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

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

Michael Bell, MD

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.

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  1. May 6, 2013 at 10:42 am ET  -   sigdoc

    Are there guidelines for when to discard a syringe and its medication after being drawn up? Single use vial, sedation medication drawn up at the start of a 2 hour procedure. How long is it safe to use that syringe/medication before there is a risk of bacterial growth? I have heard from anywhere between 1-24 hours.

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  2. September 12, 2012 at 10:29 am ET  -   Lyn Tipton

    I applaud your efforts. You may have saved the next persons life! I have some suggestions for discussion with the anesthetist…Single use does mean single use on a single patient/single procedure(using a new syringe and needle). Also if used in the clinical area, even a multi-dose vial must be discarded. These specific issues are addressed in The “Recommendations for Infection Control for the Practice of Anesthesiology 3rd edition” and by CDC (“Guideline for Isolation Precautions 2007″ pages 82-83)., The Joint Commission(MM.05.01.11 EP 4 addresses using unit dose vials), CMS(CFR# 482.23(C) and others. You may speak to your pharmacy about options using their USP 797 guidelines. If would like, I would be be happy to send you the above documents.

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  3. July 29, 2012 at 1:33 pm ET  -   Mike Brennan

    Multiple dose vials and multiple dose syringes were commonplace in the fifties and sixties. Unit dose and disposable syringes have improved antisepsis, but have done so at a cost, which cost the system may not be able to sustain. Are providers returning to obsolete practices to cope with decreasing resources and increasing patient load?

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  4. July 22, 2012 at 7:18 am ET  -   vadivel Vasantha

    I have a notion that MRSA/Staph areus present/colonies on nares, hands, skin and in the environment of the colonised/infected patients.Being a gram positive can they present in the injection vials like Hepa B, Malarial parasite? Sorry for the innocent question

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  5. July 22, 2012 at 7:16 am ET  -   vadivel Vasantha

    I have a notion that MRSA/Staph areus present/colonise on nares, hands, skin and in the environment of the colonised/infected patients.Being a gram positive can they present in the injection vials like Hepa B, Malarial parasite?

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  6. July 19, 2012 at 8:18 am ET  -   Gloria

    In my place , we have discussed about some single use medication and eye drop . We are facing the difficulity about to discard the sdv / eye drop after each pt ( normally the eye drop containing about 5-10 ml ) or some insulin , our staff thinks that it is wastage ! If we do well the disinfection before puncture the value of medication or use non touch techique to give the med /eye drop , would it be accepted ?
    Thanks
    Gloria

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  7. July 17, 2012 at 1:32 pm ET  -   rnbutts

    It is getting much harder to get medications in the size and strength required for our patients. I have recently gotten in trouble by our anesthetist for disposing of a single patient vial after a case was over. There was still enough medication in it for another dose. Because the cost of drugs is so high, I was supposedly wasting money for our company and valuable resources that have been so hard to come by lately. How do you win when you se in trouble for doing the right thing?

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