The U.S. Food & Drug Administration (FDA) recently published an FAQ and other guidance about its Unique Device Identification (UDI) requirement to permanently identify medical devices. Xerafy has experience with UDI solutions and we are getting a lot of questions about where RFID technology fits in the UDI program, which we address in the following FAQs.
Q: If I use RFID for the UDI, do I need to have a bar code too?
A. No. Bar codes are not required for UDI labeling. The FDA made a point not to require bar codes because it wanted to give labelers the flexibility to use the automatic identification technology that best meets their product requirements.
Q. Do we need to retroactively apply UDI labels to devices that were in service before the UDI Rule was created?
A. No, but it is something to consider. The UDI program provides a consistent format for identifying devices and managing data. The consistency could be very valuable for asset management, inventory control and lifecycle management operations. Otherwise, organizations will need to maintain databases that use different item ID formats, which could contribute to errors or cause interoperability issues. Your automated asset management program becomes more valuable the more items you include in it. Continue reading
Traceability and visibility are valuable for many processes, but they are necessities in the aerospace industry. If a part’s identity and history can’t be verified it can’t go up in the air, so there is a real possibility that a multimillion dollar aircraft can be grounded because of insufficient records for a $10 part. Aircraft operators can’t afford ignorance about flyable part identities, and they also can’t afford delays while parts are investigated and records are consulted. The industry simply doesn’t have the profit margins to allow expensive assets and specialized employees to sit idle because of preventable delays.
These safety and business realities are why Xerafy and RFID technology have found a home in the aerospace industry – not just for airlines, but for any organization that is responsible for maintaining and building or providing parts. As Carlo Nizam, who leads RFID efforts at Airbus said in a recent RFID Journal article: “We believe very strongly the RFID part-mark capability can improve how we trace things, not just for us but the whole value chain.” Continue reading
For information technology, past asset-tracking processes – like bar code-based asset tracking processes – are no longer timely or accurate enough to mitigate the risks of non-compliance with the growing list of regulations governing enterprise information and assets. RFID increasingly is the answer for these tracking and regulatory requirements.
Not only do RFID solutions take the time, cost and risk out of IT asset tracking and reporting needs, but with the help of Xerafy — and its experienced network of system integrators and solution providers—solutions are available for identifying servers, storage devices and networking equipment, tracking computers, laptops and smart phones, and working with IT hardware suppliers to source tag equipment for their customers. Continue reading
Xerafy works with a lot of healthcare professionals in hospitals, labs, surgical instruments services and other organizations. We’ve learned there are several important misperceptions about RFID technology in the industry. Specifically, many people are unaware of the differences between passive and active RFID technology, and thus have a limited view of what RFID can do.
Passive RFID tags transmit their data using power generated by the reader. The tag is not an active transmitter, and thus can be extremely small and durable. Active RFID tags broadcast their own signal and require a battery to power the transmission. The battery adds size and cost the tag and creates a maintenance requirement, because batteries need to be replaced periodically. The Wi-Fi tags that are commonly used in real time locating systems (RTLS) to track IV pumps, wheelchairs and other large assets are a good example of active RFID technology.
Because Wi-Fi RTLS is so well known, it has become synonymous with RFID in the healthcare industry. That is an unfortunate misunderstanding because active RFID is unsuitable for tracking surgical trays and instruments, meeting UDI traceability requirements and many other use cases. Passive UHF has several important advantages over Wi-Fi and other active RFID technologies commonly used in healthcare RTLS systems. Continue reading
There are many aspects to the RFID vs. bar code debate, too many to cover in this blog (although we already provided an overview on the topic, covered hospital considerations here and have posted about data center advantages). Let’s narrow the debate and consider applications where items need to be located and identified outdoors, such as asset management at oil & gas operations, or tool tracking at construction sites.
These applications typically only require a serial number to be encoded to link to a database, so either RFID or bar code are suitable. Beyond that there are some important differences between the technologies, most of which favor RFID. Continue reading