November 12, 2023 -  International Civil Aviation Organization (ICAO) Proposed Amendments to Air Transportation Regulations Affecting Shipments of Medical Devices

Medtech Canada, alongside other various International Associations such as Advamed and Medtech Europe, have submitted a Joint Association letter to the ICAO Dangerous Goods Panel Chairman.

This letter expresses the associations joint concerns with the proposed regulations on the transport of dangerous goods aboard aircraft which is being considered at the International Civil Aviation Organization (ICAO) Dangerous Goods Panel on November 13th, 2023.

These concerns are related to proposals impacting international air shipments of medical devices containing batteries and their significant impact on patient Care, operational, and cost implications for the medical industry.

Update on Lithium Battery Transport Issue

The International Civil Aviation Organization (ICAO) Dangerous Good Panel’s (DGP) Energy Storage Device Working Group (WG) met on November 9th and 10th in Montreal to consider two key lithium ion battery-related air transport issues: whether lithium ion batteries packed with equipment, and lithium ion batteries contained in equipment, should be subject to a 30% state of charge (SOC) limit when shipped by air. The following report is based on George Kerchner’s participation in the WG meeting as an industry representative of the Portable Rechargeable Battery Association (PRBA). MDTC was not permitted to directly participate in the WG unfortunately, but we work very closely with PRBA and they are a strong advocate for medical device considerations at ICAO.

Lithium ion Batteries Packed with Equipment

As expected, the WG agreed to support a 30% SOC limit on lithium ion batteries packed with equipment shipped in accordance with Packing Instruction 966 of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI). They also agreed that lithium ion batteries with a Watt-hour rating not exceeding 2.7 Wh should be excepted from this SOC limit. If the batteries packed with equipment are offered for transport at a SOC exceeding 30%, they would need to be shipped as fully regulated, Class 9 dangerous goods under an approval issued by the State of Origin and the State of the Operator.

Lithium ion Batteries Contained in Equipment

The WG could not reach a consensus on whether lithium ion batteries contained in equipment should be subject to a 30% SOC limit. In fact, the majority of the WG members did not support a SOC limit on lithium ion batteries contained in equipment. The WG did agree to include language in Packing Instruction 967 of the ICAO TI that states lithium ion batteries contained in equipment “should” not exceed 30% SOC. Use of “should” implies the SOC limit would become more of a recommendation rather than a mandatory regulatory requirement.

To further address the safe transport of lithium ion and lithium metal batteries packed with and contained in equipment, the WG agreed to include concerning language in Packing Instructions 966, 967, 969, and 970 of the ICAO TI requiring packages containing these products to be “capable” of passing a 3 meter stack drop test to ensure battery integrity and limit fire risk. MDTC is opposed to this requirement which does not have sufficient data to warrant such a change that would be difficult to administer and would have significant impact on millions of devices shipped annually.

Medical Devices Containing Lithium ion Batteries

Thanks to the international device trade association letter and other advocacy efforts, an exemption from the SOC limits for lithium ion battery-powered medical devices was a major topic of discussion. There was recognition by some members of the WG that such an exemption is warranted in certain situations, but the language providing an exemption has not yet been developed for consideration this week by the DGP.

The WG meeting was the first step in the ICAO dangerous goods process to finalize changes for the 2025-2026 Edition of the ICAO TI. The DGP is meeting this week in Montreal and all the lithium battery-related issues will be addressed on Wednesday, November 15th. After the DGP completes its work, the ICAO Air Navigation Commission (ANC) must approve the decisions reached by the DGP. The final changes to the ICAO TI would be scheduled to take effect at the international level starting January 1, 2025. However, it is likely that the WG is supportive of adding a one-year transition to January 1, 2026 before the new requirements take effect.

Thank you for all of your extraordinary advocacy efforts on this critical issue. While a recommendation for 30% SOC is preferable to a requirement, should ICAO accept the WG recommendation, much work will remain to be done to secure a medical device carve-out for likely future consideration of additional restrictions for batteries contained in equipment shipped via air. 

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October 6, 2023 -  Medtech Canada MDSAP Survey

Medtech Canada is planning to attend the next MDSAP meeting in Brazil in order to represent the Canadian’s industry experience around MDSAP. This is the first opportunity we have had of this nature and we are very excited!

We recently learned that the regulators and registrars are seeking from us (and other countries industry representatives) a brief presentation around MDSAP and its impact on industry (positive / negative / suggestions).

We request that you complete this survey as soon as possible so that we may use the feedback in our presentation.

https://forms.office.com/r/YLWQE9w7dv

DEADLINE to provide your feedback is October 13th, 2023