Danzz Consulting’s Dan Kimball and CISC Semiconductor’s Debangana Mukherjee Tapped for Leadership Roles
 PITTSBURGH, PA – February 13, 2019—AIM North America (NA) is pleased to announce the appointment of Dan Kimball as the new Chair of the Board and Debangana (“Debs”) Mukherjee as Vice Chair. Board members unanimously welcomed these appointments, which were made at the recommendation of a special Nominations Committee. Mr. Kimball and Ms. Mukherjee will work to fulfill AIM NA’s mission of raising awareness and adoption of automatic identification technologies.
 
Mr. Kimball succeeds Don Ertel, VP Systems & Technology Solutions, CDO Technologies, as Chair of the AIM NA Board of Directors. Mr. Ertel has served as the AIM NA Chair since 2014 and remains on the AIM NA Board of Directors.
 
“We are extremely grateful to Don for his dedication to AIM North America in his tenure as chair of the board,” says Mary Lou Bosco, COO, AIM NA. “We look forward to Dan Kimball stepping into the chairmanship and expanding his leadership role within AIM North America. Dan’s experience across many aspects of AIM North America make him a strong fit to assume this important role. Debs Mukherjee has been an integral part of our strategic planning team and having her step into the role as vice chair gives us a strong, clear succession plan for the board we are excited about.”

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:

• UDI for Medical Devices (AIM NA)| September 7
• RFID in Materials Handling Workgroup | September 12
• IoT Industry Group | September 13
• Food Traceability Workgroup (AIM NA)| September 14
• Sensors Application Identifiers Workgroup| September 21
• Technical Symbology Committee | September 24
• RFID in Healthcare Workgroup | September 27

​To learn more, contact AIM NA. 

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.
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For additional information, contact AIM by email or phone +1 724.742.4470.

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.