Petitioning US Regulatory Bodies and 3 others

Adopting Safer Connectors to Reduce the Risk of Medical Device Tubing Misconnections

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Medical device tubing misconnections are under-reported events occurring in hospitals, nursing homes and at home that can result in fatal consequences. The primary culprit, the Luer connector is currently compatible across multiple medical device applications delivering fluids or gases to patients, posing a huge risk for wrong route delivery.  Thanks to a new ISO Standard Connector series, a solution exists for enteral feeding devices (ISO 80369-3) commonly known as ENFit.   

With limited adoption in the US the risk of fatal misconnections still exists. 

Actions and measures at the national level must be in place to drive conformity to a single, safer solution for all enteral accessories and to accelerate their adoption.  Sign this petition to demonstrate to healthcare regulatory agencies and manufacturers of enteral devices the need for a mandated ENFit conversion deadline.

This petition will be delivered to:
  • US Regulatory Bodies
  • FDA
  • CMS
  • The Joint Commission

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GEDSA Global Enteral Device Supplier Association needs your help with “US Regulatory Bodies : Introduce safer healthcare connectors to reduce medical device tubing misconnections”. Join GEDSA and 395 supporters today.