As seen in the Consultant Connection August 2014 Issue
The Joint Commission Sentinel Event Alert Issue 52, June 16, 2014
Thousands of patients have been adversely affected by the misuse of single-dose/single-use and multiple-dose vials. The misuse of these vials has caused harm to individual patients through occurrences and outbreaks of bloodborne pathogens and associated infections, including hepatitis B and C virus, meningitis, and epidural abscesses. Adverse events caused by this misuse have occurred in both inpatient and outpatient settings, according to the Centers for Disease Control and Prevention (CDC).
The misuse of vials primarily involves the reuse of single-dose vials, which are intended to be used once for a single patient. Single-dose vials typically lack preservatives; therefore, using these vials more than once carries substantial risks for bacterial contamination, growth and infection.
Since 2001, at least 49 outbreaks have occurred due to the mishandling of injectable medical products, according to the CDC. Twenty-one of these outbreaks involved transmission of hepatitis B or C; the other 28 were outbreaks of bacterial infections, primarily invasive bloodstream infections. While many of these outbreaks occurred in inpatient settings, a high percentage occurred in pain management clinics, where injections often are administered into the spine and other sterile spaces using preservative-free medications, and in cancer clinics, which typically provide chemotherapy or other infusion services to patients who may be immuno-compromised. In addition, more than 150,000 patients required notification during this time frame to undergo bloodborne pathogen testing after their potential exposure to unsafe injections.
The CDC is aware of at least 19 bloodborne or bacterial infection outbreaks since 2007 associated with the misuse of single-dose/single-use vials. Seven involved bloodborne pathogen infections, and 12 were bacterial infections. All of these outbreaks occurred in the outpatient setting, with eight occurring in pain remediation clinics. According to CDC officials, these examples likely underestimate the harm resulting from the misuse of single-dose/single-use vials. Due to the difficulty of tracing the misuse of vials to infections, the adverse impact of misusing a vial is typically not seen immediately. Adverse events related to unsafe injection practices and lapses in infection control practices are underreported, and it remains a challenge to measure the true frequency of such occurrences.
Recommended processes and procedures
Single-dose/single-use vials
  • Use a single-dose/single-use vial for a single patient during the course of a single procedure. Discard the vial after this single use; used vials should never be returned to stock on clinical units, drug carts, anesthesia carts, etc. The One & Only Campaign from the CDC and Safe Injection Practices Coalition emphasizes ONE needle, ONE syringe, ONLY ONE time. Medications in single-dose/single-use vials lack antimicrobial preservatives and are therefore at greater risk to become contaminated and serve as a source of infection when used inappropriately. See campaign resources, including video at:
  • If a single-dose/single-use vial must be entered more than once during a single procedure for a single patient to achieve safe and accurate titration of dosage, use a new needle and new syringe for each entry. Note: USP 797 states that single-dose/single-use vials must be used within one hour, with any remaining contents discarded.
  • Do not combine or pool leftover contents of single-dose/single-use vials. Do not store used single-dose/single-use vials for later use, no matter what the size of the vial.
Multiple-dose vials
  • Only vials clearly labeled by the manufacturer for multiple dose use can be used more than once.
  • Limit the use of a multiple-dose vial to only a single patient, whenever possible, to reduce the risk of contamination.
  • When multiple-dose vials are used more than once, use a new needle and new syringe for each entry. Do not leave needles or other objects in vial entry diaphragms between uses, as this may contaminate the vial’s contents.
  • Disinfect the vial’s rubber septum before piercing by wiping (and using friction) with a sterile 70 percent isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic swab. Allow the septum to dry before inserting a needle or other device into the vial.
  • Once a multiple-dose vial is punctured, it should be assigned a “beyond-use” date. The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days, unless otherwise specified by the manufacturer.
  • Store multiple-dose vials outside the immediate patient treatment area; observe the manufacturer’s storage recommendations.
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