Single-Use Vials: Safety, Cost, and Availability

Laura A. Stokowski, RN, MS

Disclosures

August 02, 2012

In This Article

The Single-Use/Single-Dose Vial

According to the Institution for Safe Medication Practices (ISMP), "single-dose or single-use vials should be used clinically only for one dose for one patient, and then discarded after initial entry into the vial."[3]

Vials intended for single use are labeled "single use/single dose" for a very good reason. These vials contain no preservative or antimicrobial to prevent bacterial contamination. Because such contamination is not visible to the human eye, it must be assumed that once the stopper is penetrated or the ampule is broken, contamination may have occurred despite our best intentions, posing a risk for serious infection to the patient who next receives contents withdrawn from the vial.

The Risk Is Real

If a healthcare provider breaks infection control technique when preparing and giving a sterile injection (forgets to wash hands, fails to prepare the skin, accidentally touches the needle, etc.) the risk of introducing infection to that patient rises. This risk has always been present and probably happens more than we realize. Still, we hope that when this happens, only that patient will suffer the consequences of our lapse in proper technique. When a healthcare provider inadvertently contaminates a single-use vial and reuses that vial for more than 1 patient, it is not only a single infection that can follow, but an outbreak.

Two outbreaks of serious invasive staphylococcal infection were recently determined to be caused by the use of single-dose vials for more than 1 patient.[4] The first outbreak occurred in patients being treated at an outpatient pain clinic. It was a routine practice in this clinic to prepare a day's worth of injectable contrast doses used for radiologic imaging to guide needle placement for epidural steroid injections or nerve-block procedures. In a procedure room, contrast medium from single-dose vials was diluted with saline and then withdrawn and administered as needed, throughout the day, for different patients. Following their pain-remediation procedures, several of these patients developed severe infections (acute mediastinitis, bacterial meningitis, epidural abscess, and sepsis) with methicillin-resistant Staphylococcus aureus (MRSA) and required hospitalization.

What did these healthcare professionals do, or not do, that transmitted MRSA to these patients? Although the primary lapse in injection safety technique was determined to be the use of a single-dose vial for multiple patients, the investigation also found that staff were not wearing facemasks during spinal injection procedures.

The second outbreak occurred in a hospital-affiliated orthopedic clinic. Staff members withdrew doses of the anesthetic bupivacaine for use in joint injection procedures for multiple patients from 30-mL single-dose vials until the vial contents were depleted. Within days of their procedures, 7 patients required hospitalization, antibiotics, and debridement for infections with an identical strain of methicillin-susceptible S aureus. Investigation by the state health department identified only the use of the single-dose vial for multiple patients as the root cause of this outbreak.

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