Postmarketing surveillance of medical devices - Filling in the gaps

New England Journal of Medicine

Volumn 366, Issue 10, 2012, Pages 875-877

  Resnic, Frederic S ^a   Normand, Sharon Lise T ^b,c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE OUTCOME; BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL EFFECTIVENESS; CORONARY STENT; DEFIBRILLATOR; HEART ASSIST DEVICE; HEART VALVE PROSTHESIS; HUMAN; IMPLANT REGISTRY; LIFE CYCLE ASSESSMENT; MANDATORY REPORTING; PATIENT MONITORING; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RISK ASSESSMENT; RISK FACTOR; SHORT SURVEY; TOTAL QUALITY MANAGEMENT;

EID: 84857828102     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1114865     Document Type: Article

References (4)

1. Normand S-L, Marinac-Dabic D, Sedrakyan A, Kaczmarek R. Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty. Med Care 2010;48:Suppl:S58-S67.
2. Gross TP, Kessler LG. Medical device vigilance at FDA. Stud Health Technol Inform 1996;28:17-24. (Pubitemid 126156815)
3. Miller MA, Ulisney K, Baldwin JT. INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support): a new paradigm for translating registry data into clinical practice. J Am Coll Cardiol 2010;56:738-40.
4. Resnic FS, Gross TP, Marinac-Dabic D, et al. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA 2010;304:2019-27.