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The UDI: FDA Requirement

The UDI is an FDA requirement. The author reviews how the UDI will enable faster and more accurate product recalls and medical device reporting.

Unique Device Identifiers (UDIs) are nothing new. MASH tents in the military use 2-D barcoding to track the use of instruments in mobile operating rooms in the field. Just imagine how hard it is to count forceps and vascular clamps during a wave of shelling from a nearby front. That’s just one way UDI’s can be used to benefit patients and healthcare providers. Click here for the proposed rule. I am positive that some companies, and their lobbyists, will fight the latest regulations from the FDA regarding labeling requirements. However, this makes even more sense than electronic medical records. UDIs will enable faster and more accurate product recalls and MDRs. Click here for more information (I have copied the example provided by the FDA).

%name The UDI: FDA Requirement

This is the unique device identifier example provided by the US FDA.

If you are trying to recall a product, the last thing you want is to continue to send out letters three and four times to medical facilities that have no idea when or if your product was used. They want to close out these requests for information quickly too. UDIs present a solution for assuring correct and complete responses by hospitals the first time.

How UDI Helps with Recalls
  • Locating devices in inventory
  • Locating product in distribution centers
  • Identifying product after it is removed from the outer box
  • Tracking product to each patient
How UDI Helps with MDRs

If you’ve been in the business long enough, you have seen more than one complaint about a product that you don’t even make. When this happens, the company is obligated to open an investigation to ensure the complaint gets recorded in the complaint files. The proposed rule includes the identification of the manufacturer. Therefore, 100% of the complaints should go to the correct company. Also, the company should always receive a lot number—something that almost never occurs. What do you think about UDIs? Has your company already taken steps to implement UDIs?

Posted in: FDA

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