On Sept. 24, the first compliance deadline for unique device identifiers takes effect, requiring class III medical devices to be labeled with a UDI and for device data to be submitted to the Global Unique Device Identification Database.
The first step in a seven-year process, the beginning of UDI implementation aims to improve patient safety, clinical quality and medical device reporting.
While the initial stages of UDI implementation mainly involve medical device manufacturers, the rule will have impacting effects for the rest of the healthcare industry.
After the first deadline, manufacturers of class III medical devices will have done their part to ensure their products are adequately labeled. Now, providers have to start addressing how UDIs are going to affect their daily workflow. Gaurav Satpute, Director, healthcare IT at PricewaterhouseCoopers, says in order for UDIs to work as intended, it will require an effort across providers as well to fully reap the benefits.
"Once these UDI-compliant devices get to the providers, the providers have to start modifying their systems and processes so that there is a standardized way of how these devices are tracked," he says. "Once UDIs are used in a standardized way across device companies and providers, multiple areas from supply chain to patient safety will improve."
As it currently stands, providers aren't mandated to do anything with UDIs. But to use UDIs to their full potential, all parties in healthcare need to be involved, says Tony Ross, Director, healthcare supply chain at PwC. While change is continually met with resistance, there needs to be a concerted effort to get all members to integrate UDIs to maximize patient safety.
"Since it's not mandatory yet for the provider to [track products], it's going to be up to the hospital leadership to say this is an important thing we need to do," says Mr. Ross. "There's value in it, not only from an operational perspective, but there's the safety perspective for the patient and the quality. The materials manager really needs to recognize how UDIs will play a role in cost quality and outcome. We are about have a mountain of new data. Can we turn it into information?"
Such commitment to UDIs and a mind toward standardization will require tighter inventory controls for materials managers, Mr. Ross says, as they now need to consider new processes for tracking products through the system. He suggests the EHR will be the central touchpoint for where this may happen in the future.
"I think it's coming in the future where all of this information will get tied to the EHR," Mr. Ross says. "When someone comes down with a critical illness and they're not where they normally live or they're out of the country, there's no information that a doctor will know about that patient….Unless they visibly look for scars, there's not a visible indication [that a patient has an implant]. Completing that cycle of care would include that information being attached to your EHR."
However, getting to the point of such data being housed in the EHR requires a new way for supply chain systems to collect and house that data, says Mr. Satpute. Provider systems will need to modify and enhance their capabilities to scan the UDI labels across different processes and stages in the supply chain, requiring a comprehensive look at their operations.
"The scope in terms of what providers have to do is pretty wide," Mr. Satpute says. "The changes may not be that significant, but the number of places where changes need to be made are pretty broad. Providers need to think about the overall supply chain."
Providers are also faced with the added concern of how to finance such a system overhaul, Mr. Ross says. The small, seemingly minor tasks and costs can't be ignored, be it requiring a couple more hours of labor a day for scanning and tracking or needing to buy basic equipment like a cart for an added procedural task. What's more, hospitals and health systems may be looking at upgrading software or their inventory system to include a new data entry field for UDI numbers. Such upgrades cost money. Mr. Ross says small to mid-size hospitals are more likely to feel the strain of these costs while the bigger integrated delivery networks are already weaving these processes into their system. "It's going to take some innovation for those [smaller systems] to join in and help complete the circle," Mr. Ross says.
And while the transition won't be without its obstacles, the transition will pay off in the long run.
"In the short-term, providers need to think about investments required to adopt and use UDIs, as significant benefits will be realized in the medium- to long-term," Mr. Satpute says.
More articles on UDIs:
Supply chain's evolution from the basement to the executive suite
8 Recently Issued FDA Device-Related Guidelines
UDIs offer healthcare a long-overdue way to save lives and reduce costs