CDC stresses documenting accurate temperature history which reflects actual vaccine temperatures. Investing in reliable temperature monitoring systems is much more cost effective than replacing compromised vaccine due to inaccurate temperature readings.
CDC recommends using calibrated temperature monitoring devices with a Certificate of Traceability and Calibration Testing (also referred to as a Report of Calibration). Calibration and traceability testing is performed by a laboratory with accreditation from the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body, assuring that testing performed meets appropriate standards.
An alternative is a laboratory or manufacturer that provides documentation that demonstrated calibration testing performed meets International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 international standards for calibration testing and traceability.
Providers are responsible for maintaining up-to-date certificates of calibration. Manufacturers of medical-grade refrigerators and freezers may be able to provide a Certificate of Calibration for the unit’s built in temperature monitoring.
All temperature monitoring devices experience “drift” over time which affects their accuracy. CDC recommends calibration testing every 1 to 2 years from the last testing date or according to the manufacturer’s suggested timeline which may be more frequently. VFC providers should consult their immunization program for their required time frame for calibration testing.
For more on the safe storage of vaccines, read our latest article, CDC Vaccine Storage Recommendations for Vaccine Administration Sites.
