|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
Clutch is now a Docker Authorized Consulting Partner, having completed Docker's certification course on the "Docker Accelerator for CI Engagements." More info about Clutch's success implementing Docker can be found here. Docker is an open platform for developers and system administrators to build, ship and run distributed applications. With Docker, IT organizations shrink application delivery from months to minutes, frictionlessly move workloads between data centers and the cloud and achieve 2...
Oct. 9, 2015 10:45 AM EDT Reads: 505
Achim Weiss is Chief Executive Officer and co-founder of ProfitBricks. In 1995, he broke off his studies to co-found the web hosting company "Schlund+Partner." The company "Schlund+Partner" later became the 1&1 web hosting product line. From 1995 to 2008, he was the technical director for several important projects: the largest web hosting platform in the world, the second largest DSL platform, a video on-demand delivery network, the largest eMail backend in Europe, and a universal billing syste...
Oct. 9, 2015 10:45 AM EDT Reads: 149
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Oct. 9, 2015 10:45 AM EDT Reads: 111
There will be 20 billion IoT devices connected to the Internet soon. What if we could control these devices with our voice, mind, or gestures? What if we could teach these devices how to talk to each other? What if these devices could learn how to interact with us (and each other) to make our lives better? What if Jarvis was real? How can I gain these super powers? In his session at 17th Cloud Expo, Chris Matthieu, co-founder and CTO of Octoblu, will show you!
Oct. 9, 2015 10:31 AM EDT
DevOps has often been described in terms of CAMS: Culture, Automation, Measuring, Sharing. While we’ve seen a lot of focus on the “A” and even on the “M”, there are very few examples of why the “C" is equally important in the DevOps equation. In her session at @DevOps Summit, Lori MacVittie, of F5 Networks, will explore HTTP/1 and HTTP/2 along with Microservices to illustrate why a collaborative culture between Dev, Ops, and the Network is critical to ensuring success.
Oct. 9, 2015 10:30 AM EDT Reads: 149
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 to achieve their business goals faster and more effectively.
Oct. 9, 2015 10:15 AM EDT Reads: 143
In their session at DevOps Summit, Asaf Yigal, co-founder and the VP of Product at Logz.io, and Tomer Levy, co-founder and CEO of Logz.io, will explore the entire process that they have undergone – through research, benchmarking, implementation, optimization, and customer success – in developing a processing engine that can handle petabytes of data. They will also discuss the requirements of such an engine in terms of scalability, resilience, security, and availability along with how the archi...
Oct. 9, 2015 10:00 AM EDT Reads: 404
Today’s connected world is moving from devices towards things, what this means is that by using increasingly low cost sensors embedded in devices we can create many new use cases. These span across use cases in cities, vehicles, home, offices, factories, retail environments, worksites, health, logistics, and health. These use cases rely on ubiquitous connectivity and generate massive amounts of data at scale. These technologies enable new business opportunities, ways to optimize and automate, al...
Oct. 9, 2015 10:00 AM EDT Reads: 170
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 17th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, will share the functions and data structures used to solve everyday use cases that are driving Redis' popularity
Oct. 9, 2015 10:00 AM EDT Reads: 486
In his session at DevOps Summit, Bryan Cantrill, CTO at Joyent, will demonstrate a third path: containers on multi-tenant bare metal that maximizes performance, security, and networking connectivity.
Oct. 9, 2015 10:00 AM EDT Reads: 159
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Oct. 9, 2015 10:00 AM EDT Reads: 287
SYS-CON Events announced today that Harbinger Systems will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Harbinger Systems is a global company providing software technology services. Since 1990, Harbinger has developed a strong customer base worldwide. Its customers include software product companies ranging from hi-tech start-ups in Silicon Valley to leading product companies in the US a...
Oct. 9, 2015 10:00 AM EDT Reads: 770
Any Ops team trying to support a company in today’s cloud-connected world knows that a new way of thinking is required – one just as dramatic than the shift from Ops to DevOps. The diversity of modern operations requires teams to focus their impact on breadth vs. depth. In his session at DevOps Summit, Adam Serediuk, Director of Operations at xMatters, Inc., will discuss the strategic requirements of evolving from Ops to DevOps, and why modern Operations has begun leveraging the “NoOps” approa...
Oct. 9, 2015 10:00 AM EDT Reads: 152
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction....
Oct. 9, 2015 10:00 AM EDT Reads: 232
The last decade was about virtual machines, but the next one is about containers. Containers enable a service to run on any host at any time. Traditional tools are starting to show cracks because they were not designed for this level of application portability. Now is the time to look at new ways to deploy and manage applications at scale. In his session at @DevOpsSummit, Brian “Redbeard” Harrington, a principal architect at CoreOS, will examine how CoreOS helps teams run in production. Attende...
Oct. 9, 2015 10:00 AM EDT Reads: 1,257