While not widely advertised by regulatory bodies, Chris Sullivan, Zebra’s Global Healthcare Practice Lead, discussed in an earlier blog post how the Unique Device Identification (UDI) mandates now being enforced in the U.S., the European Union and regions around the world do much more than just help healthcare device manufacturers and their global supply chain partners quickly locate medical devices when quality or safety issues arise.
UDI labels help hospitals and other healthcare facilities better manage inventory turns, improve the accuracy of billing for each procedure, reduce waste due to product expiration and reduce annual audit shortfalls for medical implants.
UDI labels also help to protect patients. Healthcare providers who have access to UDI data can verify the model number, expiration date and recall status of an implantable device before a procedure begins. And, if there is a later recall, patients can be instantly alerted so that corrective actions can be taken to help mitigate health issues. Faulty medical equipment and implants can also be immediately identified and pulled from anywhere in the supply chain to prevent further use.
In other words, medical device traceability isn’t the only benefit of the new UDI mandates, and healthcare supply chains aren’t the only beneficiaries.
However, hospitals can only take advantage of this valuable information if they have a way to extract it from the barcode labels (yes, plural) on medical device packaging.
What Makes UDI Data Capture So Unique
Barcode symbologies are standardized in their design and data structure which is why one might think that the same barcode scanners used for positive patient identification (PPID), electronic health record (EHR) retrieval and other inventory management activities could just as easily be used for UDI capture.
Technically, you would not be wrong. Those barcode scanners are built to work universally across many different clinical workflows. However, UDI barcode labels break the mold a bit. Actually, they break it a lot.
Unlike traditional inventory or wristband barcodes that may only contain a single symbology type, a UDI barcode label may have multiple barcodes with multiple data fields and differing symbology types (depending on the issuing agency). Each data field must somehow be extracted and then entered into an EHR, ERP or other back-office systems if healthcare facilities are to take advantage of this valuable data to improve patient care, safety and business operations, including billing accuracy.
And if that doesn’t make the data capture process complex enough, there are differing label formats to read across device manufacturers.
Make This One Mistake and You Could Put Your Patients at Risk
Over the past year, health system leaders have expressed concern at industry events and in direct conversations with Zebra that many healthcare providers are still manually typing the UDI fields into the EHR instead of using a handheld barcode scanner to automatically capture UDI label data. That is concerning considering the numerous data entry delays and errors that could occur as a result. With patient safety a top priority, healthcare providers should take caution with such a risky process to track medical device availability and utilization. This is a scenario where “good enough” isn’t good enough – or good at all!
Misreading or mistyping just one letter or number in any of the device identifier (DI) and production identifier (PI) data fields is dangerous in many ways! It could mean the difference between life and death if the device is expired or the implant is recalled and swift corrective action can’t be taken because the UDI record in the EHR is incorrect.
It takes a lot of time to manually enter UDI data for every medical device that is received, used or disposed of in the course of a day. Every second spent typing in serial numbers, batch numbers, manufacturing dates, expiration dates and more into an EHR, ERP or other back-office system is time that could have been better spent with patients.
I tell anyone using Zebra scanners for clinical workflows to take the time to consider the benefits of capturing UDI’s unique data sets per the standards defined and adopted by the FDA, European Commission, the International Medical Device Regulatory Forum (IMDRF) and the Joint Commission.
The pressure is on to care for more patients, manage more inventory and move faster than ever! Mitigating mistakes is critical and, depending on where you are in the world, ensure compliance with local regulations such as the Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR).
A Few Minutes Now Can Save You Time, Money and Heartache in the Years to Come
The Zebra UDI Scan+ application we rolled out earlier this year can be easily programmed to simultaneously identify, decode and parse all UDI label data with a single trigger pull of your Zebra barcode scanners. (Not a single manual data input is required, and multiple data fields can be accurately captured in seconds!) The 123Scan Wizard, which is part of Zebra’s DataCapture DNA™, makes it just as fast and easy to configure your scanners.
There is some additional system integration required on the front end to ensure the data that’s captured via the barcode scanner properly populates your EHR and other back-end data systems. (We’ll talk more about that in an upcoming blog post.) However, it doesn’t make sense to talk about leveraging UDI data for inventory management, new patient safety measures or financial planning purposes if you don’t first automate the data capture process. That’s the only way to garner the actionable intelligence you need to make accurate decisions and take fast action when opportunities or issues arise – allowing healthcare providers to spend more time with their patients and less time on data capture tasks.
You can learn more about how to add the UDI Scan+ application to your Zebra barcode scanners on our website. Our Healthcare team is also available to answer any questions you may have or provide guidance on how to best capture and integrate UDI data into your healthcare information systems.