1. Purchase devices from production and operation enterprises with Medical Device Manufacturing Enterprise License and Medical Device Operation Enterprise License, and approve the business scope of the production and operation enterprises.
2. Confirm the supplier's legal qualification when purchasing, and investigate and evaluate the supplier's legal qualification and quality reputation. Ask for a copy of the legal license stamped with the original seal of the enterprise, including: a copy of the license of the medical device manufacturing enterprise or operating enterprise, a copy of the business license, a copy of the medical device product registration certificate (including accessories) and other supporting documents, a copy of the national medical device product testing report (including the same product batch), and a product qualification certificate.
3. The sales personnel of suppliers who have business contact with this unit shall provide a copy of their ID card, the original power of attorney of legal person stamped with the original seal of the entrusted enterprise and the seal or signature of the legal representative of the enterprise, and indicate the scope and validity period of authorization;
4. Establish supplier files and implement "one enterprise, one file" management.
5. Establish a medical device purchase acceptance record, indicating the product name, manufacturer, supplier, model specification, product quantity, production date, production batch number (serial number and number), sterilization batch number, product validity period, registration certificate number, packaging label, acceptance date, acceptance conclusion, etc. Notes and purchase and acceptance records shall be kept for 65,438+0 years after the expiration of validity or cessation of use, but not less than 3 years. Acceptance records and quality tracking records of implantable medical devices shall be kept at the same time.
6, must be partial acceptance, can not have no inspection, no inspection phenomenon. Acceptance personnel must carefully check the commodity name, specifications, registration certificate number, certificate number, validity period, registered trademark, batch number, production unit, appearance quality, etc. Carefully record the purchase acceptance, with complete contents and no defects, and sign each batch of equipment after acceptance.
7, unqualified medical devices, shall not be used, and make a record of rejection;
Medical device use, repair and maintenance system
1. Before medical devices are used, routine quality inspection shall be conducted. Before using sterile medical devices, the packaging and expiration date of medical devices in direct contact should be routinely checked. The package is damaged, the label is unclear, it is beyond the validity period or may affect the safety of use, and it shall not be used.
2, for medical devices used for diagnosis and treatment, according to the provisions of regular testing, maintenance and maintenance, establish testing, maintenance and maintenance records. The contents of the record file include: user department, equipment name, registration certificate number, specifications and models, manufacturer name, delivery time, commissioning time, overhaul time, overhaul items, overhaul units, overhaul results, etc.
3, medical equipment library (area) should be separated from the equipment library (area), are not allowed to be mixed with other items, especially with disinfectants or pollutants.
4. The environment around the warehouse is clean and tidy, free of dust, harmful gases, weeds, stagnant water and pollution sources.
5. The warehouse should be divided into: warehouse operation area (such as warehouse and keeper's studio), auxiliary operation area (such as quality inspection room and maintenance room) and living area (such as office, dormitory, canteen and toilet). ). The auxiliary operation area and living area should be kept at a certain distance from the storage operation area or have isolation measures.
6. The walls and ceilings in the warehouse are smooth and flat, the ground is flat and tidy, there is no water and garbage, and the doors and windows are tightly structured.
7. The temperature and humidity of the warehouse (area) where medical devices are stored shall meet the product performance requirements. Among them, 20℃ is suitable for cold storage and 0-30℃ is suitable for normal temperature storage. The relative humidity in the warehouse should generally be kept at 45-75%.
8, library (area) and library (area), crib and crib, crib and wall have enough spacing. The warehouses shall be divided into warehouses to be inspected (areas), qualified warehouses (areas), unqualified warehouses (areas) and returned warehouses (areas), and shall be clearly marked.
9. Product storage is managed by color code. The qualified area and delivery area are green, the unqualified area is red, and the inspection area and return area are yellow. Placed products should have obvious signs and location tags. Expired products should be valid reminder cards.
10, medical equipment warehouse must be kept dry and ventilated, no corrosive gas, and products with different properties cannot be mixed. Products with special requirements shall be stored according to their characteristics:
(1) Rubber, latex, plastic and polymer products should be kept away from direct sunlight, room temperature should be 0-28℃, relative humidity should be below 80%, away from heat sources and avoid contact with acid, alkali, oil and corrosive gases;
(2) Medical electronic and electrical equipment is strictly moisture-proof;
(3)X-ray films should be stored in a cool and dry warehouse at a temperature of 20℃, a minimum of 5℃ and a relative humidity below 60-80%, away from radioactive sources and chemical and physical pollution sources;
(4) The fluorescent screen should be moisture-proof, heat-proof, shock-proof, stress-proof and light-proof;
(5) Volatile liquid in dental materials should be stored in a special room;
(6) Dental materials such as pulp deactivator and dental tray water should be stored in special rooms according to the requirements of toxic substances and dangerous goods;
(7) The storage of in vitro diagnostic reagents should meet the requirements of special storage.
1 1. Medical devices should be stored in batches according to the manufacturer, product category and batch number, neatly arranged and clearly marked. Stacking and urging sales of effective products shall be carried out in strict accordance with the effective product management system. The use of sanitary materials and dressings, dental materials, diagnostic reagents, medical rubber products, medical polymer materials and products, medical suture materials and adhesives and other products should establish a valid period management system and records. The principles of "first in, first out", "first out in the near future" and outbound by batch number should be followed.
12, according to the circulation situation, regularly check the quality of maintenance equipment, and make maintenance records; Equipment with quality problems found during maintenance should be suspended and handled in time according to regulations.
13. Non-conforming products shall be stored in special warehouses (areas) with obvious signs, and complete procedures and records shall be made for the confirmation, loss reporting and destruction of non-conforming products.
14. Immediately stop using instruments that have expired, and handle them in time according to regulations. It is strictly prohibited to use expired, unqualified or obsolete sterile instruments.
15. Check the outbound products according to the items listed in the outbound voucher, and keep complete records. The contents include the name of the purchasing unit, product name, specification and model, quantity, production unit, production batch number, instrument number, sterilization batch number, use, usage, taboos and precautions to prevent errors and accidents.
16, articles for daily use and used disposable medical devices are strictly prohibited in the warehouse.
Medical equipment adverse event reporting system
1. Establish an organization for medical device adverse events, and designate a special person to be responsible for the collection and submission of adverse events.
2. Adverse medical device events shall be reported step by step, and may not be reported when necessary.
3, the suspicious medical device adverse events found should be recorded in detail, fill in the "report form of suspicious medical device adverse events", and report to the municipal medical device adverse events monitoring center in a timely manner.
4. Adverse events caused by high-risk medical devices or serious injuries suspected to be caused by high-risk medical devices should be reported within 10 working days after discovery, and death events should be reported within 24 hours.
Disposable sterile medical devices are destroyed after use.
1. Disposable sterile medical devices after use shall be promptly recovered, destroyed and registered for destruction.
2, syringes, infusion sets, disposable bags and other disposable items, should be decomposed after use (remove the needle, cut the infusion tube, etc. ), and soak the decomposed instruments in disinfectant.
3, medical waste (dressings, bandages, cotton balls, gauze, etc. ) can't be discarded at will, and someone will be responsible for recycling, destruction and registration.
4. Special infectious items: waste gas used by patients such as gas gangrene, Pseudomonas aeruginosa infection, tetanus, AIDS, etc. should be sealed in double-layer yellow garbage bags and treated uniformly after contacting the environmental protection department.
Review system of medical devices in and out of storage
1. The products shall be inspected before warehousing, and the registration certificate number, product batch number, date and expiration date shall be checked. At the same time, check the supplier, product name, specification, quantity, manufacturer (distributor) and quality status according to the list, and fill in the inspection records.
3. If the quality is found to be unqualified or in doubt during the acceptance process, it should be inquired, rejected and stored separately, and marked and reported.
4. When receiving medical supplies, please ask for them as needed, and both the receiver and the warehouse keeper will sign them to show their responsibility.
5. In order to ensure the accuracy of the quantity of goods in and out of the warehouse, the warehouse keeper should make an inventory once a month and make records.
Implantable medical device quality tracking system
1, the use of implantable medical devices must establish a quality management system, which has the requirements of purchasing qualification control, acceptance control, storage control, use control, quality tracking and original records. , clear the internal management department, strengthen the supervision and management of high-risk medical devices.
2, responsible for the custody of implantable medical devices, when the product arrives, according to the contract and invoice, delivery note, timely acceptance and accounting. Have the right to refuse and report in time if there is any discrepancy between the account and the goods and quality problems.
3. Establish product collection records. The content should be specific, including: product name, receiving date, manufacturer, model specification, production batch number, sterilization batch number (sterilization date), product validity period, product registration certificate number, consignee's signature, consignor's signature, etc.
4 users should do a good job in the registration and use management of implantable medical devices, and there should be a special person responsible for the registration and report of suspicious adverse events in the use of medical devices.
5. Make quality tracking records, including patient's name, gender, age, address, mailing address, contact telephone number, hospitalization number, operation time, operator, product name, product quantity, specification and model, name and registered address of the manufacturer, place of origin, license number of the manufacturer, medical device product registration certificate number, product code (serial number), production date, production batch number and expiration date.
6. Quality tracking records are made in duplicate, one of which is bound into a book, and the other is classified as patient medical record management. The original records shall be kept at the same time as the acceptance records, and the retention period shall be at least one year after the expiration of the product's validity period or after the product stops using, but not less than three years. The retention period of permanently implanted product records should be permanent.
7, regular follow-up work for users and patients.
Personnel health management system
1. New employees must undergo a comprehensive physical examination before taking up their posts, otherwise they will not be hired.
2. The contents of physical examination items should meet the requirements of post conditions. Don't miss the inspection or find someone to replace it.
3. Persons who are found to be suffering from infectious diseases and other diseases that may contaminate sterile medical devices through physical examination shall not engage in direct contact with sterile devices before the possible pollution is cured or eliminated.
4. Establish a complete health record.