1, from the "medical equipment manufacturer license", "medical equipment business enterprise license" of the production and operation of the enterprise to purchase devices, and at the same time to approve the production and operation of the enterprise's business scope.
2, purchase to confirm the legal qualifications of the supplier enterprise, the supplier's legal qualifications, quality reputation and other investigations and evaluations. Ask for a copy of the original seal of the legal license, including: a copy of the medical device manufacturer or business license, a copy of the business license, medical device product registration certificate (including accessories) and other supporting documents, the state regulations for testing medical device product testing reports (including the same product batch) copies of the product qualification certificates.
3, and the unit for business contacts with the supplier unit sales staff, should provide a copy of its identity card, stamped with the original seal of the commissioning enterprise and the legal representative of the enterprise's seal or signature of the legal person entrusted with the original authorization, and indicate the scope of entrustment and authorization and the period of validity;
4, the establishment of the supplier file, the implementation of the "one unit, one file " management.
5, the establishment of medical device purchase and acceptance records, containing the product name, manufacturer, supplier, model specifications, product quantity, production date, production batch number (number, serial number), sterilization batch number, product expiration date, registration number, packaging identification, date of acceptance, acceptance conclusions, etc., the bills and purchase and acceptance records should be kept until the expiration of the validity period or discontinued 1 year after use, but Shall not be less than 3 years. Implantable medical devices acceptance records and its quality tracking records are kept at the same time.
6, must do batch acceptance, there shall be no unchecked, missed check phenomenon. Acceptance inspection personnel acceptance must carefully check the name of the goods, specifications, registration number, certificate number, expiration date, registered trademarks, batch number, production units, appearance and quality. Do a good job of purchase and acceptance records, complete, no missing items, each batch of instruments should be signed after acceptance.
7, the acceptance of unqualified medical devices, shall not be used, and make a good record of rejection;
Medical equipment use, repair and maintenance system
1, the use of medical devices should be carried out before the quality of routine inspection. Before using sterile medical devices, should be in direct contact with the packaging of medical devices and its expiration date for routine inspection. Packaging is damaged, poorly labeled, beyond the expiration date or may affect the safety of use, shall not be used.
2, for diagnosis and treatment of medical equipment, according to the provisions of the regular testing, repair and use of maintenance, the establishment of testing, repair and use of maintenance records file. Record files include: the use of departments, equipment name, registration number, specification model, manufacturer's name, factory time, start time, testing and maintenance time, testing and maintenance projects, testing and maintenance units, testing and maintenance results.
3, medical equipment library (area) and non-device library (area) should be separated, not allowed to mix with other items, especially not with disinfectants or polluting items.
4, the environment around the warehouse is clean, no dust, no harmful gases, weeds, water, and no source of pollution.
5, the warehouse should be divided into: storage operation area (such as warehouse, custodian studio), auxiliary operation area (such as quality control room, maintenance room), living area (such as offices, dormitories, canteens, toilets, etc.), auxiliary operations and living areas should be kept at a certain distance from the storage operation area or have isolation measures.
6. The surface of the walls and roofs in the storage room are clean and smooth, the ground is flat, neat, no water, no garbage, and the doors and windows are tightly structured.
7, storage of medical equipment library (area) temperature and humidity to adapt to the product performance requirements. Among them: the cool library 20 ℃ is appropriate, room temperature library 0-30 ℃ is appropriate. Relative humidity in the warehouse should generally be maintained at 45-75%.
8, library (area) and library (area), stacks and stacks, stacks and walls with adequate spacing. Warehouse should be divided into warehouse to be inspected (area), qualified goods warehouse (area), non-qualified goods warehouse (area), return warehouse (area), and have a clear sign.
9, the implementation of color-coded management of product storage, qualified areas and shipping areas for the green, unqualified areas for the red, to be inspected and returned areas for the yellow. Placement of products should be obvious and obvious signs and location card. The expiration date of the product should be the expiration date card.
10, medical equipment warehouse must be kept dry and ventilated, no corrosive gases, different nature of the product can not be mixed. There are special requirements of the product storage according to its characteristics:
(1) rubber, latex, plastic and polymer products avoid direct sunlight, room temperature to 0-28 ℃, relative humidity below 80%, away from the heat source, avoid contact with acids and alkalis, oils and corrosive gases;
(2) medical electronic and electrical equipment, strictly moisture;
(3) X-ray films, and other medical equipment, and other medical equipment, and other medical equipment. p>(3) X-ray film stored in a cool, dry warehouse, the temperature of 20 ℃ is appropriate, the minimum can not be lower than 5 ℃, relative humidity of 60-80% or less, away from sources of radiation and chemical and physical contamination sources;
(4) fluorescent screen should be moisture-proof, heat-proof, shock-proof, anti-heavy pressure, anti-illumination;
(5) dental materials in the volatile liquids, etc. To be stored in a special room;
(6) dental materials such as pulp inactivation agent, dental bracket water should be stored in a special room according to the requirements of toxic products and hazardous materials;
(7) in vitro diagnostic reagents should be stored in line with the requirements of special storage.
11, medical devices should be stored according to the manufacturer, product categories, batch number order zoning classification and batch storage, neatly arranged, clearly marked, the expiration date of the product stacking and sales call work, should be strictly enforced in accordance with the expiration date of the product management system. The use of sanitary materials and dressings, stomatological materials, diagnostic reagents, medical rubber products, medical polymer materials and products, medical suture materials and adhesives and other products to establish an expiration date management system and records. Should follow the "first in first out", "recent first out" and according to the principle of batch number out of the warehouse.
12, according to the flow of the situation, the regular maintenance of the quality of instruments to check, and make a good record of maintenance; on the maintenance of the instruments found to have quality problems, should be suspended, and timely treatment in accordance with the provisions.
13, unqualified products should be stored in a special library (area), with obvious signs, unqualified products, confirmation, report loss, destruction of complete procedures and records.
14, more than the expiration date of the device should immediately stop using, according to the provisions of timely processing, strictly prohibit the use of expired, substandard, or eliminated sterile devices.
15, based on the items listed in the warehouse voucher for the product out of the warehouse review, and have a record, the record content is complete. Contents include the name of the purchasing unit, product name, specifications, quantity, production unit, production lot number, instrument number, sterilization lot number, use, use, contraindications and precautions to prevent errors and accidents.
16, household goods and used single-use medical equipment is strictly prohibited to be stored in the warehouse.
Medical device adverse event reporting system
1, the establishment of medical device adverse event organization, designate a person responsible for the collection and reporting of adverse events.
2, the adverse events of medical devices to implement the reporting system by level, if necessary, can be reported to the next level.
3, the discovery of suspected medical device adverse events should be recorded in detail, fill out the "Suspected Medical Device Adverse Event Report Form", and report to the municipal medical device adverse event monitoring center in a timely manner.
4, the adverse events caused by high-risk medical devices or suspected to be caused by high-risk medical devices leading to serious injuries should be reported within 10 working days after the discovery of the fatal event should be reported within 24 hours.
Destruction system of single-use sterile medical devices
1, for the use of single-use sterile medical devices have a person responsible for the recovery, timely destruction, and make a good destruction registration.
2, syringes, infusion sets, disposable drainage bags and other single-use products, after use should be decomposed (remove the needle, cut the infusion tube, etc.), the decomposition of the device soaked in disinfectant.
3, medical waste (dressings, bandages, cotton balls, gauze, etc.) can not be discarded at will, the person in charge of recycling, destruction, and registration.
4, special infected items: such as gas gangrene, Pseudomonas aeruginosa infection, tetanus, AIDS and other patients used waste gas materials, should be put into a double yellow garbage bag sealed tightly, and get in touch with the environmental protection department to deal with the unified.
Medical equipment in and out of the warehouse review system
1, before warehousing should be product acceptance, check the registration number, product lot number, date, expiration date, etc., and at the same time, according to the ticket to check the supply unit, name, specifications, quantity, manufacturer (operator) and quality status, fill out the acceptance record.
3, the acceptance of the process found that the quality of substandard or doubt should be quickly inquired, refused to accept, separate storage, marking, reporting.
4, receive medical supplies should be requested on demand, the recipient and the warehouse custodian of both signatures to show responsibility.
5, in order to ensure the accuracy of the number of in and out of the warehouse, the warehouse custodian should be counted once a month, and keep records.
Implantable medical devices quality tracking system
1, the use of implantable medical devices must be established with the purchase of qualification control, acceptance control, storage control, use control, quality tracking, original records and other requirements of the quality management system, a clear internal management department, to strengthen the supervision and management of high-risk medical devices.
2, responsible for implantable medical devices custodian, when the product arrives with the purchasing staff based on the contract as well as invoices, delivery notes, timely acceptance and accounting. If found that the account does not match the goods, quality problems, etc., the right to refuse to accept and report in time.
3, the establishment of the product's receiving records. The content should be specific, there should be: product name, date of receipt, manufacturer, model specifications, production batch number, sterilization batch number (sterilization date), product expiration date, product registration certificate number, signature of the receiver, the consignor's signature and so on.
4, the use of implantable medical devices should be used to do a good job in the registration and use of management, the use of medical devices by a person responsible for the registration of suspected adverse events and reporting.
5, do a good job of quality tracking records, including: patient name, gender, age, address, mailing address, contact phone number, hospitalization number, surgery time, the operator, product name, product quantity, specifications and models, the name and registered address of the manufacturer, place of origin, the manufacturer's license number, the medical device product registration number, the product code (serial number), the date of production, the production lot number, expiration date, supplier license number and other necessary product tracking information to ensure product traceability.
6, quality tracking records should be in duplicate, a bound book, a file into the patient's medical records for management, the original records should be kept at the same time with the acceptance records, the retention period of at least more than the expiration of the product or stop using a year, but not less than 3 years, permanent implantation of the product record retention period of permanent.
7, regular follow-up work on users, patients.
Personnel health management system
1, new personnel must be a comprehensive physical examination before starting work, or not be hired.
2, the content of the medical examination program should be in line with the requirements of the conditions of the post. Shall not miss the test or find a replacement.
3, the physical examination found to be suffering from infectious diseases and other diseases that may contaminate sterile medical devices, in the cure or exclude possible contamination, shall not be engaged in direct contact with the work of sterile devices.
4, the establishment of complete health records.