Affiliation: Food and Drug Administration
- Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspectiveJoy Samuels-Reid
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
Expert Rev Med Devices 9:275-82. 2012..Consideration of medical devices is particularly important in the pediatric population, who may be especially susceptible to device-related adverse events due to their smaller body size, weight and ongoing rapid growth and development...
- Device safety and effectiveness in the pediatric population: a US FDA perspectiveJoy Samuels-Reid
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
Expert Rev Med Devices 6:131-5. 2009..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...
- FDA-approved neurologic devices intended for use in infants, children, and adolescentsCarlos Pena
US Food and Drug Administration CDRH ODE, Division of General, Restorative, and Neurological Devices, 9200 Corporate Blvd, HFZ 410, Rockville, MD 20850, USA
Neurology 63:1163-7. 2004..We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors...
- Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse eventsJudith U Cope
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, Maryland 20850, USA
Pediatrics 121:e1133-8. 2008....