Analysis of FDA medical device recall in 2005-2006 / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 280-283, 2011.
Article
in Chinese
| WPRIM
| ID: wpr-330460
ABSTRACT
<p><b>OBJECTIVES</b>To analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.</p><p><b>METHOD</b>For each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.</p><p><b>RESULTS</b>3093 reports were identified; the recalling reasons of the three classes were significantly different. It is found that the main recall reason for medical material is package problems (39%) and design defectiveness (19%), for medical tools are design defectiveness (27%) and package problems (26%), and for medical equipment are design defectiveness (45%) and system failures (39%). The number of software recalled is 109. The main recall reason for high risk equipment is design defectiveness, and the I class level of high risk equipment recalled was decline in 2006 compared to that in 2005.</p><p><b>CONCLUSION</b>Monitoring and application of medical device recall information should be strengthened, and the objective law of medical device safety issue should be summed up, in order to provide reference for supervision of medical device.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Product Surveillance, Postmarketing
/
United States
/
United States Food and Drug Administration
/
Equipment Safety
/
Medical Device Recalls
Country/Region as subject:
North America
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2011
Type:
Article
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