Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel

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CDRH Letter to Healthcare Providers - Medical Device Safety

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Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes.

The FDA is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency, as well as recent vendor supply chain challenges, including the permanent discontinuance of certain prefilled saline lock/ flush syringes.

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The Letter to Health Care Personnel includes information about conserving prefilled 0.9% sodium chloride IV lock/ flush syringes, including:

  • Details on the shortage of prefilled 0.9% sodium chloride IV lock/ flush syringes,
  • Recommendations for health care providers,
  • Actions the FDA has taken to address the shortage, and
  • Instructions for reporting problems with a device to the FDA.

The FDA has added prefilled 0.9% sodium chloride IV lock/flush syringes (product code NGT – Saline, Vascular Access Flush) to the device shortage list and the device discontinuance list.

The FDA also added certain discontinued surgical apparel (product codes FME, FXP, FYF, LYU, and OEA) to the device discontinuance list.

Questions?

If you have questions, contact the FDA about a medical device supply chain issue.