title: Device safety and effectiveness in the pediatric population: a US FDA perspective.
abstract: The US FDA recognizes that there are many challenges to ensuring that medical devices are used responsibly and safely in the pediatric population. Education plays a key role, and manufacturers and healthcare providers must be informed of medical device issues unique to the pediatric population. Healthcare workers and device manufacturers must recognize that adverse events may differ between the adult and pediatric population and among pediatric subpopulations. Risk mitigation may also differ, and heightened awareness will reduce the potential for adverse events and promote the safe use of medical devices in children.
authors.affiliation: Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Center for Devices and Radiological Health, Office of Device Evaluation, FDA, Rockville, MD 20857, USA. joy.samuels-reid@fda.hhs.gov
authors.forename: Joy
authors.initials: J
authors.lastname: Samuels-Reid
authors.forename: Judith U
authors.initials: JU
authors.lastname: Cope
authors.forename: Audrey E
authors.initials: AE
authors.lastname: Morrison
mesh_terms: D002648:Child; D004869:Equipment Safety; D004864:Equipment and Supplies; D048788:Growth and Development; D006801:Humans; D019736:Prostheses and Implants; D011933:Reagent Kits, Diagnostic; D012307:Risk Factors; D013514:Surgical Procedures, Operative; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic