A medical device recall event tracking system was designed, which can enable the users to obtain the recall, early warning and other information related to medical devices in time. The tracking system can timely obtain and release the recall information of medical devices, effectively improve the quality control of hospital medical devices, reduce the use risk of medical devices, and ensure the life safety of patients.
Humans ; Medical Device Recalls ; Product Surveillance, Postmarketing

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

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

RESULTS3093 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.

CONCLUSIONMonitoring 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.

Equipment Safety ; Medical Device Recalls ; Product Surveillance, Postmarketing ; United States ; United States Food and Drug Administration