Shandong Province: to complete a one-time use of sterile med
In accordance with the requirements of the State Food and drug administration, according to provincial medical equipment special rectification 2015 action plan, Shandong Province food and Drug Administration in August 2015 concentrated carried out one-time use of sterile medical devices rectification. As of August 31, the province inspected production enterprises 91, 2647 enterprises, the use of units 9538, filing 208 cases, closed 192, warning, and ordered rectification 1602 home, ordered to suspend business for 1.
Through the inspection found that part of disposable sterile medical device manufacturing enterprise still exist purchase acceptance, production, testing, sales records, not standardized, employees training is not in place and other problems; part of the business and the use of units still exist purchase acceptance system is not perfect, for sterile medical medical device adverse reaction monitoring paid insufficient attention to the reporting of medical device adverse reaction reports is not actively. As of the end of 8, medical device product quality inspection center to complete the inspection of 177 batches, the inspection work is underway.
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