The Joint Committee for Vaccine Storage, formed under a partnership between CDC and NSF International, has finalized and published a new standard for vaccine storage. The new NSF / ANSI 456 Vaccine Storage Standard is designed to help providers better understand the performance of vaccine storage units and ensure vaccine storage units can maintain 5°C +/- 1°C across all potential storage locations under varying load and use conditions.
Prior to the publishing of this new standard, vaccine providers relied on the CDC’s Vaccine Storage and Handling Toolkit for recommendations and guidelines on storing and administering vaccines. The CDC addresses the type of storage equipment providers should select, as well as a variety of guidelines and steps for staff to follow to ensure vaccine storage safety and prevent vaccine loss or inefficacy. The NSF / ANSI 456 Vaccine Storage Standard helps fill some of the gaps in vaccine storage requirements left out of the Toolkit by outlining further requirements for the temperature performance of the vaccine storage unit itself.
Current CDC Guidelines
- Providers should use purpose-built or medical-grade units, designed to store vaccines and medications. Dorm-style or combination units are prohibited.
- The use of a temperature monitoring device, called a digital data logger (DDL), with a valid certificate of calibration to monitor the temperature should also be used. These DDLs should include out-of-range alarms, low-battery indicators, and a current, minimum, and maximum temperature display.
- Routine maintenance and testing to ensure vaccine storage and related equipment is functioning at maximum efficiency.
New NSF / ANSI 456 Standard
The new NSF / ANSI 456 Standard takes the CDC recommendations a step further by outlining testing and performance criteria to test the vaccine storage unit itself and ensure temperature performance, stability, and reliability across all potential storage locations. Vaccine equipment manufacturers will be able to submit their units for testing and certification to the standard. Certification is reliant on meeting the following criteria:
- Temperature performance under steady state and door opening conditions, and with minimal and fully loaded inventory
- Doors should be self-closing, with audible and visual alarms for door openings and temperature excursions
- Barriers inside the unit to prevent storage of vaccines in areas that do not meet temperature requirements.
- Protocols for both manual and auto defrost in refrigerators and freezers
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Based on broad participation of this committee, it is expected this new standard will be widely adopted across the industry. With ever changing CDC, state, and local guidelines for vaccine storage, it's important to stay up-to-date on the latest recommendations for vaccine providers.