Single-Use Vials: Safety, Cost, and Availability

Reusing Healthcare
The problem of reuse of single-use medical items and devices is not new. Almost as soon as healthcare began adopting single-use and disposable items in the 1970s for purposes of infection control, the reuse of such items began as a cost-saving measure. Despite infection control guidance to the contrary, in 2008, 20%-30% of US hospitals reported that they reused at least 1 type of single-use device.[1]
Evidence suggests that reuse practices extend to sterile vials of injectable drugs intended for one-time use. For example, some nurses and other healthcare providers admit to practices such as re-entering single-dose/single-use sterile vials after the initial access, either for the same or different patients, or inappropriately diluting contents of single-dose vials.
A 2012 online survey[2] of 5446 healthcare practitioners found that 6% of respondents sometimes or always used single-dose/single-use vials for multiple patients, 15% used the same syringe to re-enter multidose vials, and 9% sometimes or always used a common bag or bottle of intravenous solution as a source of flushes and drug diluents for multiple patients. Comments made by respondents suggest that healthcare practitioners have many misconceptions about injection safety with single-use vials.
Why would educated healthcare professionals, committed to patient safety, do such a thing? The reasons are many. Efficiency, time constraints, conservation of resources, avoidance of waste, and cost considerations have all been cited to rationalize the misuse of single-dose vials. Of significance, however, most healthcare professionals who regularly use single-use vials inappropriately don't fully realize how dangerous it is to do so. If aseptic technique is maintained, they reason, what's the problem?
[My note: When in the hospital always check to make sure this isn't happening to you. How to do that? Beats me! But maybe just the act of asking will alert the nurse that you're a 'concerned patient'. Of course, the order to re-use probably came from the top level bean counters to the top level management!!! GACK]



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.