As the number of medical devices increases, the need for better tracking and traceability of those devices becomes more and more important. Imagine the chaos and risk to patient safety if a device manufacturer issues a recall order and there wasn’t a good system for device record-keeping. Thankfully Zebra’s Unique Device Identity (UDI) Platform can help healthcare organizations as well as manufacturers comply with new regulations and requirements for medical device tracking.
When you think of tracking items, most think about UPS or FedEx. These days, you might even think of UberEats or DoorDash as you watch a little car icon move through a map to your house, preparing to deliver a sandwich from your favorite restaurant. Even in healthcare, “tracking” usually means knowing your inventory or monitoring in real-time, your asset locations.
Imagine you are a patient and you just had a pacemaker or an IUD implanted. Now imagine there was a recall on that device two weeks before you had it put in, yet nobody knew about it. Cringeworthy, right? That’s why Chris Sullivan, Global Healthcare Practice Lead and Rikki Jennings, Chief Nursing Informatics Officer (recognized as one of Crain’s Chicago Business’s “Notable Women in Healthcare.”) at Zebra were so excited about their company’s UDI solution, which they were going to showcase at HIMSS20 (alas).
The US Food and Drug Administration (FDA) introduced legislation a few years ago that required medical devices to have a unique device identifier (UDI). Without a UDI label, a device can not be sold in US. Class III devices (ones that sustain or support life, are implanted or present potential unreasonable risk of illness or injury), had to comply on September 24, 2014. By September 24th, 2020 all classes of medical devices will need to have a UDI label.
Having the label on every device is one thing. Making that label useful to healthcare providers is quite another. That’s where Zebra’s UDI Solution comes in. Using a Zebra hand-held scanner, a clinician can scan the UDI barcode on the device. The system will then retrieve all the relevant information for that device including any warnings, special instructions and most importantly, recall notifications.
“With a quick trigger scanner – just like you see at the grocery store or Home Depot – providers can have up-to-date information about each medical device,” said Sullivan. “And we eliminate the need for manual data entry of device identifiers into the EHR, which is fraught with error. We ensure the information is correct and up to date, every time. Providers can rest easy, knowing that the devices are safe to use and implant.”
Without a fully integrated solution like Zebra’s, someone would have to manually key the UDI from the device label into the patient’s record in the EHR. Since the UDI can be 25 digits long, it is easy for an error to occur during this transcription. It is not easy to find these errors once they are made in an EHR. In a recall situation, this error in documentation can have dire patient safety consequences.
Source: US Food and Drug Administration – UDI Basics
Having a direct link with the EHR means that the correct device information is tied to that patient, forever. Every time someone brings up that patient’s record, they will see the device description, the UDI, the date it was implanted and the latest information for that device.
The UDI links to a wealth of information from the device manufacturer. It is important that this information is made available to clinicians as quickly as possible. This includes recall notifications but also fraud warnings. Yes, that’s right, there are many fraudulent medical devices being sold in the US and the UDI can help to weed them out.
“We’re really proud of what it can do for patient safety,” said Jennings. “We’re also really proud to be the first company to deliver this ability to the market – to scan data from medical devices and make it readily available to clinicians. It’s a simple concept, really, but it can literally save lives.”
Zebra has a long history of helping organizations track things. For many years they have offered solutions for bedside specimen labeling, scannable patient ID wristbands and real-time location systems (RLTS). If you want something tracked, Zebra likely has a solution.
“One of our clients was able to save $700K using tracking technology,” Jennings reported. “When you better manage perioperative rooms, people, and assets, you shorten the time to turn a room over and increase the number of procedures that can be done. It’s a significant financial impact for our clients. It makes their organizations stronger.”
Sullivan added, “It’s also important for us to make technologies that are mobile and usable. There is no place in healthcare for unwieldy technology. If you think about COWs [Computers on Wheels] and WOWs [Workstations on Wheels], they are bulky, difficult to use and hard to keep clean. We’re helping to make those unnecessary. We’ve made technologies smaller. So instead of needing a clunky computer, everything is an app on a handheld device. This helps streamline workflows and deliver services the way patients and providers expect.”
As US hospitals get busier amidst COVID-19 and after and as more devices are implanted in patients, the need for solutions that help to keep track of specimens, hospital assets and devices will be sorely needed.
For more information about Zebra, visit – https://www.zebra.com/gb/en/solutions/industry/healthcare.html
This article is part of the #HealthIT100in100