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Medical devices and the pediatric population - a head-to-toe approach
Joy H Samuels-Reid1, Judith U Cope2
1a Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices & Radiological Health, Food and Drug Administration , Silver Spring , MD , USA.
Insights
Pediatric patients have unique medical device needs due to growth and developmental differences. Adapting adult devices or designing new ones requires awareness of these variations for safe and effective use in children and adolescents.
Area of Science:
- Pediatric medical device use
- Biomedical engineering
- Developmental pediatrics
Background:
- Pediatric patient assessment differs significantly from adult assessment.
- The pediatric population exhibits heterogeneity in growth and development across organ systems.
- Understanding inter- and intra-subpopulation differences is crucial for pediatric care.
Purpose of the Study:
- To highlight key differences in medical device use between pediatric patients and adults.
- To review considerations for medical device application in the pediatric population based on organ systems.
- To emphasize unique physiological and maturational differences impacting device use.
Main Methods:
- A head-to-toe approach, mirroring clinical physical examinations, was used for comparison.
- A comprehensive search of the English medical literature was conducted using PubMed and EMBASE.
- Articles reporting medical device use in pediatric populations, categorized by organ system, were identified and reviewed.
Main Results:
- Children and adolescents have distinct medical device requirements compared to adults.
- Adult medical devices are frequently modified or adapted for pediatric use.
- Physiological and maturational variations necessitate specific considerations for pediatric device application.
Conclusions:
- Medical device needs in pediatrics are unique and often unmet by standard adult devices.
- Clinicians, manufacturers, and designers must recognize the diverse pediatric subpopulations (neonates to adolescents).
- Adjustments in device design and application are essential for ensuring safe and effective use in pediatric patients.
Abstract:
Introduction: This review uses a head-to-toe approach, a standardized approach similar to the format used by clinicians during the physical examination, to highlight important differences between children, adolescents and adults. The assessment of a pediatric patient is significantly different from an adult and the heterogeneity of the pediatric population requires knowledge of the inter- and intra-subpopulation differences in growth and development for all organ systems. Areas covered: A search of the English medical literature (PubMed and EMBASE) resulted in identification and review of articles that reported medical device use in the pediatric population based on specific organ systems. The review highlights unique considerations for the pediatric population with respect to growth and development as well as important physiologic and maturational differences between children and adults pertaining to the use of medical devices. Expert opinion: Children have unique medical device needs; adult devices are often adapted or configured to address these unmet needs. It is important that clinicians, and those who manufacture and design medical devices for the pediatric population, have a heightened awareness of the varied pediatric subpopulations (neonates to adolescents) with respect to growth and development, and the adjustments needed to ensure safe and effective use of devices for their unique needs.
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