Small-bore connectors join medical components that have an inner diameter less than 8.5 mm to deliver fluids and gases. The connectors are made of plastics, including medical-grade ABS.
In addition to safety, advocates say the global standard will improve continuity of care regardless of a traveling patient's location and the health care facility's supplier.
However, the effort to implement the section of the standard that covers feeding tubes and gastric applications (ISO 80369-3) has met some delays and resistance in the United States.
Supply concerns linger about the only small-bore connectors on the market to meet the standard. Questions also have been raised about dosing accuracy. And, some patients are worried about losing legacy products with large inner diameters for homemade blenderized diets.
A nonprofit trade group of medical device manufacturers and suppliers was formed in 2013 to help the health care community make the transition to the new standards through an initiative called Stayed Connected. Based in Columbus, Ohio, the Global Enteral Device Supplier Association (GEDSA) urges compliance through adoption of connectors called ENFit, which is a GEDSA trademark that defines enteral connectors with a female-to-male orientation.
To prevent misconnections, the ENFit design reverses the traditional orientation of the small-bore connectors, which join components of feeding systems like syringes for drainage, hydration and medication as well as administration sets for either pump, gravity or bolus feeding.
The ENFit system has syringes and administration sets with female connectors that fit around the male connectors on the feeding tube. The connectors are distinctly designed for enteral use and are physically incompatible with other delivery systems.
The ENFit connectors currently are the only ones on the market that comply with the international standard, but adoption has been slow in the United States, which has 5,534 registered hospitals. Although the U.S. Food and Drug Administration recognizes the standard as a way to improve patient safety, compliance is encouraged, not required.
Currently, California is the only state to mandate the switch and set deadlines, although those dates have come and gone. The last one was July 1, 2016, according to Thomas Hancock, the out-going executive director of GEDSA.
"Despite the deadline, adoption has been limited to date. Perhaps the biggest concern cited for lack of adoption has been concern over limited supply in the U.S.," Hancock said in a phone interview.
Many health care systems have been waiting for manufacturers to build up complete inventories of ENFit components — administration sets, feeding tubes and syringes — in various sizes before changing over to the ENFit connectors. In the meantime, they are using transition connectors, which allow backward compatibility with existing inventory during the changeover phase.
"Some supply concerns stemmed from some of the bigger manufacturers that may not have had every syringe size or tube type hospitals needed," Hancock said. "We believe these concerns have been resolved and things should be moving forward."
Major health care systems, like the Mayo Clinic and Cleveland Clinic, and about 250 U.S. hospitals, have converted or will go live in the first quarter of 2018, Hancock said. And, in the state that is farthest along, the California Hospital Association says 22 percent of hospitals have completed the transition, 66 percent are beyond the halfway mark and 12 percent are in the early stages.
Manufacturers like Xeridiem Medical Devices, a GEDSA member based in Tuscon, Ariz., and part of Spectrum Plastics Group, say they have been ready for a U.S. transition but had been shipping product mostly outside the country until recently.
"Orders have picked up in the U.S. for products with ENFit connectors in Q1, so we're starting to see adoption in the U.S. take shape," Paul Melnychuck, senior director of business development and innovation, said in an email.
Not all enteral device manufacturers belong to GEDSA but the group has more than 30 members, including Baxter, Cook Medical, Boston Scientific, Halyard, Medtronic, NeoMed and Vesco Medical LLC, which Hancock helped start.
GEDSA members also use the trademark of NRFit for neuraxial tube systems.