UDI: Are Your ORs on Track?

In less than two weeks the FDA begins requiring all Class II medical devices that are required to have a UDI compliant label to bear a permanent marking on the device itself, if the device is intended to be used more than once and reprocessed. This is part of the seven-year, phased-in approach to UDI requirements by the FDA to establish a unique device identification system to adequately identify medical devices through their distribution and use.  Class III medical devices, kit and combination products and implantable, life sustaining devices are already required to be UDI-compliant.

This means that as of Sept. 24 “more than 60–75% of devices coming into the health care organization must be UDI-compliant,” according to Denise Maxwell-Downing, MS, RN, CNOR, Informatics Nurse and an AORN representative on the national working group for UDI implementation.

For perioperative leaders, Maxwell-Downing says this latest UDI deadline represents a test of their UDI processes and electronic documentation systems to ensure UDI-labeled products coming into the perioperative setting can be read, registered, and exchanged to ensure medical devices UDI data can be tracked correctly.

“With so many moving parts it takes teams working together,” she stresses. “If you had silos between OR and supply chain or OR and IT (information technology) before—UDI will be what breaks those walls down because it just can’t happen otherwise.”

UDI Compliance Checklist

Perioperative leaders can stay ahead of UDI implementation challenges with Maxwell-Downing’s five suggested keys to success:

1. Establish a UDI Policy For Manufacturers

   Because certain products such as implants may come to the OR directly from the manufacturer, rather than through supply chain, a smart perioperative leader will have a policy that outlines for the manufacturer the specific required steps they must take to be in compliance with the health care organizations’ UDI policy, register all UDI-labeled products with the facility, and work in partnership with the facility to ensure UDI-implementation and practices are in place. This will enable the OR clinicians to capture UDI data accurately and at the point-of-use.



2. Standardize Device Class Category

   Device classification is a major area of confusion as facilities work to ensure medical products are categorized by Class in a correct and standardized way. For example, supply chain may define a medical product Class in their electronic inventory management system as a Class III, but an OR electronic item master file may have the same medical product categorized as a Class II, which will create confusion when tracking UDI.

   To avoid this, Maxwell-Downing suggests health care organizations agree on assigning the same Class of a medical product in all systems and that this Class be in accordance with the FDA, according to the Global UDI Database (GUDID) the FDA has established to support UDI implementation. She also suggests that periop leaders keep an eye on the GUDID website for updates.



3. Educate Your Physicians and Staff on UDI

   Eventually UDI will be a seamless aspect of tracking medical products, but today UDI is still new and still confusing, Maxwell-Downing cautions. “Don’t underestimate the value of regular education on the ways UDI impacts both physicians and staff.” For example, physicians will interact with UDI through coordination of care and use of implants and OR staff must easily identify the UDI at the point of use to correctly scan it into their electronic patient record.



4. Communicate UDI Benefits

   Prior to the UDI rule, medical product safety information, device identification information and other use data were not available in a standardized way. UDI provides this information in a way that patients and providers are beginning to be able to access to review a product for safety and sterilization data. UDI will also help perioperative departments to understand and better control inventory for more efficient, safety recall management and cost control, Maxwell-Downing says.



5. Know What’s Coming

   Currently, there is no regulatory requirement that a health care organization has to capture UDI information at the point-of-use, but Maxwell-Downing and many others believe it is coming.

   “The hook for hospitals lies in Meaningful Use,” she explains, “the effort led by CMS and the Office of Health Information Technology to support the concept and use of certified EHR technology by providers.” Under the program, the Office of National Coordinator (ONC) issues technology and interoperability standards for EHR systems, and CMS grants incentive payments to providers who make meaningful use of those certified EHR technologies. In 2015, the ONC required certified EHRs to be able to capture UDI data and integrate with the GUDID.

The original requirements for Meaningful Use Stage 3 included capture of UDI data and CMS is updating their claims form in 2020, which will likely include UDI data, she says. “If this occurs, it will be a necessity to document UDI because these data will have to be used for reimbursement and other secondary uses, such as registries and patient safety.”

FREE RESOURCES FOR MEMBERS

Webinars

Unique Device Identifiers (UDIs): Roadmap to Implementation