Am I Required to Calibrate My COVID-19 Temperature Monitoring Device?

my covid-19CAS DataLoggers is receiving an increasing amount of telephone calls looking for temperature monitoring or digital data loggers (DDL) to handle protecting the storage of COVID-19 vaccines. However, many of the callers are not aware that the DDL is required to have a valid certificate of calibration to comply with the full Center of Disease Control (CDC) requirements.

The CDC has published two-page summary documents with information on the Storage and Handling of the Moderna and Pfizer vaccines. The requirement is clear that temperature monitoring using a digital data logger is required. What is not clear in the summary documents is the requirement to have the DDL calibrated.

These calibration requirements are detailed starting on page 10 of the Vaccine Storage and Handling Toolkit, recently updated to include an addendum on the COVID-19 vaccines. On-Page 50 of the addendum it is stated, “Always use DDLs with a current and valid Certificate of Calibration Testing.” This ensures that the data logger has been tested for accurate measurement with any inaccuracy corrected.

Furthermore, please be aware that your local authority may have additional requirements for calibration, for example ISO 17025 traceability, so it’s important to check with your respective governing body to find if there are any special traceability requirements or certifications necessary for the facility performing the calibration of the DDL.

There should be no ambiguity—any device used for temperature monitoring of critical material, especially the COVID-19 vaccines, should be calibrated. Need a calibrated digital data logger to monitor the storage of your COVID-19 vaccines? Contact us today at 800-956-4437 or request more information.