What is GEDSA to the Neonatal Clinician?

Evi Dewhurst


The neonatal enteral feeding connector mishmash clinicians have faced in the past will soon be extinct. That’s a step in the right direction. Setting physical specifications on enteral connectors limits the odds of mistakes occurring in the healthcare setting, while changing the context of the conversation with your suppliers.

Now you can make enteral feeding product decisions for your unit based on product innovation and supplier qualifications to meet your needs. But when will this occur, you wonder. Like most clinicians, the details of enteral feeding connector changes are a bit challenging: as in, when will it happen? How will it happen? While some details are still a bit hazy, there is an organization which is working to provide answers. That organization is GEDSA.

GEDSA is the Global Enteral Device Supplier Association, which was created to communicate international enteral feeding connector changes with governing agencies, associations and member suppliers. This association speaks with one collective voice to share information about new, safety-oriented enteral connectors as they are introduced to the market based on upcoming ISO (International Organization of Standardization) established standards. ISO is prioritizing safe enteral connectors, and GEDSA is working together to meet those requirements.

Medela is a charter member of GEDSA, and as such is involved in discussions and plans between other charter members who are working together to provide a solution to meets the needs of ISO. Acacia Neonatal is now a part of the Medela family, and as Medela looks to meet the new standards, they will bring those changes to the Acacia Neonatal enteral connectors. So far we can share what GEDSA has planned:

1.     Members of GEDSA have created a connector that meets the ISO 80369-1 standards. This connector is called the ENFit connector, and will potentially be widely used by many enteral feeding device suppliers.

2.     Some suppliers are already adopting the ENFit connector in anticipation of meeting California state law, requiring enteral connector changes by January 2016. This law will go into effect before the ISO standards, and the goal is to make sure everyone is compliant. Medela will begin production using ENFit connectors early in 2015.

3.     The ENFit connector is a locking connection with reversed male/female connectors. Syringes will have a female connector, while feeding tubes will have a male connector. Suppliers who already have a locking system will find it easier to adopt this new locking system due to existing production practices.

4.     During the transition time, suppliers will make transitional connectors to help you connect your current system pieces to the new ENFit connectors.

5.     This roll out of products will take time. Each supplier will be preparing as quickly as they are able. Be sure to ask questions to clarify your concerns and gather the information best suited to make a decision between your committee for your NICU.

This change in connectors may seem overwhelming at first, but the time is now to enact safety measures to truly make a difference across the health care spectrum. Your enteral feeding device suppliers are working diligently to meet the ISO requirements and maintain their dedication to you, your patients and to improving outcomes.

At Medela, our highest goal is to ensure patient safety. As a member of GEDSA, Medela is in the forefront of these new safety enteral connector advances. We will bring this new technology to you as it is passed through ISO in a time-efficient manner, while continuing to offer the product integrity you have come to expect from Medela.

If you have more questions about Medela enteral feeding products, feel free to contact us at 800-486-6677, or to email EFinfo@medela.com.


GEDSA website: http://www.gedsa.org/

ISO website: http://www.iso.org/iso/home.html

ISO 80369-1:2010: http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnu…