CCTV 315 uncovering false teeth making Lore: manufacturing scrap material, clean with an old toothbrush-315,2016 CCTV 315 party 315 evening-IT information
IT news CCTV 315 party continued, just exposed the shady made dentures in denture processing enterprises, Kita-guchi dentures using scrap material manufacturing dentures, and an old toothbrush to clean the finished product at the last disinfection procedures prior to shipment and no.
CCTV financial journalists some denture-making factory found that when they cast denture, use no flags, no registration certificate for medical device license number of broken steel. Experts, broken steel or recycling materials or raw materials. And they tend to be repeatedly recycled, harmful elements in increasingly high concentrations, endanger people! Moreover, these dentures are not disinfected, staff used an old toothbrush and brush the brush will be mailed to you.
Following is the detailed report:
Journalist recruited into the North denture technology limited, which is a company providing denture processing services for a number of medical institutions of Professional Enterprise. The company has legal production qualification of medical devices.
In accordance with the procedures of Kita-guchi dentures rely on hospitals to order denture. Hospitals in these orders are marked on dentures required material: Cobalt-chrome, titanium, promise the spirit, and so on. On the Foundry floor, piled up around hospitals sent patients Stent made of die filling molds.
Reporters saw a worker casting metal raw materials used by the General support irregular shapes, size is not uniform, and there is no sign. This is what kind of material? Compliance with national standards? Reporters into the company's raw material warehouse, but did not find the material, and even factory workers also feel a bit odd.
Denture technology research workers in the North: "(you which plant is this now? ) I don't know, this time picking, it directly on the boxes above the buckle, pour directly inside the bag, not to see how it is. ”
Reporter notes that Foundry workers occasionally use completely different metals. The metal materials are printed on the packaging of medical device registration license key rules of each metal is shaped, uniform in size and printed logo. It turns out that this is the normal metal denture materials. Custom dentures according to national requirements belong to class II medical devices. As a portal products, Denture materials in the oral environment corrosion degradation may occur and even irritate the gums, redness. According to the State food and Drug Administration issued the customized registration guidelines for the technical review of denture products: "the making of dentures, have the registration certificate of medical devices should be used in dental PFM alloy, dental casting alloys and other materials". However, in the North when casting denture dentures, most commonly used is the irregular shape, without any signs of metal materials.
Foundry with the porcelain loyalty medical supplies limited, reporters also saw this irregularly shaped metallic raw materials, casting denture workers are using it.
Medical supplies co porcelain loyalty QC supervisor: "different, large and small, industry is broken steel, most times. ”
Company QC managers told reporters that the irregularly shaped metal raw materials, in the industry is called the broken steel, the quality is relatively poor, generally used it to produce relatively inexpensive ordinary stents.
Porcelain loyalty medical supplies co worker: "(this is what Ah? ) This is steel, scaffold (stent). ”
Loyalty in porcelain factory, the reporter finally got to see this broken steel raw materials packaging boxes, neither in the above text, description and tags, and without a registration certificate for medical device license number. According to the State food and Drug Administration issued the notice on strengthening the custom dentures production supervision, as well as the description and labeling of medical devices regulations: "do not use an unregistered custom dentures denture material processing"; in the People's Republic of China territory sales and use of medical devices, should be accompanied by a description and tags. Description and tags text shall be in Chinese. Then, these unsolicited pieces of steel then where is it?
Overview of medical device is a large wholesale market. Reporter also saw the scrap steel for sale here. In the store's introduction, reporter of a rented house in Foshan, met Marquis specializes in scrap steel business owner. Here, reporters saw with porcelain loyalty medical supplies limited use of packaging the same pieces of steel materials.
Broken dentures and steel wholesalers when boss: "more than the domestic 90% are produced in Tianjin, Tianjin, because only this, he is there for a month and how many tons of weight, do it. ”
When boss told reporters that the broken steel are now shipped from Tianjin, as to the exact manufacturer, no one knows.
Broken dentures and steel wholesalers when boss: "cooperation with him seven or eight years now, and is going to see the boss. This is no card no card, mixed (mixed) too much, his capacity, he would fear an accident. ”
When the boss says, Denture processing plants in the country are using this broken steel casting denture. Its market price only regular factory of one-seventh. Why scrap steel raw material prices so cheap? National dental materials and equipment Standardization Committee member Professor Zhao Xinyi gives the answer.
National standardization Committee member Zhao Xinyi of dental materials and devices: "most of these irregular material, basically is either recycled, or it could be from the industries top circulation of this material, is not able to use as and when required. ”
Such incompatible denture production requirements of scrap steel, journalists to investigate two denture processing plant is being used.
Denture technology research workers in the North: "the popularity is its, usually titanium, promise the spirits of less. ”
In the process of casting denture denture processing plant, also produces large amounts of scrap metal.
Denture technology research workers in the North: "(this is what? ) Is a steel, cast steel, steel scrap. Knock knock it why it does not have a steel head. ”
Reporters saw the cast workers into a few pieces of steel into the Crucible, and then to add some scrap steel head. Will they melt together and pour into the mold,
Porcelain loyalty medical supplies co worker: "(I did add the melted down the steel head is) well, all without wasted (cost savings), otherwise why don't add it (back and forth repeatedly to return how many times? ) Five or six times. ”
Denture technology research workers in the North: "(you generally used a few times now) lost their sloppy now, anyway, mechanic says can't have trachoma, we can get some new steel, then continued with, as long as no trachoma has been, that's how this thing works. ”
Beijing issued by the food and Drug Administration set out in the quality system inspection Guide for custom dentures: "casting denture made of metal waste shall not be used again."
National standardization Committee member Zhao Xinyi of dental materials and devices: "use it multiple times (composition) will change much, then some useful elements may be oxidized. Some casting cavity material will enter the metal inside, causing some heavy metals or harmful elements into metals. If you repeatedly added this harmful element concentrations and higher. Harm the health of the body. ”
In order to prevent cross infection, issued by the food and drug administration in Beijing check points of the quality custom dentures System Guide provided for the "production of denture products and models should be packaged and sterilized before the factory." Reporters saw in China are loyal QC in the corner Office of the medical supplies limited, only a small sterilizer. At a press conference in the investigation, QA staff did not use this sterilizer.
Medical supplies co porcelain loyalty QC workers: "no time disinfection, sterilization of several copies of that death. ”
Journalists in Northern denture processing plants are more worrisome, according to process every denture after the processing is complete, employees are to clean it. Clean dentures using tools, turned out to be their used toothbrushes.
North denture technology co worker: "I sometimes get my toothbrush to step down, (retired) my own toothbrush at home I don't brush teeth (I used toothbrushes to dirty yourself) more than brushing your teeth clean. ”
Well, Denture factory, Kita-guchi dentures packing in accordance with the regulations strictly control the final disinfection does?
North denture technology research limited QC workers: "(we also have strict disinfection prior to shipping, program or something) not. ”
Denture technology research workers in the North: "of course, the Council does not disinfect who know? ”
央视315揭假牙制作黑幕：制造用废钢料、清洁用旧牙刷 - 315,2016央视315晚会,315晚会 - IT资讯
IT资讯讯 央视315晚会继续中，刚刚则曝光了义齿加工企业中假牙制作的黑幕，北口义齿使用废钢料制造假牙，并用旧牙刷清洁成品，在最后出厂之前也没有消毒程序。
央视财经记者深入一些假牙制作工厂发现，这些厂家在铸造义齿支架时，使用的是没有任何标志，也没有医疗器械注册许可证号的碎钢。专家介绍，这些碎钢要不就是回收料，要么就是工业原料。而且它们往往经过反复回收再利用，有害元素浓度越来越高，危害人体！而且，这些假牙不消毒，用员工用过的旧牙刷，刷一刷就寄给你。
以下是详细报道：
记者应聘进入了北口义齿技术研究有限公司，这是一家为多家医疗机构提供义齿加工服务的专业企业。该企业具备合法的医疗器械生产资质。
按照流程北口义齿会根据医院发来的订单生产义齿。医院在这些订单上都会标明义齿所要求的材料：钴铬、纯钛、诺必灵等。在铸造车间的地上，堆放着各地医院寄来的患者牙模制成的支架灌注模具。
记者看到，工人铸造普通支架所使用的金属原料形状不规则、大小不统一，并且没有任何标志。这是一种什么材料呢？是否符合国家标准呢？记者进入了这家企业的原料仓库，但并没有找到这种原料，就连工厂的老员工也觉得有些蹊跷。
北口义齿技术研究有限公司工人：“（你们这个现在用的是哪个厂的？）不知道，这段时间领料啊，它那个盒上面那直接就扣了，直接就给倒袋里边，不让看还是怎么回事。”
记者注意到，铸造工人偶尔会使用一些完全不一样的金属原料。这种金属原料的包装盒上都印有医疗器械注册许可证号，每颗金属原料都是形状规则、大小统一，并且印有相关标志。原来，这才是正规的义齿金属原料。按照国家要求定制式义齿属于二类医疗器械产品。作为入口的产品，义齿的金属材料在口腔环境中可能出现降解腐蚀，甚至会刺激牙龈，出现红肿的情况。根据国家食品药品监督管理总局下发的《定制式义齿产品注册技术审查指导原则》：“义齿的制作，应使用具有医疗器械注册证书的齿科烤瓷合金、齿科铸造合金等材料”。然而，在北口义齿铸造义齿支架时，使用量最大的却是这种形状不规则，没有任何标志的金属原料。
在瓷都忠诚医疗用品有限公司的铸造车间里，记者也见到了这种形状不规则的金属原料，工人正在用它铸造义齿支架。
瓷都忠诚医疗用品有限公司质检部主管：“大大小小不一样那种，行业来说就是碎钢，最次的。”
这家企业的质检部主管告诉记者，这种形状不规则的金属原料，在行业里被叫做碎钢，质量相对较差，一般用它来制作价格比较低廉的普通支架。
瓷都忠诚医疗用品有限公司工人：“（这是什么材料啊？）这就是钢，支架啊（做支架的）。”
在瓷都忠诚加工厂，记者终于见到了这种碎钢原料的包装盒，上面既没有中文字，说明书和标签，也没有医疗器械注册许可证号。根据国家食品药品监督管理总局发布的《关于加强定制式义齿生产监管的通知》以及《医疗器械说明书和标签管理规定》：“不得使用未经注册的义齿材料加工定制式义齿”；凡在中华人民共和国境内销售、使用的医疗器械，应当附有说明书和标签。说明书和标签文字内容应当使用中文。那么，这些来路不明的碎钢又是从哪里来的呢？
国览医疗器械城是一家大型医疗器械批发专业市场。在这里记者也看到这种碎钢在出售。在店家的介绍下，记者在佛山市的一处出租屋，见到了专门做碎钢生意的侯老板。在他这里，记者看到了与瓷都忠诚医疗用品有限公司使用的包装一模一样的碎钢原料。
义齿碎钢原料批发商侯老板：“这个呢国内百分之九十以上都是产自天津，因为只有天津有这种，他那里一个月都是多少吨的量，这样搞的。”
侯老板告诉记者，现在市场上的碎钢基本都是从天津发货，至于准确的生产厂家，没有人知道。
义齿碎钢原料批发商侯老板：“现在跟他合作了有七八年了，根本见不到老板。因为这个东西没牌没证，掺（杂）的东西太多了，他的量大，他也怕出事。”
侯老板介绍说，国内的义齿加工厂很多都使用这种碎钢原料铸造义齿支架。它的市场价只有正规厂家的七分之一。为什么碎钢原料的价格会如此便宜呢？全国口腔材料器械设备标准化委员会委员赵信义教授给出了这样的答案。
全国口腔材料器械设备标准化委员会委员赵信义：“大多数这种不规则的材料，基本上都是，要不就是回收料，也有可能是从工业上面流通过来的这个材料，按照要求是不能够使用的。”
这样的不符合义齿支架生产要求的碎钢，在记者调查的这两家义齿加工厂却被大量使用着。
北口义齿技术研究有限公司工人：“大众化就是它，一般钛合金啦，诺必灵的比较少。”
在义齿加工厂铸造义齿支架的过程中，还会产生大量的金属废料。
北口义齿技术研究有限公司工人：“（这里是啥啊？）那是钢头，铸出来的钢头，废钢头。它一敲敲开这不就有一个钢头嘛。”
记者看到，铸造工人先往坩埚里放入几颗碎钢，然后又加入一些废旧钢头。将他们融化在一起后浇筑到模具中，
瓷都忠诚医疗用品有限公司工人：“（我看都得加这个回炉的这个钢头是吧）嗯，都加，不加太浪费了（节省成本呗）对啊，要不然的话加它干吗（反复反复能回炉多少次？）五六次吧。”
北口义齿技术研究有限公司工人：“（你现在一般用几遍）现在迷了马虎的，反正是用吧，技工说了不行了有砂眼了，咱们可以换点新钢，再继续用，只要没砂眼一直用，就这么回事。”
北京市食品药品监督管理局下发的《定制式义齿质量体系检查要点指南》中规定：“铸造金属废料不得再次用于义齿制作”。
全国口腔材料器械设备标准化委员会委员赵信义：“多次的使用它里面（成分）会发生很大的变化，那么里面一些有效的元素可能被氧化。有一些铸造的型腔的这些材料的话呢，会进入到金属里面，会导致一些重金属啊，或者有害元素会进入金属当中。如果反复累加这种有害元素会浓度越来越高。对人体会产生危害。”
为了防止交叉感染，北京市食品药品监督管理局下发的《定制式义齿质量体系检查要点指南》中规定“企业生产的义齿成品和牙模型应包装并消毒后方可出厂”。记者看到在瓷都忠诚医疗用品有限公司的质检部办公室角落里，只有一台小型消毒柜。在记者调查的那段时间里，质检部的工作人员并没有使用过这台消毒柜。
瓷都忠诚医疗用品有限公司质检部工人：“哪有时间消毒啊，几份几份的消毒那要命啊。”
而记者在北口义齿加工厂看到的情况更令人担忧，按照流程，每一颗义齿在加工完成后，员工都要对其进行清洗。但清洗义齿使用的工具，竟然是员工自己用过的牙刷。
北口义齿技术研究有限公司工人：“我有时候就拿我的牙刷退下来的，（什么叫退下来的）我自己家里边牙刷我不刷了拿过来刷牙（拿咱自己用过的牙刷多脏啊）刷牙多干净啊。”
那么，在义齿出厂前，北口义齿加工厂是否按规定严把最后一道消毒关呢？
北口义齿技术研究有限公司质检部工人：“（咱这发货之前是不是也得有严格的消毒，程序什么的）没有吧。”
北口义齿技术研究有限公司工人：“不消，消不消毒谁知道啊？”