A project at Mercy to track implanted medical devices has the backing of the Food and Drug Administration. A grant recently awarded to Mercy by the FDA could amount to $5.2 million in funding over the next three years. The cooperative agreement supports the development of a new medical device evaluation system. KSMU’s Michele Skalicky has more.
The grant will allow a major expansion of Mercy’s FDA-funded Unique Device Identifier (UDI) pilot project, which was launched five years ago. The idea behind the project is to easily track coronary stents that are implanted in patients. UDIs allow healthcare workers to pinpoint malfunctions in the stents through the use of scannable bar codes and electronic health records.
Dr. Joseph Drozda, a Mercy cardiologist and director of outcomes research has overseen the healthcare system’s implementation of UDIs. He said this is the kind of thing the public has been used to in consumer goods for a long time.
"And, actually, some manufacturers had their own barcodes, but they were only useful to the individual manufacturer. These new codes will be useful to anyone who has access to the information available at the FDA and their global UDI database," he said.
Dr. Drozda said the challenge now is to get the UDIs into the information systems where they can be most useful, not the least of which is the patient’s electronic health record.
"So that any provider who has access to that record will know exactly what devices the patient has," he said.
Ultimately, UDIs will be used not just in coronary stents but also in things like orthopedic implants and even syringes.
Dr. Drozda said UDIs will help track patient safety by following performance in electronic health records, insurance claims and other places in which the information is embedded.
And they’ll help in medical device innovation.
"Because having it embedded in these various databases, it tells us what's going on in the real world with devices and can give rapid feedback to manufacturers about how the device is performing," he said.
That, he said, should lead to rapid improvements in technology and at a much lower cost.
And, according to Dr. Drozda, having the information readily available will be “a godsend” to surgeons who currently spend 20 to 30 minutes prior to surgery trying to find out what specific device they’re going to be replacing. He said 40 percent of the time they’re not able to discover what the device is until they operate, which is a safety and quality issue for patients.
The grant Mercy recently received will fund the next phase of the project, which is called Building UDI into Longitudinal Data for Surveillance and Research or BUILD for short. So far, the project has included embedding UDIs into Mercy’s clinical information systems and using it for post market evaluation of those devices, according to Drozda.
In the next phase, Mercy will work with other large healthcare systems in trying to do the same thing that Mercy has done. But the information will then be shared across the healthcare systems.
"To give us much more robust information because of the larger numbers of stents that we'll be able to analyze," he said.
According to Drozda, they’ll also look at what else is being done around the country to capture the same information. They also plan to test another form of technology for capturing the data in the electrophysiology lab of another organization, which is where pacemaker and defibrillators are implanted, he said.
The ultimate goal is to refine what was done in the first phase of the project.
"To make sure that we can generalize it to to other cath labs and that we can then share data in a way that we could grow over time to include multiple hospitals tracking data across the country to help us in assessing medical device performance in the real world," he said.
According to Dr. Drozda, the project is a cooperative effort of a public-private partnership called MDEpiNet, which the FDA instigated a few years ago. It’s made up of academics, industries and healthcare systems that are trying to figure out how this new system should work.
He said, by doing this project, they’re pulling healthcare here into the latter part of the 20th century in terms of being able to track medical devices through their entire life cycle.