Vaccine Storage and Temperature Monitoring Equipment
These items should be selected carefully, used properly, maintained
regularly (including professionally serviced when needed), and monitored
consistently to ensure the recommended temperatures are maintained. This
chapter provides only general guidelines for equipment.
Providers should consult their immunization program, particularly providers
of VFC vaccines or other vaccines purchased with public funds, for any
specific storage equipment requirements.
Keep a logbook for each piece of vaccine storage equipment. The serial
number of each piece of equipment, the date each piece of equipment was
installed, the dates of any routine maintenance tasks (such as cleaning),
the dates of any repairs or service, and the contact information of the
service provider should be recorded. A logbook is also an ideal place to
keep the instructions that came with the equipment.
Freezers and Refrigerators
Using proper vaccine storage units can help prevent costly vaccine losses
and the inadvertent administration of compromised vaccines. CDC recommends
stand-alone units, meaning self-contained units that either freeze or
refrigerate, and are suitable for vaccine storage. These units can vary in
size, from compact, counter-top or under-the-counter style to large,
pharmaceutical grade units. Studies demonstrated that stand-alone units
maintain the required temperatures better than combination units,
particularly the freezer section of household, combination units.
If existing equipment is a household, combination refrigerator/freezer,
CDC recommends using only the refrigerator compartment for refrigerated
vaccines. Use a separate stand-alone freezer to store frozen vaccines.
Research found that freezers in household combination units cannot hold
proper storage temperatures for frozen vaccines particularly during defrost
cycles. This applies to both temporary and long-term storage.
Any freezer or refrigerator used for vaccine storage must be able to
maintain the required temperature range throughout the year. The unit
should be dedicated to the storage of biologics and must be large enough to
hold inventory a provider might have at the busiest point in the year
without crowding (including flu vaccine). There should also be enough room
to store water bottles in the refrigerator and frozen water bottles in the
freezer to stabilize the temperatures and help maintain temperature longer
in a power outage. If your stand-alone freezer is manual defrost, you must
defrost regularly and have another storage unit that maintains appropriate
temperatures for temporary storage of the vaccine while defrosting. A
frost-free unit with an automatic defrost cycle may be preferred if regular
manual defrosting cannot be assured.
Good air circulation around a vaccine storage unit is essential for proper
cooling functions. A storage unit should be in a well-ventilated room with
space around the sides and top and at least 4 inches between the unit and a
wall. Nothing should block the cover of the motor compartment and the unit
should be level and stand firmly with at least 1 to 2 inches between the
bottom of the unit and the floor.
CDC does not recommend storage of any vaccine in a dormitory-style or
bar-style, combined refrigerator/ freezer unit under any circumstances,
even temporarily. A dormitory-style refrigerator is defined as a small
combination freezer/refrigerator unit with one exterior door and an
evaporator plate (cooling coil), which is usually located inside an
icemaker compartment within the refrigerator. These units have exhibited
severe temperature control and stability issues throughout the entire
storage area. Dormitory-or bar-style units pose a significant risk of
freezing vaccines, even when used for temporary storage. The use of this
type of unit is prohibited for storage of VFC vaccines or other vaccines
purchased with public funds.
Temperature Monitoring Devices
Temperature Monitoring is a critical part of good storage and handling
practice. CDC recommends using only a calibrated digital data logger with a
current and valid certificate of calibration testing (also known as a
Report of Calibration). This certificate informs the user of a temperature
monitoring device’s level of accuracy compared to a recognized standard.
Calibrated temperature monitoring devices are required for providers who
receive VFC vaccines or other vaccines purchased with public funds.
All temperature monitoring devices, through normal use, drift over time,
which affects their accuracy. Because of this, temperature monitoring
devices should undergo periodic calibration testing. Testing should be
performed every 1 to 2 years from the last testing date or according to the
manufacturer’s suggested timeline. CDC recommends that testing meets
standards defined in the Vaccine Storage and Handling Toolkit. If
calibration testing indicates that your temperature monitoring device is no
longer accurate, it should be replaced. Immunization programs are often
excellent resources for information on temperature monitoring devices.
Several types of temperature monitoring devices are available. CDC
recommends digital data loggers with the following characteristics: a
digital display easily readable from outside the unit; a detachable probe
in a buffered material, which more closely reflects vaccine temperatures
rather than air temperature in the unit; an alarm for out-of-range
temperatures; current and minimum and maximum temprature accuracy within
+/-1°F (+/-.5°C); a low battery indicator; memory that stores at least 4000
readings; and user programmable logging interval. CDC recommends a back-up
digital data logger for each vaccine storage unit. Staff should be trained
and understand how to set up, read and analyze temperature data provided by
the data logger.
Temperature monitoring device placement within the unit is just as
important as device selection. Place the buffered probe with the vaccines.
This should be in the middle, center of the storage unit away from walls,
ceiling, cooling vents, door, floor, and back of the unit. Prior to storing
vaccines in a unit, allow the unit temperature to stabilize for a week
before placing vaccines in the unit. CDC recommends using a digital data
logger to monitor the temperature in the storage unit prior to storage of
vaccines.
Temperature Monitoring
Regular temperature monitoring is key to proper cold chain management.
Store frozen vaccines (Varicella, MMRV, and Zoster) in a freezer between
-58°F and +5°F (-50°C and -15°C). Store all other routinely recommended
vaccines in a refrigerator between 35°F and 46°F (2°C and 8°C). The desired
average refrigerator vaccine storage temperature is 40°F (5°C). Exposure to
temperatures outside these ranges may result in reduced vaccine potency and
increased risk of vaccine-preventable diseases.
CDC recommends reviewing and recording temperatures in both the freezer and
refrigerator units at least 2 times each workday, in the morning and before
leaving at the end of the workday.
This best practice recommendation applies to all vaccine storage units,
regardless of whether or not there is a temperature alarm, or a digital
data logger that continuously records temperatures in the unit. These
readings will provide a better indication of any problems with the storage
unit’s function.
Reviewing and recording temperatures also provides an opportunity to
visually inspect the storage unit, reorganize the vaccines when necessary
(e.g., moving vaccine away from walls or cold air vents), identify vaccines
and diluents with short expiration dates, remove any expired vaccines and
diluents, and provide a timely response to temperature excursions.
Post a temperature log on each storage unit door or nearby in a readily
accessible and visible location. In addition, if using a device that
enables download of temperature data, review and store data at least once
every week and reset the device before returning to storage unit
monitoring.
CDC recommends maintaining an ongoing file of temperature data, including
hard copies and downloaded data for at least 3 years or according to
individual state record retention requirements. As the storage unit ages,
recurring temperature variances or problems can be tracked and documented.
This data can be important when evaluating the need for a new storage unit
or if there is a potential need to recall and revaccinate patients because
of improperly stored vaccine.
Twice daily temperature monitoring may not be accomplished when a
provider’s office is closed. A digital data logger that stores data and/or
can be accessed remotely can provide information on storage temperatures
while the office is closed and help assure that timely corrective action
can be taken if temperatures go out of range. Providers should determine
how they are to be notified in the event of an emergency (e.g., a power
outage) during hours when the facility is not open.
Equally important to temperature monitoring is taking timely corrective
action when there is a temperature excursion. If it is discovered that
stored vaccines have been exposed to temperatures outside the recommended
ranges, these vaccines should remain properly stored, but separated from
other vaccine supplies and marked “Do NOT Use” until guidance can be
obtained. Protocols after an event will vary depending on individual state
or agency policies. Contact your immunization program, vaccine
manufacturer(s), or both for guidance.
Monday, January 7, 2019
Vaccine Storage and Temperature Monitoring Equipment
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