Home Internet of Things Aerospace Apparel Energy Defense Health Care Logistics Manufacturing Retail

Access This Premium Content

Options To Access This Article:

What Subscribers Are Saying

  • "Probably the best investment I've ever made."
    Steve Meizlish, President & CEO, MeizCorp Services, Inc.
  • "I have found that RFID Journal provides an objective viewpoint of RFID. It you are looking for a resource that provides insights as to the application and implications of deploying RFID, RFID Journal will meet your needs, It gives you a broad perspective of RFID, beyond the retail supply chain."
    Mike O'Shea, Director of Corporate AutoID/RFID Strategies & Technologies, Kimberly-Clark Corp.
  • "No other source provides the consistent value-added insight that Mark Robert and his staff do. In a world dominated by press release after press release, RFID Journal is developing as the one place to go to make the most sense out of the present and future of RFID in commerce."
    Bob Hurley, Project Leader for RFID, Bayer HealthCare's Consumer Care Division
  • "RFID Journal is the one go-to source for information on the latest in RFID technology."
    Bruce Keim, Director, Hewlett-Packard
  • "RFID Journal is the only source I need to keep up to the minute with the happenings in the RFID world."
    Blair Hawley, VP of Supply Chain, Remington Products Company

Managing Medical Devices

RFID can help manufacturers of surgical implants, instruments and other items meet a new FDA mandate, improve internal operations and boost customer satisfaction.
By Jennifer Zaino
May 18, 2014

Millions of people young and old are walking around with a variety of implanted medical devices—from artificial hips and knees to heart valves and pacemakers, spinal screws and rods, breast implants and ear tubes—that are improving their health and well-being. That is, as long as the devices are safe and effective.

In September, the U.S. Food and Drug Administration (FDA) took steps to improve patient safety. The FDA issued a final rule on the Unique Device Identification System, which requires that most medical devices distributed in the United States carry a unique device identifier (UDI). The system is designed to facilitate quick and efficient identification of recalled devices, improve accuracy and specificity of reports about adverse events, and provide a foundation for a global, secure distribution chain to thwart counterfeiting and diversion.

Photo: iStockphoto
The label and package of each medical device must include a UDI in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology, such as bar codes or RFID, to convey lot or batch number, expiration date and other production-specific information. The rule is "technology neutral" on the particular form of AIDC technology to be used, leaving that to the device labeler's discretion.

In addition to implantable and single-use medical devices, the ruling applies to devices that may be used multiple times, such as surgical instruments and some life-supporting and life-sustaining devices. According to the FDA, a UDI will be required on the device itself if the device is intended to be used more than once and to be reprocessed before each use. In all cases, device manufacturers must submit data to the FDA-administered Global Unique Device Identification Database (GUDID), which will serve as a reference catalog.

"The UDI system will provide all stakeholders—health-care professionals, patients, industry, researchers, health-care community and other government agencies—with a consistent and standardized way to identify devices throughout their distribution and use," says Jennifer Rodriguez, press officer in the FDA's Office of Media Affairs. "The data in the GUDID will be foundational to realizing benefit from the UDI system. As UDIs become part of electronic health records, clinical information systems, claims data and registries, the FDA and other stakeholders can use the device identification information in the GUDID to make reliable, meaningful links across these data sources and the clinical information contained in them, within the constraints of patient privacy protection."

Medical device manufacturers that adopt RFID to meet UDI requirements should expect the effort to involve a large capital expenditure, including buying tags and building the infrastructure, says Faisal Ghaus, VP of TechNavio, a global technology research firm. But, he adds, there will be a return on that investment. From an operational standpoint, Ghaus says, the implementation of the UDI ruling will help eradicate counterfeit products that account for revenue losses for major companies. It also will allow companies to employ better inventory management across the product's value chain, since expiration dates, manufacturing dates, batches and so on will be identified almost instantaneously.

To continue reading this article, please log in or choose a purchase option.

Option 1: Become a Premium Member.

One-year subscription, unlimited access to Premium Content: $189

Gain access to all of our premium content and receive 10% off RFID Reports and RFID Events!

Option 2: Purchase access to this specific article.

This article contains 3,133 words and 7 pages. Purchase Price: $19.99

Upgrade now, and you'll get immediate access to:

  • Case Studies

    Our in-dept case-study articles show you, step by step, how early adopters assessed the business case for an application, piloted it and rolled out the technology.

    Free Sample: How Cognizant Cut Costs by Deploying RFID to Track IT Assets

  • Best Practices

    The best way to avoid pitfalls is to know what best practices early adopters have already established. Our best practices have helped hundreds of companies do just that.

  • How-To Articles

    Don’t waste time trying to figure out how to RFID-enable a forklift, or deciding whether to use fixed or mobile readers. Our how-to articles provide practical advice and reliable answers to many implementation questions.

  • Features

    These informative articles focus on adoption issues, standards and other important trends in the RFID industry.

    Free Sample: Europe Is Rolling Out RFID

  • Magazine Articles

    All RFID Journal Premium Subscribers receive our bimonthly RFID Journal print magazine at no extra cost, and also have access to the complete online archive of magazine articles from past years.

Become a member today!

RFID Journal LIVE! RFID in Health Care LIVE! LatAm LIVE! Brasil LIVE! Europe RFID Connect Virtual Events RFID Journal Awards Webinars Presentations