A new rule proposed by the U.S. Food and Drug Administration (FDA) would require most medical devices in the country to include a unique device identifier (UDI). This is a unique code system assigned to medical devices that, according to the FDA, would allow the agency to track problems with devices and develop more effective regulations to protect patient safety. Congress passed legislation, the Food and Drug Administration Amendments Act of 2007, that requires the FDA to promulgate regulations to implement a nationwide UDI system. The proposed rule will be open to public comment until November 7, 2012.
The FDA describes a UDI as a “unique numeric or alphanumeric code” assigned to a device. The UDI includes identifiers for the specific device and the device model, as well as production information including the serial number, the lot or batch number, and, if applicable, the device’s expiration date. The FDA is reportedly developing a database of “basic identifying elements” in UDIs that the public can access and review. A device’s UDI, the FDA says, will not include any personal identifying information about the person using the device.
The proposed rule, published in the Federal Register on July 10, 2012, would require all medical devices distributed within the United States to include UDIs, both on the device and on the device packaging, with limited exceptions. UDIs would have to be printed in plain text and in a version using automatic identification and data capture (AIDC) technology. AIDC includes most machine-readable formats, such as barcodes, magnetic strips, Optical Character Recognition (OCR), and Radio Frequency Identification (RFID). Devices must display the UDI in a manner that would allow it to remain readable for the entire time it is in use.
Under the FDA’s proposal, the devices deemed to have the highest risk to patients would be the first to implement the UDI system. This phased-in approach would gradually add lower-risk devices. The FDA says that it has worked closely with the medical device industry in developing the proposed rule. Devices that would be exempted from the rule include over-the-counter medical devices and devices deemed “low risk” by the FDA.
The greatest benefit of the UDI system, particularly for patient health and safety, is the ability it affords doctors, the FDA, and device manufacturers to quickly obtain and analyze data on adverse events. Doctors could have easier access to device data to help in diagnosing complications or other problems. Manufacturers and the FDA could more easily determine problems with the overall design of a device or defects in a particular batch, and could therefore more effectively coordinate recalls of products. Doctors and other medical professionals would have a uniform system for entering information about devices in patients’ health records. The UDI system could also aid patients injured by a faulty or defective device in identifying the source of the defect and asserting a claim for damages.
At Lebowitz & Mzhen, we help people in the Washington, DC area, who have suffered injuries due to faulty or defective medical devices, to recover their just compensation. For a free and confidential consultation, contact us today online, or call our attorneys at (800) 654-1949.
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