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 months we will continue to provide insight about UDI but this post is just to get us started.

Both AAMI and AORN speak to the topic of patient traceability. AAMI ST 79, 10.3.1 indicates “Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted; such traceability can be accomplished by recording the sterilizer load identifier…” Again in the rationale section of 10.3.2 (referring to sterilizer records) it states “Digitization of this process will allow quick access to load information, facilitating a quick response.” (See also AORN RPs XX,d.4 and XX,e.)

Below are three key facts to know about UDI and what means to us?

  1. 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).

  1. 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 are implants, Class III medical devices, having the most direct impact to patient safety. These are medical devices that are implantable, are life-supporting, or life-sustaining devices. The first calendar deadline then, was September 24, 2014, one year after the final rule.The following two classes of medical devices aren’t so clear and to the point. This is what we know according to our world of Sterile Processing. Most of our surgical instruments used in the Operating Rooms and Clinics are classified as Class I medical devices. The roll out date for Class I medical devices initially corresponded to the 5 year period referred to earlier (September 24, 2018) however more recent publications have extended the time period from 5 to 7 years (September 24, 2020). The guidance we are provided with for surgical instruments comes from the FDA Code of Federal Regulations CFR21, 801.45.

  1. 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.

David Craig, CRCST, CIS, CHL, CCSVP, CFER