ENFit rollout hits snags in the United States

Concerns about supply, dosing and blenderized diets are delaying the U.S. transition to a new standard for feeding tube connectors.

The sweeping series of ISO 80369 standards were developed to prevent deadly medical mistakes. The standard would make small-bore connectors for tubes used for feeding, neuraxial, respiratory, intravenous, urethral and urinary devices incompatible. That means nutrients, medicines, gases and fluids won't be delivered to the wrong tubing system.

Adoption of the international standard is nearly complete in the United Kingdom and Netherlands and at the midpoint in Australia and New Zealand.

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.

Another major manufacturer, Becton, Dickinson and Co. (BD), said it is moving forward with the new design standards for neuroaxial products for spinals but has design concerns about the female ENFit syringe and low-dose tip (LDT) syringe.

A BD spokesman pointed to the Franklin Lakes, N.J.-based company's latest public statements about the decision, which went out to customers as letters in fall 2016.

"In the enteral space, after a design was settled on by ISO and industry began planning for launch, BD learned of important patient safety concerns about dose accuracy from the clinical community — concerns that required a second look at the planned enteral connector design," one letter said.

The letters also say the ENFit designs for the two syringes don't perform as well as products already on the market, including its own, and could put vulnerable patients in harm's way, especially newborns.

BD told GEDSA that it is pursuing a male enteral syringe design that complies with the connector standard as well as defined dosage accuracy.

Hancock said he thinks BD's concerns were raised for competitive reasons. Some are related to a preliminary study based on prototype mockups that were later found to be "out of tolerance," he added. When fully validated, scaled production products were tested, Hancock said, performance concerns were completely resolved.

GEDSA's response to BD's concerns was posted on its website in a Nov. 8, 2016, letter. Regarding questions about small-volume dose accuracy, GEDSA says industry experts came up with an ENFit LTD syringe that performance tests show is "substantially equivalent" to other syringes. FDA has granted clearance for at least five manufacturers since testing was completed.

In response to another concern of U.S. clinicians, Hancock said GEDSA will publish a cleaning protocol supported by third-party testing for feeding tubes with ENFit connectors.

With the adoption rate of ENFit at 70-90 percent in many countries and no adverse events reported, Hancock said he is confident the system is "an ideal solution" for all patients, even those in neonatal intensive care units.

Other countries have not faced rollout issues and delays.

"Look deeper at the U.K.," Hancock said. "The reason why they are 95 percent converted is the national health system there got behind the change. They set deadlines and got manufacturers to agree, and if they didn't participate, they were out of a contract."

Hancock said he will suggest U.S. decisionmakers look at the new design standard as a quality issue that needs to be addressed with strong words of encouragement or even mandates and deadlines — at least for the majority of patients. Then, enforcement would likely follow.

GEDSA recommends that FDA set a deadline for health care systems to remove legacy tubes and transition connectors; the Joint Commission, which certifies 21,000 health care organizations, reissue its alert with stronger language that encourages adoption; and the Centers for Medicare & Medicaid Services (CMS) consider reimbursement for ENfit medical devices but not legacy tubes or transition connectors.

Although he does not think the latter recommendation is very likely, Hancock said GEDSA is pushing for the strongest language from CMS because of the tubing misconnection safety issue and problems that would persist with multiple enteral systems in the market.

The recommendations have drawn further ire from an opposition group called Tubies Against ENFit, who see them as attempts to create market demand for ENFit products while discriminating against patients that use legacy devices.

This group says tubies, as the patients call themselves, depend on the wide range of products sold now and oppose being forced to switch to the ENFit design.

Sanford Flach, one of the founders and a retired Navy master chief, has been tube-feeding about four years following radiation treatment for tongue and throat cancer. Like a growing number of tubies, he prefers blenderized meals, which tend to be thicker than commercial formulas.

Flach and others are concerned about the inner diameter of the ENFit connectors. These tubies point to ISO charts that show a 2.9-mm inner diameter (ID) while they currently use products with IDs up to 4.65 mm.

"This makes a big difference to those of us whose feeding tube is our lifeline," Flach said in a phone interview. "We have been attempting to stop ENFit for three years by helping the marketplace choose, but now that Hancock is taking action to make our legacy devices illegal and ineligible for Medicare reimbursement, the war is on, and we will take this to the Supreme Court if necessary to protect the rights and lives of innocent feeding tube users."

Some 250,000 hospitalized patients and many more in long-term care and home settings — an estimated 500,000 children and adults in the United States — use feeding tubes. They can't take nutrition through their mouth because of stroke, cancer or injury, so it is delivered through silicone, PVC and polyurethane components into their stomach or small intestine.

Some patients have used home-blended food for decades, but the practice got popular around 2011 as startup companies like Liquid Hope came out with organic alternatives to commercial formulas.

The latest estimates say 30-40 percent of tubies, or roughly 240,000 patients, are turning food from grocery stores and restaurants into a thin pancake-like batter for nutrition.

The trend emerged after the Joint Commission issued a 2006 alert about tubing misconnections caused by use of the classic luer connectors for a variety of medical applications. A call followed for industry-based standards and engineering designs for medical tubes and catheters that are organ-specific or need-specific and do not interconnect.

A group of manufacturers, clinicians and regulators began collaborating with the International Organization for Standardization in about 2009. They initiated the development of the standard known as ISO 80369, and many sections were published from 2010-16.

As manufacturers set out to meet the enteral standard and invested in tooling, homemade blending was surging for a variety of reasons. Some tubies say they get nausea or diarrhea from formula, that they're allergic to it or they want to limit sugars. Others simply enjoy sitting at the table and having what everyone else is, and maybe burping up a familiar taste.

David Rowland, a 78-year-old tubie in South Carolina, said he even meets friends for cappuccino and a blended sandwich. As he takes in the meal, he enjoys the smell and senses a warmth in his stomach.

"It's a nice feeling," he said.

Rowland had a chance to compare some ENFit sample products in 2014 against his feeding system, which consists of a 24 French-size tube with a large funnel connector for a catheter-tip syringe.

"I got a Subway sandwich, blended it with 20 inches of liquid and did it the legacy way, and it worked fine," Rowland said. "The next night I did it again with ENFit and I couldn't push it through. That's pushing. So you really can't gravity feed either. There's nothing unsafe about my funnel connector, yet ENFit seeks to change it."

Hancock said the Mayo Clinic and FDA studied gravity and bolus feeding of blenderized diets in 2016 and 2017. Scientists and engineers measured flow rates and looked at variables related to tube size, amount of water added, type of blender and amount of blending time. The study found "consistent" flow rates between blenderized food and commercial formula for 20-minute feeds except for two subgroups. Feeding may take 31-39 minutes for 20 and 24 French-size tubes and 40-80 minutes for 14 French sizes.

Clogging issues were studied, too, and the results indicate both ENFit and legacy tubes clog, and the problem can be addressed with a high-end blender.

However, in response to concerns from tubies on blenderized diets, manufacturers are expected to offer their legacy products indefinitely.

"So far I haven't heard any manufacturer in the U.S. say they will discontinue their legacy tubes," Hancock said.

But tubies aren't appeased, because of concern about potential ENFit mandates and lost insurance reimbursement. Rowland describes the ENFit initiative as "good intentions gone wild at the expense of tube feeders." He's also a member of Tubies Against ENFit, which started an online drive in October seeking support to preserve connector choices. They have gathered more than 1,000 signatures and 260 comments in two months.

GEDSA has an online petition, too, to gather support for the new design standard from FDA, the Joint Commission and CMS. Almost 400 people had signed it as of late January.

A video gives accounts of people whose loved ones died from tubing misconnections, including the daughter of a woman whose nurse took the line from a blood pressure monitor and inserted into an IV port instead of the blood pressure cuff. Three bursts of air went into the patient's bloodstream and she died of an air embolism.

Another woman, Glenda Rodgers, tells how her daughter died while hospitalized in 2006 with nausea, vomiting and pain when she was 35 weeks pregnant. Her IV pole contained a bag with what appeared to be a melted milkshake.

"Every corner of the bag had 'not-for-IV use,' and it was hooked to her PICC line," Rogers says in the video, adding that the formula dripped into her daughter's bloodstream for six hours before the mix-up was discovered.

Some 116 cases of tubing misconnections had been identified up to 2010. The incidents caused 21 deaths, and 84 survivors suffered respiratory arrest, sepsis, renal impairment and neurological harm. However, the problem is believed to be wider with incidents going unreported or lumped into tracked categories like medication errors.

The GEDSA petition says the primary culprit is the common luer connector, which is compatible with multiple devices. Petition supporters are asking for national action to "drive conformity to a single, safer solution for all enteral accessories and to accelerate their adoption" with a mandated ENFit conversion deadline.

Flach said experts associated with Tubies Against ENFit have reviewed many of the case studies and dispute whether ENFit would have prevented some of the injuries and deaths.

Flach said he thinks ENFit was designed with the 2.9-mm bore as opposed to the upper parameter of 8 mm to benefit commercial formula makers by making it difficult or impossible for at-home tubies to continue using blenderized foods in their feeding tubes.

Hancock's response: "I am deeply offended by this accusation. Nothing could be farther from the truth. This initiative is about improving patient safety and has nothing to do with limiting patient preference."

"ENFit feeding systems are safe for all patient populations, performing as well as legacy devices for those who prefer blenderized diets. We were very surprised to learn how prevalent blended diets were and are pleased to confirm this growing segment of patients should not experience any compromise in performance with ENFit feeding systems," he said.

Hancock said GEDSA's focus has been to support communication efforts, try to synchronize launch timing and to work with stakeholders adopting ENFit. His term as executive director of GEDSA officially ended Jan. 5. The position has been filled by Mike Cusack, who most recently was director of business development, sales and marketing at Xeridiem.