WHITE PAPER UDI: It s Not About (Just) the Barcode

Transcription

1 WHITE PAPER UDI: It s Not About (Just) the Barcode Making the Highest Use of Unique Device Identification Today to Improve Patient Safety and Reduce Waste in the Supply Chain

2 SUMMARY Most medical devices today lack a common product identification code, a leading cause of waste and inefficiency in the healthcare supply chain and harm to patients. Devices expire in storerooms, unused and sometimes even unknown. Patients are implanted with devices long since recalled by manufacturers, with potentially catastrophic results. Knowing little about usage patterns, providers, payers and regulators cannot fully evaluate the comparative effectiveness of medical devices, one of the key goals of health reform. The U.S. Food and Drug Administration recently fulfilled a mandate of 2007 federal legislation by creating a system of Unique Device Identification (UDI). The program began Sept. 24, 2014, but won t take full effect until Some suppliers have voluntarily acted to adopt UDIs in advance of regulations. A small number of healthcare providers have followed suit. However, much of the industry has done nothing. Meaningful Use regulations may someday prod providers to be able to enter data on medical devices into the electronic health record, but EHRs don t always interface with other records systems and cannot solve the recall problem by themselves. New software applications help providers meet the demands of UDI, while also bridging the gaps among data systems and paper records. Put simply, providers do not have to wait for the force of regulation to be able to record a product code once when it arrives from a distributor and then track it all the way to use in a patient case and beyond. By doing so, health systems can realize millions of dollars in labor and supply savings while averting untold harm to the patients in their care. 2

3 THE CHALLENGE As the healthcare industry prepares to fully inhabit the world of value-based care, one of the largest hurdles it must overcome is in its supply chain. A lack of common product identifiers and data standards has left most providers unaware of how devices are used in patient care and to what effect. Procurement is stymied by a large error rate due to manual inventory management processes. As a result, providers, distributors and manufacturers can t effectively track usage, inventory status and expiration dates. About 3% of all medical devices expire while in inventory. 1 The typical error rate for manual data entry is one in 300 characters. Medical device implants typically represent 30% of a hospital s total supply spend and can account for more than 50% of the cost of some procedures. 2 Implants are the single most costly item used in clinical care. As many as 30% of surgical implants are brought in the day of surgery, with little or no time to do the laborious manual legwork required to find out if the device has any reported problems. Currently, more than half of the highest-risk device recalls conclude without all products identified or removed from the market, leaving patients vulnerable to having dangerous devices implanted a ticking time bomb. Manual data entry creates inefficiencies from the minute a medical device arrives at the hospital. Someone receives the package, documents information in a paper logbook, and then enters the same information into a computer. That third step doubles the chances for input error; studies at Ohio University s Automatic Identification and Data Capture Lab have found the typical error rate for manual data entry is one in 300 characters. (In contrast, the lab has found that data matrix barcodes have an error rate of fewer than 1 in 10 million characters scanned.) As the device moves around the hospital facility onto an inventory shelf or directly into the OR, one system might document a catalog number, while another records when it is used in patient care. Through the process it s possible that no one documents the manufacturer s serial number, which is what the FDA currently uses to identify recalled products. 1 Strengthening health care s supply chain: A five-step plan, McKinsey & Co., September Industry s Achilles Heel: The Supply Chain, Supply Chain Management, August 2013 Manually managing thousands of product recalls each year requires vast expenditure of labor for highly paid, very busy OR and supply chain personnel, who spend months manually searching inventory on the shelves and in patient files to find matches to recalled product serial numbers. Even then, many devices are missed. Without specific batch information, stakeholders throughout the supply chain often return all of the products, including unaffected ones, to manufacturers. This usually results in costs incurred by both the healthcare provider and the manufacturer, often needlessly. Worse, patients are harmed or even die when recalled or expired devices are implanted in them. In a 2009 case in New York, a surgeon used a surgical clip 3

4 called a Hem-o-lok ligation system to tie off a patient s renal artery as he donated a kidney to his ailing wife. The manufacturer had previously issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in their bodies, with serious, even life-threatening consequences. Twelve hours after surgery, the clip failed and the patient bled to death internally in the hospital. In a 2013 case in suburban Chicago, a mother of a 9-year-old girl learned of a recall of a defibrillator implanted in her daughter only because she had read about it in a medical newsletter to which she had subscribed. The surgeon, the hospital and the device maker had failed to inform the family of the recall, more than a year after it was issued. Such cases can lead to expensive litigation, often involving charges of negligence, which can result to the awarding of treble damages. They also can take a significant toll on the reputation of physicians and hospitals. Over the past decade, recalls of medical devices have been on a sharp rise. In just the third quarter of 2013, FDA Enforcement-Reports documented 415 medical device recalls, totaling 29 million units. The number of Class I recall units including implantable devices increased by more than 485% during the quarter. Medical Device Recalls on the Rise No. of device recalls Class 1 Class 2 Class 3 Source: FDA 4

5 Ron Brown, Chief of the Recall Branch of the FDA s Center for Devices and Radiological Health, has pointed to several likely causes of the spike in recalls. 3 The FDA has eliminated its backlog of issued recalls. Device manufacturers, perhaps stung by an increase in litigation and scrutiny, may be more vigilant about issuing recalls. And there are simply more devices and manufacturers these days, he says. Patients who read or watch a news story about a device recall may not have the exact make and model of their device, so they have no way of knowing if they should be concerned. The number of patients reported to be injured in serious adverse events related to medical devices in the U.S. increased by 17% per year from , topping 28,000 in 2009, according to an FDA report. 4 In 66,000 medical device adverse event reports collected by the FDA, 15% of the devices lacked a model or catalog number, 50% lacked a lot number or other identifier and 10% lacked both. The challenge of more recalls is becoming too big to keep track of manually, yet many facilities still try. Patients who read or watch a news story about a device recall may not have the exact make and model of their device, so they have no way of knowing if they should be concerned. Hospitals have the information, often on either a paper record or in the electronic health record, but EHRs don t have a way to query product codes and serial numbers. The FDA, providers, payers and manufacturers lack the information infrastructure to respond quickly and directly when safety issues arise. Although the Patient-Centered Outcomes Research Institute is aggressively building a national network for collecting data to conduct comparative effectiveness research, there is no straightforward approach to include medical devices without an effective tracking system. THE FDA STEPS IN In September 2013 the FDA published its long-awaited final rule establishing a Unique Device Identification system to provide a consistent way to track medical products throughout their distribution and use. The rule, mandated by the Food and Drug Administration Amendments Act of 2007, will be phased in over seven years starting in September 2014, when implantable Class III devices, such as artificial hips and cardiac defibrillators, must have standard labels in place and corresponding information housed in a national database. 3 Brown, Medical Device Recall 2013 Update, U.S. Food and Drug Administration 4 Understanding Barriers to Medical Device Quality, U.S. Food and Drug Administration, October 2011 These labels are required to include a device identifier, which is a reference number/product code that attaches to a description of the manufacturer; a production identifier, which has a unique lot number, serial number and expiration date; and a barcode with all of that information. A publicly searchable database administered by the FDA, called the Global Unique Device Identification Database, will serve as a reference catalogue for every device with an identifier. However, this database will not store production identifiers. 5

6 The FDA is not mandating any one code that medical device suppliers must use. In December 2013 it accredited a standard promulgated by GS1, which is the typical Universal Product Code seen on retail items. That same month, it accredited a standard issued by the Health Industry Business Communications Council. The two labels look similar, but are quite different. A healthcare provider needs to have a system capable of scanning either type of code, with functionality to be able to parse out the data appropriately within the program. For implants of human origin (such as tissue grafts) that have global distribution, another coding system known as ISBT 128 is employed, including a unique identifier for the donation that provides a direct link to the donor. UNIQUE ADVANTAGES OF UDI FDA and industry officials agree that UDI is a significant milestone in improving patient safety, modernizing post-market surveillance, reducing the cost of inventory management and facilitating medical device innovation. With this rule, we are one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices, said Blair Childs, senior vice president for public affairs at the Premier health alliance. Moreover, UDI will dramatically improve the recall process. Research also shows that UDI can save as much as $16 billion annually by automating manual processes and improving efficiencies. A UDI label for a disc implant (example from Medtronic) In October 2012 McKinsey & Co. published research based on interviews with more than 80 healthcare industry leaders around the world that estimated the potential value in lives and dollars of adopting a single global identification standard in healthcare. 5 It predicted enabled inventory reduction of up to $94 billion annually, plus reduced costs of managing and storing inventory of $10 billion to $14 billion and reduced product obsolescence of $19 billion to $27 billion. Much of the savings estimates are based on the experience of the retail world, where product codes have been used for nearly 40 years, resulting in annual savings of $17 billion and assisting in countless product recalls. While retail stock clerks only rarely need to key in product information, in healthcare, much patientimplantable medical device inventory control is manual, resulting in numerous errors and wasted effort. 5 Strength in unity: The promise of global standards in healthcare, McKinsey & Co., October 2012 UDI makes it possible to integrate information across disparate IT systems clinical, operations and financial. It increases visibility into key data on cost and quality drivers. 6

7 The use of UDI tracking programs will allow primary care physicians and specialists to make more informed decisions on patient care. Knowing the specific device implanted in patients will allow clinicians to assess whether the patient has a product associated with specific complications or a recalled technology. This accessible data source for patients would allow them to take a more active role in their healthcare by providing a clear source of data on the device implanted in their bodies. Patients could then submit more precise adverse event reports and work with their healthcare providers to track product performance. The documentation of UDI in claims would offer large, longitudinal data sets for comparative effectiveness research and increase patient safety by being able to track a patient who switches providers or seeks follow up care from a physician who did not implant a device. The FDA could utilize its post-market surveillance Sentinel Initiative which relies predominantly on claims data to assess device safety, as required by Congress in the Food and Drug Administration Safety and Innovation Act of The FDA has utilized Sentinel to successfully evaluate drug safety, but a similar system for devices has been stymied by the lack of UDI documentation. Rosalind Parkinson, Chief Supply Chain Officer at The Ohio State University Wexner Medical Center, points to two key business advantages of UDIs: 6 Transaction automation: Processes and systems can be automated, eliminating most of today s manual data entry, validation and correction. Medication and medical device administration could be captured through barcode scanning through UDI tracking systems and automatically fed into logistics, billing and procurement systems that connect all stakeholders. Inventory management collaboration: Dispensing points, distributors, and manufacturers could seamlessly exchange medical device or medication usage, location and product availability information. Inventory planning and forecasting programs could analyze the data to optimize inventory levels, improve medication and medical device availability across the supply chain, and ensure that medical products are available at critical moments of treatment. 6 Parkinson, Are You Selling UDI? September 2013, accessed at A SLOW RESPONSE Many observers, while praising the FDA s UDI rule, question the need for such a prolonged rollout of UDI. Since we have already been waiting six years for UDI, it s unfortunate that patients will have to wait until 2020 to have a fully functional device tracking system, particularly since such systems are so pervasive in the retail setting, said Premier s Childs. 7

8 A number of supplier pioneers, including BD (Becton, Dickinson & Co.) Johnson & Johnson, Medtronic and a few other large manufacturer/distributors, have adopted standard product codes. Most of those are using the GS1 healthcare protocols. GS1 has been working in healthcare for several years. Its schema includes Global Location Numbers (GLNs), the 13-digit number used to identify any legal entity/trading partner, and Global Trade Item Numbers (GTINs), the GS1 System Identification Number that uniquely identifies trade items at all levels of packaging. GS1 also maintains the Global Data Synchronization Network (GDSN), a data repository of product codes. UDI Rule Implementation Time Frame Class III devices - implants and life-supporting/ sustaining labels only Class I & II Devices - implants and life-supporting/ sustaining labels only All other Class II devices labels only Class III devices - implants and life-supporting /sustaining on implant itself Class II - devices - implants and life-supporting/ sustaining on implant itself All other Class I devices Source: Champion Medical Technologies So far, most suppliers and health systems have not adopted any standards. Bruce Moilan, director of data governance and GS1 standards for the group purchasing organization MedAssets, said that his organization surveyed 500 suppliers and found most were slow to assign GTINs or have GS1-compliant barcodes on their products. The majority of larger suppliers already had GTINs on their label or said they would do so by the end of Meanwhile, although a handful of hospital systems are aggressively trying to acquire GTIN information, the vast majority is taking a wait-and-see approach. It s the, What came first, the chicken or the egg? question, Moilan said. The hospitals are saying, We ll wait until the suppliers get done with what they need to do before we started implementing UDI, and the suppliers are saying, We re going to wait until all the hospitals are ready for my information. Any effort to drive widespread adoption of UDIs is, in order of importance, up to hospital systems, distributors and the FDA, he said. We were all very excited when the FDA rolled out its UDI regulations, but it has actually had the effect of pushing back some of the GS1 standards. A lot of suppliers started saying, We are going to 8

9 follow the FDA guidelines for the timeline, so we will be assigning GTINs for Class 1 and 2 products when it s required. If the grocery stores of yesterday never bought the scanning equipment and the software to manage inventory, barcodes would have been useless. Hospitals must have the systems in place to make use of these labels. They need scanners and software to track products from arrival to use on a patient and beyond. Planning and budgeting takes time and now is the time to begin that process so that more UDI codes can be utilized as they are introduced. The UDI tracking software needs to be integrated with other programs, including EHRs. If the grocery stores of yesterday never bought the scanning equipment and the software to manage inventory, barcodes would have been useless. In order to achieve some of the public health benefits that UDI is capable of, we need to make sure that it s captured in an electronic infrastructure, said Joshua Rising, MD, Director of Medical Devices for the Pew Charitable Trusts, which has been promoting UDI. The FDA can require that manufacturers put it on a product label, but if that s all that s done, then you are only achieving just a fraction of the potential of UDI. BUCKING THE TREND A few pioneering health systems haven t waited for regulations to act on UDI. In 2010, five of them Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy Health System formed a collaborative called the Healthcare Transformation Group to share best practices and drive needed positive change across the healthcare supply chain. Its first initiative is the implementation of GS1 standards. It established timelines for UDI compliance running years ahead of the FDA regulations. HTG has established working relationships with GS1 Healthcare US, academic institutions, governmental agencies, vendors/suppliers and research institutions to advance the adoption of data standards in healthcare. The group has established business requirements that stipulate that suppliers should be able to confirm that their products are labeled with GS1 compliant barcodes with the embedded GTIN at the appropriate unit of use and that this inventory is available for purposes of scanning at the point of use. A supplier must also confirm its enrollment or plans to enroll with a certified GDSN data pool. 7 Black and Zimmerman, Perfect Order and Beyond: BD and Mercy/ROi Achieve Far-Reaching GS1 Standards Integration, GS1, 2012 In 2011 Mercy Health System, its supply chain arm ROi and BD collaborated on what may have been the first instance of full integration of GS1 standards across a medical device supply chain between a buyer and seller. 7 Standards were fully adopted at each step from manufacturing to barcode scanning at the patient bedside. After a significant number of process changes, the organizations achieved a 30% reduction in days payable outstanding; a 73% reduction in discrepancies, 9

10 including a complete elimination of vendor part number and unit of measure discrepancies on purchase orders; and improved sourcing of products. More than 200 providers, such as MedStar Union Memorial Hospital in Baltimore and Eastside Medical Center in Snellville, Ga., have adopted Champion Medical Technologies UDITracker, a secure, web-based application for implantable device tracking, including human tissue grafts and hips, knees, cardio and plastic implants. The solution helps hospitals meet UDI requirements and realize a range of other benefits, including lost charge recovery. UDITracker also allows users to:...recallconnect had been utilized to identify more than 2,600 recalled devices, the vast majority of which had been implanted in patients. Improve quality assurance for rep-delivered medical devices by providing a one-click verification to ensure a device hasn t been recalled, is approved for use in the facility and pricing is correct Track expiration dates of all medical devices and automatically alert staff of inventory close to expiration, allowing a return for full supplier credit and saving countless hours of manual stock checking Eliminate redundant data entry by integrating with other hospital systems, such as EHRs, MMIS and OR scheduling, to unify all medical device data Provide families with a printout of information on the device used, with all of the information recorded in the event of a recall or other product problems Know what s in current inventory in real time; OR can order more efficiently, which saves on rush charges Another part of the application, RecallConnect, enables real-time, automatic matching of product recalls to hospital inventory history, as well as to specific patients who have received a recalled device. As of July 2014, RecallConnect had been utilized to identify more than 2,600 recalled devices, the vast majority of which had been implanted in patients. UDITracker also addresses complexities in UDI scanning that are software-driven. Many hospitals use standard linear/2d barcode scanners, but their software is not enabled to read UDI barcodes. UDITracker scans all codes and parses the data correctly to the right fields. Eastside Medical Center found that in just a few months of use, UDITracker resulted in fewer lost implants, said Nikki Hawkins, the hospital s business manager. UDITracker s storage units including secure RFID cabinets and freezers, which automatically capture and process inventory transactions in real time were instrumental to its achievement. All of our implantables are now stored in those two units, she said. That makes it easier to find out who took an implant out of the tracker that has not been profiled. 10

11 Use of RecallConnect Total Recalls = 2, , Used in Case Found on Shelf Discarded Returned to Supplier Source: Champion Medical Technologies MedStar Union Memorial Hospital has taken advantage of UDITracker s analytics tool, which allows it to create meaningful charts and graphs to gain visual images of data and the ability to compare procedure cost from one surgery to another. It also generates contract compliance reports and charts to get a much better handling of implant inventory. This is the future of UDI, as a key component in the Big Data analytics being used to transform healthcare as it seeks to meet the Triple Aim of higher quality, greater patient safety and lower costs. With reimbursement dropping; quality metrics rising; and new payment programs targeting medical errors, excess costs per Medicare beneficiary and excessive readmissions, the Triple Aim is the key to success post-reform. And soon there will be a specific link between quality metrics and medical device implant outcomes: As of Oct 1, 2014, hip and knee arthroplasty became one of five measures used in the Hospital Readmissions Reduction program, under which hospitals with high rates of readmissions can lose up to 3% of all Medicare revenue. THE EHR IS NOT ENOUGH In proposed regulations for Stage 3 of the HITECH Act s Meaningful Use program, the Office of the National Coordinator has included a new objective for both eligible professionals and hospitals: to be able to record the FDA UDI when patients have devices implanted. However, the Obama administration has now proposed to postpone Stage 3 until 2017, which would force those providers that wanted to enter the UDI into the EHR to do so manually. Given that the UDI could be several 11

12 dozen characters long, there is a high probability that providers will choose not to enter the UDI into the EHR or there will be a high error rate associated with doing so. Upon hearing of the Stage 3 requirement, some providers have said they will simply wait to implement UDI until It s a common misconception that the EHR system will serve as a medical implant management solution. EHR systems are patient-centric and will not fulfill inventory management, regulatory compliance or product recall needs. Efforts to have the large EHR vendors adapt their systems to interface directly with materials management information systems and other systems have not gone well to date. According to separate research reports from Gartner and the Healthcare Information and Management Systems Society, U.S. hospitals with at least a basic EHR are shifting their IT priorities toward creating enterprise data warehouses that mine the EHR for insights to improve care and lower costs. This makes it clear that the two biggest priorities for medical device management are accurate data input at the clinical level and usage of a system that is interoperable with the EHR and other hospital systems. CONCLUSION Unique Device Identification is a tool that when used to its full potential can help bend the cost curve in healthcare, meet the new challenges of care quality and give providers a much-needed lift toward financial sustainability in a reformed healthcare delivery system. It can also dramatically improve patient safety. Accurate feedback from the patient experience can inform the development of new, better and safer devices. Distributors and providers can reduce inventory because both parties are better able to anticipate provider need. Supply chain departments and surgical services can more accurately budget based on device use and cost/benefit analyses, while knowing exactly what is in inventory, averting the average 3% loss due to product obsolescence. Clinicians can be more assured about right device-right patient and not wonder about recalled devices. And patients won t be harmed by those medical errors and can learn about implanted devices from the electronic health record. It will take all stakeholders including regulatory and accreditation entities to drive the famously change-averse U.S. healthcare system toward full adoption of UDI and the realization of its many benefits. However, with a new technology such as UDITracker available now, health systems and suppliers don t have to wait for the force of regulations to begin to realize those advantages. 12