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UDIs Required by the FDA (Draft for 120-day Review) – It’s about time!

In Medical Device, Medical Device Report (MDR), recall, Unique Device Identifier, US FDA on July 5, 2012 at 4:50 am

Unique Device Identifiers (UDIs) are nothing new. MASH tents in the military use 2-D bar coding to track the use of instruments in mobile operating rooms in the field. Just image 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.

For this week’s entertainment, I picked something a little different.

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).

Unique Device Identifier

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

If you are trying to recall product, the last thing you want is to continue to send out letters three and four times to facilities that have no idea when or if your product was used. The medical facilities 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 individual 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 make sure and the complaint gets recorded in the complaint files. The proposed rule includes identification of the manufacturer. Therefore, 100% of 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?

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  1. […] UDIs Required by the FDA (Draft for 120-day Review) – It’s about time! (13485cert.wordpress.com) […]

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