It is imperative that your vaccines are transported, handled, and stored properly. The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans, Temperature Monitoring Equipment, Best Practices and more. More recently, the CDC released new requirements for all Vaccines for Children (VFC) suppliers, tightening restrictions on VFC storage and transportation.
Can you be sure your vaccines have not been compromised?
Vaccine Cold Chain
To maintain and distribute vaccines in optimal condition, your cold chain process is heavily dependent upon reliable transportation and storage equipment. Exposure to any conditions inappropriate for the vaccine can affect the potency, and while some vaccines will show physical evidence of inappropriate storage, appearance is not a reliable indicator. Immediate corrective action must be taken to correct an inappropriate condition.
To protect your assets, Mesa offers cold chain monitoring services. From data logging and asset monitoring, to temperature and transport mapping, qualification, validation and package design and testing, we are there with you every step of the way. Feel confident that your vaccines haven’t been compromised with accurate, reliable asset monitoring.
Storage and Handling Plans
If you are using household combination refrigerator/freezers, please note that per the new CDC guidelines, these will no longer be allowable for VFC storage. For refrigerator-only and freezer-only units, general recommendations include developing a Routine Vaccine Storage and Handling Plan and an Emergency Vaccine Retrieval and Storage Plan, with annual updates. If you are a VFC provider, you are advised to contact your immunization program for their guidance on these plans.
The following are VFC vaccine storage guidelines to note:
- Maintain proper refrigerator and freezer temperatures
- Do not place food or beverage in the unit
- Do not place vaccines on the doors, the floor, or in drawers
- Group vaccines by type
- Place a NIST-certified calibrated probe in the center next to vaccines
Resources on proper vaccine storage and handling are available through the CDC, including:
- Keys to Storing and Handling Your Vaccine Supply Video
- Vaccine Temperature Best Practices
- Vaccine Storage Best Practices
Temperature Monitoring Equipment
The CDC will require NIST-certified calibrated probes in the center of storage units by your vaccines. For proper environment monitoring, you will be required to:
- Review and record storage unit temperature readings at least 2 times a day, and minimum and maximum temperatures once each morning.
- Use the digital data logger to store and record temperatures at regular intervals for 24-hour monitoring.
- Have a digital display for the data logger for reading outside of the storage unit.
- Maintain temperature data and document any malfunctions or outages.
Please note, as of January 1, 2017*, the following recommendations will be requirements for all VFC providers in order to maintain compliance with the CDC:
- All VFC providers must have certified calibrated digital data loggers for continuous temperature monitoring for each VFC storage unit and back-up thermometer.
- Household combination refrigerator/freezers will no longer be allowable for the storage of VFC vaccines.
- When monitoring a vaccine refrigerator, it is also recommended that the temperature of the room be monitored. Mesa’s VPx sensors can monitor both from a single unit.
*Mesa recommends checking with your state authorities for confirmation of when these requirements will be mandated at your facility.
See how Mesa’s ViewPoint Monitoring System helps to keep you compliant