UDI mandate: Is your supply chain ready?

The health care supply chain is under increasing pressure from federal organizations to comply with strict regulations governing data collection and the movement of medical devices through the distribution cycle. This year, the U.S. Food and Drug Administration’s mandate concerning the use of unique device identifiers goes into effect.

With the adoption of such an important technology looming on the horizon, it’s imperative that manufacturers and distributors learn about UDIs and how they work within the supply chain to provide improved visibility and better manage product quality issues within the medical industry.

Let’s take a look at UDI labeling and explore the reasons behind the push for adoption.

An overview of unique device identifiers
According to the FDA, UDI labeling consists of assigning alphanumeric codes to all classes of medical devices in order to track them throughout the supply chain. With this kind of tracking, both the FDA and manufacturers themselves will be able to measure the effectiveness of the labeled devices.

Within the medical supply chain, it’s crucial to implement oversight strategies that allow manufacturers and distributors to ensure product quality and address issues as soon as they arise. With UDI labeling, manufacturers will be able to closely monitor where these products go and how they perform when they reach their final destination.

How does the UDI impact the supply chain?
Modern Healthcare contributor Steven Ross Johnson reported that the FDA’s phased rollout of UDIs is beginning to take place within manufacturing companies across the country. In September 2014, medical devices like implanted pacemakers and heart valves were required to include these kinds of labeling.

This year, in late September 2015, the second phase of the mandate was put into place, which states that all implantable, life-supporting or life-sustaining devices must now include the UDI labeling to facilitate supply chain management.

“The FDA has built the [identification] system so that this information will be widely available for anyone who needs it,” Dr. Josh Rising, director of health care programs for the Pew Charitable Trusts, told Johnson. “So now that products are appearing with these new codes, it is kind of incumbent on the health care system to realize a lot of the benefits that are out there for having these new codes.”

“With the data generated by the management of UDIs, manufacturers and distributors can have more oversight.”

How can Inspirage help?
Agility within the supply chain can through responsive manufacturing and logistics processes, McKinsey & Company has noted. This is where UDI data analytics solutions come in.

With the data generated by the management of UDIs, manufacturers and distributors within the medical industry can have more oversight on the important phases of delivery. This ensures that they are better enabled to pinpoint where in the supply chain the devices are and how they are currently being used.

By partnering with Inspirage, companies can be sure they will get the best out of their UDI analytics solutions. With the UDI Foundation Pack, you can learn how to manage the data that comes with UDIs. Contact us today to see how we can help your company comply with the FDA regulations governing unique device identifiers.

Mike Lieberman

Mike Lieberman | Key Contributor

Mike Lieberman is a Director of Solution Architecture for Inspirage. Mike is focused on architecting robust value chain solutions, focusing on Agile PLM; creating and positioning innovative solution offerings to enable a customer to expand their PLM footprint; delivering deep product expertise and value to the Inspirage client base; and focusing on the sales and business development activities for PLM consulting opportunities.