National medical device monitoring and management of recall promulgated

People enjoy the medical equipment and new technology, new product brings more health security, they have to face additional security risk.

Recently in Beijing the first Chinese medical risk management workshop, how to make the public in the use of medical devices is greater benefits, take minimum of injuries, etc., become the focus of attention of the participants.

"In the hospital, and medical device-related adverse events associated with the drugs at least and adverse events as General or even higher.

"National ADR medical equipment Department officer of United States food and Drug Administration-reference (FDA) published information. United States a year 45 million people suffer and medical device-related injuries see emergency, nearly 6 million deaths or cause hospitalization; United States average received 16 million medical device adverse event reports, this may be less than the actual occurrence of 1%. China's national ADR statistics show that as China's monitoring capabilities, 2003 medical device adverse event monitoring to 366, 2007 monitoring to 12374 cases, five-year growth of nearly 34 times. Control the risk of the use of medical devices, manufacturers, government administrators, users, and is the responsibility of the healthcare institutions, etc. But in our country, the manufacturer of that responsibility was not set. State food and Drug Administration medical Scarlett O'Hara said the Deputy Director of the Division, as well as numerous enterprises just passively waiting for the Government's monitoring and notifications. Registration and approval prior to listing, a number of product risk report lack of potential risk of substantive analysis, evaluation and control; post-marketing, companies pay more attention to sales, ignored the product marketed by the risk monitoring and control. It is reported that the Ministry of health and the State food and Drug Administration is about to enact the implementation of the medical device adverse event monitoring and evaluation of management approaches and the management of the medical device recall. The State food and Drug Administration issued the "risk management for medical devices on the application of medical devices, also will be June 1, 2009 onwards practiced.