URGENT—Provider Information Regarding Use of Controlant On-Site Monitoring for Pfizer Vaccine

Dear Immunization Partners,

Please review the following update on COVID-19 vaccines regarding on-site monitoring by Controlant.

CONTROLANT ON-SITE MONITORING OF PFIZER VACCINE

The contract between the U.S. Government and Controlant that supports on-site monitoring (after product acceptance) of Pfizer COVID-19 vaccines will be ending on November 25, 2022. All sites that have used on-site monitoring provided by Controlant since the start of Pfizer COVID-19 vaccine distribution will be affected by this change.

Controlant monitors will still be used to monitor product in transit, but you will no longer be able to use these devices for monitoring storage temperatures at your location. 

• Support@controlant.com will continue.
• Onsitemonitoring@controlant.com will discontinue.
• Links to access temperature data will discontinue and must be downloaded by November 25, 2022
  
  • Upon receipt, providers press the “Stop” button to receive their final report
  • Controlant support to access data will continue until November 28, 2022.
• Controlant dashboard will discontinue.
• DDL and temperature data issues should be directed to Pfizer.
• All channels/providers should return Controlant DDLs using the return shipping label.

Please verify that all temperature reports for all vaccines received is downloaded and stored correctly as the on-site monitoring feature will be discontinued on November 25, 2022. Temperature data will be available until November 28, 2022. Remember, you must keep all logs for 3 years per the COVID-19 Vaccination Program Provider Agreement.

All channels/providers still using Controlant DDLs for in-house temperature monitoring should make plans to install their own appropriate storage and monitoring equipment.

CDC requires COVID-19 vaccine temperatures to be monitored using a “digital data logger” (DDL). A DDL provides the most accurate storage unit temperature information, including details on how long a unit has been operating outside the recommended temperature range (referred to as a “temperature excursion”). DDLs using a buffered temperature probe provide the most accurate way to measure actual vaccine temperatures. Always use DDLs with a current and valid Certificate of Calibration Testing. Note that not all DDLs can measure ultra-cold temperatures. There should be a DDL for each immunization storage unit at the facility and a back-up DDL for instances when a device may malfunction or need calibration. 

Use DDLs with the following features: 

• An active temperature display that can be easily read from the outside of the unit
• The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded and analyzed for review
• Use of a buffered, detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®)
• Alarm for out-of-range temperatures
• Low-battery indicator
• Current, minimum, and maximum temperature display
• Recommended uncertainty of +/-0.5° C (+/- 1° F)
• Memory storage of at least 4,000 readings
• Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes (every 5 minutes is highly recommended)
• Current and valid Certificate of Calibration Testing

For more information about temperature monitoring equipment, please see section three of the Vaccine Storage and Handling Toolkit as well as the COVID-19 Vaccine Storage and Handling Addendum beginning on page 49.

If you have questions, please contact checcimms@michigan.gov.

Thank you,
MDHHS Division of Immunization