Foreign medical devices are reusable medical devices that are rented or provided free of charge to hospitals by medical device manufacturers and companies, which are local special operating instruments based on ordinary surgical instruments. Due to the strong targeting of this type of equipment, expensive, complicated varieties, professional and rapid update, the general hospital is not routinely equipped with the corresponding distribution of orthopaedic implantation of human nature surgery instruments, power tools and so on are the most common. Because most of these medical devices are highly dangerous medical devices, their safety and effectiveness must be strictly controlled.
I. Acceptance of instruments
Except for emergency surgeries, the operator should contact the instrument company to send the surgical instruments to the decontamination area of CSSD one day prior to the surgery according to the surgery schedule.
2. Signing and counting
CSSD and the device company will sign the "Signing and counting sheet for foreign medical devices and implants" after both parties ****count and check the relevant information of the devices correctly. The checking information includes: the name of the operation; the name of the patient, bed number; the brand, name and quantity of the instrument; the type, specification and quantity of the implant.
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 external 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. In accordance with 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 content. Before sterilization, indicate the sterilizer number, sterilization batch, sterilization date and expiration date. Labeling should be traceable.
V. Sterilization
1. The instrument company should provide the sterilization method and sterilization cycle parameters of the instrument.
2. Sterilization is classified according to the material of the device, and high-temperature-resistant devices should be sterilized by pressure steam.
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 the issuance of sterile packages should be confirmed qualified sterilization, and no moisture, no pollution, no loose, sealed or closed package intact.
2. Implants should be issued only after the biomonitoring passes, and the corresponding information is recorded and archived. Emergency surgery can be added to the biological PCD with 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 surgery, the instruments should be returned to the CSSD decontamination area in a timely manner.
2. After counting and checking, clean, disinfect and organize according to specifications.
3. Notify the device company, the two sides *** with the counting, checking, confirming that there is no error in the "foreign medical devices and implants count signing receipt" on the signature, the device company can get back the device.
VIII. 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.