Adoption of Safer Enteral Connections Key to Patient Safety

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close up of patient and doctor taking notes

Photo credit: Depositphotos

By Mike Cusack

These are challenging times for hospitals of all sizes. Due to the crush of patients suffering from COVID-19, caregivers are stretched thin and stressed out. The ripple effects are everywhere in the hospital system.

These heavy patient loads raise the risk that a busy caregiver might make an all-too-common medical error caused by tubing misconnections. An array of technology is used at the bedside – IVs, catheters, feeding tubes and more. These devices often have compatible connectors that make it too easy to send, for instance, medication meant for a feeding tube into the IV instead. This can result in tragic patient outcomes, such as: 

  • A feeding tube was wrongly connected to a tracheotomy tube and delivered milk into an infant’s lung, resulting in death. 
  • An epidural infusion set was connected to a peripheral IV, delivering epidural medication to a patient’s bloodstream, resulting in death.
  • A feeding tube was connected to an in-line ventilator suction catheter, delivering feeding contents into the patient’s lungs, resulting in death.

These outcomes illustrate the importance of adopting solutions.

Improving Safety Through a Unified Global Standard

It’s been 10 years since the New York Times first brought this issue to light. Yet the risk continues in U.S. hospitals. A Sentinel Alert from the Joint Commission states “Tubing misconnections continue to cause severe patient injury and death.” 

The Times article spurred groups of experts around the world to come together to develop new ISO standards for tube connections to prevent errors. An enteral feeding device, ENFit (ISO 80369-3), is a direct result of this collaboration. 

The challenge now is to help hospitals around the world adopt the new ISO-compliant devices. European countries are doing quite well, with several countries approaching 100 percent conversion in only 20 months. The United Kingdom, France, Germany, Belgium, Ireland, Netherlands and Italy are leading the way.

Australia and New Zealand have also jumped aboard and are almost completely converted. Japan has completed its transition to NRFit, which meets the ISO standard for neuraxial connectors, and will complete the switch to ENFit by November 2021. China and Brazil plan to begin converting in 2021.

How did healthcare providers around the world make the transition to ENFit? They recognized that converting to the new, safer ISO-standard devices is the right thing to do for patient safety. One near miss, injury or death that results from a legacy connector is one too many. 

The results speak for themselves: There have been no reported adverse events as a result of misconnection in converted countries, even with the demands of the pandemic.

U.S. Hospitals Slow to Adopt

Meanwhile, only about 30 percent of American hospitals have adopted ENFit. On the positive side, U.S. leaders in patient-centric care are now using ENFit, including the Mayo Clinic, Sharp Memorial, Banner Healthcare and Kaiser Permanente. Nearly half of the top 25 hospitals in the U.S. have adopted ENFit.

But many more U.S. hospitals need to get started, recognizing that adoption of the standard complies with guidance from the Food and Drug Administration, the Joint Commission and the Centers for Medicare and Medicaid Services. Now is the time to start the conversion process. To promote patient safety, legacy enteral feeding products will no longer be manufactured as of July 1, 2021. 

The Global Enteral Device Suppliers Association (GEDSA), a nonprofit organizations, offers a comprehensive set of support tools that provide a starting point. We have guided many hospitals through the transition and have learned first-hand how to make a smooth transition.

First Step to a Safer Unified Standard

ENFit adoption is the first step for hospitals in a longer-term process of eliminating tubing misconnections by adopting a single global standard. The complete set of connectors is like an umbrella. While ENFit is the first panel, the umbrella won’t keep you dry until all the panels are in place. Patients won’t be completely protected until all the ISO 80369 connectors are in use. The next step, adoption of the NRFit device used for regional anesthesia connections, is already underway in some areas.

The demands of the COVID-19 pandemic have raised the stakes for patient safety. Adoption of the ISO-standard devices can be an important step in protecting patients.

Mike Cusack is Executive Director of the Global Enteral Device Supplier Association (GEDSA), a nonprofit organization that promotes patient safety worldwide through the adoption of the new ISO 80369 compliant small-bore medical connectors.

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