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Case Study: Overcoming Barriers of Adopting ISO 80369

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.



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Qosina

http://www.qosina.com
E: [email protected]
T: (631) 242-3000
F: (631) 242-3230

Address
2002-Q Orville Drive North, Ronkonkoma, NY, 11779, United States
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