Most medical devices have not been designed or tested for pediatric indications and are instead repurposed for use in children from adult applications.1 Such off-label use of medical devices does not account for the unique anatomy and physiology of pediatric patients, and clinical evidence on the effectiveness and safety of such interventions is often lacking.2,3
Wunnava S, Miller TA, Narang C, Nathan M, Bourgeois FT. US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021. JAMA. 2022;328(6):580–582. doi:10.1001/jama.2022.10041
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