The FDA’s UDI rule for Medical Labelling
In the interest of patient safety and given the nature of medical devices, they are subject to many regulations; the U.S. Food and Drug Administration (FDA) have developed new regulatory demands for medical device manufacturers to adhere to when producing devices that are to be used in the United States.
The Unique Device Identifier (UDI) is a universal and worldwide system that allows for the quick identification of medical devices. Under the UDI system the labels on medical devices will include a human- and machine-readable unique device identifier. Information on the medical device must also then be submitted to the FDA’s Global Unique Device Identifier Database (GUDID), where the public will be able to search and download the information.
As of 24th September 2014, UDI regulation compliance is require for Class III devices, with Class II and Class I devices following over the coming years.
Every year over a five year period the FDA have received nearly half a million adverse event reports. Annually, more than 280,000 of the reports noted injury to the patient, with nearly 18,000 reporting the outcome was death.
Through the implementation of UDI, the information in the adverse event reports can be quickly matched to the manufacturer’s product identification system, allowing the adverse event to be reported. The UDI system works in the other direction as well, when it comes to product recall manufacturer’s just need to inform hospitals, doctors or patients of the affected devices, which can then be quickly identified and recalled.
Other benefits of the system include the reduction of medical errors through medical healthcare professionals being able to rapidly and accurately identify a device, obtaining important information pertaining to the characterisation of the device. UDI also provides a foundation of a global, secure distribution chain, helping to address counterfeiting and diversion.
Compliance can be complicated, but the cost of non-compliance can be severe. For manufacturers in the medical industry it is important to be fully aware of these regulations, and what needs to be implemented to reach conformity.
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