As requirements for unique device identification (UDI) as specified by the U.S. Food and Drug Administration (FDA) enter their latter stages, UDI activity in the European Union is just ramping up.
This version of UDI is part of the Medical Device Regulation (MDR) document, and will be harmonized with GS1’s global standards, which are also accredited with the U.S. FDA.
As is the case in the U.S., UDI can be leveraged to help improve asset tracking and traceability for both internal and external supply chain and asset optimization activities. That creates value far beyond simple regulatory compliance. According to this article at MedTech Intelligence, one global device manufacturer said that label standardization via UDI reduced duplicate items/SKUs by 15%.
Xerafy offers UDI-compliant RFID solutions for medical devices, including durable, autoclavable RFID tags that can be used for identifying and tracking surgical instruments and other devices in a hospital setting.
UDI compliance was the subject of a recent conference in Brussels in May focused on applying lessons learned from the FDA implementation in the U.S. to European companies. In addition, the GS1 conference in Berlin in April featured a number of helpful UDI sessions that you can access here.
One particularly helpful sessions led by bioMerieux outlined the steps necessary for compliance.
Stakeholders have until May 2020 to comply with the MDR/UDI requirements or risk losing their CE-mark certification or access to the EU market for their devices. To prepare, manufacturers should:
* Evaluate their product portfolio to see which products fall under MDR, or whether those products have had a classification change
* Ensure those products are compliant with the new requirements both in terms of labeling and performance/clinical evidence documentation.
* Evaluate your existing data quality, and establish a method of creating a single, central source of accurate product data.
* Establish a process to review your labeling, make adjustments to meet the new requirements, and then ensure that the new labels are properly deployed across each class of device.
* Prepare to submit data to the EUDAMED database in Europe. UDI data will be exchangeable between EUDAMEND and the GUDID database in the U.S.
* Investigate your labeling options. Will there be size limitations? Can you correctly print the necessary labels? Can using RFID (or a combination of RFID and barcodes) improve the labeling process or provide downstream benefits?
* Start early. There will be as much as four years’ of transition time after the initial deadline, but all products must comply with the MDR; changes made to pre-MDR products after the deadline can create additional challenges for manufacturers.
Are you affected by the EU’s new UDI requirements? Xerafy’s RFID solutions can help you meet UDI requirements in both the U.S. and in Europe. Contact us with your labeling compliance questions here.
The healthcare supply chain poses unique challenges for both medical device manufacturers and hospitals. Equipment and supplies are highly regulated and often require detailed tracking up and down the chain (i.e., the FDA’s unique device identifier [UDI] requirements). And in a hospital setting, access to important supplies can directly affect patient safety and clinical outcomes.
Those factors are driving a healthcare supply chain management (SCM) market that could reach $1.5 billion this year, according to a recent market report.
In the case of UDI compliance, companies are already turning to RFID (along with barcodes) to help automate device traceability and enable other track-and-trace applications that can help hospitals better manage assets.
Using RFID in conjunction with inventory and asset management software, hospitals can improve asset optimization, receive alerts when supplies reach critical re-order levels, analyze inventory performance using real-time data, and avoid unnecessary capital expenditures because equipment is more visible.
Those benefits are also important as hospitals struggle to reduce costs and remain competitive. Patients with high-deductible insurance plans are increasingly cost sensitive. And new reimbursement schemes being tested and deployed by both private and public payers will evaluate providers both on clinical outcomes and their ability to deliver care cost-efficiently. Improving supply chain management is one strategy that can positively affect both of those metrics.
Healthcare SCM and clinical operations are more inter-dependent than ever; RFID and other technology solutions can help bridge the divide between them.
Xerafy’s rugged RFID tags are improving healthcare supply chain visibility for everything from small surgical instruments to large medical devices in a variety of hospital settings. We want to know where you think there are untapped opportunities for RFID in healthcare. Do you see processes in your own organization that can benefit from the technology? Have you already deployed RFID for inventory or asset management at a hospital? Share your stories with us in the comments section, or contact us directly here.
For more on how RFID can help improve the healthcare supply chain, see or previous blog, “Five Ways RFID is Already Improving Healthcare.”
What the Detroit Medical Center sterilization problems mean for instruments reprocessing and how CSSD can improve patient safety.
The proper sterilization and management of surgical instruments is critical to patient safety at any hospital. Automation can make surgical instrument tracking and the tracking of sterilization more accurate and efficient. Without it, a hospital can find itself putting patients in danger and risking a public relations disaster – which is exactly what happened at the Detroit Medical Center.
Reporters at The Detroit News uncovered rampant sterilization problems at the hospital’s five Midtown Detroit hospitals, including dirty, broken and missing instruments. The newspaper stories prompted an investigation by state and federal authorities.
According to recent coverage, cultural and communications issues delayed sterilization. To correct the problem, the hospital spent $1.6 million on new equipment, hired more sterilization staff, engaged a third-party sterilization service, and is conducting a massive inventory. In the meantime, the hospital has seen a reduction in the number of surgeries performed at its facilities.
These are precisely the types of problems and costs that an RFID-based surgical instrument tracking solution is designed to prevent. Instead of relying on internal staff to manually track and communicate which instruments are due for sterilization or maintenance, individual instruments can be flagged and automatically routed to those departments. If an unsterilized instrument makes its way back to the OR, a quick RFID read will alert staff to the problem before the item is reused.
The Detroit Medical Center is currently just three-fifths of the way through a surgical instrument inventory process that has already taken the better part of a year. For hospitals with RFID systems in place, such a process could be cut to a few days – and in some cases, even just hours.
This is true across categories of medical equipment. A study conducted by Ofstead & Associates, Inc., on endoscope reprocessing found that current techniques are not consistently effective. Automation, combined with better training and accountability, would ensure guideline adherence and patient safety.
How is your hospital dealing with surgical instruments reprocessing risks? Join the conversation, share your thoughts.
Xerafy is enhancing its leadership position in the UHF RFID space by joining RAIN RFID, an industry organization that promotes the adoption of EPC UHF RFID technology. The group – which is hosted by industry trade association AIM Global and includes leading technology companies like Google and Intel – promotes deployment through education, testing and support of solution developers and end users.
RAIN, founded in 2014, has played a key role in expanding education for end users to help them select, test, and deploy new solutions, as well as providing guidance in establishing RFID’s critical role in the emerging Internet of Things (IoT). RAIN RFID’s membership has now grown to more than 130 member organizations, including hardware and software providers, end users, academic organizations, and integrators. Other notable members include Amazon, the standards body GS1, Tokyo University of Technology, and most major RFID hardware and software providers.
Xerafy also becomes a member of AIM Global, the leading trade organization for automatic identification technology companies. In addition to serving as an education and advocacy resource, AIM has also developed important industry standards for both barcode and RFID technology. Most recently, the organization released a new healthcare standard for testing non-implantable medical devices to see if they are immune to emissions from RFID systems.
Through our participation in these leading associations, Xerafy not only benefits from sharing knowledge with existing and potential partner companies, we can also help educate end users about our rugged RFID solutions and work with the industry to help shape new standards and industry use cases in healthcare and the oil and gas industries.
Where do you see a need for more information, education, or standards guidance in the RFID industry or in your own specific vertical marketplace? Let us know in the comments below, or send us an e-mail.
It’s been a busy few weeks for Xerafy. We demonstrated our rugged RFID tags and surgical instrument tracking solutions at both the International Association of Healthcare Central Service Materiel Management (IAHCSMM) Conference and Expo (May 7-10) and at RFID Journal LIVE! (May 9-11). And we had the opportunity to meet face-to-face with many professionals implementing RFID solutions in their workplaces and discuss the challenges and best practices for these solutions.
We’d like to thank all of our customers and visitors who dropped by our booths at both events – we hope you had a successful and educational experience.
At the IAHCSMM event in Nashville, Xerafy was on hand with surgical instrument and medical device tracking technology that conforms to sterilization standards as well as the FDA’s Unique Device Identifier (UDI) requirements.
RFID Journal LIVE! in Phoenix included lively healthcare conference track. After attendees heard about the latest trends in RFID and detailed case studies that demonstrated how the technology could be used to improve patient safety and supply chain efficiency, many stopped by for a live demo of Xerafy’s solutions for these applications.
If you were at either event, please drop us a line and tell us what you thought of the conferences, what you saw that was particularly interesting, and what you learned!