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FDA Requiring Warning Label for Multi-Dose Diabetes Pen Devices

On February 25, 2015, the U.S. Food and Drug Administration (FDA) announced that it is requiring multi-dose diabetes pen devices and their packaging to bear a warning label stating “For single patient use only.”   Sharing multi-dose diabetes pens between patients puts patients at serious risk for spreading infection, as blood may be present in the pens after use.  Over the past six years, FDA has been notified of multiple instances where a large number of patients were potentially exposed to bloodborne pathogens as a result of insulin pens beings used on more than one patient:

  • In 2008, a U.S. Army facility found that 2,114 patients were potentially exposed
  • In 2011, the Dean Clinic in Wisconsin found that 2,345 patients were potentially exposed
  • In 2013, the Veterans Health Administration found that 716 patients were potentially exposed

FDA feels that the large number of patients partaking in this risky activity is partially due to a lack of appropriate warning on labels.  In an attempt to spread awareness of the risk of sharing multi-dose diabetes pens, FDA is requiring the “For single patient use only” warning to appear in the following locations:

  • The label attached to the pens and
  • The pen cartons
  • The prescribing information
  • The patient Medication Guides
  • Patient Package Inserts
  • The Instructions for use

Registrar Corp assists medical device establishments with U.S. FDA regulation compliance.  Registrar Corp Label Review Specialists can review medical device labels for FDA compliance and help determine whether a specific product is required to bear the “For single patient use only” warning label.  For assistance with medical device labeling or other FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/LiveHelp