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  5. UDI Required On Most Medical Devices

Unique Device Identification System Being Required On Most Medical Devices

Increasing concerns about product recalls, counterfeit devices, and patient safety has led the FDA (Food and Drug Administration) to start the process of developing a UDI (Unique Device Identification) System in regards to most medical devices. Currently identification methods are fragmented and it’s sometimes difficult to trace the original product back to the manufacturer.

The UDI is a unique numeric or alphanumeric code which includes a uniform list of product identifiers. As part of the UDI system, the FDA has created a GUDID (Global Unique Device Identification Database). This will have a standard set of basic identifying elements. According to the FDA website, “Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information.”

The FDA’s Unique Device Identification System Final Rule was issued in September 2013. As with many new laws, there are several different compliance dates, depending on the type of medical device—whether it’s a Class III, II or I. For a complete list of compliance dates, check out the FDA website.

Basically there are three steps to take to be in compliance:

  1. Create and assign the UDI.
  2. Choose the right labeling software to label the products with the UDI.
  3. Submit and store the UDI in the GUDID.

For a more detailed explanation, see the Medical Design Technology website. Another source for information is the e-book, “Unique Device Identification for Medical Device Manufacturers – Guide to Label and Marking Compliance” by ID Technology.

While medical cords are not classified as a medical device by the FDA, at Interpower we can provide serial numbers on medical cords per your specific requirements. For more information, contact Customer Service at (800) 662-2290 between 7 a.m.–6 p.m. Central Time or e-mail info@interpower.com.

Sources:
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
CompliancedatesforUDIRequirements/default.htm

www.mdtmag.com/articles/2014/05/unique-device-identification-three-steps-compliance

www.labelingnews.com/downloads/UDI_eBook.pdf