On February 23, 2023, the FDA updated the medical device misconnection information and announced some cases of medical device misconnection. It also evaluates the potential hazard level of each case, and provides safety tips and suggestions to reduce the wrong connection of equipment.
Medical Device Connectors: Connectors are device components that connect catheters and syringes to other medical devices.
Medical Device Misconnections: Medical device misconnections can occur when one type of medical device is incorrectly connected to another type of medical device that performs a different function.
In the general ward of a hospital, several different types of medical equipment may be used on a single patient at the same time; in special environments such as the intensive care unit (ICU) or emergency room, patients may need dozens of different devices at the same time. use and may be compatible with different medical devices, so users may mistakenly connect unrelated systems to each other. This could lead to drugs or other substances being delivered through the wrong catheter to the wrong area of the body, causing injury or death to the patient.
To reduce the risks associated with incorrect connections of medical devices, the FDA has recognized certain standards for medical device connector design designed to enhance device safety: the ISO 80369 series of standards, and incorporated into product-specific standards. Many medical device connectors in the United States follow the ISO 80369 standard.
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