Two, the enterprise storage of medical devices shall meet the following requirements:
1. Store interventional medical devices (category codes are III-682 1, III-6846, III-6863, III-6877), with at least 5000 unpacking and sorting positions.
2. Store disposable sterile consumables medical instruments (category codes are III-68 15, III-6845, III-6864, III-6865 and III-6866), with no less than 2,000 pallets, and the height between pallets shall not be less than1.5m. The specifications of pallets shall meet the national standards.
3. If medical devices need to be refrigerated or frozen, the cold storage volume shall be not less than 1 000 cubic meters, and the freezer volume shall be not less than 50 cubic meters.
4. For the storage of other types of medical devices other than the above categories, there should be no less than 65,438+0,000 pallets and no less than 5,000 unpacking and retrieval positions.
Three, storage equipment and facilities are mainly composed of storage management equipment, cargo information automatic identification equipment and other links, the specific requirements are as follows:
1. Warehouse management equipment. Including but not limited to bar code compiling, printing equipment and computer information management equipment, it can encode the purchased medical devices without effective automatic identification labels, and realize the automatic collection, storage and traceability of the information of the purchased medical devices.
2. Automatic cargo information identification equipment. Electronic identification system should be used to manage the warehousing, warehousing, sorting, inspection, inventory and warehousing audit of medical devices (for implantable medical devices, the serial number of products should be identified and recorded), and the whole process of storage and distribution of medical devices can be traced by bar code and radio frequency identification equipment.
Four, enterprises should establish a central control room. The central control room should have the functions of temperature and humidity monitoring of warehouses, constant temperature warehouses, cold storage and refrigerated trucks, video monitoring of general storage areas, storage equipment control and abnormal alarm.
Normal temperature warehouse shall automatically record real-time temperature and humidity data at least once every 30 minutes; Constant temperature storage, cold storage and freezer shall automatically record real-time temperature and humidity data at least once every 10 minute; The refrigerated truck shall automatically record real-time temperature data at least once every 5 minutes; When the monitored temperature and humidity values exceed the specified range, real-time temperature and humidity data shall be recorded at least once every 2 minutes.
Five, the storage of cold chain medical equipment enterprises should be equipped with standby power supply equipment or dual power supply, with emergency power protection function.