- Meet Consumers/Patients
|Responding to Consumer Concerns on New Enteral Connectors|
For some time, the Oley Foundation has been bringing consumers and industry together for give and take on upcoming changes to enteral connectors. The Global Enteral Device Supplier Association (GEDSA) and individual manufacturers have been at Oley’s annual conference for the past two years discussing the changes with consumers. In December 2015, Oley organized a summit to bring consumers and caregivers, clinicians, and representatives from the Food and Drug Administration (FDA), enteral manufacturing companies, GEDSA, and other stakeholders together for demonstrations of consumers’ practices and an in-depth discussion of what consumers do now, and what the upcoming changes may mean in practical terms.
In June, because of concerns raised during the Oley meeting and information gathered by FDA through consumer e-mails and meetings with consumers held by the Association for the Advancement of Medical Instrumentation (AAMI), the FDA and Mayo Clinic (in Rochester, Minnesota) will begin research on flow rates with enteral feeding tubes and connectors. The research will provide an independent review of the impact the new ENFit® connector system has on flow rates of homemade blenderized diets as well as commercially produced standard and blenderized formulas. The goal is to provide insight into the equipment needs of consumers using homemade blenderized diets.
The FDA, the Mayo clinic researchers, Oley, enteral equipment manufacturers, and GEDSA are collaborating on this research. All parties have provided input into the testing (products for testing, input into the test procedures and set up), but only FDA and Mayo will conduct research. The Oley Foundation has helped by providing input into the testing, collecting formulas from consumers to use in testing, and having formula shipped from individual donors to Mayo and the FDA, using the Oley Equipment-Supply Exchange Program. (Thank you to those who have donated formula!) We look forward to hearing—and sharing—the results of this testing.
LifelineLetter, May/June 2016
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