Badly designed devices caused 320,000 medical problems

Source:Global Times Published: 2016-5-28 1:13:01

More than 320,000 adverse events caused by medical devices were reported to the government nationwide in 2015, a 21.1 percent rise from 2014, according to an annual report released by the China Food and Drug Administration on Friday.

Among all the adverse events, 184 were fatal, while 47,000 cases have allegedly caused severe damage to the patients' health, the report said.

According to the report, these two types of grave incidents account for 14.7 percent of the total reports, and the number of severe cases has increased 15.2 percent from last year. Disposable syringes, IUDs, monitors, and infusion and injection pumps were particularly likely to be dangerous.

Only 17.5 percent of the adverse events were reported by the manufacturers themselves, whom the report blamed for their lack of responsibility.

The report stressed that adverse events caused by medical devices are different from regular failures, resulting from poor design rather than a lack of quality control.



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