For over 10 years now we have been hearing about Unique Device Identification (UDI), but like with all new guidelines it takes time for the rules to roll out. So we wanted to take some time and review what Unique Device Identification means to us as an industry. Over the coming
Both AAMI and AORN speak
Below are three key facts to know about UDI and what means to us?
- How and when did it start?
Going way back, in 2004 the FDA released the Pharmaceutical Barcode Rule, to specifically address medication errors, just one segment of preventable medical errors. In 2007, the FDA was directed to address other types of medical errors and they were tasked to create a UDI for medical devices. Fast forward to the final rule and compliance dates for Unique Device Identification requirements in September 2013. You can review the breakdown and specific dates and device classifications by clicking here. The compliance roll out was 1 year (Class III), 3 years (Class II), and 5 years (Class I).
- What does it mean?
There are several items of interest, the first of which is pretty straight forward. The roll-out of the final rule started with devices that
- What else is new?
The FDA has since spent significant time and efforts defining terms included in the register. Some of these terms include reprocessing and convenience kits. In terms of reprocessing, terminal sterilization is considered a form of reprocessing. In terms of convenience kits, the reference is to those kits that are manufactured and distributed sterile. Much of this discussion is not yet definitive. For more information, visit the FDA’s website (www.fda.gov) to review the Draft Guidance Document issued on June 26, 2015.