System Safety in Healthcare

Unique Device Identification (UDI): A New Government Initiative to Improve Patient Safety

Abstract

Unique Device Identification (UDI) is a recent development to protect patients from hazards in medical devices. The UDI relates to adverse event reporting, identifying and analyzing devices in use. Currently, hospitals are unable to report many adverse events because the device identification has to be manually located — and often, they are not easily readable, or the person reporting makes an error in reading or documenting the identification information. If a cardiac monitor malfunctions, it’s critical for the information in the adverse event report to match the manufacturer’s product identification system; otherwise, the adverse event may go unreported to U.S. Food and Drug Administration (FDA), and the device may not be recalled as soon as it should. The same urgency holds for a product recall sent from a manufacturer to the doctor, hospital or patient. An inability to identify the device affected by the recall could have potentially disastrous results for patients. In addition, if the device is for personal use, the user may not have access to information about the hazards other users of the device have experienced. With this new system, a user can easily search for hazards.