2 hospital infection management department is responsible for:
(1) Conduct relevant audits on new products or disposable sterile medical supplies replacement products, including auditing relevant certificates required by the state, and make proper registration.
(2) Supervise the registration, storage and distribution of disposable sterile medical supplies, and check the appearance quality of products;
(3) Supervise the clinical use and harmless treatment after use, and investigate the abnormal clinical reactions in time;
(4) daily and regular supervision, inspection and management of disposable sterile medical supplies, and timely report and feedback to the hospital infection management committee and relevant departments;
3 hospital equipment department is responsible for:
(1) Purchase and keep disposable sterile medical supplies, and do a good job in quality acceptance and registration;
(2) Check the valid certificates of products and register for the record;
(3) Register the warehousing products, and establish a register. The registered items include warehousing time, manufacturer, product name, batch number, quantity, specification, unit price, disinfection or sterilization date, expiration date, handlers, etc. , and carry out quality inspection, including the order contract, delivery place, loan remittance account number, which should be consistent with the production enterprise/business enterprise, and check the certificate of conformity, production date, disinfection or sterilization and validity period. The warehouse should be cool, dry and ventilated, and the room should be kept clean. Articles should be placed on the shelves, and products of different types and models should be placed separately, with a distance of ≥20CM from the ground, ≥5CM from the wall and ≥50CM from the ceiling.
4 disinfection supply room is responsible for:
(1) distribution of disposable sterile medical supplies, re-inspection of large, medium and small packaging of products, sampling inspection of product appearance quality, and inspection of product batch inspection reports;
(2) Register the warehousing products and establish a register, including warehousing time, manufacturer, product name, batch number, quantity, specification, disinfection or sterilization date, validity period, handlers, etc. , and quality acceptance, check each box (package) product certificate, production date, disinfection or sterilization and expiration date. Imported disposable sterile medical supplies shall be marked in Chinese; The warehouse should be cool, dry and ventilated, and the room should be kept clean. Items should be placed on the shelf, ≥20CM or more from the ground, 5 cm or more from the wall and 50 cm or more from the ceiling. Different types and models of products should be placed separately.
(3) Strictly implement the disposable goods distribution system, and do not distribute the products with damaged, invalid and moldy packaging to the user department;
(4) Sterilization is prohibited when disposable sterile medical supplies are reused;
(5) If problems are found in the above work, record them in time and report to the nursing department and the hospital infection management department;
(6) A large number of disposable sterile items in the department shall not be distributed at one time.
5 The user department shall:
(1) The person in charge of the user department is responsible for reviewing the small package of the product, the production batch number, the appearance quality of the product, whether the imported product has the Chinese logo, etc.
(2) Before use, the user should check the sealing performance of the small package, the effective sterilization date and validity period, the appearance quality of the product, and whether the imported product has Chinese logo, etc.
(3) If there is any abnormal reaction during use, stop using it immediately, keep the sample book and register it, check the heat source of the sample, and report it to the doctor and head nurse on duty in time, who will report it to the nursing department, infection management department and equipment department, and seal the same batch of unused items for future reference when necessary;
(4) Disposable sterile medical supplies shall be treated in strict accordance with the classification of infectious wastes, properly registered and signed, and shall not be discarded or sold to any unit or individual at will; It is strictly forbidden to flow into society;
(5) Each department shall not purchase disposable sterile medical supplies by itself;
(6) Prohibit departments from importing a large number of disposable sterile medical supplies;
6. The harmless treatment of disposable sterile articles shall be managed by the nursing department, general affairs department and infection management department;
7. Disposable sterile medical supplies brought back by individuals from outside the hospital shall not be applied in principle; If smearing is needed, the date, validity period and appearance quality of disinfection and sterilization should be checked. Before use, it should be registered in the undergraduate course room and signed by the director of the department before use. If it is used in the operating room, it should also be registered in the operating room nurses' strengths. If there is a quality problem, it will lead to medical disputes. , users and department heads should bear corresponding responsibilities;
8 Reuse of disposable sterile medical supplies is prohibited, otherwise all consequences arising therefrom shall be borne by the parties concerned and their departments;
9 Departments and individuals who violate the above provisions shall be ordered by the Hospital Infection Management Committee to make rectification within a time limit, and may be fined 500- 1000 yuan depending on the seriousness of the case; If it endangers human health and constitutes a crime, the relevant personnel shall be investigated for legal responsibility according to law.
The "Regulations" shall be implemented as of the date of issuance, and the original document "Several Provisions on the Administration of Disposable Medical Devices" in our hospital shall be abolished at the same time.
July 30(th), 2008
In order to protect people's health, prevent the spread of iatrogenic diseases and strengthen the management of disposable sterile medical supplies, this system is formulated.
The hospital infection management department or full-time staff is responsible for supervising the use, management and recovery of disposable medical and health supplies in the unit and monitoring the quality of purchased products.
1, disposable sterile medical supplies used in hospitals must be purchased by the equipment department, and the user department shall not purchase them by itself.
2. When hospitals purchase disposable sterile medical supplies, they must purchase qualified products from manufacturers that have obtained the Medical Device Manufacturing Enterprise License, the Industrial Product Production License, the Medical Device Product Registration Certificate and the Hygiene License issued by the health administrative department or enterprises that have obtained the Medical Device Operating Enterprise License; The import of sterile medical supplies such as disposable catheters shall have the medical device product registration certificate issued by the drug supervision and administration department of the State Council.
3, where the purchase, the purchasing department must carry out quality inspection, the order contract, delivery place and loan remittance account number should be consistent with the production enterprises and operating enterprises, and check the inspection certificate, production date, disinfection or sterilization, product identification and expiration date of each box (package) of products. Imported disposable catheters and other sterile medical supplies shall be marked with sterilization date and expiration date in Chinese.
4. The equipment warehouse is responsible for establishing a registration account to record each order, arrival time, manufacturer, supplier, product name, quantity, unit price, product batch number, disinfection or sterilization date, expiration date, factory date, hygiene license number, names of management personnel of both supply and demand sides, etc.
5, items stored in a cool, dry, well-ventilated shelves, ≥20cm or more from the ground, 5 cm or more from the wall. Products with damaged, invalid and moldy packaging shall not be distributed to the user department.
6. Before use, the department should check whether the package is damaged or invalid and whether the product is clean.
7. In case of pyrogen reaction, infection or other abnormal conditions during use, samples must be kept for inspection in time, recorded in detail according to regulations, and reported to the hospital infection management department and equipment department.
8. If the hospital finds unqualified products with suspicious quality, it shall immediately stop using them and report to the local drug supervision and administration department in time. No return or exchange is allowed.
9, disposable sterile medical supplies after use, must be disinfected, destroyed, harmless treatment, prohibit reuse and into the market.
10, the hospital infection management department shall perform the supervision and inspection duties on the procurement, management and recycling of disposable sterile medical supplies.
Disposable sterile medical supplies must be kept strictly. Disposable sterile medical supplies with damaged packaging, exceeding the "sterilization validity period" and without marked sterilization date and sterilization validity period on the packaging shall not be used in clinic.
Disposable sterile articles shall be stored in a cool, dry and well-ventilated shelf, which is more than 20 cm from the ground, more than 5 cm from the wall and more than 50 cm from the ceiling.
The supply room will inspect each batch of disposable infusion sets and syringes, and the factory will check the qualified bacterial endotoxin test report before distributing it to the clinic. And designate a special person to recycle, destroy and treat the disposable infusion sets and injection instruments after use, and record and file them. It is strictly forbidden to reuse and merge into the market.
Disposable sterile medical supplies can only enter the sterile storage room after the outer packaging is removed.
Strengthen warehouse management to ensure that the monthly plan is consistent with the import and export accounts.
According to the clinical needs, the disinfection supply room agreed to send it to the clinical department, and the two sides checked and went through the formalities of signing the material list.
Distribution should be strictly trade-in, and distribution and recycling should maintain dynamic consistency.