Have you heard of UDI? It stands for unique device identifiers; more specifically, it refers to the U.S. Food and Drug Administration’s Unique Device Identification Rule. If you are a busy healthcare executive, it is not surprising if you haven’t, but you should – for multiple reasons. UDI will likely become part of the growing regulatory lexicon for providers, and it can also play an important role in helping achieve the objectives of healthcare reform.
We all remember the “To Err is Human” report. The landmark 1999 Institute of Medicine study found that as many as 98,000 people die in U.S. hospitals each year as the result of preventable errors.1 Many studies indicate that number may have more than doubled in the years since.2 Many of those errors were medication related – wrong medicine, wrong dosage, wrong patient – leading the FDA Center for Drug Evaluation and Research to work toward creation of a rule requiring prescription drugs and over-the-counter medicine dispensed in hospitals to carry a barcode containing the drug’s National Drug Code (NDC) number. At the same time, the side of the FDA that regulates medical devices, the Center for Devices and Radiological Health (CDRH), wanted to do the same thing, only to find there was not a code analogous to the NDC in wide use for most medical devices. That set the wheels in motion for the UDI rule.
In 2007, the FDA Amendment Act called for creation of “a unique device identification system for medical devices, requiring the label of devices to bear a unique identifier … [to] adequately identify the device through distribution and use, and may include information on the lot or serial number.” It took the FDA another five years to publish the final rule, in large part because the agency wanted to make sure the use of UDI would have faster uptake in hospitals than its pharmaceutical counterpart. In other words, if hospitals and healthcare providers do not use the UDIs, all the rule will have done is add cost and regulatory burden to healthcare manufacturers, which eventually everyone pays for – if not in cost, then certainly in patient safety.
UDI and patient safety
During the time the FDA was working on the UDI rule, there were a number of notable recalls of medical devices due to problems the agency believes it could have identified sooner if UDI had been in place. The UDI is central to the FDA’s plan for “Strengthening our National System for Post-Market Surveillance,” which envisions capturing UDIs for implantable devices in a patient’s electronic healthcare record (EHR) and eventually in product registries.3 Other regions of the world, including Canada, the European Union, South Africa, and China, are also seeking their own UDI regulations for similar purposes. Thanks to efforts of the International Medical Device Regulatory Forum, those regulations could be globally harmonized, which would mean data captured about usage of a medical device in a registry in one part of the world would be relatable to data about the same product on the other side of the globe. If this vision can be realized, clinical researchers and providers will have access to much more robust data on the real-world performance of medical devices.
UDI regulatory requirements
The UDI Rule as it currently stands primarily impacts medical device manufacturers that sell their products in the United States, although there is one current requirement for healthcare providers and others on the horizon. Briefly, the rule requires medical device manufacturers to assign a UDI-compliant code to each of its covered products, to label those products with the code in both human and machine-readable (e.g., barcode, RFID) formats, and to publish additional data on those devices to the FDA’s Global UDI Database. The deadline for Class III devices to be in compliance was last September, with the second batch of products (those deemed implantable, life saving, and life sustaining) required to comply by September and with the database component by Oct. 24. That means all implantable devices, regardless of class, should bear UDIs this year. The compliance deadline for the balance of Class II devices is Sept. 24, 2016, and two years later for all non-exempt Class I devices.
When the FDA published the final rule, the agency also announced it was going to make amendments to some existing regulations to conform with the new rule in order to create a more holistic approach to integrating medical device information throughout the entire healthcare system. In other words, UDI will be fundamental to everything CDRH does around medical devices going forward. That includes how it receives information about adverse events. One of the conforming amendments changed Part 803.32 in the Electronic Code of Federal Regulations, requiring hospitals and other sites the FDA deems user facilities to include the UDI when reporting adverse events involving serious injury or death.
Earlier this year, the Centers for Medicare and Medicaid Services (CMS) issued a proposal that would require providers to exchange UDIs for implantable devices as part of the proposed Common Clinical Data Set (CCDS) in EHRs to meet Meaningful Use Stage 3 (MU3), while the Office of the National Coordinator for Health IT (ONC) would expand the criteria that EHR technology must meet to be certified for MU3, including the ability to:
- Create a list of a patient’s implantable devices in the EHR;
- Parse the device identifier and production data, (e.g., lot, serial number, expiry date) from the UDI;
- Link to the Global UDI Database (GUDID) to retrieve additional device information; and
- Add the UDI to the CCDS to enable the list of implanted devices to be exchanged as part of a patient’s core medical history.
CMS and ONC are expected to issue their final rule based on comments received on the proposals by the end of the year. While support among hospitals is mixed, supporters believe UDIs in EHRs can help answer critical questions such as:
- Is an implanted device compatible with MRIs?
- Which patients must be notified in the event of a recall?
- How well is the device performing?
- Does the surgeon know, prior to revision surgery, which device needs to be explanted?
As you might imagine, many of the EHR vendors (with the notable exception of athenahealth), commented that they thought the proposals were premature, with some suggesting that, if anything, UDI capture should be handled as free text. Surprisingly, given that the UDI rule specifically requires manufacturers label devices in a manner that the UDIs can be captured using auto-identification and capture (AIDC) technology, there was no mention of AIDC requirements in the 2015 proposal. Prior proposals and the FDA post-market surveillance plan both highlight the importance of deploying such technology, which can avoid manual entry errors when capturing UDIs and other information.
Others requested more information, such as how to define an implantable device or document implantable devices in the consolidated clinical document architecture (CCDA) guidelines. These types of questions raise some of the technology challenges that need to be overcome to achieve the full potential of UDI. One of the comments questioned the necessity of UDI in the first place, noting that it will require significant investment from a software perspective with little return. These comments mirror some of the original concerns stated by manufacturers who questioned, if they go to the expense of implementing UDI – which can easily be in the tens of millions of dollars, even for a mid-size supplier – will their customers use the data?
There are a few pioneering provider organizations that have started on the journey to UDI adoption and implementation, even without government regulation. One of the first was St. Louis-based Mercy, which conducted a UDI demonstration project in the cath lab under the FDA’s Medical Device Epidemiology Network (MDEpiNet). The primary purpose was to create a database that would match patient information from clinical records with UDI-associated data attributes for coronary stents implanted in those patients, although a secondary objective was to identify obstacles in the process. One of the technology lessons learned was that the hemodynamic software deployed in the cath lab could not receive barcode product information from the point-of-use system, requiring double scanning by clinical staff until a functioning interface could be developed.
Figure 1 depicts where Mercy uncovered integration challenges in capturing and sharing UDI-like data.
Initial discussions with the technology vendors uncovered a perception that developing closed architecture systems is a competitive advantage. That relatively prevalent opinion among many vendors is starting to change, especially in light of heightened Congressional interest in the interoperability of EHRs. Other issues included the inability of some software to hold the full UDI, which includes both the device identifier and production data, such as serial number and expiration date, and the need to crosswalk between various product identifier formats, as well as standards used for facilities and locations.
While there were challenges, there were also recognized benefits in a variety of areas, including:
- More accurate and automated charge capture,
- Improved inventory management,
- Reduced supply chain inefficiencies,
- Reduced days payable outstanding,
- Visibility to real-time product usage and automated replenishment, and
- More effective adverse event reporting and comparative effectiveness research.
Mercy has quantified the value of many of these improvements. For example, one of the cath labs discovered it had $1.9 million in physical inventory, compared to an estimated $800,000 listed on the books. Within just six months, it had already cut that number by nearly 20 percent. In another case, the effort uncovered $300,000 in expired inventory for a single vendor, prompting negotiations to create a shared savings program around reducing product wastage.
On the other hand, other benefits are hard to quantify. By being able to link specific implant data with patients, Mercy cannot only save time responding to recalls but it can also reassure patients like one who commented, “I feel exposed and anxious that if there is a recall I won’t know if I have that cardiac device.“ As the MasterCard commercials say, some things you can quantify, while others are “priceless.”
- Institute of Medicine: “To Err is Human: Building a safer health system,” September 1999.
- Journal of Patient Safety: “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care,” September 2013.
- FDA: “Strengthening our National System for Postmarket Surveillance,” April 2013.