Unique Device Identification: The supply chain and beyond

The FDA’s proposed UDI system is a hot topic in healthcare because of its potential to provide more accurate adverse event reporting, better recall management and improved accuracy and visibility into products used in patient care. But unique device identification goes beyond suppliers enumerating and labeling products. Trading partners must find ways to effectively use these data standards within their internal systems and in their interactions with one another.

Since today’s healthcare supply chain is largely linear, with trading partners operating independently from one another using disparate systems, data sharing is a major challenge to the UDI vision. To address this issue, the FDA held a UDI for Postmarket Surveillance and Compliance Public Workshop, September 12-13, 2011 in Bethesda, MD, where multiple healthcare stakeholders came together to address how they will put UDI into practice using various health-related data systems.

Rosalind Parkinson

Parkinson, who is also a GHX Global Data Standards User Group Leadership Team Member, participated in a panel discussion at the workshop on the integration of UDI into hospital systems. She shared her insights on the workshop during the September GHX Global Data Standards User Group meeting.

"Jay Crowley from the FDA assembled a great group of people who spoke to various aspects of the upcoming UDI implementation," said Parkinson. "There were six different groups speaking on six different issues during the two-day period. So many of us tend to focus on what the UDI means to our individual functions within our organizations. It was great to have this opportunity to hear so many different perspectives on the cross-functional impact of UDI within healthcare organizations and how it will impact our interactions with suppliers, other business partners and government agencies."

Parkinson’s presentation focused on how the FDA’s UDI system will make it easier for hospitals to comply with the Centers for Medicare & Medicaid Services (CMS) mandate around medical device replacement credits. Under the mandate, the provider must report to CMS when it receives manufacturer credit (50 percent or more of the device cost) for an implantable device that must be replaced because of malfunction, recall or another product quality issue. CMS, in turn, reduces the amount that it pays to the hospital for the replacement of the device to offset the manufacturer credit.

Currently, a lack of interconnectivity among internal business systems, written logs for operating room device tracking and the use of different product identifiers by different departments (clinical, billing, purchasing and accounts payable) make it challenging and time consuming for providers to identify credited devices and gather the necessary information to meet the CMS mandate using internal data. As a result, many providers rely on their suppliers to provide information on CMS patients, dates of service and treating physicians for credited implants. This adds time, labor and complexity to the process.

Looking to the future, Ohio State University Medical Center is implementing a new process through which it will leverage UDIs and integrated technology to identify credited devices and comply with the CMS mandate. Ohio State will soon adopt an electronic medical record (EMR) that will be integrated with its business systems, providing visibility throughout the clinical-purchasing process. When UDI is available, it will be used in all clinical and business systems as the common descriptor for all implants, enabling Ohio State to pursue device credits using its own internal data.

"Today, the disconnect between hospital supply chain, billing and clinical systems and the lack of standardized product identification impedes implant tracking," said Parkinson. "Hospitals are often the passive recipients of vendor data, which limits our ability to comply with CMS in a timely manner. The UDI will help facilitate and connect the clinical-purchasing process, enabling hospitals to actively pursue device credits and more readily comply with CMS credit management policies."

As the activity around the proposed UDI rule continues to grow, it is obvious that unique device identification has the potential to positively impact many different areas of the healthcare industry, from supply chain efficiency to patient safety and offer numerous benefits that we’ve not yet uncovered. Educating providers, suppliers and others on the value proposition of global data standards will help accelerate their adoption in the weeks, months and years to come.