Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection

Author:

Beck Adam W.,Lombardi Joseph V.,Abel Dorothy B.,Morales J. Pablo,Marinac-Dabic Danica,Wang Grace,Azizzadeh Ali,Kern John,Fillinger Mark,White Rodney,Cronenwett Jack L.,Cambria Richard P.

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine,Surgery

Reference23 articles.

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2. Eastern Research Group. Unique Device Identification (UDI) for Medical Devices. Final Report. Available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM320179.pdf. Accessed May 16, 2016.

3. Daniel GW, McClellan MB, Gardina S. Unique Device Identifiers (UDIs): a roadmap for effective implementation, 2014. Available at: https://www.brookings.edu/research/unique-device-identifiers-udis-a-roadmap-for-effective-implementation/. Accessed May 16, 2016.

4. Daniel GW, McClellan MB, Colvin H, Khaterzai S, Aurora P. Strengthening patient care: building an effective national medical device surveillance system. Engleberg Center for Health Care Reform at Brookings. http://www.brookings.edu/∼/media/research/files/papers/2015/02/23-medical-device-policy-surveillance/med-device-report-web.pdf. Accessed May 16, 2016.

5. The Mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system;Drozda;Healthc (Amst),2016

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