Literature

Relevant articles are listed here. You are welcome to indicate contributions that can be included. Please send an email.

Pediatric Medical Devices

Review

Tüshaus L, von Sengbusch S, Worringen U, Herting E, Wünsch L, Frielitz F. (2018). Medizinprodukte für Kinder- und Jugendliche: Ein „Niemandsland“ (Pediatric Medical Devices: A "no man's land"). Deutsches Ärzteblatt. 2018.
https://www.aerzteblatt.de/pdf.asp?id=202835 

Innovation

Fischer GA, Wells SM, Rebuffoni JF, Peterson BM, LeBien TW. A model for overcoming challenges in academic pediatric medical device innovation. J Clin Transl Sci. 2019.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676500/ 

Fleurence RL, Forrest CB, Shuren J. Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data. J Pediatr. 2019.
https://www.ncbi.nlm.nih.gov/pubmed/31378521 

Regulatory Affairs

Off Label Medicine Use

Knopf H, Wolf, IK, Sarganas G, Zhuang W, Rascher W, Neubert A. Off-labelmedicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health 13. 2013.
https://www.ncbi.nlm.nih.gov/pubmed/23822744 

Wimmer S, Rascher W, McCarthy S, Neubert A. The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans. Paediatr Drugs. 2014.
https://www.ncbi.nlm.nih.gov/pubmed/25056717 

EU

Dooms, MM. Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive? Orphanet J Rare Dis. 2016.
https://www.ncbi.nlm.nih.gov/pubmed/26939863 

Worringen, U. The Humanitarian Device Exemption of the United States as a Pioneering Concept in Orphan Device Regulation and its Implications for the Policy of the Regulation of Medical Devices for Small Populations in the European Union. Wissenschaftliche Prüfungsarbeit zum „Master of Drug Regulatory Affairs“, Bonn. 2015.
https://dgra.de/media/pdf/studium/masterthesis/master_worringen_u.pdf 

FDA

Bleicher EW. Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context. Food Drug Law J. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/19999642 

Dolcimascolo F. Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions. J Cardiovasc Transl Res. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/20559980 

Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531281/ 

Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act. JAMA Pediatr. 2019.
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/30452498/ 

Jenkins KJ, Beekman RH, Vitale MG, Hennrikus WL, Minich LL, Ackerman MJ, Berger S, Jaquiss RD, Mahle WT, Marino BS, Vincent JA, Morrow WR, Otsuka NY, Abzug JM, Ganley TJ, Herman MJ, Hyman JE, Segal LS, Shaw BA, Schwend RM. Off-Label Use of Medical Devices in Children. Pediatrics. 2017.
https://www.ncbi.nlm.nih.gov/pubmed/28025239 

Samuels-Reid J, Cope JU, Morrison AE. Device safety and effectiveness in the pediatric population: a US FDA perspective. Expert Rev Med Devices. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/19298160 

Samuels-Reid J, Lawrence B, Millin C, Cope J. Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective. Expert Rev Med Devices. 2012.
https://www.ncbi.nlm.nih.gov/pubmed/22702258 

Samuels-Reid J  Blake ED. Pediatric medical devices: a look at significant US legislation to address unmet needs. Expert Review of Medical Devices. 2014.
https://www.ncbi.nlm.nih.gov/pubmed/24387679 

Ulrich LC, Joseph FD, Lewis DY, Koenig, RL. FDA's pediatric device consortia: national program fosters pediatric medical device development. Pediatrics. 2013.
https://www.ncbi.nlm.nih.gov/pubmed/23569100 

Medical

Neonatology

Fuerch JH, Sanderson P, Barshi I, Liley H. Developing safe devices for neonatal care. Semin Perinatol. 2019.
https://www.ncbi.nlm.nih.gov/pubmed/31662216 

Pediatric Cardiology

Almond CS. The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician. Prog Pediatr Cardiol. 2012.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363973/

Beekman RH, Duncan BW, Hagler DJ, Jones TK, Kugler JD, Moore JW, Jenkins KJ; Workgroup on Pediatric Cardiac Devices, Section on Cardiology and Cardiac Surgery, American Academy of Pediatrics. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions. Pediatrics. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/19564262 

Almond CS, Chen EA, Berman MR, Less JR, Baldwin JT, Linde-Feucht SR, Hoke TR, Pearson GD, Jenkins K, Duncan BW, Zuckerman BD. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices. ASAIO J. 2007.
https://www.ncbi.nlm.nih.gov/pubmed/17237642

Joseph F. Pediatric cardiovascular device registries--the need for such data and the potential impact. J Cardiovasc Transl Res. 2010.
https://www.ncbi.nlm.nih.gov/pubmed/20585915 

Liberski AR, Butcher JT, Nawrat Z, Golesworthy T, Al Thani DA. Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients. Translational Medicine Communications. 2019.
https://link.springer.com/article/10.1186/s41231-019-0046-3 

Sutherell JS, Hirsch R, Beekman RH. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/20136851 

Pediatric Orthopedics

Sheha ED, Hammouri Q, Snyder BD, Campbell RM, Vitale MG; POSNA/SRS Task Force for Pediatric Medical Devices. Off-label use of pediatric orthopaedic devices: important issues for the future. J Bone Joint Surg Am. 2014.
https://www.ncbi.nlm.nih.gov/pubmed/24500593 

Pediatric Radiology

Daldrup-Link HE, Sammet C, Hernanz-Schulman M, Barsness KA, Cahill AM, Chung E, Doria AS, Darge K, Krishnamurthy R, Lungren MP, Moore S, Olivieri L, Panigrahy A, Towbin AJ, Trout A, Voss S. White Paper on P4 Concepts for Pediatric Imaging. J Am Coll Radiol. 2016.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4860067/

Pediatric Surgery

Gauderer MW. Creativity and the surgeon. J Pediatr Surg. 2009.
https://www.ncbi.nlm.nih.gov/pubmed/19159713

Rothenberg SS. Developing neonatal minimally invasive surgery: Innovation, techniques, and helping an industry to change. J Pediatr Surg. 2015.
https://www.ncbi.nlm.nih.gov/pubmed/25638608

Sack BS, Elizondo RA, Huang GO, Janzen N, Espinoza J, Sanz-Cortes M, Dietrich JE, Hakim J, Richardson ES, Oden M, Hanks J, Haridas B, Hury JF, Koh CJ. Pediatric medical device development by surgeons via capstone engineering design programs. J Pediatr Surg. 2018.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5545169/

Pediatric Urology

Grant M, Stanasel I, Koh CJ. Pediatric medical device consortia: a novel pathway for pediatric device development for pediatric urologists and other pediatric specialists. Urology Practice, 2015.
https://www.sciencedirect.com/science/article/abs/pii/S2352077914002088