Unique Device Identification

UDI Challenges Addressed at HealthPack

This September, the labeling and packaging of Class III medical devices must bear Unique Device Identification, reads FDA’s final rule.

Getting Ready for UDI at MD&M West

With initial deadlines for FDA’s Unique Device Identification rule to begin phasing in later this year, medical device manufacturers are busy studying the regulation and looking for implementation support. On February 11, attendees at Medical Design & Manufacturing West 2014 got the chance to see potential solutions on the “Get UDI Ready” show floor tour.

Specialty Label Substrates for UDI Debut

As the medical device industry begins to prepare for Unique Device Identification, FLEXcon has launched FLEXcon MedFLEX, a line of label substrates designed to meet FDA’s performance requirements. The FLEXcon MedFLEX line can support unique coding as well as comply with rub tests, the company reports. Specifically, the line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marking durability rub tests, the company reports, and three of the products are UL-recognized with inks and ribbons.

FDA's Jay Crowley Joins Keynote Panel at GS1 Connect 2013

FDA's Jay Crowley will participate in a new general session keynote panel at GS1 Connect 2013 called “Held to Higher Standards: Doing Business in a Digital World.” Panelists will discuss the digital transformation taking place in business and global commerce. The panel, moderated by GS1 US President and CEO, Bob Carpenter, will include:

AIM North America Announces New Committee Leaders

AIM North America (AIM NA), the Association for Automatic Identification and Mobility in North America, reports the following new committee leaders for 2013:

  • Tom Dills, President of Elder Mountain Associates LLC (Warner Robbins, GA) will lead the UID Suppliers Alliance.
  • George Wright, IV, Vice President, Product Identification & Processing Systems Inc. (Port Chester, NY), will lead the UDI Committee.

These industry experts have been elected chair of their respective committees for one year.

Medical Device Companies Prepare To Implement Unique Device Identification

With a final rule from FDA for UDI expected this year, device makers have accelerated development of a UDI system. As a first step, “labelers” need to adopt a system for issuing UDIs from an issuing agency accredited by FDA. Support continues to grow in the supply chain for the GS1 System of Standards, embraced by early innovators pushing for a global standard for device identification and tracking.
In an interview with PMPN, Siobhan O’Bara, senior vice president, industry engagement, GS1 US discusses issues raised by manufacturers in comments on the proposed rule, and the advantages of using GS1’s system.
[Editor’s note: Siobhan O’Bara will join Jay Crowley, senior advisor patient safety, FDA, and panelists from Medtronic, GHX, and Premier speaking on Creating a Roadmap For UDI Compliance at the upcoming MD&M West trade show and conference, Feb. 11-14 in Anaheim, CA.]

Device Firms Seek More Time On Unique Device ID

As the provider community stresses prompt implementation, manufacturers call for clarifications to the proposed UDI regulation and extended compliance timelines.
 
 
By David Vaczek, Senior Editor
While industry generally supports the objectives of a unique identification system for medical devices, implementing it will take longer than envisioned by FDA in its proposed regulation, according to some device manufacturers responding to the agency on the proposed rule.

HIBCC Standards and FDA’s Proposed UDI Rule

An identification standards body speaks out on the draft regulation for medical devices.
The Health Industry Business Communications Council (HIBCC; www.HIBCC.org) was originally established in the United States in 1983 to develop bar code standards for use in the healthcare supply chain. Its bar code standard is internationally accredited and widely deployed. FDA in its recent proposed rule for Unique Device Identification (UDI) addressed the importance of leveraging existing standards, such as those administered by HIBCC. PMP News reached out to HIBCC’s CEO, Robert A.
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Direct Part Marking

Many challenges are likely to come to medical device manufacturers’ minds as they dissect FDA’s proposed rule for Unique Device Identification (UDI), but direct part marking (DPM) could pose one of the biggest.

The agency’s proposal would require most medical devices distributed in the United States to bear UDI, and in certain instances UDI would need to be marked directly on the device. These include devices that would remain in use for extended periods of time and would be likely to become separated from their labeling, the draft reads.

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