Vaccines are critical tools in maintaining the health of our communities. The logistics of delivering vaccines and verifying that they consistently maintain their recommended temperature has always been a difficult task. At times, vaccines were found being stored outside of the manufacturer’s recommended range. Prolonged temperature excursions can result in the vaccines becoming ineffective.
In 2014, the Centers for Disease Control and Prevention (CDC) responded and published its CDC Vaccine Storage & Handling Toolkit, establishing guidelines for vaccine storage and handling. We suggest checking with your state authorities for confirmation of when these requirements will be mandated at your facility. We have highlighted the primary requirements from this Toolkit and direct Mesa solutions for you below:
Key CDC Requirement:
- Digital Display
- Temperature readings at least 2x a day
- Memory Storage of at Least 4,000 Readings
- Download and review stored temperature data at least 1x a week
- Maintain ongoing temperature data for 3 years
- Alarms for Out-of-Range Temperatures
- Take immediate action to correct out-of-range temperatures and record incident and action taken
- Review and record minimum and maximum temperatures at the beginning of each day
- Record times of readings and initials of person who took readings
- Low Battery Indicator
- Accuracy of ± 1°F (± 0.5°C)
- User Programmable Logging Interval
- Primary vaccine coordinator reviews records at least 1x a week
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Direct Solution with Mesa Labs’ VPX Digital Data Logger:
- LCD Digital Display that allows temperature readings without opening appliance doors
- Continuous monitoring with real-time alerts
- Stores at Least 4,000 Data Points
- Continuous monitoring with automatic download of any sensor-stored data to a central database
- Permanent electronic record of all readings and corrective actions with no storage date limits
- Audible and Visible (Red Blinking LED) Alerts (with Mute Button)
- Real-time alerts with permanent corrective action records maintained in accordance with FDA 21 CFR Part 11 requirements
- Displays Minimum, Maximum and Current Readings on LCD Display
- All data is time-stamped, and temperature data reviewer electronically signs daily check record
- 12V AC line-powered battery and Wireless Signal Strength Indicators
- ± 0.5°C Accuracy in Range -20°C </= T </= 40°C
- User Programmable Logging Periods (T = 1 to 120 minimum)
- Regular managerial review of daily reports requires electronic signature
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Mesa Labs’ VPx sensors meet and exceed all of CDC’s VFC requirements. Contact us today for more information.
Related Links
Vaccine Storage and Handling: Recommendations and Guidelines
Vaccine Storage and Handling Toolkit
CDC’s Temperature Excursion Checklist
Let’s talk monitoring!
Talk with one of our experts to get your questions answered and see how we can help you solve your continuous monitoring pain points.
Roy Chien
Roy is the Sr. Director of Product Management for Mesa Labs. He is an expert in the field, with an MSEE, MBA and over 12 years of experience in Continuous Monitoring.
