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U.S. FDA Addresses Healthcare Providers to Use Safer Enteral Device Connectors

Hospitals and clinicians are urged to use ISO 80369-3 design compliant connectors, commonly known as ENFit, to reduce the risk of misconnections and patient injury.

COLUMBUS, Ohio, Sept. 12, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) is concerned about misconnections with enteral devices. A letter addressed to manufacturers of enteral feeding, healthcare professionals, and hospital purchasing departments, was written by the U.S. FDA regarding the concern. The letter was published on Friday September 7th, 2018 on fda.gov.

New Design Changes

The letter states that the FDA is "concerned that many misconnections, including enteral misconnections, are not reported, or are reported as medication errors," thus masking the true extent of the misconnection rate.

"The FDA recommends hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections. There are currently marketed enteral connectors that meet the 80369-3 standards, many of which are identified by the tradename ENFit," said William H. Maisel, M.D., M.P.H. Director of the Office of Device Evaluation Center for Devices and Radiological Health.

The letter concludes with a list of specific recommendations for manufacturers, health care professionals and hospital purchasing departments to support the transition to safer enteral device connectors and accelerate their adoption across the U.S.

Please view the full letter here: https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM619782.pdf               

Please visit stayconnected.org for additional resources and a list of organizations in support of adopting ENFit.

The Global Enteral Device Supplier Association (GEDSA) is a 501(c)(6) nonprofit trade association formed to help introduce international standards for healthcare tubing connectors. Comprised of manufacturers, distributors, and suppliers of enteral nutrition devices worldwide, GEDSA facilitates information flow about the three-phase initiative, which is designed to increase patient safety and optimal delivery of enteral feeding by reducing the risk of tubing misconnections. ENFit is a federally registered trademark of GEDSA in multiple jurisdictions throughout the world.

Contact: Amy Baetjer, (614) 947-0041, amy@gedsa.org


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