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By Institute of Medicine, Board on Health Sciences Policy, Committee on Postmarket Surveillance of Pediatric Medical Devices, Hugh Tilson, Marilyn J. Field

Leading edge scientific units have helped decrease the weight of disorder and harm and increase the standard of lifestyles for numerous young children. Mechanical ventilators and different respiration aid units rescue hundreds of thousands of fragile newborns each year. young ones who as soon as could have died of congenital center stipulations live to tell the tale due to implanted pacemakers, mechanical center valves, and units that shut holes within the center. Responding to a Congressional request, the Institute of drugs assesses the method for postmarket surveillance of scientific units used with little ones. The publication in particular examines: the meals and drug administration's tracking and use of inauspicious occasion stories; the agency's tracking of brands' achievement of commitments for postmarket experiences ordered on the time of a device's acclaim for advertising; the adequacy of postmarket experiences of implanted units to judge the consequences of kid's energetic life and their progress and improvement on gadget functionality; and postmarket surveillance of clinical units used with teenagers is a bit investigated subject, partly as the marketplace for so much clinical items is targeted between older adults. but teenagers vary from adults, and their distinct features have implications for assessment and tracking of the fast- and long term security and effectiveness of clinical units used with younger sufferers.

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FDA’s authority to order postmarket studies is limited. It cannot require studies as a condition of clearing devices for which the more extensive premarket approval process is not required. In addition, for devices that have already been approved or cleared, the agency cannot require studies to last more than 3 years. For children, some important developmental consequences may not be evident within that period. 5: Congress should amend Section 522 of the Federal Food, Drug, and Cosmetic Act to • permit FDA to order postmarket studies as a condition of clearance for the categories of devices for which Section 522 Postmarket Surveillance studies are now allowed and • allow FDA to tailor the duration of Section 522 studies of devices likely to have significant pediatric use so that studies can take into account children’s growth and development and, if appropriate, exceed the current 3-year limit on study length.

A death due to the incorrect setting of an infusion pump for chemotherapy is both an adverse outcome and an adverse event. The charge to the committee refers to adverse reactions, but FDA refers to adverse events. 5 Adverse events are sometimes defined to include events that have the potential to cause harm, such as close calls or near misses that could have resulted in harm but did not. To cite an example, when a device malfunc- 5The Joint Commission on the Accreditation of Healthcare Organizations uses another term, “sentinel event,” by which it means “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof” and requiring prompt investigation (JCAHO, 2005a, unpaged).

2001; Basse, 2003) Through the determined creativity of single individuals such as John Holter and the contributions of organized teams of medical and engineering researchers, advances in biomedical science and engineering—combined with achievements in public health—have brought innumerable benefits to millions of children and their families and communities. Notably, in addition to improved sanitation and nutrition, the development of vaccines to prevent common childhood diseases and antibiotics to treat infections have saved the lives of countless children.

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