We all wait in anticipation of “the rule.” John Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health for the FDA, joked at the beginning of the UDI conference in November that we’re only two weeks away from releasing the rule and have been for almost six months now. That became the running joke for the conference that often had the audience in hysterics.
Joking aside, it is going to be released and it will have a dramatic effect on medical device manufactures and healthcare providers. The benefits of UDI will be realized throughout the supply chain, benefits that are a mere concept right now in areas such as patient safety and supply chain efficiencies. Much like the Item Unique Identification (IUID) policy from the Department of Defense, the UDI rule from the FDA is based upon “license plate” encoding standards, technology standards, and data transmission standards. This is good for the industry.
However implementing these technology and data standards does not come naturally to medical device manufacturers and hospitals, nor is it straightforward for all of the distributors in between. Extra care is required in the early planning stages for anyone responsible for implementing UDI on behalf of the FDA rule. There won’t be much guidance or direction. The FDA expects industry to “figure it out.” This will require an extraordinary amount of sharing by way of working groups, standards organizations such as AIM North America andGS1, and conferences such as this most recent one.
After the running jokes from the conference died away, the concerned looks on the faces in the audience were very telling as to how seriously they were going to need to take Unique Device Identification (UDI) for many years to come.