1. The supplier must obtain the "Medical Device Manufacturing License" of the manufacturer or obtain the "Medical Device Operator License" of the operating company to purchase qualified products, and verify the product registration certificate, authorization, product qualification certificates, as well as the manufacturer's license or operator's license, "three certificates ". Procurement and use of unregistered, no certificate of conformity, expired, expired or eliminated products is strictly prohibited.
2. All implantable materials must be unified bidding before the procurement of implantable materials; other departments shall not purchase without authorization.
3. External expert consultation, surgery, self-provided medical implantable materials, the need for experts to carry medical implantable materials should also be consistent with the above provisions, there are equipment acceptance of the Department of the record before use.
Medical consumables (including implantable consumables) management system
1. Medical consumables used in the hospital (including implantable tip consumables) must be unified bidding procurement, the clinical departments shall not purchase and try on their own.
2. The Equipment Section shall conscientiously fulfill its duties of supervision and inspection on the procurement management, clinical application and recycling of medical consumables (including inserted consumables).
3. Hospital procurement of medical consumables (including insertion of consumables) of the three certificates of copies should be filed in the hospital equipment section, that is, the supplier must obtain the "Medical Device Manufacturing License" of the manufacturer or obtain the "Medical Device Operator License" of the operating company to purchase qualified products, and verification of the product registration certificate, authorization, the product qualification certificate, and the manufacturer's license or operating company license. License" three certificates. It is strictly prohibited to purchase and use unregistered, unqualified, expired, invalid or obsolete products. And the establishment of medical consumables procurement registration system.
4, outside the hospital expert consultation, surgical self-provided medical implantable materials, do need to experts to carry medical implantable materials should also be consistent with the above provisions, there are equipment section acceptance for the record before use.
5. In the procurement of medical consumables (including insertion of consumables), must carry out acceptance, in addition to the ordering contract, delivery location and payment remittance account number should be consistent with the production and operation of the enterprise, check each box (packet) of the product inspection certificate, the internal and external packaging should be intact, the packaging marking should be in line with national standards, imported products should be marked in Chinese.
6. Instrument storehouse set up a special place for medical consumables (including insertion of consumables), the establishment of the entry and exit registration system, according to the expiration date of the successive storage in a cool, dry, well-ventilated shelves, prohibit the mixing of other items, shall not be clearly marked, damaged packaging, failure, moldy products issued to clinical use.
7. When substandard products or products of doubtful quality are found in the instrument storehouse, they should be stopped immediately and reported to the relevant departments in time, and should not be returned or exchanged on their own.
8. Medical consumables (including inserted consumables) are disposed of according to the State Council's "Regulations on the Management of Medical Waste" after use.
9. Orthopedic internal fixation devices, pacemakers, and other implantable or interventional medical devices, must establish a detailed record of use.