Maintaining VFC Compliance with Data Loggers
In order to maintain their potency and safety, vaccines must be handled and stored carefully. Vaccines are essential for the prevention and eradication of many infectious diseases. It’s the duty of VFC providers to adhere to the state or local immunization programs as well as the storage and handling guidelines published by the Centers for Disease Control and Prevention (CDC). Data loggers can help maintain VFC compliance so vaccines and other medicines are kept safe and effective.
Why is a Data Logger Important for VFC Compliance?
The CDC requires VFC providers to use a data logger in each vaccine storage unit because it is the most reliable and effective way to ensure that the vaccines are stored at the appropriate temperature at all times. In addition, it’s also a requirement that a data logger must have certain features and specifications to be VFC-compliant. These include:
- A detachable probe that accurately reflects vaccine temperatures
- A buffered probe (with either glycol, glass beads, sand, or Teflon®) that mimics vaccine temperatures
- A digital display that shows current, minimum, and maximum temperatures
- An alarm system that indicates high or low temperatures
- A low-battery indicator
- A reset button
- A continuous monitoring capability
- A memory storage of at least 4,000 readings
- A logging interval (or frequency) of at least every 30 minutes
- A current and valid Certificate of Calibration Testing
A Certificate of Calibration Testing is a document that verifies that the data logger has been tested and calibrated by an accredited laboratory or manufacturer. This certifies that it meets certain accuracy standards. The certificate should include information such as name and address of the laboratory or manufacturer, model and serial number of the device, date and method of calibration, and more.
The CDC recommends that VFC providers obtain a new Certificate of Calibration Testing for each data logger at least every two years, or sooner if indicated by the manufacturer or immunization program.
How to Properly Maintain a Data Logger
To maintain a data logger, VFC providers should follow these steps:
- Purchase a VFC-compliant data logger.
- Install the data logger according to the instructions.
- Check and record the temperature at least twice daily, once at the start of each workday and once at the end. It’s also recommended to read and document the current, minimum, and maximum temperatures from the display, and reset the device after each reading. Finally, check and document the battery status and alarm status of the device.
- Download and review the temperature data at least once a week, or more frequently if required by the immunization program. Transfer the data from the device to a computer and generate a temperature log or report. Review the log or report for any temperature excursions or gaps and take corrective actions if needed.
- Store and archive the temperature data for at least three years, or longer if required by the immunization program. Save the data in a secure and accessible location, such as a computer, a flash drive, or a cloud service. Keep a backup copy of the data in case of loss or damage.
- Recalibrate the data logger at least every two years, or sooner if indicated by the manufacturer or immunization program. Obtain a new certificate after each recalibration, and update the device information in their records. Find out more about data logger calibration.
By following these steps, VFC providers can ensure that their data loggers are functioning properly and providing accurate and reliable temperature data for their vaccine storage units. This will help them protect their vaccine supply, prevent vaccine wastage, and comply with the VFC program requirements.