Introduction
The high stress of an emergency room or ICU creates an environment in which 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, creating a high-harm state as deemed by the FDA. To prevent that risk, the FDA identified the responsible and necessary step of mistake-proofing small-bore medical device connections to improve patient safety. To that end, ISO 80369 was written to better define this process for applications ranging from enteral to neuraxial to intravascular/ hypodermic, among others. The standard defines connector geometry and design changes, potential improvements and validation methods to ensure the risk of misconnection of small-bore medical devices is minimized, if not eliminated entirely.
While both the need for and benefits of the new standard are clear in principle, the industry has seen an unexpected challenge: the U.S. has been slow to adopt the standard in practice, due to lack of training,improperly specified geometries, poor supply chain, decreased scale economies of (now) different connector geometry, and/or hospitals resisting change. Manufacturers and government agencies have defined and validated solutions for the typical justifications that facilities (reluctant to adopt ISO 80369) cite: supply chain and availability, performance,and safety/cleanliness.
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