Advanced search
Publication Cover
Expert Review of Medical Devices Volume 9, 2012 - Issue 3
Submit an article Journal homepage
104
Views
3
CrossRef citations to date
0
Altmetric
Review

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective

Joy Samuels-Reid Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device EvaluationCenter for Devices and Radiological Health, US FDA, White Oak – Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. [email protected]; Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device EvaluationCenter for Devices and Radiological Health, US FDA, White Oak – Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. [email protected]
,
Brenda Lawrence Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA; Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA
,
Courtney Millin Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA; Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US FDA, Silver Spring, MD, USA
&
Judith Cope Office of Pediatric Therapeutics, Office of the Commissioner, US FDA, Silver Spring, MD, USA; Office of Pediatric Therapeutics, Office of the Commissioner, US FDA, Silver Spring, MD, USA
Pages 275-282 | Published online: 09 Jan 2014

References

  • Samuels-Reid J, Cope JU, Morrison AE. Device safety and effectiveness in the pediatric population: a US FDA perspective. Expert Rev. Med. Devices 6(2), 131–135 (2009).
  • 1998 US Congress Federal Food, Drug, and Cosmetic Act. Sec. 201 [321] [21 UC. § 321(h)] (1998).
  • Pediatric Medical Device Safety and Improvement Act of 2007 also known as the Food and Drug Administration Amendments Act of 2007 (FDAAA) Public Law 110-85. Sec. 303 (2007).
  • Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices. US FDA, MD, USA, 14 May 2004.
  • Draft Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design. US FDA, MD, USA, 22 June 2011.
  • Rutala WA, Weber DJ; Healthcare Infection Advisory Committee (HICPAC). Guidelines for Disinfection and Sterilization in Healthcare Facilities. Centers for Disease Control and Prevention, GA, USA (2008).
  • Lyon SM, Given M, Marshall NL. Interventional radiology in the provision and maintenance of long-term central venous access. J. Med. Imaging Radiat. Oncol. 52(1), 10–17 (2008).
  • Stokowski LA. A primer on apnea of prematurity. Adv Neonatal care. 5(3), 155–170 (2005).
  • Maurer J, Marangos N, Ziegler E. Reliability of cochlear implants. Otolaryngol. Head. Neck Surg. 132(5), 746–750 (2005).
  • Reefhuis J, Honein MA, Whitney CG et al. Risk of bacterial meningitis in children with cochlear implants. N. Engl. J. Med. 349(5), 435–445 (2003).
  • Rubin LG, Papsin B; Committee on Infectious Diseases and Section on Otolaryngology-Head and Neck Surgery. Cochlear implants in children: surgical site infections and prevention and treatment of acute otitis media and meningitis. Pediatrics 126(2), 381–391 (2010).
  • Eakle M, Gallauresi BA, Morrison A. Luer-lock misconnects can be deadly. Nursing 35(9), 73 (2005).
  • Millin CJ, Brooks M. Reduce-and report-enteral feeding tube misconnections. Nursing 40(11), 59–60 (2010).
  • Kunac DL, Reith DM. Identification of priorities for medication safety in neonatal intensive care. Drug Saf. 28(3), 251–261 (2005).
  • Maisels MJ, McDonagh AF. Phototherapy for neonatal jaundice. N. Engl. J. Med. 358(9), 920–928 (2008).
  • Walters TP. Pulse oximetry knowledge and its effects on clinical practice. Br. J. Nurs. 16(21), 1332–1340 (2007).
  • Brenner D, Elliston C, Hall E, Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR. Am. J. Roentgenol. 176(2), 289–296 (2001).
  • American College of Radiology. One size does not fit all: reducing risks from pediatric CT. ACR Bull. 57, 20–23 (2001).
  • Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA 294(12), 1541–1543 (2005).
  • McCarthy PW, Heusch AI. The vagaries of ear temperature assessment. J. Med. Eng. Technol. 30(4), 242–251 (2006).
  • Cope J, Gross T. Pediatric medical device use. In: Medical Device Epidemiology and Surveillance. Brown S, Bright R, Tavris D (Eds). John Wiley & Sons Ltd, Chichester, UK, 203–218 (2007).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.