Medical device unique identification UDI cloud data management system

Medical device UDI cloud data management system

The medical device UDI cloud data management system is a system used to manage unique device identification (UDI) data of medical devices. The medical device UDI cloud data management system can upload the UDI code of medical devices and related product information to the cloud database for storage and management. This system can be used by medical device manufacturers, distributors, medical institutions, regulatory agencies, etc. to track and monitor the use of medical devices.

Using this system, medical institutions can obtain relevant product information, including manufacturer information, product model, production date, etc., by scanning the UDI code of medical devices. This information can help medical institutions trace the source and use of medical devices, as well as conduct recalls and repairs. Regulatory agencies can supervise the medical device market through this system, track and understand the use of various medical devices on the market, and ensure the safety and health of the market.

1. Medical device UDI cloud data management:

1. Data entry and upload: Medical device manufacturers enter the UDI code of the medical device and related product information into the system, and upload these data to the cloud database through cloud technology. Data can include manufacturer information, device model, batch number, production date, expiration date, etc.

2. Data storage and management: The uploaded data is Stored and managed in the cloud database. Systems can structure, organize and index this data, making it easy to retrieve and manage. At the same time, the system also needs to ensure the security and integrity of the data and take appropriate technical measures to protect the data from illegal access, tampering or loss.

3. Data query and access: Medical institutions and regulatory agencies can query and access data in the cloud database through the system's user interface or API interface. They can obtain detailed information about the medical device by scanning the UDI code of the medical device or entering relevant search terms.

4. Data update and maintenance: Medical device manufacturers may need to update and modify uploaded data, such as updating product batches, adding recall information, etc. The system needs to provide corresponding functions and permission management mechanisms to ensure that only appropriate users can update and maintain data.

5. Sharing and collaboration: The system can also provide data sharing and collaboration functions, allowing different organizations to share and access specific data. For example, medical institutions can share their data with other institutions to enhance the evaluation and supervision of medical devices.

6. Data analysis and reporting: The system can provide data analysis and reporting functions, conduct statistics and analysis on the usage and safety of medical devices, and generate corresponding reports and charts to provide support for decision-making and management.

The system also needs to consider user rights management, data backup and disaster recovery mechanisms, and compliance with relevant privacy protection regulations. Based on the above functions and requirements, the medical device UDI cloud data management system can realize the full life cycle management and supervision of medical devices.

2. Implementation of medical device UDI cloud data management system (Plan 1).

1. Coding standard design

The UDI code is divided into two parts: DI and PI. According to the product code, we use the GS1 encoding mode. The UDI code uses the DATAMATRIX code. The PI part includes the batch number, serial number, and expiration date.

The batch number remains unchanged according to the coding method; the expiration date is adjusted according to the GS1 specification and Party A's original service life is adjusted to a 6-digit number in the YYMMDD format; the serial number is based on the batch number + letter (ABC) + serial number, where A represents the body. , B stands for boxed, C stands for boxed.

Label coding printing system integration

The label printing method is a software transformation and upgrade on Party A's existing label printing system, and the original fixed label printing method is adjusted to variable printing, with the variable part being the product serial number. The modified printing system has variable code generation and printing functions, and all printed variable codes will be uploaded to the UDI data management platform.

3. UDI label packaging data correlation collection system

The last link of the production line is the packaging link. After the implementation of UDI packaging data related collection, this link will add data collection related links. A computer and a QR code scanning gun are installed at the packaging station. Workers must perform scanning and correlation operations after packaging single products and entire boxes.

4. UDI tag outbound collection system:

When products are shipped out of the warehouse, after selecting the product recipient, the products to be shipped out of the warehouse must be scanned and shipped out.

5.UDI data management platform:

The UDI data management platform mainly provides product batch information management, single product information management and customer information management. Provide users with functions such as traceability query, product data maintenance, and customer information maintenance.

The medical device UDI cloud data management system is a Tool that can improve the traceability and safety of medical devices and can help medical institutions and regulatory agencies better manage and supervise medical devices.