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“In hospitals, adverse events associated with medical devices are at least as common or even higher than drug-related adverse events.†Zhang Sumin, director of the Medical Device Department of the National Center for Adverse Drug Reaction Monitoring, quoted the information released by the U.S. Food and Drug Administration (FDA). Say.
In the United States, 450,000 people are seen in the emergency department because of injuries related to medical devices. Nearly 60,000 of them died or caused hospitalization. The United States received an average of 160,000 medical device adverse event reports each year, which may be less than the actual occurrence. 1%. According to statistics from the National Center for Adverse Drug Reaction Monitoring (ADR) in China, 366 cases of adverse events in medical devices were monitored in 2003, and 12374 cases were monitored in 2007, an increase of nearly 34 times in five years.
To control the use of medical devices, manufacturers, government administrators, users, and health care organizations are responsible. However, in China, this sense of responsibility of manufacturers is far from established. Wang Lanming, deputy director of the Department of Medical Devices of the State Food and Drug Administration, said that there are still many companies that are only passively waiting for government monitoring and notification. In pre-listing registration approval, some product risk reports do not provide substantial analysis, evaluation, and control of potential risks. After listing, companies pay more attention to sales and ignore the risk monitoring and control after the product is put on the market.
It is reported that the Ministry of Health and the State Food and Drug Administration will soon promulgate and implement the Measures for the Administration of Surveillance and Reassessment of Medical Device Adverse Events and the Administrative Measures for Recall of Medical Devices. The “Application of Medical Device Risk Management to Medical Devices†issued by the State Food and Drug Administration will also be implemented on June 1, 2009.
National Measures for Medical Device Monitoring and Recall Management to Be Promulgated
When people enjoy more health protection brought by new technology and new products of medical devices, they have to face more security risks. At the 1st China Medical Device Risk Management Symposium held in Beijing yesterday, how to make the public get more benefits when using medical devices and suffer the least harm became the focus of the delegates.