You have been working hard to place Unique Device Identification (UDI) numbers on each of your devices. You now know more about bar codes, QR codes, scanner systems, and federal databases than you ever wanted to know, but congratulations: you’ve achieved FDA and IMDRF UDI compliance.
So now what? You probably deserve a long stint on a secluded beach. When you get back, here are five additional ways that you can benefit from all of the effort you have expended.
1. Comply with Order Tracking
The FDA states that manufacturers of devices with tracking orders must be prepared to report where each and every device is located at any moment. Manufacturers have three (3) days to locate and report on devices that still reside within the device manufacturer's ecosystem. Up to ten (10) days are permitted for devices that operate with (or in) a patient.
In addition to knowing where each device is (or who it's with), there is required data that must be stored alongside the device information – including patient data (HIPAA protected) and physician information.
Now that your devices have UDIs, there is a host of scanning technology that can allow seamless tracking. Ideally, you would scan your device when it leaves the manufacturing facility, at the distributor, the health delivery organization (HDO)'s shipping/receiving dock,and when delivered to the patient. The mobile and cloud technology exists to make this a reality.
2. Keep DHRs Complete
Many Enterprise Resource Planning (ERP) systems exist to build the Device History Record (DHR) of a medical device throughout the manufacturing process. But, how best to keep that information up-to-date throughout the device’s useful life while it is “in the wild”?
UDI – ERP integration can allow service techs to scan the device when they arrive on a service call. In an integrated system, the UDI is linked to databases that store detail for the device’s current state. As service is performed on the device, the technician’s mobile UDI software can automatically update the device record so that the Device History File (DHF) maintains its integrity.
Historically, postmarket Device History Record (DHR) updates have been executed with manual data entry or hard copy files. This process is fraught with error, non-compliance, and delay. UDIs provide an avenue for making DHF maintenance much more straightforward.
3. Maintain Devices Proactively
Now that you can have your entire support chain scanning the UDI, you can make suggestions on recommended activities.
For example, you see that the device you recently scanned has delivered 170 therapies and has scheduled maintenance at 175 therapies. So you go ahead and perform the maintenance 5 therapies early and save the patient a trip back to the service center.
Or, perhaps a legacy device arrives. Can it accept the update you just released? Is it lacking any updates, e.g. security updates, that it has not yet received? Using the complete DHF – pulled via the UDI – you can check device compatibility and compliance status.
4. Turn the Whole Delivery Chain into a Team
Now that UDIs are going to be everywhere, there is a unified "point of data entry" that resides directly on the device. If everyone understands the need to scan the device every time someone in the chain touches it, then the data from the UDI can be retrieved and the device record updated.
Device tracking was never this practical when it required significant manual data entry. Now, as automated UDI tracking becomes widely implemented, it is highly useful to have everyone in the delivery chain involved in the monitoring of the device.
5. User-Based Field Activity
If you have the right IT solution, one that can look at user access levels and privileges, then upon UDI scan, you can present relevant, appropriate, and allowable information to that user.
Depending on your device, you might consider providing different levels of service certification. Then, based on the service center's certification, you could offer work instructions and next-step actions via your service mobile app. Is your device user-serviceable in any way? What about HDO-serviceable? App integration with your UDI system can help you adequately support each use-case and service case at the level appropriate.
The Bottom Line
Yes, UDIs are required for FDA and IMDRF compliance, but a robust UDI system can help you do so much more than check a box on your submissions paperwork, or keep track of inventory during shipment. When designed and executed correctly, ERP-and-mobile-integrated UDI systems can become a competitive advantage for offering superior user experience, technical support, and postmarket surveillance that saves on resources and headache for DHR maintenance and grows your company’s reputation with patients, HDOs, and regulators.
Contact us today to learn more about how Velentium’s manufacturing and postmarket expertise can help you set up a UDI solution that is right for your device.