At the end of April, medical device regulatory professionals, FDA representatives, technology providers and other industry members met together in Baltimore to discuss all things related to Unique Device Identification at the annual UDI Conference. If there was one overarching theme to the conference presentations and conversations overheard in the exhibit hall, at the lunch table and hotel bar, it was the importance of data quality.
Downstream Users are Multiplying and the Stakes are Getting Higher
Nearly four years after the first UDI data submission deadline in 2014, industry members have more and more stories to share of downstream data use throughout the healthcare supply chain. Manufacturers, healthcare providers, clinicians, payers, researchers and even patients themselves are leveraging the value of UDI data downstream to improve their processes and track outcomes.
UDI is making its way into Electronic Health Records (EHRs), Adverse Event Reports (AERs), recalls, insurance claims, virtual product catalogs, inventory management and supply chain systems, smartphone apps for patients, and more. In short, the healthcare chain is beginning to realize the benefits of the UDI initiative promised from the beginning.
You can read more about the UDI adoption efforts underway across the industry in the Learning UDI Community webpages from AHRMM .
As more and more users look to realize the benefits of UDI downstream, one thing has become blatantly evident—all of these programs and improvements are only as good as the data in the individual UDI records.
Data Value vs. Data Compliance
FDA representatives and industry thought leaders urged conference attendees with UDI reporting responsibilities to look beyond the bare minimum requirements of compliance and focus on providing valuable, complete data. An example given during a session on compliant versus valuable data was the device description field within a GUDID record. While a record can still be accepted if this field is left blank, its value to downstream users is severely diminished. One presenter reported that currently, just 50% of GUDID records contain a unique free text description and 27% contain a more generic description repeated across multiple device records, while the remaining 23% contain no description at all.
Access to complete, accurate information is vital to improving the processes and systems mentioned above, some of which directly impact patient well-being. In the words of John Terwilliger of Abbott, “UDI is the foundation of post-market surveillance and recalls.” As individuals who will all someday be patients, children of aging parents, friends and family members of patients suffering from various ailments, we should all be deeply and personally invested in this data quality initiative.
As you have probably realized by now, UDI is not a one-time effort you can simply check off your list after entering data into the GUDID. UDI is the new world in which device industry members, providers, payers and patients live, and it will always require ongoing education and effort to stay up-to-date. If you’re overwhelmed with how to start, or continue, your UDI journey, contact the UDI experts at Reed Tech. We’ll be happy to help.
This is Part One of a two-part blog on the 2018 UDI Conference. Read Part Two here.