A new global design standard from the International Organization for Standardization (ISO) for medical tubing connectors is currently being applied to enteral feeding devices in the marketplace. In this issue of The Channel, we speak with Tom Hancock, a founder and executive director of the Global Enteral Device Supplier Association (GEDSA) about how that organization is helping the medical device industry transition to the new global design standards for enteral feeding connectors.
Visit gedsa.org for more information on GEDSA
The Channel: What is GEDSA and can you describe the organization’s origin and mission?
GEDSA is the Global Enteral Device Supplier Association and it was formed officially on October 1, 2013. Unofficially, the conversation in the enteral device industry began some years ago, revolving around connector concerns and standardization.
The discussion at the time was primarily about what do these connectors look like. How do they fit together? How are they going to be compatible for the connections they are supposed to make and not compatible with the devices they are not supposed to be? Once that became defined, the questions began to be raised as to how will we introduce these new connectors to the marketplace and we started to get into conversations around that concern.
The feeding system has at least four components that must fit together to be complete, a bag or bottle that carries the nutrition, an administration set that connects to the bag or bottle to deliver nutrition, a feeding tube for patient access and then a syringe for bolus feeding, hydration, medication or aspiration. So, there are four primary pieces, if you will, to the puzzle of a feeding system that all have to work together. Those four components can often come from four different manufacturers.
Now, imagine if you are going to create a new connector and it’s supposed to be universal, all the manufacturers will have to make sure they connect at the same time. That’s where the members of GEDSA came up with this notion of having a synchronized launch plan where the new connectors would be introduced by different manufacturers to help ensure compatibility, avoid any disruption of therapy and improve patient safety.
I was actually working for Abbott Nutrition at the time and I was just another guy representing one of the manufacturing companies. We were kind of unofficially acting like a trade association. Then, as we got a little bit closer sometime early to mid-year, I approached the group and said “it appears there is an opportunity for a joint communication effort, aligning on common introduction timing and having someone lead that effort.” And that’s what ultimately turned into the GEDSA.
The Channel: What is your role with GEDSA and can you tell us about the organizational structure?
I am the executive director and a founder of the organization.
GEDSA is a federally tax exempt 501(c)(6) non-profit trade association. To be considered an official non-profit, you are required to have a board of directors and in so doing we also created a set of officer positions. So we have a chair, a vice chair, a treasurer and a secretary. Those are all elected positions, and then the board itself is made up of appointed positions.
When we set out to do this, we have always been about inclusion and not exclusivity. We did this because we are focused on a patient safety initiative that we all benefit from and the more companies that align to these standards, the safer the system will be. Therefore, we did not want to exclude any company from participating and help address this misconnection concern. To encourage full participation from the industry we needed a way to attract companies both large and small so it became apparent that we needed two levels.
We further delineated the membership between two categories: There are charter members and there are associate members. The two primary distinct differences are that charter members get a seat on the board for helping guide and lead the organization as a whole, as well as a primary position on all communication efforts. The associate-level members have a secondary position and no seat on the board.
The Channel: Can you explain the benefits supplied by GEDSA and also comment on collaboration with other interested organizations?
Some of the formal benefits are that we do have joint communication efforts because with these connector changes that are coming there’s a lot to communicate. As you can imagine with a feeding system changing because of the connectors, you have to inform lots of personnel within the hospital. You have a doctor, a nurse, a pharmacist, supply chain personnel, risk managers, safety officers, administration, and the list goes on with who you would need to inform.
In a sense, we are helping to ensure that we have a single message, and we are doing a lot of work to help get that message out. We are doing that through the stayconnected2015.org website, brochures, press releases, articles, FAQs, webinars and live speaking engagements and conferences. I work with the Food and Drug Administration, the Association for the Advancement of Medical Instrumentation, the Joint Commission, the American Society for Parenteral and Enteral Nutrition and other key opinion leaders. We are all working collaboratively to develop a consistent message and raise awareness of the impending change.
There is a complete list of GEDSA members, supporting organizations and partner associations on the Stay Connected website, including A.S.P.E.N., ISMP, the Oley Foundation, NPSF and AHRMM.
The Channel: How can clinicians and hospital staff learn more about your work?
I would certainly point them to the Stay Connected website first. It is intended to be a great resource for anyone whether you are a manufacturer, a sales rep, or a clinician anywhere on the healthcare continuum. We encourage everyone who visits the site to sign up for our Stay Connected email updates that provide the latest news and resources to aid in the transition. Another resource is gedsa.org, which provides more details on GEDSA membership and our contact information.
We also work through our partner associations and share articles in their publications and host webinars for their members. We also attend a lot of conferences, annual conventions and other trade shows because we feel the best way to communicate these changes is to physically show them. We hand out lots of brochures and wristlets. The wristlets are a neat way to demonstrate what the new connectors will look like along with a reminder to visit the website for more information. The Stay Connected brochures provide more background on this initiative, why we are doing this, what is the change going to look like and how we will transition the market.