AdvaMed® leads Global Effort to Push Back on Lithium Battery Transport Restrictions

WASHINGTON, D.C. – As the International Civil Aviation Organization (ICAO) Dangerous Goods Panel meets this week, AdvaMed®, the Medtech Association, led a group of 24 global medtech organizations in expressing concerns about the panel’s proposed regulations on the transport of dangerous goods aboard aircraft. The proposed regulations would negatively impact the international air shipments of medical devices containing batteries.

From the letter to ICAO: “For patients requiring timely access to life-critical devices such as defibrillators, implantable medical devices (e.g., pacemakers and neuromodulators), and wearable medical devices (e.g., heart monitors, heart pumps, ventilators), a disruption to the supply chain poses serious threats to public health.

“The medical device community produces state-of-the-art products that are already heavily regulated by international agencies to the highest standards of safety and effectiveness. The medical device industry is not aware of a single aviation incident involving lithium battery-powered medical devices. To the contrary, there has been consistent concern about the public health risks of restricting air shipment of medical device batteries and has allowed for exemptions for life-saving medical devices to be flown on passenger flights.”

In the letter, the groups outline the issues with requiring shipments of rechargeable lithium ion batteries packed with or contained in equipment to be shipped at the lowest state of charge not to exceed 30%, including implications to patient care and operational costs for medtech companies:

• As proposed, this rule would place new requirements on life-saving medical devices that are already designed to meet all medical device regulations AND current transportation regulations, which already provide additional safety benefits.
• Requiring batteries to be shipped at 30% SOC or less directly impacts patient safety because the devices need to be ready for immediate use. The proposed rules would decrease shelf life and delay care for patients.
• Lithium ion batteries can also be permanently damaged if the SOC drops to 0% for an extended period, which is more likely to occur if devices are shipped with less than 30% SOC and then stored for an extended period of time.

Read the full letter here.