The Centers for Disease Control and Prevention (CDC) has developed guidance for storage and handling of vaccines.
- CDC recommends that practices maintain a calibrated, temperature monitoring device (data logger) and manually record temperatures in each unit containing Vaccines For Children (VFC) vaccines. This should be done twice daily.
- Data loggers have many different features. CDC recommendations are below, but call your VFC coordinator to learn what is required in your state.
- Consider a phone-enabled or internet-aware alarm to alert you by phone/internet anytime temperature excursions occur. Multiple people should be on the notification list to ensure the best chance that appropriate action is taken to correct the problem.
It is recommended that your data logger have the following functionality:
- Hi/Lo auditory alarm for out-of-range temperatures;
- Displays current temperature, as well as the minimum and maximum temperatures recorded since last manual recording of temperature (values must be visible from outside of the vaccine storage unit);
- Low battery indicator;
- Accuracy of +/- 0.5 degrees C (+/-1 degrees F) as certified by a current Certificate of Traceability and Calibration. o Certificates may last 1-2 years. o Speak to your VFC coordinator for your options. It may be cheaper to purchase a new device, or they can discuss acceptable testing laboratories.);
- Records continuously with memory storage of at least one month of data* (no less than 4,000 readings);
- Data recording loops when memory is full.* (Remember to download and transfer data to more permanent storage. Reset device after each data download.);
- Detachable, buffered temperature probe, that can remain in the unit while the temperature is displayed on the outside of the unit (near vaccines); and
- User programmable logging interval (or sampling rate) of 10 minutes or less.
* While the CDC recommends 15 minutes or less, a more frequent sampling rate is allowed and may be preferable to capture more data points and to better estimate the duration of temperature excursions.
What do I do with the data stored on my data logger? Even though the data logger is recording, the temperature will need to be checked and manually recorded by office staff twice daily, along with the maximum and minimum temperatures since the last data reset. This recommendation can prevent inadvertent loss of vaccine and the potential need for revaccination by allowing temperature excursions to be identified quickly so that immediate corrective action can be taken. This also provides an opportunity to visually inspect the storage unit, reorganize vaccines by date, and remove any expired vaccines. *Please note this adds to CDC guidance.
Data logger temperature data should be downloaded, reviewed weekly, and stored for at least 3 years. Documentation of known excursions or thermometer malfunctions should be recorded along with the temperature data and should include corrective actions taken to address the excursions. Software will likely be needed in order to view the stored data. Many data loggers are sold with software included, but some are sold separately. You must be able to review historical data.
DO ELITECH HAS CERTIFICATE FOR CDC, FDA AND NIST? IN PR HEALTH DEPARTMENT SAY NOT, AND NOW I CAN’T SELL THIS IN PR.
By jose RIVERA
Jul 06, 2022