A vaccine left outside of a refrigerated environment will not be safe for very long. During a power outage, even a medical-grade refrigeration system may experience temperature fluctuations in a very short period of time. Moreover, should the medical refrigerated unit become opened, it can create pockets of warmer air depending on the ambient temperatures in the room.
The most recent guidance from the FDA indicates that previously thawed COVID-19 vaccines can be stored in a refrigerator for one month2°C to 8°C (35°F to 46°F)before the entire lot is compromised. This update reflects the new authorization-led guidance from the original 5-day window directed at the beginning of the pandemic.
For the ultimate protection of the COVID-19 vaccines, a battery backup power system is recommended. These are designed to provide continuous power to your medical refrigeration unit in the case of power outages or other unanticipated malfunctions.
How Do Battery Back-Up Systems Work with Medical Refrigeration Units?
Batter backup systems work seamlessly with medical refrigeration units. They vary depending on the type of power system you may need. The battery back-up systems we offer as companions to our laboratory-grade refrigerator units feature details such as:
- Independent Voltage Regulators
- Built-In Isolation Transformers
- 6W-30KW of Power Phase Conditioning
- Plug and Play Adaptability
- Small Footprint Design
- Reliable Functionality
What Additional Guidance is Offered for Protecting Vaccines During a Power Outage?
The CDC indicates preparation is key and should be carefully outlined in a set of SOP’s or Standard Operating Procedures.
During An Active Power Outage
- Continually monitor the temperatures and do not discard vaccines that are in refrigerators or freezers affected by temporary power outages.
- Do not administer any vaccines following a power outage without consulting the proper authorities.
- Keep the doors to all refrigerators and freezers closed.
- Do not open units to check temperatures during the power outage. Instead, record the temperature as soon as possible after the power is restored, and the duration of the outage. This will provide data on the maximum temperature and maximum duration of exposures to elevated temperatures.
- If alternative storage with reliable power sources is available (i.e., hospital with generator power), transfer to that facility can be considered. If transporting vaccine, measure the temperature of the refrigerator(s) and freezer(s) when the vaccines are removed. Record all temperatures that the vaccines are exposed to during the cold chain storage transfer.
When Power is Restored
Record the temperature in the unit as soon as possible after power has been restored. Continue to monitor the temperatures until they reach the normal 2–8 degrees Celsius range in the refrigerator, or -15 degrees C or less in the freezer. Be sure to record the duration of increased temperature exposure and the maximum temperature observed.
- If you receive a vaccine from your state or local health department, they will contact you with guidance on collecting information on any COVID-19 vaccine exposed to extreme temperatures.
- If you are concerned about the integrity of your vaccine lot, do not administer the vaccine until you have consulted your state or local health department.
- Keep exposed vaccine lots separated from any new vaccine lots you receive and continue to store at the recommended temperatures.
- Do not discard any vaccine that might have been exposed to increased or fluctuating temperatures.
Why Should You Invest in a Battery Back-up System to Protect Your COVID-19 Vaccines?
The bottom line is that the COVID-19 vaccines are expensive. Preserving them is a lot about saving MONEY. Power outages do happen and when they do occur, you do not want to have to toss out an entire lot of vaccines. In the case of the COVID-19 vaccines. Pharmacies estimate that the billable cost per injection ranges from $30-$40.
Because the shots are being administered to the public for free at this time, the pharmacies are unfortunately wedged in a unique loop where reimbursement is neither guaranteed nor swift. This makes the preservation of the vaccine even more critical. Having to throw out an entire lot due to a blip in power can add up to thousands of dollars in vaccines lost in a matter of hours.
The U.S. Energy Administration reports that in 2016, the average utility customer had 1.3 power interruptions, and their total blackout time averaged four hours. - Popular Science Magazine
K2 Scientific provides Battery Backup Systems in addition to FDA approved medical refrigeratorsand freezers. For more information, contact one of our team-members. We want to help our medical and pharmaceutical partners in their efforts to preserve public health.