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Ensuring the Safety and Efficacy of Medical Devices for Children

August 11, 2023

Editor’s Note: Eli Cahan is a resident physician in pediatrics at The Boston Combined Residency Program at Boston Children's Hospital and Boston Medical Center, and an investigative journalist whose work focuses on the intersection of health equity and social justice. -Rachel Y. Moon, MD, Associate Editor, Digital Media, Pediatrics

Pre-rounding on hospitalized children involves clicking through many tabs: vitals, intake and output, labs, imaging, notes, other notes, media (read: other, other notes). There’s also another tab that, in recent decades, has become increasingly routine: the LDA—or “lines, drains, and airways”—button. Other devices are more and more common, too: for example, over 1,000 ventricular assist devices were used in children between 2012-2019.

Device placement typically occurs in children with chronic, often severe illnesses—a group referred to alternatively as children with medical complexity (CMCs) or children with special healthcare needs. Over the past decade, this group has grown some 5% per year—faster than the growth rate of children as a whole. These children are likewise occupying an increasing share of pediatric hospitalizations: studies have estimated that up to 11% of hospitalized children are those with medical complexity.

Still—even as devices become increasingly common amongst children—the availability of pediatric-specific instruments has lagged. For example, one study found that adult devices were used off-label in 63% of children undergoing cardiac catheterization, despite a lack of evidence to support their efficacy or safety. A January 2023 study demonstrated that 79% of high-risk therapeutic devices do not have pediatric approval by the Food and Drug Administration; moreover, 40% of devices approved for pediatrics were based on studies that did not include a single child.

“Despite programs to increase pediatric medical device development, few devices are evaluated and approved for pediatric populations compared with adults,” the authors wrote.

To better understand the evidence base for pediatric devices, in an article being early released this week by Pediatrics with an accompanying video abstract, Quazi and colleagues analyzed nearly 500 studies regarding medical devices (10.1542/peds.2022-059842). They found that over two-thirds of studies were based in a single institution, and nearly three-quarters were open-label. The majority of studies enrolled less than 50 patients. Fewer than 20% of studies included an outcome addressing safety of the device. And, for almost 80% of studies, no results were made available for public review within 3 years from the trial start date.

“Pediatric device innovation and development lags substantially behind the advances that have been achieved for adult diseases and conditions,” the authors wrote, “[I]ncreased understanding of clinical research conducted to evaluate devices in children, including funding sources, s[t]udy design, and availability of trial findings, will serve to further inform pediatric needs in device development and clinical evidence generation.”

Clinicians interested in understanding what data do—and don’t—say about the safety and efficacy of devices commonly used in pediatrics can read more in the September issue of Pediatrics.

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