Condition of UDI Compliance? Fair…for Now
by Craig Hodgson, on July 5, 2016
The results are in. Working closely with our partner USDM Life Sciences, a leading global professional services firm focused on working with Life Science and Healthcare organizations, we recently polled about 200 Medical Device Industry professionals to see where their companies stand with Unique Device Identifier (UDI) compliance and their overall UDI readiness. We also wanted to gain insight into the UDI label software they’re using to help meet U.S. Food and Drug Administration (FDA) requirements.
Just a quick refresher: the FDA created the Unique Device Identification system in 2012 in response to growing calls for the development of a standardized medical device identification system. The UDI system will provide a number of benefits to the health care delivery system, including more precise tracking and tracing of medical devices, faster response to product recalls, and overall improved patient outcomes.
UDI labeling regulations are being phased in through 2020 in a concerted effort to provide a comprehensive methodology for medical practitioners, caregivers, and patients to identify and track and monitor the safety and efficacy of medical devices. When fully implemented, most devices will include a UDI—which will be both human readable and encoded in a barcode typically. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID).
At the time of this survey, medical device manufacturers were gearing up for the next deadline of September 24, 2016, when the labels and packages of Class II devices must bear UDI barcode labels with correctly formatted dates on the labels, and data for Class II devices must be submitted to the GUDID. Also, Class II standalone software must include its UDI as required by the mandate. In addition, Class III devices that are intended for reuse must bear a UDI as a permanent marking on the device itself.
So, what did we learn? While a great majority of respondents indicate they will be UDI compliant in time for the impending deadline, there are clearly some underlying, longer term challenges associated with the regulation. From uncertainty in meeting international UDI requirements to an alarming lack of internal auditing processes, there are enough red flags to conclude that a large percentage of companies still have a lot of work in front of them.
We invite you to take a look at the full results of the survey in the report "Taking the Pulse of UDI Compliance" and see how you compare with other professionals in the Medical Device Industry. At the end of the report, you’ll learn about a new approach to UDI barcode software, including a way to dramatically reduce the time and cost of implementing a validated, sustainable Enterprise Labeling Solution—one that will help you meet your long-term UDI requirements. Check it out.