Incorporating Unique Device Identification Into Your Hospital

摘要

Has your hospital's clinical engineering department ever evaluated a medical device for which the manufacturer could not be identified? If the packaging was not available, how would you know whom to contact based on the one identifier you could find on the device, for example, the serial number?To improve postmarket surveillance, as well as device tracking and data integration into patient health records, the US Food and Drug Administration (FDA) issued a final rule for establishing a Unique Device Identification (UDI) system on September 24, 2013.1 A UDI is an alphanumeric number that is unique to a specific medical device.