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Two Worlds Collide: UL’s Medical Device Expert Tackles Interoperability Challenges

June 6, 2017

Nearly a thousand people could die from an opioid overdose this year, and in a setting you’d least imagine – the controlled setting of a hospital. That’s because patient-controlled analgesic (PCA) pain pumps, an oft-prescribed pain management mechanism for in-hospital patients, often do not exchange information with either infusion pumps delivering medicines and nutrition intravenously or with monitors tracking a patient’s vital functions. This lack of technological interoperability among medical devices can lead to a fatal – yet highly preventable – outcome.

This is just one of the many projects UL Principal Engineer Anura Fernando is focused on as he helps clients build greater trust in the digital healthcare environment. Over the past five years, Anura and his team have been working with Massachusetts General Hospital and Partners HealthCare on their Medical Device Plug-and-Play (MD PnP) Interoperability Lab. The lab conducts research and develops open source technologies to enable the interoperability of individual medical devices made by different manufacturers – such as PCA pumps with heart monitors and pulse oximeters – to advance the integration and safety of the devices in clinical patient care settings.

“The system is lacking sufficient interoperability across all devices in the clinical workflow to alert the PCA pump to shut off if, for example, a patient is going into respiratory distress,” Fernando says. “Collaborating with industry colleagues to develop standards that allow these devices to talk to each other safely and securely gives us the very real opportunity to avoid these unnecessary types of clinical errors.”

Fernando’s work as a Medical Software and Systems expert within UL’s Health Sciences division is not limited only to clinical settings. The increasing digitization of healthcare has driven a desire for more people to take ownership of their health and wellness through the daily use of everything from fitness trackers to glucometers to heart rate monitors. In fact, the current worldwide market for all wearable technology products is on track to exceed more than $34 billion in annual sales by 2020.

“As exciting as it is to see the surge in consumer adoption of wearable technologies to manage personal health, safety is paramount,” Fernando explains. “UL plays a strong role in building trust in the marketplace for these products by working with manufacturers to help ensure not only that a device avoids physical safety risks to the user, but also that the data collected on the device is accurate and kept secure as well.”

Consumer safety first piqued Fernando’s interest as a potential career back in the 1970s, when he was just a kid watching “far too much TV” on Sundays. He was a faithful viewer of Fight Back! with David Horowitz, a consumer advocacy show that attempted to inform consumers about sub-standard products on the market. He’ll always remember the week that a UL expert came on the show to demonstrate a ball impact test on a television screen.

Fernando recalls, “I was pretty young and didn’t fully understand the benefits of consumer product advocacy, but I remember having this ‘aha!’ moment of realizing that there existed jobs where people could break things just to make them safer for other people. That really stuck with me.”

Studying engineering was the obvious choice to prepare for a career in safety science, but his family wanted him to consider medicine. To cover all of his bases, he earned a bachelor’s degree in electrical engineering from Purdue University, a bachelor’s degree in biology and chemistry from Indiana (University), and a master’s in software engineering from the University of Maryland. But while clinical medicine would allow him to address issues at the “application level,” he was more interested in drilling down to the root cause of problems in a way that could help more than one person at a time.

“With primary care medicine, you’re able to help a single patient at any given point in time,” Fernando explains. “But, through safety standardization, you have the opportunity to create a positive and lasting impact on the health and wellbeing of whole groups of people within a population.”

After a few years in academia teaching human anatomy and physiology at Indiana University Northwest, he found himself intrigued again by UL – and this time, permanently. In his 19 years at UL, Fernando has logged experience with safety-critical software and control systems certification and conducted research across multiple applications, including industrial automation, alternative energy, medical, nanotechnology and battery technologies, among others.

Just as UL has expanded its focus from the hardware and electrical aspects of technologies to now include the software that enables the connectivity of multiple products, the nature of Fernando’s role has also changed. His latest tenure in the digital health field feels like a serendipitous homecoming, given his dual passions for medicine and engineering. It is an arena that allows him to explore the opportunities and challenges associated with medical device technology in the era of big data.

“Big data is transforming every aspect of our world, including the practice of medicine. For example, genome mapping has made the early detection of diseases and disorders possible, and what we’ll see next is the personalization of medical therapies to specifically fit an individual’s particular health needs and prognostics far beyond anything we’ve seen to this point in history,” Fernando says. “Before we get there, though, it’s critical to understand and address the potential risks and unintended consequences of the big data analytics being utilized in this way, so that we’re delivering peace of mind to all persons with regard to their health and safety.”

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