Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective.
Medical devices are often overlooked as a contributor to adverse events. In clinical practice, physicians are aware of the potential for adverse effects from drug products, which are routinely included in differential diagnoses of patients' presenting complaints. However, physicians may not always consider that the use, misuse or malfunction of a medical device, and/or its components, may result in a patient's presenting signs and symptoms or lack of improvement. 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.
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. joy.samuels-reid@fda.hhs.gov
Joy
J
Samuels-Reid
Brenda
B
Lawrence
Courtney
C
Millin
Judith
J
Cope
D049628:Body Size; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D018795:Device Approval; D003937:Diagnosis, Differential; D004864:Equipment and Supplies / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics / Q000379:methods*; D012306:Risk; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration