In 2013, the FDA released a rule that established a unique device identifier (UDI) system designed to identify and track medical devices through their distribution and use. Per the FDA rule, device labelers are required to provide a UDI on all device labels and packages in both a plain-text version and in a format that uses automatic identification and data capture (AIDC) technology. The UDI must also be marked directly on a device that is intended for more than one use and intended to be reprocessed before each use.
Since the aim of UDIs is to achieve standardization, the FDA rule also specifies that all UDIs must be created and issued under a system operated by an FDA-accredited issuing agency. The standards themselves (to which all UDIs must adhere) are maintained and overseen by the Global Unique Device Identification Database (GUDID), created by the FDA. The FDA rule stipulated that the UDI system would go into effect in stages over a period of seven years in order to ensure smooth implementation and to spread the cost and burden of implementation over time.
So, what does this mean for health delivery systems? First we need to understand the potential benefits of the UDI system as they pertain to hospitals. At the most fundamental level, the FDA is promoting UDI standards to improve overall patient safety. An industry white paper published by McKinsey estimated that in the U.S. alone, medical device product recalls occur 15 times per week and 20 times per week for pharmaceuticals. The same report attributed more than 100,000 deaths annually to adverse drug events. While standardization through UDI implementation will not necessarily address all safety issues related to device and drug manufacturing, it will provide vastly improved mechanisms by which to track devices, thereby enabling all stakeholders across the healthcare supply chain to more deftly manage product recalls, adverse event reporting, and counterfeit product identification.
A secondary though equally far-reaching benefit of UDI implementation is its impact on the overall improvement of healthcare supply chain management. As hospital supply chain infrastructures become increasingly sophisticated, the integration and communication of consistent data across disparate functions (inventory management, contract management, procurement, purchasing, etc.) and systems (MMIS, requisition platforms, content cleansing tools, etc.) become more imperative. This is especially true given the advances in data standardization capabilities in recent years afforded by classification systems, such as the United Nations Standard Products and Services Code (UNSPSC), which is commonly used to automatically tie Item Master data to general ledger account entries, and the Global Trade Item Number (GTIN), which is frequently used to associate trade items to individual purchase orders, packing slips, and invoices. Most healthcare information systems on the market today are capable of capturing and leveraging these advanced data points, and healthcare institutions are becoming increasingly reliant on the ability to share this data both across internal systems and with external business partners, such as suppliers and manufacturers. UDIs augment the ability of hospitals to leverage data strategically and achieve synergies with these business partners by providing a universal language for device identification. Moreover, UDI provides a crucial, seamless link between the aforementioned supply chain systems and the patient’s electronic health record (EHR), ultimately leading to more effective charge capture (down to the individual item level) and more efficient management of physician preference cards, a key component of perioperative process optimization.
With this in mind, there are three general strategies that hospitals should employ to make UDIs work.
Invest in IT Infrastructure, Especially EHRs
Given the complexities of capturing and integrating UDIs, it is essential that a hospital’s IT infrastructure be equipped to use and share this data across multiple platforms. Disparate systems that do not integrate with each other should be examined for possible interface builds. It is especially important to ensure that robust EHR systems are in place to associate UDIs with the individual patient record in accordance with the meaningful use guidelines set forth by the Centers for Medicare and Medicaid (CMS) EHR incentive programs as well as the FDA UDI mandates.
Keep Abreast of Regulation Timelines
UDIs are being phased in over a seven-year period set by the FDA. The implementation dates by which devices must bear a UDI are:
- September 24, 2014: labels and packages of Class III medical devices and devices licensed under the Public Health Service Act
- September 24, 2015: labels and packages of implantable, life-supporting, and life-sustaining devices
- September 24, 2016: labels and packages of Class II medical devices
- September 24, 2018: labels and packages of Class I medical devices and devices that have not been assigned a class
- September 24, 2020: Class I devices and devices that have not been classified into Class I, II, or III that are required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
Additionally, the CMS final ruling on EHR meaningful use includes the following specific language pertaining to UDI use:
“The documentation of UDIs in a patient medical record and the inclusion of that data field within the CCDS requirements for the summary of care documents is a key step toward improving the quality of care and ensuring patient safety.”
Understanding the provisions and timelines associated with both the FDA and CMS programs is essential, especially since the incentive structures under both programs may have important ramifications on hospitals’ reimbursement rates and overall profitability.
Leverage Relationships with Trade Partners
It is important to keep in mind that many different groups of stakeholders are affected by the UDI rollout. Therefore, hospitals should tap into their relationships with existing trade partners and business associates (suppliers, manufacturers, distributors, GPOs, technology providers, etc.) for insight and knowledge-sharing related to UDIs. Since sharing standardized information across multiple platforms is an inherent component of the UDI program, collaborative scoping and testing is also paramount to ensuring that all stakeholders are able to capture and leverage UDIs appropriately.
Consider one large urban academic medical center, which used a collaborative approach to UDI implementation. In order to ensure effective downstream data capture, the institution asked vendors to provide UDI information on certain classes of items during the upfront contracting phase. The UDI was then included in both the contract file and the Item Master upload file. This approach linked the UDI to both the vendor/manufacturer item number and the hospital’s specific MMIS number (this level of granularity is necessary because there may be a different UDI for each unit of measure that a vendor carries). Additionally, the institution invested in IT-related development by adapting end-user barcode scanners in order to be able to scan and use UDI information and enhance the clinical documentation system so that is could accept the UDI information, match it to a specific product, and appropriately document the specific item use. As the organization continues to expand, it plans to update all existing Item Master elements continuously in order to have the ability to accommodate UDIs (a manual process). The institution’s commitment to supply chain enhancement as it relates to UDIs offers a positive example of how hospitals can make UDIs work for the health of healthcare.