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.  Enteral administration sets with ENFit connectors and Transition Connectors (allows backwards compatibility to legacy feeding tubes) have been in use throughout the world for nearly two years.  Feeding tubes and syringes with ENFit connectors have been manufactured and are now readily available for use across the globe. 

While adoption rates are well over 50% throughout most of Europe (UK > 90% transitioned), Australia & New Zealand, adoption in the US lags far behind with some estimates at less than 10% of hospitals.  Fully adopted hospitals note that ENFit feeding systems work well without concern. In addition, 69% of surveyed patients at home rate ENFit to ENFit connections as a more-favorable experience than current connectors primarily due to the locking feature that keeps ENFit connected.  For those hospitals, nursing homes and patients at home that have not transitioned, issues have been raised with the temporary ENFit Transition Connectors, either leaking and/or cracking leading to sub-optimal performance with an incomplete system.

With limited adoption in the US the risk of fatal misconnections still exists. Stakeholders, including converted healthcare providers, AAMI and the International Organization for Standardization, Clinical Associations and Patient Safety Organizations (ASHP, ASPEN, ECRI, Feeding Tube Awareness Foundation, ISMP, NPSF, Oley Foundation), believe that ENFit is a safer solution that requires immediate adoption.  However, without an enforceable deadline, patients, hospitals and caregivers that have not adopted continue to be at risk. 

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

GEDSA Global Enteral Device Supplier Association started this petition with a single signature, and now has 268 supporters. Start a petition today to change something you care about.




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