Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective

Joy Samuels-Reid Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device EvaluationCenter for Devices and Radiological Health, US FDA, White Oak – Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. [email protected]; Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device EvaluationCenter for Devices and Radiological Health, US FDA, White Oak – Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. [email protected]

Brenda Lawrence Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA; Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA

Courtney Millin Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA; Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA

Judith Cope Office of Pediatric Therapeutics, Office of the Commissioner, US FDA, Silver Spring, MD, USA; Office of Pediatric Therapeutics, Office of the Commissioner, US FDA, Silver Spring, MD, USA

Abstract

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.

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Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement in any organization or entity with financial interest in or financial conflict with the subject matter or materials discussed with the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

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Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective

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Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective

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