26 medical network on October 27, reporter learned from shandong province food and drug administration that since April of this year special medical apparatus and instruments in shandong province "2016 actions" to 1753 producing enterprises, trading enterprises and use the unit shall be ordered to make correction, shall be ordered to four suspension and transferred to public security organs suspected criminal case 4 cases, strong shock and awe the violation behavior.
Since April, the shandong province food and drug administration from the occurrence of adverse events, and more public attention is higher, the quality of the product to sample, and then evaluation found that the problem is more, the products of throughout the province organization carried out over a period of five months medical equipment rectification of 2016 operations in shandong province ", for sodium for injection of hyaluronic acid, chitosan products, decorative color contact lenses, customised denture for full implementation of rectification of four types of products, at the same time to carry out the circulation field illegal conduct during the action.
194 in shandong province at present, a total of check production enterprises, trading enterprises, 6810, 11479 units used, the one to give order rectification 1753, order to suspend production or business operation, four FaMeiKuan 20.8389 million yuan, transferred to public security organs four suspected criminal case.
Yu-hong li, deputy director of food and drug administration of shandong province is introduced, the current medical device testing center of shandong province 199 batch of rectification of product inspection, including 180 batch of qualified products, 19 batches of unqualified products, percent of pass is 9.5%. Unqualified products are mainly for chitosan products (4) and decorative color contact lenses (15). Part of the unqualified products are for verification.
Yu-hong li said that shandong province food and drug administration for used in medical equipment production and management link has some prominent problems affecting the quality of products, continue to strengthen the supervision and inspection, perfect the relevant regulations, to establish a long-term mechanism to ensure the safety of medical equipment, ensure the people by machinery safe and effective. |
