Overcoming Barriers of Adopting ISO 80369


The high stress of an emergency room or ICU creates an environment where the probability of human error spikes dramatically, adding a layer of risk to an already-tense situation. Asking medical professionals to make rapid diagnoses and decisions in that stress-filled state can lead to device misconnection. To that end, ISO 80369 was written to improve patient safety and reduce the risk of small-bore misconnections used in liquid and gas healthcare applications such as enteral, neuraxial and intravascular/hypodermic, among others.

In this case study, you’ll learn how McLaren Health Care in Grand Blanc, MI successfully implemented ENFitTM, the ISO 80369-3 compliant enteral connectors, with minimal disruption in their supply chain. They executed their strategy in phases:

  • Phase 1 — changing over tube feeding sets
  • Phase 2 — medically administered implements — this phase was delayed due to the FDA approval process, but McLaren began including communication about the changeover in meeting agendas to prep the facilities for the coming shift
  • Phase 3 — implanted and non-implanted tubes

In this study, find out McLaren’s:

  • Barriers to adopting ISO 80369-3
  • Application and proposed solutions
  • Assessment and recommendations