Patient safety is the top priority for the global healthcare community, which is why strong action is being taken in the United States, European Union (EU) and beyond to improve accountability and traceability for medical device implants. Though currently mandated using regionally-defined regulations such as the Food and Drug Administration (FDA) Amendments Act of 2007 in the U.S. and the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in the E.U., the widespread enactment of the Unique Device Identification (UDI) labeling requirement facilitates complete traceability of the millions of individual medical devices utilized for patient care at the serial level, as described here.
The shared goal by global supply chains and healthcare communities is to be able to locate implanted medical devices at any point in time, from the moment they’re manufactured to the moment at which they’re disposed, in order to avert negative point-of-care outcomes when a safety or quality issue is identified.
For example, if there is a recall for breast implants as was the case recently, someone would be able to instantly identify and contact patients with those implants to offer resolution options. Even better, the UDI could allow manufacturers and medical providers to pre-empt such issues by locating and pulling faulty medical devices from the supply chain – whether they’re currently on production lines, warehouse shelves or in hospital storage rooms – or flagging when an implanted device is about to expire so that it can be replaced.
There’s just one problem…
It can be very difficult to capture all available data from UDI labels and even more challenging to effectively integrate it into your many different systems in a way that benefits your practice and patients.
(Ok, those are really two different problems. But the good news is that there is a way to solve both, which I’ll get to shortly.)
The UDI Data Capture Challenge
The UDI itself can be as long as 75 characters and there are potentially hundreds of thousands of data points that can be integrated into the Device Identifier (DI) and Production Identifier (PI) serializations in each barcode, making it nearly impossible to manually extract all relevant information in an efficient and accurate manner. (Did you know that, on average, one manual data entry error is made for every 300 keystrokes?) To make it more complicated, the FDA has authorized three different standards bodies to issue the device identifiers to manufacturers, and each uses a different UDI format – all of which are regulatory compliant. Such labeling inconsistencies make UDI data capture difficult regardless of whether an employee is typing in the UDI attributes or using a barcode scanner.
The good news is that the International Medical Device Regulator Forum (IMDRF) is working with regulatory bodies, manufacturers and healthcare leaders in the European Union, U.S. and several other countries to implement a more globally harmonized and consistent approach to medical device management, especially as it relates to UDI standards. However, that will take time and you need to ensure you have the right tools to take advantage of all the valuable enterprise intelligence that UDI is delivering to your physicians, nurses, patients and administrators today – starting with a barcode scanner.
But not just any barcode scanner. It must be equipped with software that enables hospital staff to immediately capture all barcodes and UDI data fields on either the medical device packaging or the device itself with complete accuracy with a single scan.
Why is this so important?
The only way that hospitals such as yours will fully benefit from the UDI mandate is if you have a way to pull in all of the data crammed into each UDI label – and pull it all together in your back-end systems – in a highly automated fashion.
The faster you can get UDI-derived data into the electronic health record (EHR) and ERP, the faster you’ll be able to act to mitigate operational risks and improve outcomes. Depending on your UDI data strategy and system interoperability, you may be able to set up clinician alerts if there are any known issues with that device, including recall notifications. You may also be able to keep staff appraised of device expiration dates so that they can employ a first-in-first-out methodology when putting away and picking inventory in storage rooms. Then there are the billing and claims-related benefits, among a host of other potential gains. Watch this video.
Already Have Barcode Scanners in Your Hospital?
Not all barcode scanners are capable of reading all UDI label formats or data fields, and the poor quality of some 1D and camera-based scanners makes it hard to capture data on the first scan or in full. There is also a bit of specialized integration required to ensure back-end systems are properly synced with both the data capture devices – i.e. the barcode scanners – as well as the mobile computing hardware and workflow software that will subsequently be used to apply the UDI data beyond basic medical device track-and-trace applications. (We’ll discuss UDI data utilization strategies in more detail in an upcoming blog.)
That is why I always recommend that healthcare providers work with a solution partner who is highly familiar with UDI requirements and the necessary technology systems. They will help you determine which best practices and technology solutions you should implement to maximize the actionable intelligence you’ll gain from UDI labels.
In fact, if you’re headed to HIMSS 2020 in Orlando in March, I recommend that you book a meeting now with our UDI experts. They can help you assess your current technology architecture to see if you first have the data capture technologies you need to take full advantage of the UDI mandate on medical device manufacturers. From there, they can help you determine what other mobile computing and RFID technologies you may need to execute new UDI data-dependent patient care and administrative workflows. They’ll also outline hardware and software interoperability requirements and talk with you about the system integration process, some of which involves our partners. This team is well-versed in UDI requirements and experienced in designing effective solutions, as you can see in this infographic, and they can ensure you don’t miss out on an opportunity to improve your hospital’s accountability, inventory management and collections processes or patient safety measures.
If you’re not going to HIMSS but still want to learn how your hospital can best leverage UDI data now that manufacturers’ UDI mandates will be in full effect, you can also reach out to us here to set up a call or meeting.
I highly recommend that you also take a couple of minutes to watch this video if you skipped over it above. It gives a great overview of how the healthcare community can take full advantage of UDI.