It didn't take much. The button sized lithium batteries used to power most electronic temperature data loggers, along with other devices, recently became the center of a heated (and as it turns out - an unnecessary) regulatory and industry debate. A letter from Delta Airlines Cargo broadcast to its customers in late November, lead with the following:: “Effective immediately, Delta Cargo cannot accept shipments containing devices powered by lithium batteries, regardless of the amount of lithium contained. Such devices include, but are not limited to temperature sensitive shipments.”
Delta did not interpret the current regulations to include devices powered by lithium batteries that are used to monitor cargo.
The concern, and why lithium batteries are regulated in transportation in the first place, is because they can present a potential fire hazard. In Delta’s opinion, the current CFR, as written, covered batteries as cargo both in bulk and within equipment itself, or batteries in carry-on or checked passenger luggage, but not attached to cargo such as a monitoring device. This interpretation nearly short-circuited the pharma logistics community and several other airlines were poised to follow Delta's lead.
Direct negotiations with officials at the US DOT PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION on behalf of the healthcare industry, the IATA Time & Temperature Task Force, and the data logging industry-at-large, were championed by Henry Ames, Director of Strategic Marketing for Sensitech, Inc. Sensitech, who clearly has a vested interest in the outcome, submitted a formal request for interpretation of HMR 49 CFR Parts 171-180 to the DOT over the Thanksgiving Holiday. Such responses can typically take a very long time. Ames shrewdly enlisted other contacts within the industry and invoked the US FDA and concerns for protecting the integrity and quality of the nations drug supply and received a prompt written response from HMPSA Director Edward Mazzullo. The US DOT said “these cargo monitoring devices are subject to applicable provisions of the HMR” but based on the extensive documentation Sensitech provided to the DOT relevant to its devices, added, “that these devices qualify for the exceptions provided for small lithium batteries under SP 188.” (CFR 172.102). Will other device manufacturers have to provide similar letters to DOT to document the lithium content and configurations of their devices with the agency, and demonstrate conformity with the exception requirements? Perhaps. The HMR advises that “beginning October 1, 2009, the cells or battery must be of a type proven to meet the requirements of each test in the UN Manual of Tests and Criteria 171.7.”
Meantime, Delta has not changed its position, other airlines and international transportation regulators have yet to officially weigh-in pending the DOT's response and device manufacturers, whether they make data loggers, pumps, or other devices powered by small lithium batteries, need to perform their due diligence. It is the responsibility of each individual manufacturer to provide evidence if requested, that the lithium batteries and cells used to power their devices are in compliance with the applicable Parts of 49 CFR for content, configuration, application and testing, and meet the requirements of special provision 188.
You can read more on this important topic, including a detailed explanation of the potential hazards, requirements and special provision requirements for small lithium batteries, in the next issue (Jan / Feb) of Pharmaceutical & Medical Packaging News (PMPN).
Further information is available at Sensitech's website and PMPN's blog.