The annual Smart Monitoring meeting features many new technologies for critical care. This year, the FDA keynoted the regulatory clearance process for critical care decision support devices featuring the Burn Navigator as a case study.
Suzanne Schwartz, MD, MBA, lead reviewer of the 510(k) submission: “On a personal note, as a surgeon trained in burn trauma management and having been a clinical researcher in the field for many years, I’d be hard pressed to identify for myself a greater professional reward to date, than seeing this technology come to fruition and made commercially available to our injured population. And for that, I have all of you on the panel to thank as colleagues who were instrumental in championing this effort.”
Kevin Chung, MD, Medical Director of Burn ICU at USAISR, provided the background of why the Burn Navigator was developed originally. Maria Serio-Melvin, RN, MS, described the Human Factors testing process required to ensure the device was straight-forward, safe, and easy to use.