Every stage of medical device development is dependent upon the collection of accurate data. From trial data collected during the research and development phase (R&D) all the way through to patient data gathered through post-market surveillance, it is the only way to deliver safe and effective products to the marketplace.
While the U.S. Food & Drug Administration (FDA) and other regulators have long required device manufacturers to track and report metrics related to product quality and safety, in recent years regulations have increased. New initiatives aimed at product data standardization, tracking and reporting, with the most notable being the FDA’s Unique Device Identification (UDI) rule. Improved patient safety requires access to data to understand patient outcomes – that’s where UDI comes in.
Published on September 24, 2013, the main purpose of the UDI rule is to enhance patient safety by helping manufacturers and healthcare providers work collaboratively to improve adverse event reporting and better manage device recalls. It requires manufacturers of most Class I, II and III medical devices to assign unique identifiers to their products and apply the UDIs to all levels of packaging down to the lowest unit of use in both human and machine readable formats. Manufacturers are also required to submit data on their products to the FDA’s Global UDI Database (GUDID).
At present, the industry is close to having more than 50 percent of medical devices with a UDI assigned, incorporated into the product label and published to the GUDID. The goal is to have the regulation fully implemented by September 2018.
The Role of Healthcare Providers
The UDI initiative’s aim of improving patient safety only works if healthcare provider organizations use manufacturers’ UDIs within their internal systems to identify the devices used in patient care. A manufacturer can’t accurately track down a recalled device or conduct effective post-market surveillance if its customers – hospitals and other healthcare facilities – are using their own language to identify products. With UDI, everyone speaks the same language.
Today, supply chain departments are already capturing information on the medical-surgical products their facilities procure and storing this information in their item masters. The item master has been described as the center of a healthcare organization’s universe because its content drives not only supply chain processes but a broad range of clinical and financial functions as well. It only makes sense that UDI adoption on the provider side starts here.
A growing number of healthcare organizations are using their item masters to feed UDIs to their electronic health records (EHR), which enables them to pursue the tenets of healthcare reform. By having an accurate and complete record of which products were used on which patients, providers can evaluate the role of specific products in patient care and use this information to increase care quality and improve outcomes.
With Obligation Comes Opportunity
From a manufacturer’s perspective, UDI affords an important business opportunity. It opens the door for them to become the ‘source of truth’ for products within their customers’ organizations, not just for supply chain operations, but also for clinical processes (i.e., implant logs), billing, reimbursement and much more. The FDA absolutely recognized this with the UDI rule. This is why manufacturers have the opportunity and the obligation to serve as the source of truth for product data.
Collaborating with healthcare providers on product data standardization also presents the opportunity for manufacturers to work with their customers on new solutions for higher quality, more cost-effective care. Healthcare delivery today is all about delivering value, which means balancing cost and quality. When healthcare suppliers and their customers use common systems to access and manage the same data, they can take steps to not only improve patient care, but also drive down costs for both parties.
For example, standardized and synchronized data throughout the supply chain is the key to strengthening post-market surveillance. Both manufacturers and healthcare providers need visibility to adverse events sooner and the ability to locate recalled devices faster. Getting potentially dangerous products out of the supply chain in a timely manner can prevent patient harm and the costs associated with it, such as treatment for complications, revision surgeries, denied reimbursements, lawsuits, reverse payments, etc.
Manufacturers and their customers can also use standardized data to improve business processes for improved care and lower costs. For example, better product identification can help trading partners optimize inventory levels to meet patient needs while reducing waste. It can also improve the accuracy and efficiency of the procure-to-pay process, which cuts down on costly errors for both manufacturers and healthcare providers.
The healthcare industry continues to experience unprecedented pressure to not only corral costs but, more importantly, deliver measureable improvement in the value of the care being delivered. For medical device manufacturers, the key is data.
The healthcare supply chain has been tapped as a goldmine for data, and the past few years have seen providers and suppliers mine that data to do extraordinary things for patient care. This year, with the healthcare supply chain on the road to accelerated maturity, I believe that manufacturers will look for even more sophisticated ways to control and manage their product data – both alone and in collaboration with their customers. This will allow them to fulfill both the regulatory and commercial demands of their businesses. That’s where our industry is heading.