(I) Receiving Instruments
1. Elective Surgery
(1) Orthopedic manufacturers' registration book is set up in the operating room, and the manufacturer's personnel are required to fill in the following items one by one: date of registration, name of the doctor, name of the surgery, number of copies or pieces of the instruments, name of the manufacturer, and signature of the personnel who deliver and pick up the instruments.
(2) Manufacturers send instrument personnel to the operating room before 8:00 two days before the operation to send instruments, in accordance with the operating room cleaning process. The process is completed with the operating room teacher handover and registration.
(3) The manufacturer's instruments must be packed by the operating room teacher, strictly following the requirements for packing of instruments in the operating room, and at the same time indicating the implant and the related matching instruments (item name), the date of the operation, the expiration date, the expiration date, the name of the person who packed the instruments, the pots, and the batch number.
(4) The use of surgical instruments sterilized outside the hospital is strictly prohibited in the operating room.
(5) The supply room is responsible for the sterilization of elective surgical instruments.
(6) The operating room and the supply room conduct a handover, handing over the name of the item and the date of use. Biological monitoring is qualified before starting the surgery.
2, emergency surgery
The operating room is responsible for the sterilization of emergency surgical instruments and implants. Patients with life-threatening or physical disability and other emergencies, such as implants, in addition to placing the crawl card, must be accompanied by pot for biological monitoring. After the end of sterilization, crawl card qualified can be used as a sign of early release. At the same time, the biological spores and pressure sterilization test results records will be sent to the Laboratory for culture. After the emergency release, the operating room needs to explain in writing the reason for the release, the surgeon's signature
(ii) the principle of instrument handling:
Only one instrument company personnel is allowed to enter the sterilized supply center for each surgery, and change clothes, shoes, masks and hats according to the management procedures of the sterilized supply center before entering.
Two, counting and signing
CSSD and the device company both *** with the counting and checking of device-related information is correct, *** with the signature on the "foreign medical equipment and implant counting and signing of receipt". The checking information includes: the name of the operation; the name of the patient, bed number; the brand, name and quantity of the instruments; the type, specification and quantity of the implants.
3. Cleaning and disinfection
1. The instrument company should provide detailed cleaning and disinfection procedures and precautions.
2. CSSD full-time staff should clean and disinfect all foreign medical devices.
3. The cleaning and disinfection process should strictly follow the requirements of the relevant Ministry of Health CSSD specifications.
(1) Cleaning and disinfection should be categorized.
(2) Removable instruments must be disassembled.
(3) Exposed implants must be contained in specialized cleaning baskets (racks).
(4) Water-resistant instruments can be mechanically cleaned; power tools that are not water-resistant can be cleaned by hand.
(5) The instrument box should be cleaned and sterilized.
Four, inspection and packaging
1. According to the "foreign medical equipment and plant figure count signing receipt" to organize the instruments.
2. Check the cleaning effect and instrument function.
3. Select appropriate packaging materials according to the material and sterilization method of the instruments.
4. The volume and quality of the sterilization package should strictly follow the requirements of the relevant norms of the Ministry of Health CSSD.
5. In the sterilization package in the most difficult to sterilize the package placed in the package chemical indication card, rigid containers should be placed in the package chemical indication card in the two opposite corners. Outside the packet of adhesive chemical indicator tape.
6. Package identification should indicate the use of the device of the surgical patient bed number, the name of the operation, the brand and name of the device, the packer and other internal
Contents. Sterilization before indicating the sterilizer number, sterilization batch, sterilization date and expiration date. Labeling should be traceable.
V. Sterilization
1. The device company should provide the device sterilization method and sterilization cycle parameters.
2. According to the instrument material classification sterilization, high temperature instruments should be used pressure steam sterilization.
3. Physical, chemical, and biological monitoring should be performed to confirm sterilization and avoid wet packs.
4. Extended sterilization cycle parameters should be used for overweight and oversized packages.
5. Specialized tools should be used in transit to avoid physical injury to handlers.
VI. Issuance
1. Before issuance should confirm that the sterilization of sterile packages qualified, and no moisture, no contamination, no loose, sealed or closed package is intact. 2. Implants should be issued only after passing the biomonitoring, and the corresponding information should be recorded and filed. Emergency surgery can be
In biological PCD with the addition of 5 types of chemical indicators, 5 types of chemical indicators qualified can be used as a sign of early release, but the results of biological monitoring should be promptly notified after the results of the use of the department.
VII. Recycling
1. After the end of the operation, the instruments should be returned to the decontamination area of CSSD in time. 2. After counting and checking, clean, disinfect and organize according to specifications.
3. Notify the device company, the two sides *** with the inventory, check, confirm that there is no error in the "foreign medical devices and implants inventory sign-off
sheet" on the signature, the device company can retrieve the device.
Eight, quality traceability
All foreign medical devices and implants should be tracked using the traceability management system, record each set of foreign medical devices and implants cleaning, disinfection, sterilization, monitoring and application of relevant information, so that at any time tracking and query.