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CDC Guidance for Monitoring Vaccine Temperatures


March 2016 - Vol. 13 No. 3 - Page #22

Maintaining an accurate temperature history that reflects vaccine temperatures over time is critical to appropriate vaccine management. As many organizations have learned the hard way, investing in reliable temperature-monitoring devices is less expensive than replacing vaccines that must be wasted due to inaccurate temperature readings. Protecting vaccines throughout the cold chain (from manufacturer to delivery and storage through administration) ensures that patients receive effective vaccines that have been properly stored. Use of calibrated temperature-monitoring devices and digital data loggers assist in this endeavor.

Calibrated Temperature-Monitoring Devices

The Centers for Disease Control and Prevention (CDC) recommends using only calibrated temperature-monitoring devices with a Certificate of Traceability and Calibration Testing (also called a Report of Calibration) for measuring vaccine storage unit temperatures. Calibration testing and traceability should be performed by a laboratory with accreditation from an International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body, or a laboratory or manufacturer that can provide documentation that demonstrates that the calibration testing performed meets International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 international standards for calibration testing and traceability. It is important to note that because a temperature-monitoring device claims to be certified does not necessarily mean that it has been tested to meet ISO/IEC standards.

CDC recommends that ILAC-accredited laboratories perform testing because it is an easy way to verify that the device has been tested correctly according to international standards. Providers are responsible for maintaining up-to-date certificates of calibration. Certificates for testing performed by ILAC-accredited laboratories should include the following information:

  • Clearly identifiable accreditation
  • Name of device (optional)
  • Model and serial number
  • Date of calibration (report or issue date)
  • Measurement results that indicate that the device passed testing and documented uncertainty within suitable limits. Recommended uncertainty is +/– 1°F (+/– 0.5°C)

Non-ILAC accredited laboratories and manufacturers must provide a Certificate of Traceability (Report of Calibration) that includes the following elements:

  • Name of device (optional)
  • Model and serial number
  • Date of calibration (report or issue date)
  • Measurement results that indicate that the device passed testing and documented uncertainty within suitable limits. Recommended uncertainty is +/– 1°F (+/– 0.5°C)
  • Measurement results for the device
  • A statement that calibration testing conforms to ISO 17025

Digital Data Loggers

Digital data loggers, which can be programmed to record temperatures at chosen intervals throughout the day for continuous temperature monitoring and recording, are recommended. These data loggers typically are battery operated, simple to use, and have multiple beneficial features. Digital units store continuous temperature data, which can be downloaded or retrieved from the Web for review and archiving. The devices may be used with software that allows the user to set the frequency of temperature readings, download data from the device, and review minimums and maximums. To accurately trend temperature history, users must download data on a regular basis.

Choose a data logger with an alarm that sounds outside of the storage unit to facilitate a quick response. Temperatures displayed on the unit, as well as minimum and maximum temperatures since the last reading, should be reviewed and recorded a minimum of two times each day to determine if a temperature excursion has occurred. If the alarm activates, take immediate corrective action.

Key characteristics for data loggers include:

  • Alarm indicating out-of-range temperatures
  • Current, minimum, and maximum temperatures
  • Low battery indicator
  • Accuracy of +/– 1°F (+/– 0.5°C)
  • Memory storage of at least 4000 readings
  • User-programmable logging interval (or reading rate)

Use of digital data loggers is a best practice.

Conclusion

Failure to store and handle vaccines appropriately can reduce their potency, resulting in inadequate immune responses in patients and improper protection against disease. In addition, storage and handling errors can result in significant financial loss if vaccines cannot be used. Following CDC recommendations and implementing best practices ensures patients receive effective, safe vaccines.


The information presented in this article is from the CDC’s Vaccine Storage & Handling Toolkit, which is available in its entirety at http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf.

In addition, CDC offers You Call the Shots: Vaccine Storage and Handling Module, an interactive, Web-based training module that provides learning opportunities, self-test practice questions, and references and resource materials (available at http://www.cdc.gov/vaccines/ed/youcalltheshots.htm). Continuing education or a certificate of completion is available.


Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine, and can be reached at jkarpinski@ridgewoodmedia.com.

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