FDA Issues Draft Guidance - Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications
Published: Aug 3, 2012
The U.S. Food and Drug Administration (FDA) recently announced publication of draft guidance: Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications.
This guidance outlines policy changes for the review and clearance of 510(k) submissions for enteral devices with small-bore connectors. The goal of the guidance is to ensure patient safety by improving the design and testing of small-bore connectors used with enteral devices to prevent the connection of enteral devices to non-enteral devices. These adverse events are known in the clinical arena as tubing or Luer misconnections and they can have devastating consequences for patients, including death.
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