Does your company manufacture products that need to comply with unique device identification (UDI) guidelines? If so, you may be able to use advanced software to better label and track your products. Sage Enterprise Management provides a flexible software solution aimed at managing the most elaborate business processes simply and efficiently. Find out how this ERP system can help you comply with these important medical device requirements.
What Is UDI?
Unique device identification (UDI) is a system developed by the Food and Drug Administration (FDA) to identify and trace all medical devices. The tracking system applies a unique code to each device that allows it to be tracked from the point of distribution and throughout its use. The codes must be readable for humans, while also including a barcode or machine-readable text that can be decoded and interpreted by automatic identification and data capture (AIDC) technology. In addition, code details must be submitted to the FDA's Global Unique Device Identification Database (GUDID).
These requirements are fairly new, but they are expected to provide major benefits in terms of improving patient safety and health care industry accountability. The codes will assist with modernizing device post-market surveillance and facilitating medical device innovations.
Challenges for Medical Device Manufacturers
Most medical device manufacturers are excited about the potential benefits of the new UDI system. However, it does pose a number of challenges for the companies that produce these devices. Some of these challenges include:
- Understanding and adhering to the timeline for UDI requirements being phased in.
- Noting all device revisions and model variations.
- Tracking serial numbers, expiration dates, lot numbers, and manufacturing dates for each device produced.
- Requesting a Device Identifier (DI) for each device from an FDA-accredited issuing agency.
- Requesting submission to the GUDID for each device.
- Selecting a machine-readable element like a barcode for your UDIs.
- Finding software that works with your selected machine-readable element.
How Sage Software Can Help
Sage software allows companies to comply with UDI requirements without causing too much of an interruption to their manufacturing and tracking processes. More specifically, Sage Enterprise Management offers a number of features that streamline UDI-compliance tasks so you can make this a passive, automated process for the medical devices you manufacture.
The following are some of the key benefits to use Sage Enterprise Management for medical device manufacturing:
- Work with machine-readable elements to store barcode and other DI information.
- Develop automated tracking for critical data, such as serial and lot numbers.
- Take advantage of forward and backward lot traceability.
- Enjoy access to historical records for every device produced.
- Gather and monitor relevant process information in one central hub.
- Eliminate manual procedures and other time-consuming tasks.
Once you've secured DIs for your devices, Sage Enterprise Management makes sure that all the tracking and record-keeping involved is seamless and efficient. These tasks will be integrated with other Sage features to provide superior accountability when it comes to tracking your products without requiring huge investments in additional labor or equipment.
Make patient safety a top priority for your company using Sage Enterprise Management for UDI compliance.
Learn more about this medical device manufacturing software by contacting Southeast Computer Solutions.