How to Implement UDI
On Your JD Edwards Environment
The FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human and machine readable form. In this article, we’ll show you how to implement UDI in JD Edwards to stay within medical device reporting requirements.
Current Medical Device Reporting Requirements
The Medical Device Reporting Regulation (MDR) 21 CFR 803, contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. With the establishment of the unique device identification system (which includes a UDI), you might be wondering what steps are necessary to stay within FDA compliance.
All of these requirements can be effectively reached through implementing UDI in JD Edwards. Some features that JDE offers are totally out of the box, so you may need to change some processes, create additional reports, and purchase compatible hardware for bar-coding.
How to Implement UDI in JD Edwards
The following segments are needed to implement UDI:
- Device identifier.
- Production identifier: Application identifier, expiration date, lot/batch, serial number.
Below are rules you need to follow to effectively implement UDI in JD Edwards:
- Verify that your environment allows the use of lots and/or serial numbers.
- Your JDE configuration should support expiration dates.
- Work order numbering is a must if you are in a manufacturing environment.
- The production number is an excellent way to track finish goods through the supply chain.
- Your JDE environment allows you to set different units of measurement, and set an additional identifier for every package unit.
Potential Benefits of Implementing UDI
There are various potential benefits of implementing UDI into your JD Edwards platform. These might include the following:
- Reduce medical errors through attainment of important device information.
- Simplify data systems integration.
- Provide for more rapid identification of medical devices with adverse events.
- Provide for more rapid development of solutions to reported problems.
- Provide for more rapid and efficient management and resolution of device recalls.
- Better focused and more effective FDA safety communication.
- Better inventory management.
- Identify alternative devices in the event of a shortage.
- Detect counterfeit devices and diversion practices.
- Ensure dates on device labels are clearly understood.
We Can Help
Our team of JD Edwards specialists can help you implement UDI into your JDE platform to stay within FDA compliance. We can help your team implement data repositories, lot trace and track reporting, and update Government data basis through web services.
Blockchain technology can also be integrated in your platform to help you track lots. Our subject matter experts can educate your team on blockchain opportunities, identify your current processes, and show you the path of using this technology to remain in FDA compliance.
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