1. The supplier must purchase qualified products from the manufacturing enterprise that has obtained the medical device production license or the operating enterprise that has obtained the medical device business license, and verify the product registration certificate, power of attorney, product certificate and the "three certificates" of the manufacturing enterprise license or the operating enterprise license. It is strictly prohibited to purchase and use unregistered, unqualified, expired, invalid or obsolete products.
2. All implantable materials must be subject to unified bidding before purchasing; Other departments shall not purchase without authorization.
3. Hospital expert consultation, surgery should bring their own medical implant materials, medical implant materials that really need to be carried by experts should also comply with the above provisions, and can be used only after acceptance and filing by the Equipment Department.
Management system of medical consumables (including embedded consumables)
1. Medical consumables (including classified consumables) used in hospitals must be purchased by unified bidding, and clinical departments are not allowed to purchase and try them out by themselves.
2. The Equipment Department shall earnestly perform the duties of supervision and inspection on the procurement management, clinical application and recovery of medical consumables (including implantable consumables).
3. A copy of the three certificates of medical consumables (including implantable consumables) purchased by the hospital should be filed in the Hospital Equipment Department, that is, the supplier must purchase qualified products from the manufacturing enterprise that has obtained the medical device production license or the operating enterprise that has obtained the medical device business license, and verify the product registration certificate, power of attorney, product certificate and the "three certificates" of the manufacturing enterprise license or the operating enterprise license. It is strictly prohibited to purchase and use unregistered, unqualified, expired, invalid or obsolete products. Establish a registration system for purchasing medical consumables.
4, the outer court expert consultation, surgery should bring their own medical implant materials, medical implant materials that really need to be carried by experts should also comply with the above provisions, and can be used only after the acceptance of the instrument department for the record.
5. When purchasing medical consumables (including embedded consumables), in addition to the ordering contract, delivery place and payment remittance account number, it must also be checked and accepted, and the inspection certificate of each box (package) must be checked. Internal and external packaging should be intact, packaging labels should meet national standards, and imported products should be marked in Chinese.
6. Set up a special place for medical consumables (including implantable consumables) in the equipment warehouse, establish a warehousing registration system, and store them on cool, dry and well-ventilated shelves according to the validity period. It is forbidden to mix with other articles, and products with unclear identification, damaged packaging, failure and mildew shall not be distributed for clinical use.
7. When unqualified products or products with suspicious quality are found in the equipment warehouse, they should stop using them immediately and report to the relevant departments in time, and they are not allowed to return or exchange goods by themselves.
8 medical consumables (including disposable consumables) shall be disposed of in accordance with the regulations of the State Council Municipality on the management of medical wastes.
9. For orthopedic internal fixation devices, pacemakers and other implantable or interventional medical devices, detailed use records must be established.