Feature
Henry Ames says tens of millions of
Sensitech’s data loggers have been
shipped aboard aircraft all
over the world.
• Packages that
contain 5 kg or less net
weight of primary lithium batteries or cells that are contained
in or packed with equipment and the
package contains no more than the
number of lithium batteries or cells necessary to power the piece of equipment.
• For lithium metal or lithium alloy
cell, the lithium
content is not
more than 1 g ( 2 g
aggregate).
• For lithium-ion
cell, the equivalent content is not
more than 1.5 g (8
g aggregate).
• Effective 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 of this subchapter).
• Cells or batteries are separated so as to
prevent short circuits and are packed in a
strong outer packaging or are contained
in equipment.
Additional provisions are not relative to
temperature-monitoring devices. Special
Provision 188 addresses the “watch type”
lithium batteries used to power nearly all
temperature-monitoring devices. Their
lithium content is roughly 0.062 g, well
below the maximum allowable, and
above. Effective 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 of this
subchapter). These tests include, but
are not limited to voltage discharge
rates, and the robustness of the cells
or batteries to withstand the rigors of
transportation.
Additionally, Part 173.185 lists the
general requirements for shipping and
packaging, which include safety venting
or package design which will preclude a
violent rupture under conditions normal
to transport, and must be equipped with
an effective means to prevent reverse
current flow and/or short-circuiting.
This is where 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 prove 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.
■
they are
included in the
device in such a way
as to be well protected and to
prevent short circuits. The ambiguity
seems to lie in whether a package’s data
logger device in the cargo hold of a passenger aircraft is a “piece of equipment,”
and whether the fact that it is activated is
relevant.
“There have been tens of millions of
our data loggers shipped aboard aircraft
all over the world over the past cou-
ple of decades,” Ames said. “While we
have been requested to provide test data
from airlines and other transportation
service provid-
ers with regard to
our devices, this is
the first time, that
I’m aware of, that
an airline refused to
ship them. Overall,
I believe the risk to
patient safety as a
result of a product
subjected to tem-
perature abuse is
significantly greater
than the risk of any
small lithium bat-
tery used in our
devices which
we have demonstrated, and DOT
agrees, are fully compliant with the
current regulations.”
A knee-jerk reaction
sent a leading
temperature-
monitoring company
scrambling to request
interpretation of
the Final Rule
from DOT.
ASSURING COMPLIANCE
Data logger manufacturers
must pay particular attention to
one aspect specific to the DOT
requirements mentioned
Temp Tale monitors travel both to and
from a destination, returning with a premade label.
