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FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur


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FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled


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CDC Releases Report on Infection Transmission from Single Dose Vial Use for Multiple Patients

Tuesday, July 17, 2012

The Centers for Disease Control and Prevention (CDC) July 13 Morbidity and Mortality Weekly Report (MMWR) reminded health care professionals of the serious consequences of using a single dose vial (SDV) for multiple patients even when they believe they have taken necessary precautions.  According to CDC,   

"This report summarizes the investigation of two outbreaks of inva­sive Staphylococcus aureus infection confirmed in 10 patients being treated for pain in outpatient clinics.  In each outbreak, the use of single-dose or single-use vials (SDVs) for more than one patient was associated with infection transmission.  In both investigations, clinicians reported difficulty obtaining the medication type or vial size that best fit their procedural needs.  These outbreaks are a reminder of the serious consequences that can result when SDVs are used for more than one patient. Clinician adherence to safe injection practices, particularly when appropriately sized SDVs are unavailable, is important to prevent infection transmission.  If SDVs must be used for more than one patient, full adherence to U.S. Pharmacopeia standards is critical to minimize the risks of multipatient use."

Specifically, the repackaging of medications from a previously unopened SDV should only be performed using a laminar-flow hood in accordance U.S. Pharmacopeia General Chapter 797. 

ASA supports CDC’s position, and adopted CDC’s Safe Injection Practices in the Recommendations for Infection Control for the Practice of Anesthesiology (3d ed.).  ASA has also worked with the International Spine Intervention Society (ISIS) in reviewing policies on the use of SDV for multiple patients.  ISIS President, Ray Baker, M.D., recently issued a statement on safe injection practices.  Dr. Baker explains that ISIS "thoroughly reviewed nine documented outbreaks involving pain clinics, including five unpublished reports," and concluded that "the use of SDVs for multiple patients has causally contributed to infectious disease outbreaks from interventional pain procedures, resulting in severe morbidity and even mortality."

ASA will continue working with government agencies and medical societies on this important issue.

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