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.