To steal a phrase from this past election, “change is coming.”  With the new administration in Washington, this change will manifest itself in all forms of ideas and approaches to public policy.  Nowhere will this be more noticeable than in healthcare. Even prior to taking the oath of office, President Barack Obama signaled healthcare reform would be central to his economic stimulus package. 

For example, he proposed investing $20 billion to advance the use of electronic medical records.  Achieving this goal has long been touted as a way to improve patient care and reduce much of the waste and inefficiency in the U.S. healthcare system. Other efforts to bolster the use of electronic medical records have faltered. However, with a new administration faced with an ailing economy and a hunger to demonstrate actions to fix it, the time is right for true progress on this issue. 

This timing presents many opportunities for the medical technology industry, especially in two important areas, unique device identifiers (UDIs) and product data standards.  While hardly new concepts, both will be essential building blocks of an effective electronic medical records system.  And like the overall electronic medical record movement, UDIs and product data standards have experienced frustrating fits and starts on their way toward broad adoption. To date, efforts to increase their use have been voluntary and devoid of urgency.

Today, some medical device and diagnostics companies use proprietary systems to track products from the manufacturer to the distributor or end user. Due to the lack of a single UDI standard, distributors or end users often overlay manufacturers' product identifiers with their own. In addition, not having standardized product data forces hospitals to spend countless hours and resources manually gathering, cleansing, modifying, and reconciling product data to populate their procurement systems, electronic health records, and clinical systems. Inputs from each of these error-prone processes come from various supply-chain players, including suppliers, distributors, and group purchasing organizations (GPOs). As a result, many pricing, delivery, and chargeback errors that exist today stem from a lack of common product data standards and a system to synchronize this information across the supply chain. 

UDIs and synchronized product data standards can help ensure that the right product gets to the right patient at the right time with the right price and right information. Besides missing opportunities to eliminate transactional waste and inefficiency, customers indicate that the absence of standards governing UDIs and product data causes the entire healthcare system to forego many significant patient safety benefits. 

In September 2007, then-President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007 (Public Law No: 110-85), which required the agency to establish a UDI system for medical devices. It was influenced by an active group of industry stakeholders, citing the need to enhance patient safety, reduce medical errors, facilitate device recalls and improve adverse-event reporting. For the most part, the medical technology industry stood quietly on the sidelines as the law was being written.

As the next step in establishing a UDI system, FDA recently announced a February 12, 2009, public workshop to “help us better understand the issues involved in the establishment of a unique device identification system.” This public workshop will be an important opportunity for the industry to voice its ideas for a workable and beneficial system.
 
With increased scrutiny on FDA's ability to protect patients, the medical technology industry should realize that the UDI train is leaving the station. It should get onboard by offering constructive ideas on how best to shape the agency's regulation. The worst thing the industry can do now is not engage in this process. While a properly designed UDI regulation will clearly be good for medical technology companies and the entire healthcare system, a flawed one could negate its benefits.

The industry must work with FDA and other stakeholders to design a regulation in tune with its capabilities and customers' needs. It needs a regulation that is not too light, and thus, completely meaningless. At the same time, the industry needs a regulation that is implemented practically and does not get ahead of customers' capabilities to make the best use of UDIs.  

From BD's extensive experience with UDIs, the company has learned there is no one-size-fits-all solution. BD's customers have indicated that they do not value scanning and tracking all medical products the same. The benefit of scanning and tracking a molecular diagnostic instrument is vastly different from a single hypodermic needle. Hence, any UDI regulation should take into account different types of products and their roles in patient care. 

In addition, global medical technology companies are keenly aware that product numbering requirements are growing worldwide. It is imperative that FDA develop a system that supports the global market and drives global harmonization, rather than one that encourages costly country-specific numbering systems and bar-code requirements.  

If movement on the regulatory front is not enough to convince the medical technology industry that UDIs and product data standards are inevitable, then companies should take note of what is happening at the customer level. Hospitals on the vanguard of product data synchronization report that bar-coded products and point-of-care scanning systems are helping them implement patient safety initiatives. These systems provide them with the ability to track products, record serial numbers, and understand key product attributes, such as sterility and expiration dates. 

Word of these successes, especially from high-profile pilot projects, is spreading quickly. Calls are echoing throughout the supply chain for industry-wide adoption of UDIs and product data standards. Prominent hospital systems and GPOs are now requiring suppliers to adopt GS1 data standards—particularly the Global Trade Item Number (GTIN). 

To steal another often-used phrase, “healthcare policy must keep pace with 21st century medical technology.”  In the case of UDIs and product data standards, the industry must catch up to 20th Century information technology. Large retailers have utilized product data standards for years to improve supply-chain efficiency and improve customer service. These efficiencies have helped many of them remain competitive in tough economic times. 

As an industry known for being on the cutting edge, medical device and diagnostics companies must embrace innovation in health information technology that has the ability to transform the way they transact business. Healthcare regulators and customers are already riding this wave of change. The medical technology industry can either ride the wave with them or risk getting swept up by it.

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