AIM North America allotting expertise as a resource to direct and guide organizations of the UDI regulation for medical equipment during Pandemic.
June 23, 2020 – Pittsburgh, PA – The COVID-19 Pandemic had a detrimental impact on both Healthcare Organizations and individual persons in our backyard and around the world. According to the CDC, the number of cases continues to increase, and the future of this virus remains uncertain. In this time, many non-traditional companies from outside industries have stepped up to manufacture medical devices for hospital groups, employees working under new safety guidelines, and patients. AIM North America (NA) has announced that they will be providing their expertise in advising organizations on the accurate way to ensure traceability for their own lines of devices.
Devices including respirators, face masks, and other essential medical equipment are required by the FDA to be uniquely identified, tracked, and traced to ensure the safety of both the patient and the supply chain. The Unique Device Identifier (UDI), seeks to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. Product data can be uploaded to the AccessGUDID database which is made available to patients, caregivers, healthcare providers, hospitals, and other industry professionals providing transparency and traceability. UDI markings can be found on device labels, the device’s package, and even directly on the device.
“As a manufacturer of medical devices, we understand the need for traceability for patient safety and brand integrity. The UDI standard is critical to visibility of our product and working with AIM NA and its members has provided us with a wealth of knowledge and guidance,” stated Patti Blessing, Chair, AIM NA UDI Work Group and Vice President of Business Development, CAVU Group.
“COVID-19 Pandemic has pushed many more players to enter the medical equipment manufacturing market to meet the rising demands. We see a trend of faster product release without following the correct guidelines. Guidelines are in place to offer both visibility and safety; therefore, education and implementation of these guidelines are critical,” stated Debangana Mukherjee, Chair, AIM NA and Director of Business Development + Sales, CISC Semiconductor.
Before this pandemic took place, the manufacturing workflow was substantial in nature. With new manufacturers in the market, the need for these standard processes becomes more critical. Companies, small and large, have banded together to support demands of the industry. AIM NA has guaranteed their assistance in educating how to accurately follow the FDA/UDI regulated guidelines.
For more information on how you can start the conversation today, be sure to fill out our form and read through the AIM NA Digital Supply Chain Whitepaper.
AIM North America releases Digital Supply Chain Whitepaper to assist organizations in understanding how AIDC technologies and standards are being used to ensure traceability for all lines of devices.
This new webinar series focuses on the importance of UDI compliance during this era of COVID-19. All webinars are free and will be posted on the AIM NA YouTube Channel.
The AIM NA Work Groups met on April 21. The Food Supply Chain WG continues with their webinar series and will respond the FDA’s latest request for comments. The Cannabis WG, the newest of the work groups, was introduced and a state of the industry was presented. The group will meet with the GS1 US Cannabis team to identify ways to collaborate. UDI for Medical Devices WG will launch a webinar series and distribute a press release message that AIM NA is a resource for inventory tracking and supply chain management during this unprecedented time. The Pharma WG will develop an educational program and submit a response to the latest FDA request for comments.
Debangana “Debs” Mukherjee today assumed the role of chairperson of AIM North America. She succeeds Dan Kimball, who has retired after serving as chair since 2019 and will remain on the board as an emeritus member.
Mukherjee will further advance the association’s strategic, member-driven roadmap and provide oversight to AIM NA on business policy. Prior to stepping into her role as chair, Mukherjee served as vice chair helping execute member engagement and marketing initiatives. She also leads the Aviation group in the RAIN RFID Alliance. For the last seven years, Mukherjee has been employed as the Business Development Director at CISC Semicondutor where her work focuses on the development RAIN technology with special focus on testing and verification of RAIN hardware and application set-up.
“Thank you and my sincerest thanks and appreciation to my fellow members of the Board. I'm humbled and honored you have entrusted me with this responsibility. Taking the reins at this time is made easier by the groundwork laid by Dan over the last few years”, says Debs. “I look forward to continuing work on AIM NA mission to support the development and adoption of automated data capture technologies In North America in the upcoming years.”
Mary Lou Bosco, COO, AIM NA added, “We look forward to working with Debs in this new role. Her extensive industry and business development experience make her the ideal candidate to lead our association into the future. Debs has already been an integral part of our strategic planning team and is poised to bring new ideas forward to address the important issues of our industry.”
Mukherjee officially assumed their positions for AIM North America on February 1, 2020.
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting focused on possible Agency level approaches to data quality, data stewardship, data exchange, and data analytics. The meeting will take place on March 27 in Silver Spring, MD. For complete details including how to submit comments and registration (in person and virtually), visit: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020#event-information
AIM - AIM NA and GS1 Host Committee Summit - April 21 - 23 in Arlington, VA
Open to members and non-members
Participating on a committee gives you an insider's perspective and access to information, resources, standards and key players within today's AIDC industry. Each committee is poised to enhance the advancement and adoption of our technologies on a global basis.
To learn more and to register, visit here.
In response to Frank Yiannas, FDA's Deputy Commissioner for Food Policy, announcement regarding a new FDA approach to food safety, the AIM North America Food Policy WG launched a webinar series to engage and insight discussion around a smarter food supply chain. Each webinar will feature a conversation with an AIM NA food safety professional sharing their experiences of the important job of safeguarding the worlds food supply chain.
FDA Smarter Food Safety Initiative - What is it and What Does It Mean? Register Now
Wednesday, January 29 | Noon ET
During next week's webinar, Jeanne Duckett, Chair, AIM NA Food Policy Committee, explains the FDA’s Strategic Blueprint, currently under development that will outline how FDA plans to leverage technology, and other tools, to create a more digital, traceable and safer food system. This plan includes the use of technologies that are currently used in society and business sectors all around us, such as blockchain, sensor technology, the Internet of Things, and artificial intelligence. Register today!
Pittsburgh, Pennsylvania |January 22, 2020 |AIM, the leading industry association and global authority for innovation, standards, and solutions in barcode, biometrics, IoT, NFC, RFID, RTLS, and RAIN, for nearly 50 years, has named its 2020 industry group chairs. To become an active industry group member, sign-up here. These industry groups will be meeting April 21 - 23 in Arlington, VA. To attend, register here
Scott Austin, Senior Executive VP at Everledger, has been selected to lead the Internet of Things Industry Group (IoT). The committee, which helps to direct and influence one of the fastest growing areas of innovation in the AIDC industry, provides a forum to better understand and help shape IoT and blockchain technologies that will bring better efficiency using automatic identification and mobility technology solutions.
Jeanne Duckett, Manager, Technology Development at Avery Dennison RBIS, will chair the Track & Trace Industry Group (T&T). The committee was created to develop, educate, promote and aid in the adoption of automatic identification strategies designed to support compliance of global regulations related to product traceability.
Jerry Peyton, President and CEO of the Vista IT Systems will assume the Chair position for AIM’s RFID Experts Group (REG). The committee is responsible for addressing global standards and issues associated with radio frequency identification (RFID). The REG is currently comprised of more than 40 organizations from the U.S., Europe and Asia.
Ray Vaughan, Manager, Solutions Engineering at OMRON Microscan will lead the Technical Symbology Committee (TSC), which is comprised of AIM members who are the world’s leading experts on Symbology design. The committee actively works with companies around the world to ensure global technical specifications are available to the market.
"AIM is about supporting standards, community, advocacy, and knowledge. The 2020 leadership reflects deep expertise and a strong commitment to support the goals across all industry groups,” said Mary Lou Bosco, AIM Chief Operating Officer. "This team is passionate about and dedicated to the growth and interoperability of all AIDC technologies. We look forward to a productive year and continued success with our strategic plan and initiatives."
For more information, biographies, or photos, contact AIM’s headquarters by email or call +1.724.742.4470.
Information | Insight | Influence
Those are the catalysts for success in this industry. In as little as an hour a month, committee involvement is a great way to broaden your industry knowledge while networking and building partnerships with new colleagues.