FDA Issues Draft Guidance - Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications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.
Want to read the full alert and receive alert emails?