Medical device udi packaging level management

In the process of assigning UDI codes to medical device products, in addition to UDI coding registration and UDI label design and printing, there is also an important step in the determination of PI information. We are establishing a packaging hierarchical relationship. PI information plays a key role in this link. PI is not a required option in UDI coding, but for companies with larger output and more product specifications, when product packaging exceeds two or more levels, it is necessary in the management of medical device inbound and outbound. Product inbound and outbound management Establishing a packaging hierarchical association with traceability can not only meet the needs of the circulation and use links, but also avoid corporate operational risks and achieve accurate traceability and tampering prevention issues, thereby improving the company's precise management level. So, how to establish product packaging hierarchical association? Let’s take a look at how to comply with the requirements for using UDI coding.

Medical device udi product packaging hierarchical relationship

UDI is the unique device identifier on the packaging of medical devices. It is traceable and identifiable globally. The UDI logo consists of a series of standardized and unified numbers and strings, which includes the DI code, the identification code of the medical device registered by the manufacturer, and PI code, which includes batch number, production date, expiration date, serial number, internal management information of the enterprise, etc. In general, when companies assign coding and packaging levels to medical devices, the UDI mark will appear at the following levels.

1 Outsourcing: transportation and inbound and outbound management of medical devices, such as cartons, boxes, bags, etc. The udi code will also appear on the outer packaging.

2. Medium packaging: Most medical device manufacturers have medium packaging, such as foam boxes, small packaging boxes, medium plastic bags, etc., and udi codes will also appear.

3 Single product packaging: Each medical device can be sold separately. This is what we usually call the "minimum unit" of medical devices. Enterprises can package one package according to their own product characteristics and product needs, and in compliance with medical device udi regulations. Assign a code to the product in batches, or each product can have a unique udi code, which plays a final traceability role in the "three medical linkages".

In the specific application and hierarchical management of medical device UD coding, some local regulations and Hospitals have different management of PI, and there will be some differences. The specifics also depend on local laws, regulations and requirements.

Applications associated with packaging levels

Medical device entry and exit: When managing the entry and exit of medical device products, there is no need to unpack. You only need to scan the outermost packaging to complete the entry and exit of the whole box. The UD code information and level are coded on the organized outer packaging. Management already includes all product information for the entire box, greatly improving management efficiency.

Medical device circulation: It is convenient for transportation, sellers, terminal sales, and inventory management. At present, some hospitals and retailers have begun to require manufacturing companies to establish product packaging hierarchical associations and establish data management database management. Data upload and docking management can be implemented through the corporate medical device UDI database API interface.

Medical device traceability: Once there is a problem with the product, the product batch can be accurately located and the production line and production personnel can be accurately identified through the company's internal management code. The product can be quickly recalled and processed in a timely manner to minimize the company's losses.

Anti-channeling of medical devices: When users scan the QR code on product packaging, the big data background can clearly know where the products are sold, which solves the problem of medical device channeling for enterprises.