2 The Hospital Infection Management Section is responsible for:
(1) Conducting relevant audits on new or proposed replacement of single-use sterile medical supplies, including auditing the relevant certificates required by the state and making a good registration
(2) supervising the registration, storage and issuance of single-use sterile medical supplies, and randomly checking the appearance and quality of the products;
(3) supervising clinical use and harmless treatment after use, and carrying out timely investigations of abnormal reactions in the clinic;
(4) carrying out daily and regular supervision, inspection and management of single-use sterile medical supplies, and Timely reporting and feedback to the Hospital Infection Management Committee and relevant departments;
3 Hospital Equipment Division is responsible for:
(1) the procurement and storage of sterile disposable medical supplies, and do a good job of quality acceptance, registration, etc.;
(2) checking the validity of the product certification, registration and filing;
(3) registering the incoming products, and establishing the registration account book (3) registration of incoming products, the establishment of registration books, registration items including the time of entry, manufacturer, product name, batch number, quantity, specifications, unit price, date of disinfection or sterilization, expiration date, the person in charge, etc., and quality acceptance, including ordering contract, delivery location and loan remittance account number should be consistent with the manufacturer / business enterprise, and inspection certificate of conformity, date of production, disinfection or sterilization and expiration date, etc., imports of sterile single-use medical supplies should be Chinese labeling; warehouse requirements cool, dry, ventilated, indoor clean, items placed on the shelf, ≥ 20CM from the ground, ≥ 5CM from the wall, ≥ 50CM from the ceiling different types, different models of products should be placed separately;
4 disinfection and supply room is responsible for:
(1) the issuance of sterile disposable medical supplies, review of the product, large, medium, and small packages, spot checks Product appearance quality, inspection of product batch inspection report;
(2) registration of warehousing products, the establishment of registration books, registration items including warehousing time, manufacturer, product name, batch number, quantity, specifications, date of disinfection or sterilization, expiration date, the person in charge, etc., and quality acceptance, inspection of each box (packet) of product testing certificate of conformity, date of production, disinfection or sterilization and expiration date, etc., imported single-use sterile medical supplies. Period, etc., imported single-use sterile medical supplies should be marked in Chinese; warehouse requirements cool, dry, ventilated, indoor cleaning, items placed on the shelf, ≥ 20CM from the ground, ≥ 5CM from the wall, ≥ 50CM from the ceiling, different types, different models of products should be placed separately;
(3) strict implementation of the issuance of disposable items system, shall not be packaged broken, failure, Moldy products shall not be issued to the using departments;
(4) Disinfection and sterilization for the reuse of single-use sterile medical supplies are prohibited;
(5) If problems are found during the above work, they shall be recorded in a timely manner and reported to the Department of Nursing and the Department of Infection Management of the hospital;
(6) Multiple quantities of single-use sterile items shall not be issued to departments at one time;
5 Using Department should do:
(1) the person in charge of the use of the department is responsible for reviewing the small package of products, production batch number and product appearance and quality, imported products with or without Chinese labeling, etc.;
(2) the use of personnel should be checked before use of the small package of the sealing, the effective date of sterilization and expiration date, the quality of the product's appearance, the imported products with or without Chinese labeling, etc.;
(3) the use of The process of close observation, the emergence of abnormal reactions, should immediately stop using, do a good job of retaining samples and registration, samples of heat source test, and timely report to the physician on duty and the head nurse, the head nurse reported to the Department of Nursing, Infection Management Division, Equipment Division, the same batch of unused items, if necessary, sealed for inspection;
(4) After the use of single-use sterile medical supplies are classified strictly in accordance with the classification of infectious waste disposal, and do a good job of registering and signing, shall not be discarded. Signed and registered, shall not be arbitrarily discarded or sold to any unit or individual; strictly prohibited to flow into the community;
(5) departments shall not purchase any single-use sterile medical supplies;
(6) prohibit departments to receive a large amount of single-use sterile medical supplies;
6 after the harmless disposal of single-use sterile supplies by the Department of Nursing, the General Affairs Section, the Management, Infection Management Section for supervision and management;
6 single-use sterile supplies after harmless disposal by the Nursing Department, the General Affairs Section, the Management, the Infection Management Section for supervision and management. Infection Management Division for supervision and management;
7 for individuals from outside the hospital to bring back sterile medical supplies, in principle, should not be applied; if the need to apply, it should be checked sterilization date, expiration date, the appearance of quality, etc., before the use of the department registered for the record by the director of the department for approval and signature before use; such as the use of the operating room, but also should be registered for the record in the operating room head nurse. If quality problems occur, resulting in medical disputes, etc., by the user and the department responsible for the corresponding responsibility;
8 single-use sterile medical supplies are prohibited from reuse, otherwise all the consequences arising from this, all by the parties concerned and their departments are responsible for;
9 violation of the above provisions of the departments and individuals, by the Hospital Infection Management Committee ordered rectification and, depending on the severity of the case, may be fined 500-500 yuan, which may include a fine of up to $10,000 per month. The seriousness of the case, may be fined 500-1000 yuan; harm to human health constitutes a crime, according to the law to investigate the legal responsibility of the relevant personnel.
The provisions of this "regulations" since the date of issuance of the implementation of the hospital's original document "on the management of disposable medical devices, a number of provisions" at the same time repealed.
July 30, 2008
In order to protect the people's health, prevent the spread of health-care-induced diseases, strengthen the management of single-use sterile medical supplies, the development of this system
Hospital Infection Management Department or a full-time staff is responsible for the use of disposable medical and sanitary supplies use of the unit's management and recycling and disposal of supervision, and the quality of purchased products to monitor. The quality of the products purchased is monitored.
1, single-use sterile medical supplies used in the hospital must be centralized procurement by the equipment section, the use of the department shall not purchase their own.
2, the hospital procurement of single-use sterile medical supplies, must be obtained at the provincial level or above the drug supervision and management department issued a "medical device manufacturer's license", "industrial products production license", "medical device product registration certificate" and health administrative department issued a sanitary permit approval of the manufacturer or obtain "medical device business license" of the business enterprise to purchase qualified products; imports of disposable catheters and other sterile medical supplies. Disposable catheters and other sterile medical supplies should have the State Council Drug Administration issued the "medical device product registration certificate.
3, each purchase, the procurement department must carry out quality inspection and acceptance, the order contract, delivery location and loan remittance account number should be consistent with the production enterprise, business enterprises, and check each box (package) product inspection certificate, date of production, disinfection or sterilization and product identification and expiration date, etc., imported disposable catheters and other sterile medical supplies should be with the date of sterilization and expiration date of the Chinese mark.
4, the equipment warehouse is responsible for the establishment of a register to record each order and the arrival of time, manufacturer, supplier, product name, quantity, unit price, product lot number, disinfection or sterilization date, expiration date, date of shipment, health license number, supply and demand, such as the name of the person in charge.
5, items stored in a cool, dry, well-ventilated shelves, from the ground ≥ 20cm, from the wall ≥ 5cm. shall not be packaged broken, invalid, moldy products issued to the use of the department.
6, the department should be checked before use of small packages are not damaged, failure, the product is not clean.
7, the use of pyrogenic reactions, infections or other abnormalities must be promptly retained samples sent for testing, detailed records in accordance with the provisions of the report of the Hospital Infection Management Department, Equipment Division.
8, the hospital found that substandard product quality suspicious products, should immediately stop using, and promptly report to the local drug supervision and management department, not to make their own return, replacement processing.
9, disposable sterile medical supplies after use, must be disinfected, disfigured, harmless disposal, prohibit re-use and return to the market.
10, the hospital infection management department shall fulfill the responsibility of supervision and inspection on the procurement, management and recycling of single-use sterile medical supplies.
Single-use sterile medical supplies must be strictly kept, shall not be damaged packaging, more than "sterilization expiration date" and packaging is not indicated on the date of sterilization and sterility of single-use sterile medical supplies for clinical use.
Disposable sterile items are stored in a cool, dry, well-ventilated shelves, from the ground >20cm, from the wall >5cm, from the ceiling >50cm.
Supply room for each batch of disposable infusion sets, syringes, verification of the factory the batch of bacterial endotoxin test report form and then issued to the clinic. And designate a person to the use of disposable infusion sets, syringes and equipment for recovery, disfigurement and harmless disposal and record archives, is strictly prohibited from reuse and remittance to the market.
One-time use of sterile medical supplies, remove the outer packaging before passing into the sterile goods storage room.
Strengthen the management of the warehouse, to achieve a monthly plan, in and out of the goods account is consistent.
Sterilization and supply room according to clinical needs, agreed to send to the clinical departments, both sides after checking the list of goods after signing procedures.
Distribution should be strictly old for new, distribution and recovery to maintain dynamic consistency.