Serialization/Unique Device Identification

By David Vaczek With the RxTEC Act, pharmaceutical supply chain members are proposing a phased-in approach to track-and-trace with a federal law imposing uniform requirements on all states. The act was developed by the Pharmaceutical Distribution...

“Introduction of counterfeit products in the normal international supply chain poses particular issues for pharmaceutical companies, both from direct risk to their customers and to their own reputation within what is a highly competitive industry...

California’s State Board of Pharmacy (CA BoP) met this week to begin preparing for implementation of the state’s electronic pedigree requirements. CA BoP hosted Connie T. Jung, FDA’s acting associate director for policy and communications in the...

The US Senate by voice vote today passed the Drug Quality and Security Act/H.R. 3204, pharmaceutical traceability legislation that establishes a national requirement for tracing of pharmaceuticals through the supply chain.In preempting...

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...

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...

Can a medical device that costs pennies actually end up costing a hospital thousands of dollars? Perhaps. Consider this scenario: “Using latex gloves as an example, with 50 distributors each assigning their own item number to each box of latex...

Michael Innes, former Kaiser Permanente Program Director, has joined GS1 US to lead GS1 Healthcare US.PMP News Editor Daphne Allen asks for details on how he and the organization will help medical device manufacturers prepare for UDI and other...

Solutions are underway to address challenges in code reading, substrates, lighting, validation, and more. By Rick Roszkowski, Senior Director of Marketing, Vision Products Business Unit, Cognex Corp. FDA’s final rule establishing a Unique Device...

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...