Mercy Receives FDA Award for Medical Device Tracking

A project at Mercy to track thousands of implanted medical devices and improve patient safety now has the financial backing of the U.S Food and Drug Administration (FDA).

The FDA has awarded Mercy a multi-year, cooperative agreement to support the development of a new medical device evaluation system. Over the next three years, the grant could amount to $5.2 million in funding, with an initial $450,000 the first year and the remainder to be paid in subsequent years, depending on Mercy’s performance and the availability of funds.

The grant is a major expansion of Mercy’s already acclaimed, FDA-funded Unique Device Identifier (UDI) pilot project, launched five years ago to pinpoint malfunctions in coronary stents through the use of scannable bar codes and electronic health records (EHR). Those labels provide access to medical device information, such as product name, its expiration date, reference and lot numbers, manufacturer information and other key attributes.

“This FDA grant speaks volumes about Mercy’s leadership role and our success in prior medical device surveillance and research,” said Dr. Joseph Drozda, Mercy cardiologist and director of outcomes research, who has overseen Mercy’s implementation of UDIs. He currently serves as chairman of the Healthcare Transformation Group’s Research and Development Team – a group of physicians and clinical researchers from Geisinger, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy who have been working together to develop a global tracking system.

“In just the last year, our database tracked more than 2,500 Mercy patients who received coronary stents in our cath labs,” Dr. Drozda said. “And that’s just the beginning. Tens of thousands of new medical devices are flooding the market every year, so it’s critical that we continue to perfect the way we track them. That leads to improved patient safety when we identify product problems more quickly and better target recalls.”

It’s also cutting costs. For example, one of Mercy’s heart cath labs initially recorded $800,000 in inventory, but, “when we put barcodes on everything and scanned them, we found that they actually had $1.9 million worth of items on the shelf,” Drozda said. “We managed that down to $1.56 million in six months, resulting in significant savings related to the costs of excess inventory.”

“Mercy is passionate about this project and it’s being noticed,” said Vance Moore, senior vice president of operations at Mercy. “The FDA is pleased with the work Mercy and Dr. Drozda have done, and we will collaborate with other health systems to expand it, lower costs and improve quality in our industry. With this new agreement, Mercy will be working with another group of organizations that includes two other large health systems and two universities.”

The new initiative, supported by the National Medical Device Surveillance System Planning Board and the Medical Device Epidemiology Network (MDEpiNet) Public Private Partnership, is called Building UDI into Longitudinal Data for Surveillance and Research – or BUILD.

“Our findings will help strengthen the nation’s medical device safety surveillance system, from the supply chain, through EHRs and onto processing,” Dr. Drozda said. “That means the FDA and other agencies will be able to better protect patients from harm caused by faulty or ineffective medical devices. Then, we’ll create a roadmap so other health systems can track their devices as well, monitoring performance, costs and recalls.”

The BUILD initiative will be led by Dr. Drozda, who hopes to bring on even more partners as the UDI project inevitably expands in the coming years.

“We need others across the country to join us with BUILD because it is critical work,” said Drozda. “Medical devices can be lifesaving, and can relieve pain and improve the quality of life, but they can cause safety issues as well. We want to expand our reach in the medical device space with this UDI project so we can impact the lives of even more patients.”