Shanghai, one-time use of sterile medical equipment supervision and management of certain provisions

 Shanghai, one-time use of sterile medical equipment supervision and management of certain provisions of the Shanghai Municipal People's Government Order No. 5 "Shanghai Disposable Sterile Medical Device Regulatory certain provisions" have been July 29, 2003 14th executive government meeting, is hereby released from October 1, 2003 into effect. Mayor Han Zheng, Shanghai ○ ○ 三年 八月 一日 single-use sterile medical equipment supervision and management of certain provisions (August 1, 2003 Shanghai Municipal People's Government issued Decree No. 5) Article (legislative intent) in order to strengthen one-time use of sterile medical equipment supervision and management, prevention of iatrogenic disease, prevention of environmental pollution, protect human health and safety, according to the "Medical Devices Regulations" requirement, combined with the actual city, enactment of this provision. Article II (meaning) The term single-use sterile medical equipment (hereinafter referred to as sterile equipment), is in accordance with sterile equipment for product registration and labeling on the product packaging, "sterile", "one-time use "There can not be reused or similar expressions such as medical devices. Article III (Scope) This provision applies to the city's sterile equipment production, management, use, destruction and their supervisory activities. Article IV (administration) Shanghai Drug Administration (hereinafter referred to as Drug Administration) is the city's sterile equipment production, management, use and destruction supervision and management authorities. Counties and Drug Administration is responsible for the administrative area of ​​sterile equipment production, management,Football Boots Soccer Cleats Shoes Nike CR Mercurial Vapor 7 Superfly III FG Safari White Pink , use, destruction of supervision and management. Shanghai Municipal Health Bureau is responsible for organizing, directing and supervise municipal medical institutions to use sterile instruments and their destruction. Environmental, business and other relevant administrative departments in accordance with their respective responsibilities and work together to sterile equipment supervision and management. Article (business start-up conditions) offered sterile equipment manufacturing enterprises, in addition to meeting "Supervision and Regulation of Medical Devices" the conditions stipulated in Article 19, should also meet the following conditions: (a) who are familiar with the production of sterile equipment professional and technical personnel, and two or more professional inspectors; (two) have adapted their production of sterile equipment air purification systems, clean area and production environments. Opened sterile equipment enterprises, in addition to meeting "Supervision and Regulation of Medical Devices" conditions stipulated in Article 23, should also have to adapt to their sterile equipment business operating space, so set apart business premises and warehouses, warehouses within the sterile instruments and other medical devices partition storage. Article VI (quality system requirements) sterile equipment manufacturing enterprises in the original site or off-site construction, reconstruction, expansion of clean plant shall, in accordance with relevant state regulations, municipal and Drug Administration for the first instance of sterile device quality system, quality system on-site review testing and product testing. Article VII (enterprise quality management standard) sterile equipment manufacturing enterprises should be in accordance with the relevant quality system requirements for medical devices, sterile medical equipment production management practices and production implementation details of the requirements of production, and organize regular internal quality audits. Article VIII (clean area) aseptic equipment manufacturing enterprises should their production environment clean area to focus on monitoring, timely recording of temperature, humidity,Sale Nike Mercurial Victory III IC Boots Retro Orng Red 1206 , the number of colonies and other parameters to ensure the production environment, comply with the relevant requirements of sterile equipment production environment. Article IX (raw materials and components) sterile equipment manufacturing enterprises producing raw materials used sterile equipment, parts, shall comply with the national standards or requirements. Sterile equipment manufacturing enterprises producing raw materials used sterile equipment, parts, and should be determined at the time of registration approved raw materials, components aligned. Need to change in the production process of raw materials, components, and shall apply to the city and Drug Administration for the record. Laws, regulations otherwise provide, shall prevail. Sterile equipment manufacturing enterprises for the purchase of raw materials and components shall be qualified acceptance or inspection. Article (product batch file) sterile equipment production enterprise shall establish a sterile instrument product batch file. Products, including products, raw materials batch file batch number, batch number and sterilization batch and other information. Product batch file should be true, complete and accurate reflection of the whole process of production. Product batch file retention period shall be not less than two years after the expiration of sterile instruments. Article XI (packaging) from sterile equipment manufacturing enterprises should comply with the conditions prescribed in the Regulations production units purchased for aseptic packaging material or a small instrument package, and the establishment of purchased product packaging, storage, distribution, use, etc. aspects of the management system. Sterile equipment manufacturers produce aseptic packaging equipment should be in accordance with the first use of a small amount of the request, the implementation of a single package. Shall not be included in a small package with reusable parts. Article XII (label) on the packaging in a sterile instrument shall be in accordance with the regulations printed on or affixed with a single-use sterile instruments labels marked "sterile", "single-use" message or not reusable symbols. Sterile instruments should be approved label instructions for use, and indicate the production date, batch number, and expiration date, etc. sterilization methods. Article XIII (substandard product disposal) sterile equipment manufacturing enterprises for substandard products, parts, expired, failed products, or waste products small packages and their labels should be in place in the factory district disfigurement or destroyed and be recorded. Sterile equipment manufacturing enterprises for substandard products, parts, expired, failed products, or waste products of small package and its label, the place disfigurement later, as industrial solid waste disposal, shall not be dumped, discarded. Their disposal shall comply with the environmental regulations. Article XIV (quality tracking system) sterile equipment production, management companies shall establish a system for tracking the quality of sterile equipment, sterile equipment sales or purchase and sale records shall be true, complete, accomplish sales, purchases can be traced to a batch of products the quality of the case. Sterile equipment production enterprise sales records shall include the date of sale, sales targets, sales, product name, model specifications, production batch number, sterilization batch number, product expiration date. Sterile equipment enterprises on the safety and effectiveness must be controlled or strictly controlled sterile equipment, purchase and sale records should include the date of purchase and sale, purchase and sale of objects, buying and selling quantity, product name, manufacturer, model specifications, production batch number, batch sterilization , product expiration date, Manager, responsible person signature. Sterile equipment sales records or purchasing records and valid documents retention period should be no less than two years after the expiration of products. Article XV (measures to prevent damage) sterile equipment manufacturing enterprises found that the production of sterile equipment is seriously flawed, even when used correctly are still likely to endanger human health and safety, they shall immediately suspend production and stop selling; sold should take urgent measures to inform business enterprises, medical institutions and users moratorium on the sale or use, and recall the batch products, while the Municipal Drug Administration reports. Sterile equipment manufacturers produce sterile instruments exist preceding case, and the producers did not take the measures specified in the preceding paragraph, the city and Drug Administration may require producers suspend production, discontinued,Football Boots Soccer Cleats Shoes WholeNike CTR360 Maestri II FG White Silver Purple Gallery , and sold products to take the batch recall measures. For Medical Device Industry Association found that sterile equipment production enterprises serious defects in sterile equipment can be made to the city and Drug Administration to make recommendations accordingly. Article XVI (annual examination) City, State Drug Administration in accordance with the relevant provisions of the "Medical Device Manufacturing Enterprise License" annual validation, aseptic equipment manufacturing enterprises should implement the quality system requirements for medical devices, sterile medical equipment production implementation of management practices and production conditions in conjunction verification. Article XVII (production environment supervision and inspection) drug supervision and administration departments in accordance with the relevant requirements of the production environment sterile instruments, sterile equipment manufacturing enterprises on the environmental situation in the clean area for daily supervision and inspection. Found that the production of sterile equipment manufacturing environment does not comply with the relevant requirements of sterile equipment production environment, drug supervision and administration department shall order correction by a deadline; corporate deadline is not correct or corrected still unqualified, drug supervision and administration department shall be announced, and corporate governance file to be recorded. Drug Administration for routine supervision and inspection shall comply with the procedures prescribed. For sterile equipment manufacturing enterprises to implement temporary sampling, on the spot checks show notifications. Routine supervision and inspection shall not affect the production of sterile equipment the normal production and business activities. Article XVIII (purchase inspection) Medical institutions shall operate legally obtained qualifications from sterile equipment production, procurement of qualified enterprises sterile instruments; national regulations which purchased two, three sterile instruments should be obtained from the "medical Device Manufacturing Enterprise License "or" Medical Device Distribution Enterprise License "production, procurement of qualified enterprises sterile instruments, and verifying the product for medical device registration certificate, product quality certificates and other identification. Medical institutions shall purchase does not meet the requirements of sterile instruments. Article XIX (save storage requirements) medical institutions shall sterile equipment storage requirements, keep sterile instruments and other medical devices with storage partitions. Article XX (pre-use checks) prior to use in sterile equipment, medical institutions should follow procedures check aseptic packaging equipment. Small package appears damaged, or other circumstances beyond the date of sterile equipment, should stop using it. Article 21 (sterile devices implanted in the body using a file) implanted medical institutions should be created using a sterile instrument files. Article 22 (disfigurement after use and disinfected) after the use of sterile equipment can spot disfigurement, medical institutions should require users to spot disfigurement; disfigurement can not be on the spot, it should be carried out within the medical institution focus disfigurement; scalpel sharp no ability disfigurement, warning signs should be stored in a special container. Medical institutions shall disfigurement and disfigurement sterile instruments can not be sterilized, and stored in a special container warning signs. Article 23 (focus on the destruction of records) medical institutions shall state and city regulations, promptly after disinfection disfigurement and can not disfigurement sterile equipment delivered by a legally licensed institutions in the medical waste disposal concentrated destruction disposal. Medical institutions shall be sent to the destruction of records sterile equipment case. Article 24 (prohibitions) medical institutions following acts are prohibited: (a) re-use sterile instruments; (two) used sterile equipment should be destroyed but not destroyed; (three) will be used without Bacteria equipment sold to others; (four) will be used sterile equipment dumped, discarded; (five) No disfigurement and disinfect the used sterile equipment delivered outside the medical institutions for processing. Article 25 (right production, operating illegal administrative penalties) in violation of the provisions of the following acts by the drug supervision and administration department shall order correction, and can be based on the circumstances, to give 1,000 yuan more than 30,000 yuan Penalty: (a) sterile equipment manufacturing enterprises are not in accordance with the amount of disposable single-use packaging, or in the small packaged with spare parts available for re-use; (two) sterile equipment manufacturing enterprises for substandard products , parts, expired, failed products, or waste products of small package and its label is not disfigured or destroyed. Violation of the provisions of the following acts by the drug supervision and administration department shall order rectification; overdue correction, can be given a warning or impose a fine of 5,000 yuan: (a) sterile equipment manufacturing enterprises not established product batch file or counterfeit product batch files; (two) sterile equipment manufacturing enterprises are not in accordance with the provisions of sterile equipment in its production printed on the packaging or attached to a one-time use of sterile equipment labels; (three) sterile equipment production and business enterprises not established record of sales or the purchase and sale, or selling or buying and selling of counterfeit products recorded. Sterile equipment manufacturing enterprises will be substandard products, parts, expired, failed products, or waste products dumped small packages and their labels, discard, or dispose of violation of environmental regulations, and by the environmental protection administration departments punishable by law. Article 26 (right to use, the destruction of illegal administrative penalties) medical institutions, one of the following circumstances, the drug regulatory authority in accordance with the "Supervision and Regulation of Medical Devices" Article 43 shall be punished: (a) re-use sterile instruments; (two) used sterile equipment should be destroyed without destruction. Medical institutions, one of the following circumstances, by the drug supervision and administration department shall order correction, and can be based on the circumstances, to give 1,000 yuan more than 30,000 yuan shall be imposed: (a) will be used sterile equipment sold to others; ( two) used sterile equipment is not disfigurement and disinfection, delivered outside the medical institution for processing; (three) can not justify the use of sterile equipment had disposed of through legal channels. Medical institutions of the following circumstances, by the drug supervision and administration department shall order rectification; overdue correction, can be given a warning or impose a fine of 5,000 yuan: (a) Unrecorded used sterile equipment sent to destroy the situation; (two) are not in accordance with the provisions of storage, safekeeping or storage of sterile instruments. Medical institutions violation of environmental regulations, random dumping, illegal disposal of discarded or sterile instruments used by the administrative department for environmental protection punishable by law. Article 27 (Effective Date) This provision since October 1, 2003 onwards.