medications occurred.
An outbreak of HCV was identified and linked to contamination of a multi-dose saline vial in the hospital setting.3 Three of four patients who received saline flushes from a multi-dose saline vial had acute HCV infection, whereas none of the nine patients who did not receive saline flushes had HCV infection (P = .01). A cluster of four patients with HCV infection was identified in a surgery clinic, and all cases were linked to a multi-dose vial of fentanyl contaminated by reused injection materials.4
These and other outbreaks of
viral hepatitis could have been prevented by strict adherence to aseptic
technique for the preparation and administration of medications, including use
of single-use, disposable needle and syringe for each injection given. Whenever possible, the use of a single dose
vial is preferred over multi-dose vials, especially when medications are
administered to multiple patients.
Myth: Multi-dose vials should be refrigerated in order to deter bacterial growth.
Fact: While most multi-dose vials contain preservatives that allow for refrigeration, some antimicrobial preservatives are less effective at lower temperatures.5-8 Since refrigeration of vials containing those preservatives actually reduces their antimicrobial effectiveness, vials should be stored in accordance with the manufacturer’s recommendations and discarded if sterility is compromised.
1. CDC 2007 guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings. Atlanta, GA: US Department of Health and Human Services, CDC; 2007.
2. CDC. Transmission of hepatitis B and C viruses in outpatient settings-- New York, Oklahoma, and Nebraska, 2000-2002. MMWR Morb Mortal Wkly Rep 2003;52(38):901-6.
3. Krause G, Trepka MJ, Whisenhunt RS, Katz D, Nainan O, Wiersma ST, Hopkins RS. Nosocomial transmission of hepatitis C virus associated with the use of multidose saline vials.Infect Control Hosp Epidemiol. 2003 Feb;24(2):122-7.
4. Germain JM, Carbonne A, Thiers V, Gros H, Chastan S, Bouvet E, Astagneau P. Patient-to-patient transmission of hepatitis C virus through the use of multidose vials during general anesthesia. Infect Control Hosp Epidemiol. 2005 Sep;26(9):789-92.
5. Lehmann CR. Effect of refrigeration on bactericidal activity of four preserved multiple-dose injectable drug products. Am J Hosp Pharm 1977; 34:1196–200.
6. Longfield RN, Smith LP, Longfield JN, Coberly J, Cruess D. Multipledose vials: persistence of bacterial contaminants and infection control implications. Infect Control 1985; 6:194–9.
7. Lehmann C, Reed B. Refrigeration of used multidose vials. Am J Hosp Pharm 1993; 50:1138.
8. Bongaerts G, Jansen L. Why Refrigeration Paradoxically Prolongs Bacterial Survival in the Presence of Preservatives. Clinical Infectious Diseases 2003; 37:10, 1403.
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