6 Ways to Ensure Compliance with Vaccine Temperature Monitoring

Temperature control is integral to ensuring the validity and reliability of temperature monitoring for critical lab, research, and medical environments. Vaccine efficacy has come under scrutiny after a report conducted by the US Department of Health and Human Services led to concerns about potential impacts to vaccine efficacy, particularly as it pertains to children’s vaccines.

The Vaccines for Children Program, a federally funded program of the Centers for Medicare and Medicaid Services (CMS) through the Centers for Disease Control and Prevention (CDC), provides vaccines at no cost to children who, in many cases, may not otherwise be able to receive the appropriate vaccinations. Tens of millions of vaccines are administered via state and local health departments each year. Every single dose of vaccine must be handled, stored and administered through a universal process adopted consistently across the board. This protocol ensures that efficacy and safety of these vaccines.

Vaccines are temperature-sensitive and must be stored within specified ranges. According to Melinda Suchard, Head of the Centre for Vaccines and Immunology at the National Institute for Communicable Diseases, “Live vaccines such as measles may lose potency if stored at temperatures that are too high. Diluent [liquid mixed with some vaccines] may also became a problem if it’s stored too cold and accidentally freezes. Vaccines for tetanus, human papilloma virus, pneumococcal disease and rotavirus, for example, are destroyed by accidental freezing.”

Appropriate temperature conditions are instrumental; reliable and accurate monitoring systems ensure the integrity of the vaccines, preserving the viability of biological components and the vaccine’s effectiveness from storage to administration. The guidance around ensuring that temperatures are maintained properly is quite extensive, with a number of procedures to ensure that temperatures are maintained consistently. Having a Digital Data Logging (DDL) Thermometer is critical to knowing that these processes are working, as well as being compliant with program guidelines.

Traceble Digital Data Logger Display
Figure 1: Visual display on a Traceable® digital data logger thermometer.

VFC-compliant, DDL thermometers provide real-time data and accurate information to ensure vaccines that have not been compromised from extreme hot (over-heated) or cold (frozen) temperatures.

Regardless of your local or state regulations, here are six ways to maintain VFC compliance:

  1. Ensure that the DDL is individually calibrated in an ISO 17025 accredited laboratory with the ILAC/MRA recognition.
  2. A DDL should have a visual display of current temperatures, as well as min and max temperatures. See Figure 1.
  3. A DDL should continuously record temperatures with a logging interval of 10 minutes or less and have at least a 4000-point data storage minimum.
  4. Traceble Digital Data Logger Display
    Figure 2: Traceable® digital data logger thermometer with probes.
  5. A DDL should have an accuracy of at least +/-0.5°C.
  6. A DDL should have a buffered temperature probe [likely in glycolor or another inert solution]. See Figure 2.
  7. A DDL should alarm if there is an out of temperature event and should have a low battery indicator.

Over time, advances in technology have made it easier and more cost-effective to use DDLs in critically controlled environments. Continuous, real-time monitoring DDL’s with remote access and notification are also available to ensure even greater preservation of data and monitoring of lab environments, regardless of the physical proximity to the storage location.