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

: 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. : 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.

Pediatric medical devices: a look at significant US legislation to address unmet needs.

There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials.

Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.

Background: Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S.