The Postmarket Surveillance of Medical Devices: Meeting the Challenge

Medical Device Epidemiology and Surveillance

Volumn , Issue , 2007, Pages 483-486

  Gardner, Susan N ^a   Schultz, Daniel ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

'denominator' problem; Assessing medical device safety and user role; CDRH in monitoring marketed medical devices; Center for Education and Research on Therapeutics (CERTS); Data mining utilities; Medical Device Reporting (MDR) system; Optimally effective postmarket surveillance program; Postmarket surveillance identifying safety problems

Indexed keywords

EID: 84889499907     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470060872.ch31     Document Type: Chapter

References (4)

1. Brown SL, Bright RA, Tavris DR. Medical device epidemiology and surveillance: patient safety is the bottom line. Expert Rev Med Devices 2004; 1: 1-2.
2. O'Shea JC, Kramer JM, Califf RM, Peterson ED. Part I. Identifying holes in the safety net. Am Heart J 2004; 147: 977-984.
3. AHRQ expands therapeutics education and research network to focus on critical issues facing the healthcare system. Centers for Education and Research on Therapeutics, April 25 2006: http://www.certs.hhs.gov/whats_new/archive/20060425_01.html [accessed May 2006].
4. Schultz D. Ensuring the safety of marketed devices. Center for Devices and Radiological Health, Food and Drug Administration, January 4 2006: http://www.fda.gov/cdrh/postmarket/mdpi.html [accessed May 2006].