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Understanding the CDC Recommendation for Having a Certificate of Calibration

Posted on Apr 06, 2017 by Miranda Allen

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Proper vaccine storage and monitoring equipment is essential to delivering safe and effective vaccines to patients. Medical-grade vaccine refrigerators and accurate temperature monitoring devices can be thought of as an insurance policy for sensitive and expensive vaccines. To fully ensure the efficacy of the vaccines, CDC recommends a purpose-built vaccine refrigerator with a temperature monitoring device that has a current and valid Certificate of Calibration (also referred to as a Report of Calibration).

CDC recommends that your temperature monitoring device’s current and valid Certificate of Calibration Testing (Report of Calibration) should include:

  • Model/device name or number
  • Serial number
  • Date of calibration (report or issue date)
  • Confirmation that the instrument passed testing (or instrument in tolerance)
  • Recommended uncertainty of +/-0.5° C (+/-1° F) or less

If you need to determine if a Certificate of Calibration Testing or Report of Calibration was issued by an appropriate entity, check to see if the certificate indicates one or more of the following items about calibration testing:

  • Conforms to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 international standards for calibration testing and traceability
  • Performed by a laboratory accredited by International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body – A list of ILAC/MRA signatories may be found at ILAC.org/ILAC-MRA-and-signatories/ 17 Vaccine Storage and Temperature Monitoring Equipment
  • Traceable to the standards maintained by the National Institute of Standards and Technology (NIST)
  • Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 Tolerance Class F (< +/-.5° C or < +/-1° F) or better
  • Refers to another acceptable accuracy validation method, such as comparison to other traceable reference standards or tests at thermometric fixed points. Certain types of temperature monitoring devices have significant limitations and should not be used to measure temperatures in a vaccine storage unit.

CDC does NOT recommend these temperature monitoring devices which are difficult to read and, because they only show the temperature at the exact time they are read, may fail to detect temperatures outside the recommended range. Specifically, CDC does not recommend the following temperature monitoring devices:

  • Alcohol or mercury thermometers, even if placed in a fluid-filled biosafe liquid vial
  • Bi-metal stem temperature monitoring devices
  • Food temperature monitoring devices
  • Chart recorders
  • Infrared temperature monitoring devices
  • Temperature monitoring devices that do not have a current and valid Certificate of Calibration Testing

Devices sold in hardware and appliance stores are generally designed to monitor temperatures for household food storage. They are not calibrated and not accurate enough to ensure vaccines are stored within the correct temperature range. Using these devices can pose a significant risk of damaging expensive vaccines.

All of this information can be found in the CDC Vaccine Storage and Handling Toolkit.

To assist you in meeting CDC guidelines, for a limited time, Helmer is offering a free Certificate of Calibration with qualified vaccine refrigerator purchases, now through June 30, 2017. Helmer monitoring devices conform to the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 international standards for calibration testing and traceability. Learn more about this offer today by following the link below.

Learn More about this Promotion »

Miranda Allen

Written by Miranda Allen

Helmer designs, manufactures, and sells reliable medical-grade refrigeration. Miranda specializes in the pharmacy segment in regards to proper cold storage for refrigerated and frozen medications and vaccines.

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