FDA advisory panel votes against approval of DMD drugWhen it comes to methods for tracking critical medical devices ready for or already in-use by patients (in some cases implanted in the body), it doesn’t take much consideration to see the benefit of an electronic means for knowing where a certain device is (think: safety recall) over a rudimentary system…like color-coded Post-It notes.

From rudimentary to sophisticated: one hospital dramatically improves device tracking

But the sticky-note “system” is exactly what Missouri-based Mercy hospital had in place to denote when a product would expire. In 2013, however, the facility—along with ROi, its supply chain organization—participated in a program sponsored by the FDA that looked at the outcome of recording Unique Device Identification (UDI) from coronary stents into the hospital’s inventory management database.

Unsurprisingly, the study revealed that UDI capture managed inventory more efficiently by lowering costs, increasing revenue, and preventing delays in procedure.

According to the FDA: “UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”

Beyond the obvious benefit of eliminating a Post-It note tracking system that leaves itself open to massive gaps or preventable errors, UDI capture goes beyond improving what came before. According to Paul Helmering, ROi’s vice president of information and technology systems, it makes a new level of oversight possible: tracking outcomes related to specific devices in specific patients. He says more providers need to know about this benefit.

Do providers have a “burning desire” for this kind of data?

“For providers, there’s really not that burning desire to utilize the information,” Helmering says. “Until that becomes clear and people start understanding, I think there’s going to be slow adoption.”

Currently Mercy hospital is expanding UDI use to include operating rooms and catheter labs, which allows practitioners to scan the barcodes of products and log data into its inventory management system.

However logically and undeniably efficient UDI use is, Mercy hospital is not one among many when it comes to utilization of this system. Many hospitals lack the kind of sophisticated inventory management system that is required for UDI tracking, while others lack the thorough awareness of what it can do for their facility and their patients.

Although the FDA has created a new UDI system designed to make locating a device easier (whether it’s still in the supply chain or in-use in a patient), it’s not a given that healthcare providers possess all the necessary technological components to use the system as it’s intended.

Nearly a decade ago, Congress passed legislation asking for a UDI system. The FDA’s program in response to that stipulates that manufacturers (and less commonly, distributors) label every device or packaging with a unique number or barcode. On the healthcare side, when providers scan the barcode or input the numbers, they receive information about the equipment from the FDA’s Global UDI Database. Some common pieces of information are serial numbers, lot numbers, and manufacture and expiration dates.

Manufacturers outpace healthcare providers in UDI implementation

The FDA published its final UDI regulations three years ago, and since then the bulk of manufacturers and distributors have begun phasing in UDIs for their equipment. However, only a small fraction of healthcare providers can make full use of the electronic information and the benefits it affords.

An underlying problem is that many electronic health records (EHRs) lack the capacity to capture UDIs. This gap will likely be a thing of the past before too long, though: in order for EHRs to stay certified under a federal incentive program, they must be able to record UDIs. At this stage providers are not mandated to fold UDIs into patient records.

However, when EHRs are capable of recording UDIs, healthcare practitioners can easily use the data to identify patients impacted by the recall of a medical device. The current alternative? Sending out blanket communications or combing through paper records…and hoping no patient has been overlooked.


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