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

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.

KEYWORDS:

• Growth
• development
• head-to-toe examination
• medical devices
• pediatric differences
• premarket assessment

Article Highlights

• The FDA CDRH defines pediatric patients as persons aged 21 years or younger at the time of their diagnosis or treatment and pediatric subpopulations are categorized into the following age groups: neonates (birth through the first 28 days of life (subpopulations by gestational age, preterm or term, and birth weight categories), infants (29 days to 2 years), children (2 to 12 years), and adolescents (12 through 21 years not including the 22nd birthday). 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.

• Children have unique needs that may be taken into consideration to adequately treat and manage them. It is important that devices for the pediatric population be available in several sizes to accommodate the various dimensions of each pediatric subpopulation and to adjust to the changing growth and development of the pediatric patient.

• In many cases, adult devices are adapted or configured to address the unmet needs of children and some devices may require reimplantation as children outgrow them, especially if they may be needed for their lifespan.

• Pediatric safety considerations may include not only physiologic effects but also developmental, behavioral, and psychosocial consequences for children.

Declaration of interest

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

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.