Rachel Glenn loves to puree food and put it in her 4-year-old's feeding tube. The Arkansas mom said her thick concoctions of fruit, vegetables, meat and grains provide the concentrated nutrition he needs.
When he was on formula, Asher, who can't swallow due to a brainstem condition, vomited several times a day. Since his mom started making his meals in a blender, when he was about 15 months old, that has stopped and Asher has more energy. Plus: "He gets his two cups of greens a day and he doesn't argue about it."
So Glenn was upset to learn about a new type of connector being promoted for feeding-tube equipment that could prevent her son from consuming her home-blended food. It has a one-size-fits-all opening that's much narrower than the holes on syringes she currently uses to push food through the feeding tube implanted in his abdomen.
When Glenn and her husband tried using a syringe tipped with one of the new plastic connectors, called ENFit, they could barely get Asher's food to budge. She worries her son's health will suffer if manufacturers start putting ENFit connectors on all feeding devices.
"We feel being forced back onto formula is unfair to him," said Glenn. "I don't see any evidence that they have taken the needs of actual tube-feeding families into consideration."
As the new connector standard intended to prevent deadly errors in hospitals has been introduced in the niche device industry, patients and their families who use feeding tubes long term at home say their concerns have been largely ignored. The ability to consume normal food and control their nutrition is a precious benefit they fear could vanish.
Some critics say ENFit also creates new risks, including dosing errors and infections among preemie babies.
ENFit sprung from an industry effort backed by patient safety groups and the Food and Drug Administration to create a global system of connectors that would prevent devices with different functions from being linked.
Both the Joint Commission, which accredits hospitals, and the World Health Organization flagged such misconnections as a risk more than a decade ago. In 2010, The New York Times drew attention to the issue with a case of a pregnant woman who died after a bag of formula was connected to her IV port.
An industry committee, led by an FDA official, convened to set a standard for feeding-tube connectors. Some manufacturers began investing in production and marketing years before the standard was approved in 2016.
At some point, "the 'P' that stood for patient safety that should have been in the center of decision-making was changed for a 'P' that stood for profit," said Maureen Burger, chief nursing officer at Visante, a pharmacy consulting firm based in St. Paul, Minn. Her firm has served as a consultant for Becton Dickinson and Co., a leading syringe maker.