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Safety of cardiac devices in children

Publication ,  Journal Article
Corey, KM; Li, JS; Pasquali, SK; Hill, KD
Published in: Progress in Pediatric Cardiology
May 1, 2012

Implanted cardiac devices have improved and prolonged the lives of countless children. Some of these devices have undergone vigorous pre-market assessment and are US Food and Drug Administration (FDA) approved for use in children; however, many devices are used "off label" following approval in adults. The potential for unrecognized and/or under-estimated long term complications is a very real concern, particularly in children where there are unique constraints related to growth, development and need for prolonged device longevity. Long-term oversight is necessary to identify rare and unanticipated device related complications. Current systems include FDA surveillance via adverse event reporting databases and mandated post-approval studies, as well as device related registries. Adverse event reporting databases have provided important information on rare device-related complications but are hampered by a documented very low rate of reporting. Recently several large registries have been developed to track outcomes, however, registries are inherently more effective at tracking short-term safety and efficacy. Looking forward, it is incumbent on physicians, regulatory agencies, and manufacturers to recognize the potential for rare, but serious, device-related complications and to report such complications to established registries and FDA surveillance databases. © 2012 Elsevier Ireland Ltd.

Duke Scholars

Published In

Progress in Pediatric Cardiology

DOI

ISSN

1058-9813

Publication Date

May 1, 2012

Volume

33

Issue

2

Start / End Page

111 / 114

Related Subject Headings

  • Cardiovascular System & Hematology
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

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Corey, K. M., Li, J. S., Pasquali, S. K., & Hill, K. D. (2012). Safety of cardiac devices in children. Progress in Pediatric Cardiology, 33(2), 111–114. https://doi.org/10.1016/j.ppedcard.2012.02.003
Corey, K. M., J. S. Li, S. K. Pasquali, and K. D. Hill. “Safety of cardiac devices in children.” Progress in Pediatric Cardiology 33, no. 2 (May 1, 2012): 111–14. https://doi.org/10.1016/j.ppedcard.2012.02.003.
Corey KM, Li JS, Pasquali SK, Hill KD. Safety of cardiac devices in children. Progress in Pediatric Cardiology. 2012 May 1;33(2):111–4.
Corey, K. M., et al. “Safety of cardiac devices in children.” Progress in Pediatric Cardiology, vol. 33, no. 2, May 2012, pp. 111–14. Scopus, doi:10.1016/j.ppedcard.2012.02.003.
Corey KM, Li JS, Pasquali SK, Hill KD. Safety of cardiac devices in children. Progress in Pediatric Cardiology. 2012 May 1;33(2):111–114.
Journal cover image

Published In

Progress in Pediatric Cardiology

DOI

ISSN

1058-9813

Publication Date

May 1, 2012

Volume

33

Issue

2

Start / End Page

111 / 114

Related Subject Headings

  • Cardiovascular System & Hematology
  • 1102 Cardiorespiratory Medicine and Haematology