The General Administration of Food and Drug Administration responded to the gas blinding incident: the problem gas has been discontinued

Yesterday, in response to media reports that Beijing University Third Hospital and Nantong University Affiliated Hospital used Tianjin Jingming New Technology Development Co., Ltd. (here is called the enterprise involved) eye perfluoropropanane gas serious adverse events, the State Food and Drug Administration spokesman said publicly that it is not yet possible to identify the impurity components causing injury, the problem products have been recalled last year, the enterprises involved have stopped using perfluororopane gas, and fined more than 5.18 million yuan.All recalls of non-conforming product identification results
On July 7, 2015, the State Administration of Food and Drug Administration received a report of adverse events in suspected groups of eye-use perfluoropropanane gas from the General Administration's Drug Evaluation Center (hereinafter referred to as the Evaluation Center), and seven patients with suspected adverse events occurred in the third hospital of Peking University with the same batch of ophthalmated perfluoropropane gas produced by the enterprises involved (lot number: 15040001). According to the preliminary findings of Jiangsu Province and Beijing Drug Adverse Reaction Monitoring Center, as well as the evaluation of the database search of the product, the evaluation center suggested that the occurrence of this incident and the product "may be related", suspected product quality problems.
The General Administration of Food and Drug Administration immediately organized a study of the safety risks of the product in the event of adverse events in the product, as well as the opinions of the evaluation center. In order to control the risk, the General Administration issued a circular on 8 July requesting all localities to immediately suspend the sale and use of the eye-to-eye perfluoropropane gas with batch number 15040001 produced by the enterprises involved and to strengthen the monitoring of adverse events in such products. At the same time, the Tianjin Municipal Market and Quality Supervision and Administration Commission was requested to immediately order the enterprises involved to suspend the production of perfluorofropane gas for eye use and recall the corresponding batch of products; On July 10, the inspection team of the General Administration went to Tianjin for on-site supervision.
July 22, the evaluation center's investigation report on the adverse event showed that there were 45 adverse events reported at Peking University Third Hospital and 26 adverse events reported at Nantong University Affiliated Hospital, which had a clear correlation with the use of perfluoropropanane gas in the eye. Tianjin Market and Quality Supervision and Administration Commission investigation, the batch of product sales areas involving 25 provinces (regions, cities), in addition to The Third Hospital of Peking University, Nantong University Affiliated Hospital, there are 82 other medical institutions using the batch number of 621 boxes of products, no adverse events were found. In order to prevent and control product risks, the enterprises involved in July 28 completed the 2015 production of two batches (production lot number: 15040001, 15040002) a total of 8632 boxes of eye perfluoropropanane gas recall work, the product has been fully controlled.
July 27, the Chinese Academy of Sciences completed the inspection of the products involved, the test results are not in line with the standards.
July 30, the General Administration issued a circular on the follow-up disposition of adverse events of suspected groups of eye-use perfluoropropanane gas produced by Tianjin Jingming New Technology Development Co., Ltd. (No. 114 of the Food and Drug Administration), and tasked the Tianjin Municipal Market and Quality Supervision and Administration Commission to open an investigation into the enterprises involved and investigate the enterprises in accordance with the law.can not be found to cause injury impurities
the eye perfluoropropanane gas belongs to Class III. medical devices, product specifications of 15 ml. The product is an inert gas, can make pigment epithelial cells and retinal sensory layer firmly bonded, support retinal reset, limit the activity of the growth of cells and growth factors, mainly used in glass body cutting, retinal disengagement and other eye surgery.
After investigation, Peking University Third Hospital purchased a total of 110 boxes of the batch of gas, used in May and June 2015, the remaining 5 boxes were sealed by the Beijing Haidian District Food and Drug Administration, and then sent to the Central Inspection Hospital for inspection; On July 7, 10 and 15, 2015, the Chinese Academy of Sciences received samples from the Jiangsu Food and Drug Administration, Tianjin Binhai New Area Market and Quality Supervision Administration, and the Beijing Haidian District Food and Drug Administration. In accordance with the YZB/Country 4936-2014 "Eye Perfluoropropanane Gas", GB/T16886.10-2005 standards for inspection, July 27 completed the inspection and issued an inspection report, the test results are: Beijing, Jiangsu and enterprises recall products "content" items do not meet the standards, Jiangsu related products and enterprises recall products "skin reaction" project does not meet the standards.
Due to the small number of samples involved in the third hospital of Peking University and Nantong University Affiliated Hospital, it is not possible to further analyze the impurity gas contained in the sample after completing the test of the legal items such as sample content, in-skin reaction and cytotoxicity. Inspection found that the recalled product uniformity is poor, both qualified products, but also non-conforming products, because the product is the characteristics of the gas, in the screening of non-conforming products at the same time, the existing technical means can not confirm the impurity components in the sample. Since then, the General Administration has organized experts to analyze and discuss product inspection issues. Experts believe that due to the small number of samples left, according to existing testing technology, it is still not possible to find out the impurities that cause injury. At present, the Chinese Academy of Sciences is still organizing experts to further explore and study feasible testing methods, while requiring enterprises to further identify the cause.In view of the enterprises involved in the production of perfluoropropanane gas
On July 27, 2015, the Tianjin Binhai New Area Market and Quality Supervision Administration opened a case against the enterprise involved, and according to the inspection report of the Central Inspection Court and the results of the on-site inspection, determined that the enterprise produced medical devices that did not meet the product registration standards, and imposed penalties in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Devices. On October 12, an administrative penalty decision was issued: confiscation of all illegally produced eye perfluoropropanane gas, and a fine of 7.5 times the value of the illegally produced products, totalling 518.8113 million yuan. The enterprises concerned have no objection to the administrative penalty, which was completed on October 14 and published on the official website of the Tianjin Municipal Market and Quality Supervision and Administration Commission. At the same time, the Tianjin Municipal Market and Quality Supervision and Administration Commission requires the enterprises involved to fulfill their main responsibilities, to find out the cause of the incident, and not to resume production of perfluoropropanane gas before the cause is identified. At present, the enterprise involved in the eye perfluoropropanane gas in a state of shutdown.since the
incident, the General Administration of Food and Drug Administration and the National Health and Family Planning Commission have been in close communication, and actively and properly do a good job in the handling of the incident, urging hospitals to do a good job in treating patients; At present, the enterprises involved are cooperating with the court to deal with related matters. Beijing Youth Daily