Allied Health Professions

Download Safe Medical Devices for Children by Institute of Medicine, Board on Health Sciences Policy, PDF

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

Cutting edge clinical units have helped decrease the load of sickness and harm and increase the standard of lifestyles for numerous childrens. Mechanical ventilators and different breathing aid units rescue hundreds of thousands of fragile newborns each year. young ones who as soon as may have died of congenital center stipulations live on by way of implanted pacemakers, mechanical middle valves, and units that shut holes within the middle. Responding to a Congressional request, the Institute of medication assesses the method for postmarket surveillance of scientific units used with youngsters. The booklet in particular examines: the foodstuff and drug administration's tracking and use of difficult occasion stories; the agency's tracking of brands' achievement of commitments for postmarket stories ordered on the time of a device's popularity of advertising; the adequacy of postmarket reviews of implanted units to judge the consequences of kid's energetic life and their progress and improvement on machine functionality; and postmarket surveillance of scientific units used with teenagers is a bit investigated subject, partially as the marketplace for such a lot clinical items is targeted between older adults. but young ones vary from adults, and their detailed features have implications for evaluate and tracking of the quick- and long term security and effectiveness of clinical units used with younger sufferers.

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Appendixes E and F present case studies of surveillance issues related to two complex devices—cerebrospinal fluid shunts and cochlear implants. The final appendixes provide a glossary and committee biographies. 27 INTRODUCTION SELECTED CONCEPTS AND DEFINITIONS Discussions of medical device regulation are replete with legal and technical terminology that is unfamiliar to most audiences but reflects the complexity of medical products and their regulation. This section defines a number of terms found in the study’s statement of task as well as some related terms.

As a case in point, disturbances in cardiorespiratory function at young ages may have lifelong neurological consequences, which is an argument for early intervention as well as for long-term monitoring of the consequences of device use and other interventions that may create such disturbances. ” For example, some devices for treatment of scoliosis are used in conjunction with a spinal fusion process that limits further growth of the spine and surrounding structures, including the rib cage. In young children, such a limitation in thoracic growth can even prove fatal if the lungs are unable to grow and develop sufficiently.

3: As a resource for itself and others, FDA should create or collaborate with others to create a registry of relevant registries, that is, a database with information about registries that are either device specific or that have the potential to provide information useful in evaluating device safety and effectiveness. 4: As part of a public commitment to postmarket surveillance of device safety, the Center for Devices and Radiological Health should have its own extramural research program to support studies using external data sources.

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