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Article

ISO 80369: A New Standard to Avoid Medical Device Misconnections

Healthcare Market

In a hospital environment, patients often have multiple medical devices and lines connected to them to receive medicine and nutrients. Numerous devices and systems use universal connectors to deliver medicine, food and fluids to the patient.

A medical device misconnection is often defined as “a connection between devices that is not intended to connect, unintentionally delivering medication, oxygen or fluid to the wrong place.” To mitigate this problem, the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO) and the medical device industry have taken actions to reduce the likelihood of misconnections by creating a new industry standard: ISO 80369.


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