Medical-device manufacturers say it makes no sense to mark their products with unique identification numbers since hospitals and other healthcare providers are not required to use the system.
But that's no longer true, at least for some devices. The Food and Drug Administration last month began requiring that reports on adverse events that led to a patient death and involved high-risk medical devices (such as implants whose malfunction could be life-threatening) must include the unique device identifier, or UDI, if the safety failure occurs at specified facilities such as hospitals, ambulatory surgery centers or nursing homes. Those medical facilities are required by law to report cases of patient deaths related to a device to the FDA and now are required to report the UDI, as well. Manufacturers also must notify the FDA.
“This is the one piece where they impact providers,” said Karen Conway, executive director of industry relations for GHX, a trading exchange that seeks to reduce costs for medical and surgical suppliers and hospitals.