Interpower can now put serial numbers on medical cords per a company’s specific request. While medical cords are not classified as a medical device, companies may choose to identify their cords as a part of the UDI (Unique Device Identification) System, a new process being mandated by the FDA (Food and Drug Administration).
Increasing concerns about product recalls, counterfeit devices, and patient safety has led the FDA to start an UDI System in regards to most medical devices. The UDI is a unique numeric or alphanumeric code which includes a uniform list of product identifiers. Currently identification methods are fragmented and it’s sometimes difficult to trace the original product back to the manufacturer.
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.
Three steps to be in compliance:
- Create and assign the UDI.
- Choose the right labeling software to label the products with the UDI.
- Submit and store the UDI in the GUDID.