The AIM NA Public Policy Healthcare UDI Work Group responded to the International Medical Device Regulators Forum's (IMDRF) call for consultation regarding their proposed UDI guidance documents. The group’s comments focused on the effective use of AIDC technologies in meeting the FDA’s requirements for direct marking of devices for unique device identification purposes. To view the team’s comments, download the AIM NA IMDRF Public Consultation submission.
As fall approaches, two happenings are always on the seasonal agenda -- back-to-school and our Industry Groups in action. September kicks off in a big way...take a look:
AIM has received several inquiries to get more information about the EU Frequency Regulation changes and what it means for AIM member companies. A recent interview with Jacques Hulshof, AIM|RAIN’s Regulatory Consultant and Josef Preishuber Pflügl, ETSI ERM TG34 Vice Chair, provided these answers:
Do you expect any Member State (MS) to reject the Commission ruling (RSCOM17-60rev3) "Draft Commission Implementing Decision on the harmonization of radio spectrum for use by short range devices within the 874-876 and 915-921 MHz frequency bands?"
No they cannot but the EU mandate does not apply for non-EU CEPT countries (20 CEPT countries are not EU members). Some non-EU MS closely follow the EU. (CEPT – European Conference of Postal and Telecommunications Administrations)
Can MS "opt-out" or maybe add country specific limitations?
Yes, they can. EU MS will be encouraged by the EC to change to a 3-channel plan by February 2019 but not all EU MS will follow.
Can MS delay their implementation?
No, MS cannot delay the implementation of the Mandate after 01 February 2019. If MS accept the frequency bands mentioned in the Mandate, they have to implement these by 01 February 2019.
Can companies sell compliant reader products within the RFID band 915-921 MHz in MS that haven't yet ratified the regulations (like Germany) before 01 February 2019?
No. And even after 01 February 2019 it may not be possible to sell compliant reader products within the RFID band 915-921 MHz, because of Article 3 Item 2 RSCOM17-60rev3 below.
Member States may take appropriate measures to protect existing use in the 874-876 MHz and 915-921 MHz spectrum to the extent necessary and where no alternative protective solution may be found through coordination of the various types of uses in those bands. This may include the imposition of additional technical, geographic or operational requirements for the use of the band while complying with the harmonised technical conditions for spectrum access set out in the Annex.
EN 302 208 will be updated. The update will start on 18/19 September 2018 within the first meeting of ETSI ERM TG34 in Rosenheim, Germany.
From a practical standpoint, it might make sense to implement all 4 channels now and have a software configuration that allows the selection of the supported channels after 01 February 2019, unless the extra effort is rather high.
It should also be noted that the issue with Germany is not resolved. Germany very likely will not implement what the EC asks with the speed of other countries. What this means is unclear. It could be months, years or decades. An update may be expected after the summer break and when the official EC documents are circulated.
We hope this information addresses some of the questions you are currently dealing with.
While AIM does not have an official list of who passed the vote, who voted negative and who abstained, we are working to get that information along with a copy of the official documents, and will share with the membership as soon as we obtain it.
For additional information, contact AIM by email or phone +1 724.742.4470.
Pittsburgh, Pennsylvania | August 16, 2018 |AIM, the trusted worldwide industry association for the automatic identification industry, providing unbiased information, educational resources and standards for nearly half a century, announced today the appointment of five new industry executives to its Board of Directors.
Joining the board are Patti Blessing, Vice President - Business Development for Alien Technology; John Greaves, Strategist - RFID, IoT & Blockchain at Lowry Solutions; Ralf Kodritsch, Director Segment Manager RAIN RFID Solutions for NXP Semiconductors; Anna Lau, PhD, Chief Executive Officer of Laxcen Technology Pte Ltd and Amber Richards, President & Chief Executive Officer at Integrated ID Solutions.
“We are excited to welcome these incredibly innovative leaders to the board," said Mary Lou Bosco, AIM's Chief Operating Officer. "The range and depth of their industry experience will undoubtedly bring strength to the AIM global community and offer the association greater diversity than ever before. Each new director has a unique perspective along with a reputation for collaborative leadership and integrity, attributes essential to AIM's continued success around the world."
The new directors join a board that guides the strategic direction, financial health, policies, procedures, vision and mission of AIM, serving nearly 400 member companies and their employees around the world.
The current AIM Board also includes executives from Aware Innovations, BlueStar, CDO Technologies, Datalogic, Honeywell, Lyngsoe Systems, ScanSource, Schneider Kennzeichnung GmbH and Zebra Technologies.
One of the most reliable ways to ensure a UDI lasts the lifecycle of a device is by affixing a permanent mark to the device. Direct part marking (DPM) is not a new concept but is relatively new territory for many medical device manufacturers. AIM North America has assembled an expert panel who will discuss how AIDC technologies, such as DPM, into your compliance strategy will help you meet the next UDI compliance deadline. Complimentary with prior registration. Register now.
AIM's Track & Trace Industry Group recently released a Fundamentals of Track and Trace whitepaper. This foundational document addresses track and trace on an abstract level -- defining and detailing the necessary steps for tracking and tracing regardless of the commodity or system that is finally adopted. Thus, this document does not detail any of the unique data elements that may be required by regulation or industry practice for that commodity. Download a FREE copy of the whitepaper here.
AIM North America Taps Leaders from Avery Dennison, CISC Semiconductor, Technologies ROI and Danzz Consulting
AIM North America (NA) announced today the appointment of four industry executives to its seven-member Board of Directors. Joining the board are Jeanne Duckett, Manager, Technology Development & Printer Research for Avery Dennison; Dan Kimball, President of Danzz Consulting; Patrick King, Ph.D, Founder of Technologies ROI; and Debangana Mukherjee, Director of Business Development & Sales for CISC Semiconductor.
“We are very pleased to welcome these outstanding innovative leaders to the board. The breadth, depth, and diversity of their experience will strengthen AIM North America. Each of them has a reputation for collaborative leadership and integrity,” stated Mary Lou Bosco, COO, AIM NA.
The new members join a board that guides the strategic direction, financial health, policies, procedures, vision, and mission of AIM North America.
“These appointments reflect AIM North America’s continued commitment to finding the very best industry leaders to lead and guide the organization,” said Don Ertel, chairman of the AIM North America Board. “I’m certain their unique industry knowledge and skills will provide invaluable strategic insight and direction to AIM NA.”
The current NA board also includes executives from Aware Innovations, CDO Technologies, and ID Integration.
AIM NA also thanks outgoing board member Louis Parks, President of SecureRF, for his contributions.
AIM North America (AIM NA) announced this morning it has named Basil S. Jeffers of NASA as the recipient of the 2018 Automatic Identification Technology (AIT) in Government Award.
The AIT Award, created in 2013, is presented annually to an individual, committee, group, or organization from the government sector that has championed the successful use of automatic identification technology within local, state, or national government. It is sponsored by the AIM NA Public Policy Committee, dedicated to raising awareness about AIT and encouraging the adoption of AIT policies within U.S. government agencies and the U.S. government contractor community.
Basil Jeffers currently serves as the Project Lead Parts Engineer for NASA's James Webb Space Telescope (JWST). Considered one of the most complex NASA missions in modern history, JWST will be a large infrared telescope with a 6.5-meter primary mirror. The telescope will be launched on an Ariane 5 rocket from French Guiana in 2020 and is anticipated to be the premier observatory of the next decade, serving thousands of astronomers worldwide.
As the building of the telescope components progresses in multiple locations across the U.S., it is necessary to track every single component - not only so that when it is time for the final assembly, but so that none of these high value parts or equipment is lost or misplaced. These two factors - tracking the hardware for assembly (so that no time is lost, and parts are assembled correctly) and being good stewards of taxpayer dollars, ensuring that nothing goes lost or missing are the key goals with this radio frequency identification (RFID) project being lead by Mr. Jeffers. This application is truly unique in that it embodies the simplification and automation of a process with RFID. Because this is one of many ongoing projects at NASA it shows the benefits gained by utilizing an RFID based solution, from both a low-cost implementation to the simple overlay it provides to an existing process.
AIM North America announced the selection of Mr. Jeffers at the annual AIM Partnership Breakfast held during RFID Journal LIVE! earlier this morning in Orlando, Florida. The award was presented by George Daddis, CEO of Omni-ID, an AIM North America member and corporate contributor to the JWST project.
For more information, contact AIM North America Headquarters by email or phone (724.742.4473).
AIM NA has announced the first group of recipients for the 2018 AIM North America Awards, which honor excellence and outstanding achievement in the automatic identification and data capture industry.
AIM NA's 2018 award winners are being announced at two separate industry events this year, with the first presentation during a special reception held in Sunnyvale, California as part of Connections Summit 2018, hosted by AIM, NFC Forum and RAIN RFID Alliance. Next month at the AIM Partnership Breakfast during RFID Journal LIVE! the final award honoree will be revealed.
Jeanne Duckett, Manager - Printing Research & Development at Avery Dennison was named 2018 AIM North America Professional of the Year. Established in 2007, the AIM North America Professional of the Year is presented annually to an individual in recognition of innovative and exceptional contributions to the development of the AIDC industry through their work as a contributor, collaborator, or mentor.
Ms. Duckett has been a featured presenter at numerous events produced by both AIM NA and AIM in the last decade and serves as a member of several AIM/AIM NA industry groups. Additionally, she has held leadership positions for both the RFID Experts Group (REG) and the Internet of Things (IOT) Industry Group. Nominated by an AIM peer, Ms. Duckett was praised for her many talents. "Her technical expertise is especially useful as it reflects a user perspective as well as that of a producer and she has the innate talent to deal with otherwise thorny issues, going straight to the root problem," the nominator wrote. "Jeanne is exceptionally well versed in the technical aspects of our industry and her approach to standardization remains simple and straightforward. She is one of those people every Chair wants in their group."
At yesterday's ceremony, AIM North America also honored Avery Dennison by presenting the company with its 2018 AIM North America Organization of the Year. This award is presented annually to an organization in recognition of outstanding contributions and service that have furthered the growth of the AIDC industry.
Avery Dennison has a strong global presence and a long history of innovation, making them adept at responding to the unique requirements of businesses from a variety of vertical and global markets. The company’s approach to each customer allows them to be a partner that delivers comprehensive, scalable and reliable solutions to solve business problems and improve business processes. With innovations rooted in efficiency, utility and sustainability, Avery Dennison solutions are agents of change working inside major worldwide brands.
As an early innovator of Radio Frequency Identification, the organization has become a global leader in RFID-enabled technologies with more than 800 patents and applications supported by state-of-the-art manufacturing capabilities. Currently, the company operates RFID initiatives in over 80 countries, providing innovative solutions that have transformed productivity in the apparel retail space while streamlining operations, improving inventory management and facilitating distribution in other sectors, like perishable foods, cosmetics and aviation.
Avery Dennison’s commitment to leadership development has also earned the company recent accolades, having been ranked 8th in an industry survey of employers (private & public sectors) that provide a positive work environment for women.
AIM Inc also announced the winners of the Dilling, Percival, and Williams awards. Complete details can be found here.