5 Ways to use your UDI

5 Ways to use your UDI

September 8, 2016 | Posted by Dan Purvis

So you have been working hard with many of your colleagues to get UDIs placed on each of your devices.  You know more about bar codes and federal databases than anyone should ever be exposed to.  

So now what?  You probably deserve a long stint on a secluded beach.  When you get back, here are 6 ways that you can benefit from all of the effort you have expended.


1. Comply with tracking orders

The FDA states that manufacturers of devices with tracking orders must be prepared to report where each and every device is at any moment.  Manufacturers have 3-days to locate and report on devices that still reside within the device maker's ecosystem.  10 days are given for devices that reside with (or in) a patient.

In addition to the task of 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 the tracking of the device more seamlessly.  Ideally, you could scan your device when it leaves the manufacturing facility.  Scan it again at the distributor.  Scan it again at the hospital's shipping/receiving dock.  And scan it when delivered to the patient.  The mobile and cloud technology exists to make this a reality.

2. Keep DHRs complete

Lots of systems exist to build the device history record (DHR) of a medical device making its way through manufacturing.  But, how best to keep that information up to date throughout its useful life while it is "in the wild".  

UDIs can allow service techs to scan the device when they arrive on a service call. The UDI can be linked to databases that store the current device state.  As service is performed on the device, the technician can update the record so that the DHF maintains its integrity.

Historically, this has been done with manual data entry or hard copy files.  The historical 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 scan or enter the UDI, you can make suggestions on recommended activities.  

For example, you see that the device just scanned has delivered 170 therapies and there is a 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 an older, legacy device arrives.  Can it work with the latest high res screen that you just released?  Using the complete DHF - pulled from the UDI - you can check device compatibility.

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 when it is being transfered, then the data from the UDI can be retrieved and the device record updated.  

Device tracking was never as practical before - as it required significant manual data entry.  Now, with widespread UDIs implemented, it is highly practical to have everyone in the delivery chain involved in the tracking of the device.

5. Rules based field activity

If you have an IT solution that can look at user access levels and privileges, then you can scan the UDI and present relevant, appropriate, and allowable information to that user.  

What if you had different levels of service certification?  Then, based on the service center's certification, you can provide work instructions and next step actions.

With the advent of widespread UDI adoptation, there has never been a better time to advance the operational efficiency of device manufacturer's service and device tracking.  For a personal demonstration on how MedDeviceTrack can help, click here.



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