Smart Solutions / Blog / December 2017 / New CDC Requirements for VFC Providers

New CDC Requirements for VFC Providers

CDC temperature monitoring equipment requirements for Vaccines for Children (VFC)

Regular review of temperature storage data is critical for determining whether vaccines have been safely and properly stored. Starting January 1, 2018 all VFC providers are required to use continuous temperature monitoring devices, such as a temperature data logger, in all refrigeration equipment that is used to store vaccines that will be administered to VFC-eligible children. Temperatures must be recorded and reviewed a minimum of 2 times each day.

Data loggers are powerful tools for recording continuous temperature of critical inventories. However, as the data must be downloaded from the device they do not provide real-time alerts should a temperature fall out of the public safety range or if a piece of equipment should fail. Additionally, other types of temperature monitoring devices have significant limitations and should not be used to measure temperatures in a vaccine storage unit. In this group would be any device that only displays temperature at the exact time that it is read, and therefore can mask intermittent temperature violations.

To meet VFC program requirements, the temperature monitoring device must be equipped with:

  • Temperature probe. Such as a glycol product simulator.
  • An active temperature display that can be easily read from outside the unit.
  • Provide continuous monitoring and recording of data that can be reviewed.

The following features may also be required by your local immunization program:

  • Alarm for out-of-range temperatures.
  • Current, minimum, and maximum temperature indicator.
  • Low-battery indicator.
  • Accuracy of +/- 0.5° C (+/- 1° F).
  • Memory storage for at least 4,000 readings.
  • Recommended maximum logging interval (or reading rate) of every 30 minutes that can be programmed by the user.
  • Use of a probe—such as a buffered probe—that best reflects the temperature of the vaccine.
  • Consult your immunization program for more information on how to meet these VFC storage and handling requirements.

Your facility should have a temperature monitoring device for:

  • Each vaccine storage unit
  • Each emergency transport unit (this is particularly important if there are more transport units than storage units).
  • At least one backup temperature monitoring device in case a primary device malfunctions or is out for calibration testing (make sure the backup device has a different calibration testing schedule than the primary device so it is available when the primary device is being tested)
  • CDC recommends temperature monitoring devices with the following characteristics:
  • Detachable probe in a thermal buffered material (e.g., glycol, glass beads, sand, Teflon®) 
  • Alarm for out-of-range temperatures Low-battery indicator 
  • Current, minimum, and maximum temperature indicator 
  • Recommended uncertainty of +/-0.5° C (+/-1° F)
  • Logging interval (or reading rate) that can be programmed by the user

 


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Digi SmartTemps Exceeds VFC Requirements
Digi SmartTemps is an affordable and easy to use solution that meets and exceeds all of the CDC’s 2018 requirements for VFC providers. Digi Smart Guard (link) monitors and manages the temperatures collected from vaccine storage units and has an option for a glycol product simulator probe. Digi Smart Guard logs temperatures every 15 minutes, and real-time alerts are sent for any temperature excursions ensuring product and equipment efficacy. Digi SmartTemps reporting exceeds all CDC, SDOH, and VFC requirements and CDC, JCAHO, FDA, and CMS record keeping requirements. Speak to an industry professional today to see how Digi SmartTemps can keep you compliant. 

 

 

Source: https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

Additional VFC resources:

December 18, 2017
Healthcare Pharmacy Regulation