MedWatch: FDA's new medical products reporting program

Journal of Clinical Engineering

Volumn 18, Issue 6, 1993, Pages 489-492

  Kessler, David A ^a   Kennedy, Dianne L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INTERACTIONS; DRUG THERAPY; MONITORING; PHARMACODYNAMICS;

CLINICAL ENGINEERS; MEDWATCH PROGRAM; SIDE EFFECTS; SURVEILLANCE;

DRUG PRODUCTS;

BIOMEDICAL TECHNOLOGY ASSESSMENT; DOCUMENTATION; FOOD AND DRUG ADMINISTRATION; MARKETING; MEDICAL INSTRUMENTATION; REVIEW; SAFETY;

BIOMEDICAL ENGINEERING; EQUIPMENT FAILURE; EQUIPMENT SAFETY; MAINTENANCE AND ENGINEERING, HOSPITAL; ORGANIZATIONAL OBJECTIVES; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0027692831     PISSN: 03638855     EISSN: 15503275     Source Type: Journal    
DOI: 10.1097/00004669-199311000-00009     Document Type: Article

References (9)

1. Kessler, D.A. (1992), Introducing MedWatch, Journal of American Medical Association, 269:2765-2768.
2. Stehlin, D. (1992), When rubber rubs the wrong way, FDA Consumer, 8:17-21.
3. U.S. General Accounting Office (1986), Medical devices: Early warning of problems is hampered by severe underreporting, PEMD, 1:62-63.
4. U.S. General Accounting Office (1990), Medical devices: Underreporting of serious problems with a home apnea monitor, PEMD, 17:6-7.
5. Press, R.I. and Peebles, C.L. (1992), Antinuclear autoantibodies in women with silicone breast implants, Lancet, 340:1304-1307.
6. FDA (1993), Hazards of heated-wire breathing circuits, FDA Safety Alert, Center for Devices and Radiological Health, Rockville, MD, July 14.
7. FDA (1993), Fluoride contamination of hemodialysis water supply, FDA Safety Alert, Center for Devices and Radiological Health, Rockville, MD, August 19.
8. FDA (1993), Unsafe patient lead wires and cables, FDA Safety Alert, Center for Devices and Radiological Health, Rockville, MD, September 3.
9. FDA (1993), Hazards of volume ventilators and heated humidifiers, FDA Safety Alert, Center for Devices and Radiological Health, Rockville, MD, September 15.