[Analysis of FDA medical device recall in 2005-2006].

OBJECTIVES

To analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.

METHOD

For each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.

RESULTS

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.

CONCLUSION

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.