By Lindsay Engle
Is it possible to improve medical device safety, simply by gathering unique identifier data? According to Ben Moscovitch, the project director for health information technology at Washington, D.C.-based think tank Pew, the answer is yes. The thought is that by including unique device identifiers (UDIs), medical device safety will improve because potential issues may be discovered at a much faster rate. Here, we discuss several key benefits that patients, providers, and manufacturers may obtain by gathering this data.

The problem? Millions of patients rely on medical equipment every day, but researchers can’t trace the performance of these devices and determine safety issues promptly. Enter UDIs. By tracking what works and what doesn’t, current and future beneficiaries can see real advantages.

Understanding the Benefits

Insurance claims data may be used to increase data on device safety from electronic health records—something that could facilitate a more inclusive view of safety. Currently, a similar method is used when dealing with medications: A patient receives a drug and the drug’s unique identifier is entered into the insurance claim form. Such information is then used to determine if a specific drug may cause inadvertent harm.

Many health safety experts have touted the UDI system as extremely beneficial due to the proliferation of medical devices. Specifically, UDIs may help to identify which equipment is harmonious with other systems, like implant devices used safely with MRIs. Along with improving patient safety, this data may also help to lower costs, experts say. And the costs can be significant—Pew Trust officials estimate that the Medicare costs attributed to faulty cardiac devices, for instance, are in excess of $1.5 billion.

Fortunately, something as simple as device tracking could help lower Medicare expenses, they maintain. Electronic health records and clinical data can be a great resource in collecting data; however, if a patient changes provider, that data becomes less useful as far as population-level surveillance and tracking the performance of equipment goes.

Compelling Research

Researchers from Brigham and Women’s Hospital of Boston, Geisinger Health System of Pennsylvania, and Blue Cross Blue Shield of Massachusetts conducted a study with data from almost 5,000 patients. Of this group, more than 2,000 patients received hip replacements—along with those who received stents. All medical events were then tracked within 90 days after the patients underwent the procedures. The researchers first reviewed the data from electronic health records and then proceeded to add in claims data.

That’s where it gets interesting. When the researchers added in the claims data, they saw a dramatic uptick in the number of patients needing to be readmitted to the hospital. Specifically, those who received stents were much more likely to be readmitted for possible strokes. And patients who received hip replacements saw a 72% increase in hospital readmissions.

To Ben Moscovitch, these numbers speak for themselves.“The data shows that insurance claims are a crucial source of information and can help reveal more widespread problems or trends,” he says. “And this information—if used to evaluate medical device safety—could help determine whether certain types of products lead to higher risks of hospital readmissions, surgeries to revise and implant, or other complications.”

Safety First

Obviously, the first thing that comes to mind is patient safety. As stated above, UDIs can potentially provide much earlier visibility to adverse reactions. If the equipment is identified with the same identifier and caught by more organizations, there will be an increase in available data that leads to potential issues. This, in turn, enables manufacturers to recall products, if needed, as well as help identify which patients have been treated with the recalled equipment.

This data can also be used to help hospital officials, clinicians, health regulators, and manufacturers determine which products work well—and which patients will benefit most from these products. Using this information can help to expand medical equipment labels, as well as indications of use for certain medical products. This can also help determine how medical equipment performs in routine clinical practices. After all, with UDIs, manufacturers can market products based on actual, real-life evidence.

Summing It Up

In summation, the major key benefits of using unique device identifiers are to help improve utilization, safety, and performance of unique medical equipment when it’s in use. UDIs also enable officials to conduct health outcomes research on a much wider and less-costly scale. Plus, they can help with the recall management process by allowing health plans to cover product recalls. Quality of care also improves, thanks to the increased knowledge about medical device outcomes via UDIs.

Finally, with UDIs, care costs are better organized, due to the increased transparency for both patients and insurance companies. As the research suggests, it seems as though UDIs are the way to go.

Lindsay Engle is the Medicare expert for Elite Insurance Partners & MedicareFAQ. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at [email protected]