CDC Position Statement on Single-dose/Single-use Vials

The Virginia Department of Health’s (VDH) Healthcare-Associated Infections Program has notified us of a recently issued position statement from the Centers for Disease Control and Prevention (CDC) regarding the importance of protecting patients against preventable harm from the improper use of single-dose/single-use vials. This statement was created in response to ongoing questions and misinformation about CDC’s injection safety guidance.  A recent document circulated by the American Society of Interventional Pain Physicians may be causing confusion among clinicians.

CDC is aware of confusion about and misrepresentation of guidelines protecting patients from disease that occurs when clinicians use single-dose/single-use vials for more than one patient. In an effort to ensure that clinicians are clear about CDC guidelines, the agency is restating its position on the use of single dose/single-use vials and also seeks to dispel inaccuracies being disseminated to healthcare providers.

Highlights from the CDC position statement include:

  • Vials labeled by the manufacturer as “single-dose” or “single-use” should only be used for a single patient. These medications typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection when they are used inappropriately.  Ongoing outbreaks provide ample evidence that inappropriate use of single-dose/single-use vials causes patient harm.
  • Since the CDC safe injection practices guidelines were published in 2007, CDC is aware of at least 26 outbreaks due to unsafe injection practices. These outbreaks resulted in more than 95,000 patients being referred for testing after potential exposure to infectious diseases. Nearly three-fourths (73%, n=19) of these outbreaks involved use of single-dose/single-use medications for more than one patient.
  • All of the outbreaks associated with improper use of single-dose/single-use medications occurred in outpatient settings, with pain clinics (n=8, 42%) representing the most common facility type.
  • In times of critical need, contents from unopened single-dose/single-use vials can be repackaged for multiple patients. However, this should only be performed by qualified healthcare personnel in accordance with standards in United States Pharmacopeia (USP) General Chapter 797, Pharmaceutical Compounding – Sterile Preparations. Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient. Healthcare facilities can proactively arrange for these doses to be split, in accordance with USP standards, when necessary.
  • Lowering safety standards will not address the problem of drug shortages, which are a result of manufacturing, shipping, and other issues unrelated to the above guidelines.

More information on safe injection practices is available from the following: