|By PR Newswire||
|April 16, 2014 10:00 AM EDT||
LAWRENCEVILLE, N.J., April 16, 2014 /PRNewswire-USNewswire/ -- GS1 Healthcare US® has published an implementation guideline for using GS1 Standards to address the U.S. Food and Drug Administration's new regulation for Unique Device Identification (UDI). The guideline, titled "Using the GS1 System for FDA Unique Device Identification (UDI) Requirements", is designed for medical device trading partners, including medical/surgical manufacturers, and is available for free download at www.gs1us.org/udiguide. GS1® was named the first accredited issuing agency for FDA UDI in December of 2013.
"With the UDI rule now final, and implementation deadlines just around the corner, industry partners are transitioning from educating themselves about the regulation to implementing the multiple components to meet the requirements," says Michael Pheney, vice president of healthcare, GS1 US. "The guideline is an important resource for industry members implementing today, as well as for those preparing to meet future deadlines."
GS1 Standards, including the Global Trade Item Number® (GTIN®) which is already recognized across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging, can be used for UDI. The UDI rule provides phased implementation deadlines based on risk class. With the first deadline of September 24, 2014, manufacturers of Class III devices and devices listed under the Public Health Services Act must act swiftly to meet UDI requirements.
The guideline, developed by a collaboration of medical device industry members, introduces the applicable GS1 Standards, including the GTIN, GS1 data carriers, GS1 application identifiers, direct part marking, and the Global Data Synchronization Network™ (GDSN®), and provides detailed guidance on how to implement these standards in the context of the UDI regulation.
In addition, the detailed document provides guidance in the following areas:
- Assigning, encoding, and storing GTINs for UDI device identifiers
- Defining and encoding GS1 application identifiers for UDI production identifiers, including serial number, batch/lot, production date and expiration date
- Encoding GS1 BarCodes for UDI AIDC format
- Helpful tips for suppliers and data "receivers"
"For decades, the U.S. healthcare industry has struggled to overcome problems caused by bad or conflicting data in its supply chain, including multiple, differing or proprietary descriptions of medical/surgical products. Sharing unreliable or unverifiable product data has led to challenges in the product recall process, shipping the wrong product and storing expired or outdated inventory, among other serious, and preventable, problems," said Pheney. "With FDA UDI, and the acceleration of GS1 Standards in the healthcare supply chain, the industry bolsters its efforts to improve patient safety, reduce costs and improve efficiencies."
The guideline is the newest addition to GS1 US's suite of resources about UDI, which includes the GS1 US UDI resource site (http://www.gs1us.org/hcudi), educational webinars, UDI workshops and other helpful tools for industry. UDI will also be one of many healthcare topics featured during GS1 Connect, an annual business conference hosted by GS1 US, which takes place this year from June 8-12 in San Diego. To register for GS1 Connect, visit www.gs1connect.org.
About GS1 Healthcare US
GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the supply chain issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 Healthcare US is one of over 30 local GS1 Healthcare user groups around the world that support the adoption and implementation of global standards developed by GS1. For more information, visit www.gs1us.org/healthcare
About GS1 US
GS1 US, a member of GS1, is an information standards organization that brings industry communities together to solve supply chain problems through the adoption and implementation of GS1 Standards. Nearly 300,000 businesses in 25 industries rely on GS1 US for trading-partner collaboration and for maximizing the cost effectiveness, speed, visibility, security and sustainability of their business processes. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code-based RFID, data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code® (UNSPSC®). www.gs1us.org.
SOURCE GS1 US
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackIQ...
Jan. 16, 2017 10:15 AM EST Reads: 7,621
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
Jan. 16, 2017 09:00 AM EST Reads: 3,904
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Jan. 16, 2017 08:30 AM EST Reads: 3,008
WebRTC sits at the intersection between VoIP and the Web. As such, it poses some interesting challenges for those developing services on top of it, but also for those who need to test and monitor these services. In his session at WebRTC Summit, Tsahi Levent-Levi, co-founder of testRTC, reviewed the various challenges posed by WebRTC when it comes to testing and monitoring and on ways to overcome them.
Jan. 16, 2017 06:30 AM EST Reads: 5,827
"A lot of times people will come to us and have a very diverse set of requirements or very customized need and we'll help them to implement it in a fashion that you can't just buy off of the shelf," explained Nick Rose, CTO of Enzu, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 16, 2017 06:30 AM EST Reads: 4,481
Every successful software product evolves from an idea to an enterprise system. Notably, the same way is passed by the product owner's company. In his session at 20th Cloud Expo, Oleg Lola, CEO of MobiDev, will provide a generalized overview of the evolution of a software product, the product owner, the needs that arise at various stages of this process, and the value brought by a software development partner to the product owner as a response to these needs.
Jan. 16, 2017 05:30 AM EST Reads: 1,074
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive ad...
Jan. 16, 2017 05:15 AM EST Reads: 1,502
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, introduced the technologies required for implementing these idea...
Jan. 16, 2017 04:30 AM EST Reads: 4,475
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
Jan. 16, 2017 04:00 AM EST Reads: 3,708
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Jan. 16, 2017 04:00 AM EST Reads: 5,261
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
Jan. 16, 2017 03:30 AM EST Reads: 5,217
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Jan. 16, 2017 03:30 AM EST Reads: 2,833
While not quite mainstream yet, WebRTC is starting to gain ground with Carriers, Enterprises and Independent Software Vendors (ISV’s) alike. WebRTC makes it easy for developers to add audio and video communications into their applications by using Web browsers as their platform. But like any market, every customer engagement has unique requirements, as well as constraints. And of course, one size does not fit all. In her session at WebRTC Summit, Dr. Natasha Tamaskar, Vice President, Head of C...
Jan. 16, 2017 03:15 AM EST Reads: 5,723
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 16, 2017 03:00 AM EST Reads: 2,374
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, discussed the impact of technology on identity. Sho...
Jan. 16, 2017 02:30 AM EST Reads: 3,916