Strengthening medical device postmarket safety surveillance

JAMA Internal Medicine

Volumn 175, Issue 8, 2015, Pages 1350-1351

  Ross, Joseph S ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE RECALL; DEVICE SAFETY; EDITORIAL; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; HEALTH CARE SYSTEM; HEALTH INSURANCE; HEART VENTRICLE ARRHYTHMIA; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; MEDICAL DEVICE; PACEMAKER; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; SUDDEN CARDIAC DEATH; BRAIN HEMORRHAGE; CARDIAC RESYNCHRONIZATION THERAPY DEVICE; DEVICE FAILURE; ETIOLOGY; FEMALE; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; MALE; MORTALITY; PNEUMONIA; SUDDEN DEATH;

CARDIAC RESYNCHRONIZATION THERAPY DEVICES; DEATH, SUDDEN; DEFIBRILLATORS, IMPLANTABLE; EQUIPMENT FAILURE; FEMALE; HUMANS; INTRACRANIAL HEMORRHAGES; MALE; PNEUMONIA; TACHYCARDIA, VENTRICULAR; VENTRICULAR FIBRILLATION;

EID: 84939863198     PISSN: 21686106     EISSN: 21686114     Source Type: Journal    
DOI: 10.1001/jamainternmed.2015.2650     Document Type: Editorial

References (6)

1. Center for Devices and Radiological Health, US Food and Drug Administration. Strengthening our national system for medical device postmarket surveillance. Published September 2012. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM301924.pdf. Accessed April 22, 2015.
2. Center for Devices and Radiological Health, US Food and Drug Administration. Strengthening our national system for medical device postmarket surveillance: update and next steps. Published April 2013; http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf. Accessed April 22, 2015.
3. Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2014;174(11):1773-1779.
4. Rising J, Moscovitch B. The Food and Drug Administration's Unique Device Identification System: better postmarket data on the safety and effectiveness of medical devices. JAMA Intern Med. 2014;174(11):1719-1720.
5. Hauser RG. Here we go again: failure of postmarketing device surveillance. N Engl J Med. 2012;366(10):873-875.
6. Tseng ZH, Hayward RM, Clark NM, et al. Sudden death in patients with cardiac implantable electronic devices [published online June 22, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.2641.