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Patient Ergonomics in Pediatric Settings
Published in Rupa S. Valdez, Richard J. Holden, The Patient Factor, 2021
Siddarth Ponnala, Orysia Bezpalko, Ethan Larsen, James Won
Pediatric patients have distinct and changing anatomical and physiological characteristics from their adult counterparts. These differing characteristics present several challenges to delivering health care and therefore require the support of patient ergonomics.
Pediatric ventricular assist devices: what are the key considerations and requirements?
Published in Expert Review of Medical Devices, 2020
Roland Hetzer, Mariano Francisco del Maria Javier, Eva Maria Javier Delmo
While heart transplantation has gained recognition as the gold standard therapy for advanced heart failure, the scarcity of donor organs has become an important concern. The evolution of surgical alternatives such as ventricular assist devices (VADs) has enabled recovery of the myocardium and ensured patient survival until heart transplantation becomes possible. While several device options are available for the adult population with heart failure, many of these have been unavailable for children. VADs for pediatric patients continue to lag in development. The main cause for limited device availability for pediatric applications is clear – small numbers of affected children make it difficult for manufacturers to justify the expense for development and legalization and other resources required for the limited pediatric market. Likewise, there is no heart pump with the design innovation to support dysfunctional states of heart failure and the anatomic heterogeneity of cardiac defects in pediatric patients.
Medical devices and the pediatric population – a head-to-toe approach
Published in Expert Review of Medical Devices, 2019
Joy H. Samuels-Reid, Judith U. Cope
FDA has long recognized the need for pediatric medical devices specifically designed to accommodate the unique physiology and anatomy of pediatric patients. FDA’s Center for Devices and Radiological Health (CDRH) has specific guidance for pediatric devices: Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and Food and Drug Administration Staff, 24 March 2014 [1]. The guidance defines the pediatric population as birth through 21 years of age and recognizes the varied pediatric subpopulations from neonates to adolescents. It also identifies key issues to be considered by sponsors conducting clinical trials involving pediatrics.