The demand for device data

One theme prevalent throughout the event was increasing regulatory and market pressure on providers and suppliers to collect and report device-related data. During the presentation entitled, Practical Clinical Use Cases for UDI, Rosalind Parkinson, administrative director of Materials Systems for The Ohio State University Medical Center, pointed out that complying with meaningful use of electronic health records (EHRs) is just the beginning. She said that the Office of the National Coordinator for Health Information Technology’s ultimate vision is for EHRs to document a wide range of data from various hospital systems – from the devices used in a procedure to what the patient ate during his/her hospital stay.

Parkinson described how her organization conducted a special project to help 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.

Parkinson and her team linked clinical and supply systems to calculate device credits owed to CMS and found that their organization owed more than $390,000 in device credits for procedures performed in 2010.

"Now that CMS is seeing these refunds, the agency is likely to become more vigilant and request that hospitals provide even more device-related information," said Parkinson. "Healthcare providers must find the least expensive way to comply with this increasing demand, which means shifting from manual to automated processes. EHRs provide the vehicle for this and now we just need the identifier, and that’s what we’ll get from the FDA’s UDI system."

During a presentation entitled, The Use of UDI in Clinical Information Systems, Joe Pleasant, FHIMSS, senior vice president and CIO of Premier Inc., noted that the sweeping changes in healthcare are changing the way that trading partners look at their processes and the data that they collect.

"Today, hospitals generate and collect data in silos, with separate data streams for purchasing, clinical and financial information," said Pleasant. "We need to break down walls and find a consistent way of accessing and understanding data within hospitals and across all entities involved in patient care. Standards, including the FDA’s UDI system, will play a central role in helping us achieve this vision."

Transforming device data into knowledge

A number of presentations focused on how providers and suppliers could leverage the FDA’s proposed UDI system to address industry challenges, such as recall processing, adverse event reporting and ordering/invoicing errors. Many pointed out the fact that product enumeration itself isn’t the answer. As Jay Crowley, senior adviser for Patient Safety with the FDA Center for Devices and Radiological Health stated, assigning UDIs to medical devices is not the "end game" of the UDI initiative. The ultimate goal is for stakeholders to use the UDI system to improve efficiencies, reduce costs and most importantly, enhance patient safety.

During their presentation entitled, Perfect Order and Beyond, Dennis Black, director of eBusiness for BD, and Alex Zimmerman, director of Integrated Business Solutions for ROi, the supply chain company founded by Mercy, demonstrated how product data standards could be implemented to help providers and suppliers achieve the "Perfect Order." They cited the Strategic Marketplace Initiative’s (SMI) definition of "Perfect Order" as one in which "a purchase order (PO) is processed electronically (from order to payment) without human intervention, and is delivered to the correct location, on time, undamaged, at the right price, with the desired quantity, on the first attempt."

To achieve the "Perfect Order," BD and Mercy/ROi collaborated on an end-to-end integration of GS1 Global Location Numbers (GLNs) for organization and location identification and GS1 Global Trade Item Numbers (GTINs) for product identification where these data standards were used in supply chain processes from the point of manufacturing to the point of use. The trading partner pair now uses GLNs and GTINs in EDI transactions through GHX and tracks products via barcodes representative of the GTINs during distribution, on the receiving docks, in the storerooms and at patient bedsides. Today Mercy scans the BD GTIN barcode on products at the patient bedside triggering inventory replenishment, patient charges to the billing system and device documentation in the patient’s EHR. By implementing this fully automated system with BD, Mercy/ROi reduced its transactional discrepancies with BD by 73 percent for more accurate POs, invoices and payments.

"Using data standards in EDI transactions isn’t magic," said Black. "Trading partners must be prepared to modify internal systems, establish new business rules and cleanse their data, and it takes some effort to get there. But now that we’ve achieved this, we’ve improved the infrastructure and data accuracy for our current processes and set the stage for future patient care initiatives and recall processes." Zimmerman continued on this theme by adding, "Because of BD’s appropriate barcoding of product, we are now able to achieve the same level of efficiency as seen in retail environments. When a product is scanned and charged at any common retail store, the store is able to identify a customer’s purchasing habits, how much product needs to be replenished and how much the store can expect to be reimbursed by the credit card company. With data standards, we can emulate this process with a surprising degree of similarity."

The changing role of supply chain

One interesting perspective voiced by conference presenters was how global data standards initiatives, including the FDA’s UDI system, are changing the way that various functions within hospitals view the supply chain.

"In the past, the supply chain was seen as set apart from the real mission of the hospital, but that is changing," said Parkinson. "The UDI has made clinicians more aware of the potential for capturing data in the EHR on supplies used and the role that the supply chain plays in patient care."

During a discussion on the use of UDIs in clinical care, Michael Innes, program director, Supply Chain Processes & Systems, Kaiser Permanente, stated, "Right now, clinicians only notice the supply chain when a product is missing. I’m hoping that helping clinicians understand the UDI system’s benefits will give the supply chain a more prominent role in provider organizations."