Good Data Key to UDI Labeling Implementation
by Laura Johnson, on November 7, 2017
Manufacturers of medical devices have to deal with rules and regulations unique to their sector, and with good reason: If anything goes wrong, their products must be quickly and accurately traceable to prevent further harm. With deadlines passing for the successful implementation of Universal Device Identification (UDI) labels, the legal requirements of the industry have come into focus again. It's time for manufacturers to step up and comply without missing a beat.
Keeping Accurate Data
GS1 U.S. Vice President of Healthcare Greg Bylo recently used a Healthcare Packaging column to call for device manufacturers to manage the quality of data in their systems. Keeping clean information and ensuring these facts make it onto packages without any errors or inconsistencies will be critical to the overall success of the UDI program.
Bylo noted there have been some errors in data entry thus far, with Class II and Class III devices already required to be logged in the UDI system. With the final device type, Class I, due to enter the system by September 24, 2020, it's important to clear up these mistakes now. Companies need to employ strong governance practices and train employees to ensure they're generating and storing good records.
Earlier this year, Packaging Digest named data management one of the five main issues that medical device companies have to keep up with. Ensuring the solutions involved are up to the task is important, as off-the-shelf database software may have sufficed in years past, but not be capable of keeping up with compliance.
Labeling That Matches Databases
Medical device labeling software is a critical element of a compliant and effective UDI program, as manufacturers have to ensure their consistent and shared databases have accurate representation on the physical devices they create. Effective UDI label software takes its data directly from central business applications, without adding another potential source of confusion or inconsistency.
For more on Medical Device Labeilng check out our Q&A report on the topic.