Unique Device Identification

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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GS1 Working Ahead of Mandates

No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.

With U.S. mandates slowly emerging, pharmaceutical and medical device companies should consider business needs as they prepare for unique product coding, GS1 representatives urge. The identification standards organization promotes its systems for standardizing product identification throughout the supply chain.

Health Systems Group Seeks GS1 Standards

Speakers at GS1 Connect in June shared several business reasons to standardize product identification. Health systems representatives spoke of efficiencies that standardized identification could bring in product and patient identification and tracking as well as improvements in billing, ordering, and inventory. Many spoke of the need for standards, such as the GS1 family of standards.

FDA Proposes Unique Device Identification

FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.

Advising FDA on Unique Device Identification

AIM North America has formed a new committee to address FDA’s forthcoming Unique Device Identification (UDI) proposed rule. The AIM-NA UDI committee will offer recommendations for a final rule as well as implementation models that are sensible and address the need for interoperability with other national and international unique device and unique item identification requirements.

Healthcare Supply Chain Executives Ask for Release of FDA's Proposed UDI Rule

A group of health care organizations have written a letter to Jeff Zients, Acting Director of the Office of Management and Budget (OMB), asking for the release of FDA's proposed rule on Unique Device Identifiers (UDIs). According to FDA, Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs FDA to issue regulations establishing a UDI system for medical devices. This system is intended to improve the identification of devices throughout distribution and use.

The associations that submitted the letter are:

UDI Efforts Stretch Worldwide

The Global Harmonization Task Force (GHTF) has released its proposal for a draft guidance on a Unique Device Identification (UDI) system that could be used around the world. The goal of the guidance is to provide a common global framework for identifying medical devices, which could facilitate recognizing recalled items and reporting specific devices involved in adverse events. Comments on the draft are welcomed through April 30.

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Adding Up the Numbers behind UDI

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