New CDC Vaccine Requirements

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

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