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The Scarcity of Approved Pediatric High-Risk Medical Devices.

“Children are not little adults” is a common refrain in pediatrics, intended to stress the differences in physiology, neurodevelopment, disease presentation, diagnosis, and treatment. Unfortunately, these differences between children and adults also extend to how we fund our systems of care and innovation. Although individuals younger than 18 years represent nearly one-quarter of the US population, less than 12% of the National Institutes of Health budget funds pediatric research, and less than 10% of all health care spending is for pediatrics.1,2 Pediatric medical devices, which are critical tools for the diagnosis and treatment of disease in children, also are affected by this disparity and have long lagged behind their adult counterparts in terms of availability, options, and innovation.3 The result of this has been that for certain diseases, children have either no device options, inadequate options, or adult devices that are modified and used off-label with little or no safety or efficacy data for their use in pediatrics. The study by Lee et al4 provides us with an interesting opportunity to quantify this gap among the highest risk medical devices: class III devices requiring a premarket approval (PMA). The US Food and Drug Administration (FDA) defines these high-risk devices as those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury,”5 and include such products as pacemakers, defibrillators, implanted prosthetics, and high-frequency ventilators.4 To better understand which currently approved devices include a pediatric indication, Lee et al4 leveraged the OpenFDA application programming interface to access all publicly available PMA documents and then used natural language processing to abstract data from thousands of documents. They identified 102 unique devices with an explicit pediatric indication, with most of these indicated in older children and adolescents. (For a sense of scale, the OpenFDA database contains thousands of PMA documents dating back to 1976.) Only 42 devices were indicated for infants and neonates. Cardiology, ophthalmology, and clinical chemistry were the clinical specialties most commonly associated with devices. These results do not imply that there are only 102 pediatric devices approved by the FDA. As Lee et al4 point out in their discussion of limitations, there are several factors that potentially contribute to missed devices. Some devices designed specifically for pediatrics do not actually mention a pediatric patient population, even though the device treats a pediatric-specific condition (see the authors’ discussion of the Amplatzer Piccolo Occluder). They also did not include devices approved through the Humanitarian Device Exemption (HDE) pathway, which accounts for a substantial number of high-risk pediatric devices. Finally, their search and identification strategy requires the presence of certain key words in the PMA document, so devices intended for pediatrics that did not use those key search terms would not have been included in the study. Despite these limitations, the overall results are consistent with other reports on the lack of high-risk devices with pediatric indications. Hwang at al3 were only able to identify 22 devices with pediatric indications among all approved PMAs and HDEs from 2008 to 2011, and only 1 of those had been studied in children younger than 18 years. An internal analysis done by the FDA in 2018 found that only 18 of 66 devices that received a PMA or HDE approval in 2017 had a pediatric indication in their labeling.6 Interestingly, an internal panel of pediatric experts reviewed those same PMAs and found that 42 of the remaining 48 devices with an adult-only indication had the potential to be used in pediatrics.6 Taken together, it would be reasonable to conclude that the innovative methods of Lee et al4 + Related article