One and Done: Single-Dose/Single-Use Vials Are Meant for One Patient

Categories: Healthcare-associated infections, Injection Safety, Outpatient Care

July 16th, 2012 11:35 am ET - .

Michael Bell, MD

Author: Michael Bell, MD,
Associate Director for Infection Control at CDC′s Division of Healthcare Quality Promotion.

CDC released a report today detailing two outbreaks that occurred when healthcare providers failed to follow basic injection safety elements of Standard Precautions. These breaches resulted in life-threatening – yet completely preventable – infections in a number of patients receiving injections for pain relief. How does this happen in today’s advanced medical settings?

In both outbreaks, healthcare providers were splitting single-dose/single-use medication vials meant for one patient into new doses for multiple patients. There was a lack of awareness that this practice puts patients at risk of infection. Because injections were prepared with new needles and syringes and, in one of the clinics, in a separate “clean” medication preparation room, providers thought they were being safe. However, these preservative-free medications are not safe for multi-patient use. Ultimately, ten patients in these two clinics required hospitalization for treatment of mediastinitis, bacterial meningitis, epidural abscess, septic arthritis, bursitis, and sepsis – all severe infections caused by either Staphylococcus aureus (Staph) or its drug-resistant form MRSA.

In both of these outbreaks, providers reported difficulty obtaining smaller vial sizes that better matched patient treatment needs, either because of a drug shortage or because the smaller vial size isn’t manufactured. These scenarios do not excuse unsafe practices. However, providers do have options. High-quality pharmacies that adhere to standards in United States Pharmacopeia General Chapter <797> can be used to more safely split doses from SDVs to increase availability, prevent waste, and minimize risk to patients. In addition, some providers are using appropriate alternate medications in times of shortage.

CDC is working with a number of partners to develop longer-term, systematic solutions. In the interim, it is imperative that clinicians read vial labels carefully to determine which ones are for single patients only, double check injection practices, and ensure that any handling of medication vials is performed correctly under appropriate conditions. Our obligation is to deliver care that does no harm. Ensuring our patients are protected from unsafe injections is at the core of safe care.