Tag Archives: medical

UDI for 2020: Why You Should Start Now!

September 24th, 2020 for Class I UDI compliance is just a heartbeat away, particularly when evaluating the scope of the UDI initiative and the breadth of products impacting your company.

Many suppliers that have previously submitted Class III and Class II product data have already begun gathering and sending Class I data.

Key Challenges for UDI Labelers:

  1. Understanding the complexities of the UDI legislation as it applies to your organization’s products.
  2. Finding the existing data, creating data that does not exist, and organizing the data into a single point of truth for submission to the FDA GUDID.
  3. Setting up the proper data governance to ensure that the information is correct to meet the deadline and continues to stay up-to-date and accurate in the future.

How 1WorldSync Can Help You

  1. Understanding Rules – Our experts are well versed in the UDI legislation, definitions, and terminology to be able to help your organization identify attributes relevant for UDI per the legislation. Watch our latest and greatest UDI Video to see how we can set you up for success!
  2. Data Collection – Our organization has vast experience with previous UDI customers and can provide education and guidance around attribution. In addition, we can also leverage previous knowledge to directionally aid in the sourcing of attribution. Read our new case study to learn how Teleflex partnered with us to implement a data management solution to comply with the upcoming UDI regulation.
  3. Data Governance – Our team can provide the structure necessary to ensure that information stays up-to-date and accurate, integrating the data collection into day-to-day processes and reducing effort in the future.

Getting To Good Data in the GUDID With 1WorldSync

The general structure of a UDI project is very similar to a typical supplier implementation, with some key exceptions. At the end of the day, data needs to be sent by the supplier to a recipient. 1WorldSync handles this use case on a daily basis and we can provide insight as to proven best practices and strategies.

There are key differences in a UDI project that our experts are trained to guide you through. These key differences include applying for a GUDID account, testing with the FDA, and understanding FDA specific attribution.

Whether your organization relies on a HIBC or a GTIN (or you’re looking for definitions on what those terms mean), 1WorldSync offers multiple solutions to send your data to the FDA. A primary benefit of submitting data through a 1WorldSync solution is that the data collected can be easily sent to other recipients, including GPOs, distributors, and other healthcare providers.

Generating Value Beyond Compliance with 1WorldSync

The amount of time and effort to prepare for compliance with the FDA UDI regulation is frequently underestimated. Your organization may need to start sooner than you think.

If you’re like us, you like to be ahead of the game. With the 1WorldSync UDI Solution, your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.

Make plans to stop by 1WorldSync (Booth # 6) at the UDI Conference taking place June 7-8 in Baltimore. Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID from our experts first-hand!

For more information around our offerings and experience, please contact us at healthcare@1worldsync.com or visit http://solutions.1worldsync.com/-unique-device-identification.

The Power of 1WorldSync Product Information Cloud

As an avid reader of Bloomberg Businessweek, I was excited to see cloud technology, code, data management, everything that we, 1WorldSync, live and breathe, dominating the June 2015 issue. It got me thinking, how do we as a world, as an industry, as a business, educate decision makers on:

  • ‘Understanding and unlocking’ the value of the cloud?
  • Understanding the power and presence of data?

It is a new frontier, a ‘Data Revolution’, and the healthcare industry, specifically, is on the proverbial cliff ready to jump in head first. With the ongoing transformation of the U.S. healthcare delivery system, supply chain has become a key component to meeting organizational goals by driving clinical value, implementing innovation, and delivering operational efficiency. In order to fulfil its multifaceted objectives, supply chain is engaging with various stakeholders in pursuit of a common mission to foster a coordinated healthcare delivery system. Specifically, the impact of the ‘Data Revolution’ and the ‘Big Data’ explosion on the healthcare industry has spurred the creation of governmental and regulatory mandates, such as the Unique Device Identification (UDI) regulation set forth by the FDA. The UDI regulation require all medical device manufacturers to publish complete and accurate product information to the Global UDI Database (GUDID). To comply with the regulation, all medical device manufacturers must publish all required medical device product attributes to the GUDID by the specified time or face strong consequences.

Whether it’s in the form of regulatory compliance, seamless deployment along the supply chain, expanded storage, or collaborative networks or solutions, companies and businesses are looking to improve their top and bottom lines, and trusted product information is proving itself as a time and cost saver with the ability to help businesses grow. This is the core of 1WorldSync services and solutions. By building genuine business relationships and developing detailed strategic solutions 1WorldSync services address the most critical challenges within organizations in support of supply chain efficiency and regulatory compliance.

Join 1WorldSync at AHRMM15 to explore key ideas, trends, and best practices around building strategic stakeholder engagement, with an emphasis on supply chain perspective. Visit 1WorldSync at booth 924 and learn how the leaders in data pool management solutions and services can support your business for trusted product information exchange.

We look forward to seeing you there!

 

OUR Mission:

To be the Healthcare industry leader in product information exchange and the change agent that drives the industry forward through global regulatory compliance and improving healthcare standards.

I’m not sure what UDI stands for, how will my Organization be ready for compliance?

A recent United States Food and Drug Administration (FDA) regulation, issued on September 24, 2014 has medical device manufacturers on a global basis, readying their organizations for compliance. The new regulation requires most medical devices to be marked and labeled with a unique device identifier (UDI) and then entered into the FDA’s Global Unique Device Identification Database (GUDID) with a set of FDA-specified attributes.  Compliance dates are driven by the class of medical device. Continue reading