Medical device industry ready for ENFit transition

A doctor ordered a feeding tube for a patient who was 35 weeks pregnant and hospitalized for vomiting and weight loss.

A nurse mistakenly hooked the tube for the liquid-food bag to the woman's vein instead of inserting it through her nose to her stomach. The patient, 24-year-old Robin Rodgers, and her unborn baby died soon after the thick nutrition was delivered directly into her bloodstream.

The Kansas woman left behind a 3-year-old son and a distraught family as her name was added to a growing list of victims of hospital tube mix-ups.

That was in 2006. The incident drew more attention to the deadly consequences resulting from physically compatible connectors for medicine, gases and fluids. In other cases, intravenous fluids were connected to tubes meant to deliver oxygen, causing suffocation, and when a tube to inflate a blood pressure cuff was connected to an intravenous line, the patient died of an air embolism.

A long-time global call for new standards that would make tubes for different functions incompatible eventually got traction and is slowly being implemented. The effort has been likened to gas stations having different pump nozzles so drivers don't use the wrong fuel. To improve patient safety, the ISO 80369 series of standards was developed to address the design changes needed for the various devices that access different points of the body, including the bloodstream, stomach, airway, spine and bladder.

An important section of the standard, which covers enteral (feeding) tubes and gastric applications (ISO 80369-3), is about to roll out in the United States. Products that meet the standard are listed under the trademarked name of ENFit connectors.

"The medical device industry is ready, has been ready, and is shipping products, mostly outside the U.S., but we believe that's going to change in the fourth quarter of this year," Paul Melnychuck, senior director of business development and innovation for Spectrum Plastics Group, said in a telephone interview. "In the last year, much of Europe has converted from the legacy product to ENFit. Now the medical devices industry expect clinicians and their institutions will begin the conversion in the U.S."

Based in Tuscon, Ariz., Xeridiem Medical Devices, which is a part of Spectrum, has been focused on meeting ISO 80369-3 requirements since 2013. Melnychuck said the business is an original design manufacturer and a contract manufacturer within the group's $200 million medical division.

When the ISO standard was in its infancy, Xeridiem prepared for change on two fronts.

"We anticipated the market would transition to these new connectors so we invested in the engineering and tooling to start producing these connectors," Melnychuck said. "Secondly, we developed a fully Xeridiem-owned G-tube and got the regulatory clearance."

Xeridiem G-tubes meet requirements for 510(k), CE Mark and Health Canada and are available under private labels.

The manufacturing and assembly of the device starts with a multi-lumen silicone extrusion. The silicone access-ports housing is over molded on one end of the extrusion and a silicone balloon is bonded over an inflation outlet on the other end. An adjustable silicone retention bolster, which is made via liquid injection molding, then is slid over the extrusion. The bolster acts as a wound barrier and protects stomach incisions for feeding tubes from infection.

"The result is a platform from which you can take it off the shelf with just the private label customization or with several engineering improvements made to the shaft, bolster and most notably the balloon," Melnychuck said.

The end of the G-tube that contains the small balloon is inserted into an incision in the stomach and then is blown up through an inflation port. The inflated balloon prevents the feeding tube from being pulled out.

Xeridiem designed G-tubes used in Spectrum Plastics Group's proprietary OptimaX silicone process, which the company says extends the life of the balloon under harsh stomach acid conditions.

"We started in 2013 and began with the connectors and G-tube design, the regulatory clearance, which isn't trivial, and then the business development cycle of working with our customers," Melnychuck said. "Now we service all the major Tier 1 companies in the industry."

Xeridiem began supplying its customers in 2015 but most of the product has ended up overseas, where the market has been to date. However, that appears to be changing.

Last July, the state of California began prohibiting health facilities from using enteral feeding connectors that are compatible, but adoption has been slow in part because there was no immediate enforcement to meet the mandate.

An ENFit summit was held at Children's Hospital Los Angeles in January to determine what was impeding the transition there and elsewhere. Task forces were created to handle supply concerns and educate end users.

Then, in April, a "critical notice" about preventing tube misconnections was issued by the ECRI Institute, a nonprofit group that works to improve patient care through research.

"To prevent any more errors, ECRI is urging facilities to move to the new connectors as soon as practicable — ideally by the end of 2017," Tom Ritter, a senior project engineer at the nonprofit ECRI Institute, said in the notice.

The Pennsylvania-based institute supports efforts of the Global Enteral Device Supplier Association (GEDSA), a nonprofit trade group that consists of 40 companies, including Xeridiem. The aim of GEDSA has been to give device makers, suppliers and distributors a voice about issues as well as help everyone transition to the new standard. Their initiative to reduce medical tubing mishaps is called "Stay Connected."

"Change takes time, especially with hospitals that have certain protocols for their standard of care and committees meeting to determine safety and cost implications," Melnychuck said.

Home care service providers also are preparing for the transition. About 500,000 children and adults in the United States rely on feeding tubes and the number is expected to rise by 8 percent over the next three years, according to Pediatric Home Services in Roseville, Minn.

The business has 1,800 patients affected by the ENFit conversion, and it began educating users in February about the changes coming to the connector ends on all feeding bags, enteral syringes and extensions.

"These changes are happening to avoid incorrect connections to IV lines, trach tubes and other medical tubing," Katie Dahlberg, a clinical specialist, said in a news release. "We've seen one such example at PHS where a patient's mom unintentionally administered enteral products into their child's IV line, a potentially life-threatening situation. Thankfully the patient is OK, but it goes to show that this can happen even with the most skilled and careful of caregivers."

The U.S. rollout of the ENFit conversion will continue into 2018 and likely begin in Japan and Latin America in 2019.

"Japan is notable because of the aging population," Melnychuck said. "People are living longer and there are improved health care options for that population. We see enteral feeding being a big growth area there."