Single-Use Vials -- The Debate Continues

Laura A. Stokowski, RN, MS

Disclosures

December 11, 2012

In This Article

What Infections?

An oncologist asked, "What about drawing out 1 dose, then immediately drawing out a second dose? This is actually common practice in some large oncology practices."

It would seem from some of the comments that not only is this common practice, but that many healthcare providers simply don't believe that it poses significant risk to the patient. A dermatologist claimed that "thousands of outpatient surgeons draw up local anesthetic at the beginning of the week and never have a problem, even when the lidocaine sits around in a syringe for a week."

A nurse in geriatric practice wrote, "For years, I watched anesthesiologists draw all the contents of single-use vials into several syringes for use throughout the day. Never saw a problem. There's a difference between pulling all the contents into single-dose syringes when the seal is first breached and treating a single-use vial as you would a multidose vial to be used over a couple of weeks."

These opinions beg the question: Does "never saw a problem" mean that no problems ever resulted from these unsafe practices, or that these providers were just not aware of them? To those who assume the former, a CDC representative told Medscape, "Infections associated with unsafe practices can take years to present symptoms (eg, hepatitis), so clinicians might never realize that their patients were infected." A medical student also cautions, "Don't think you are not harming patients just because the infection has not been traced back to you...yet."

Still, some healthcare providers clearly believe that the infection risk is a nonissue. An oncology pharmacist writes, "There is a widespread impression that drug vials without preservative are at risk for exponential microbial growth. This is not supported by the evidence.[1] Microbial growth in simple solutions doesn't occur without both macro- and micronutrients present. Even in dextrose 5% in water, there is no growth. Therefore, contamination risk is a function of the number of breaches of the sterile envelope. It doesn't matter whether you use bacteriostatic solutions or plain sterile water, and it doesn't matter how long the vial sits. Sterile technique and restricting the number of punctures are the important factors. It's reasonable to use single-use vials for a limited number of entries under circumstances of high cost and supply shortages."

The problem with this belief, according to CDC, is that no data exist to inform us about how many vial entries are "safe," so we lack evidence-based guidelines. How many entries constitute a "limited" number? One entry is too many if the provider inadvertently and unknowingly contaminates the drug upon breaching the seal. If that happens, using the vial once, as intended, might result in 1 infected patient but will avoid a multipatient outbreak.

An anesthesiologist asks, "If the drug is drawn up in 2-3 sterile syringes at the same time when the vial is initially punctured (in a sterile fashion) and used within a few hours, what is the difference from the drug being drawn up in 1 larger syringe and used on 1 patient over a 3- to 4-hour case? I see patients in the ICU on propofol drips that are hanging for many hours, if not an entire day or two. That is a single-use drug and the vial has been punctured for quite a while! Is the nurse to dispose of the drug after 2, 4, 6, or 8 hours?"

Here is what the CDC has to say about it. "Drawing up doses in advance of a day's procedures, let alone a week's or more supply, puts patients at risk for infection and the clinician at risk for disciplinary or criminal consequences -- even if new needles and syringes are used. If medications become contaminated, pathogens can multiply in the vial. For example, in a recent outbreak of S aureus in an outpatient clinic in Delaware,[2] reuse of single-dose vials for multiple patients was the only breach of safe practice identified during the investigation and represented a recent change in practice. Only 1 vial was opened at any time; each dose was drawn up in a separate, clean medication room; and each vial was accessed over a course of several hours for multiple patients until all contents were withdrawn. Seven patients at the clinic were infected with S aureus."

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