Literature DB >> 31195845

Medical devices and the pediatric population - a head-to-toe approach.

Joy H Samuels-Reid1, Judith U Cope2.   

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.

Entities:  

Keywords:  Growth; development; head-to-toe examination; medical devices; pediatric differences; premarket assessment

Mesh:

Year:  2019        PMID: 31195845     DOI: 10.1080/17434440.2019.1629285

Source DB:  PubMed          Journal:  Expert Rev Med Devices        ISSN: 1743-4440            Impact factor:   3.166


  2 in total

1.  Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.

Authors:  Samuel J Lee; Lauren Cho; Eyal Klang; James Wall; Stefano Rensi; Benjamin S Glicksberg
Journal:  JAMA Netw Open       Date:  2021-06-01

Review 2.  Medical Device Development for Children and Young People-Reviewing the Challenges and Opportunities.

Authors:  Paul Dimitri; Valeria Pignataro; Mariangela Lupo; Donato Bonifazi; Maria Henke; Umberto M Musazzi; Floris Ernst; Paola Minghetti; Davide F Redaelli; Sophia G Antimisiaris; Giovanni Migliaccio; Fedele Bonifazi; Luca Marciani; Aaron J Courtenay; Nunzio Denora; Angela Lopedota
Journal:  Pharmaceutics       Date:  2021-12-17       Impact factor: 6.321

  2 in total

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