Every year, millions of people receive vaccines to boost their immunity and increase their resistance to infectious illnesses. According to the World Health Organization, immunization is a proven tool to control life-threatening infectious diseases that kill almost 3 million people annually.  It's one of the most cost-effective investments to protect the health of vulnerable populations.

Vaccines contain antigens similar to viruses like chickenpox, measles, and mumps. For example, an influenza vaccine may contain genetic material from specific strains.  Their antigens are weak or dead, so they don't cause illness, unlike live viruses. Yet, they are potent enough to trigger an immune system response that produces antibodies.

The Centers for Disease Control says that vaccine-preventable disease rates have decreased mostly because of proper storage and handling. Storage and handling errors can cost healthcare providers time and money. These mistakes result in loss of patient trust, wasted doses, and re-vaccination because repeated doses are required.

In this guide, you will learn how to properly store and refrigerate vaccines that you use in your health care facilities.

 

Selecting Refrigerator Units for Vaccine Storage

A physician partner should be directly involved with the clinical staff person that's responsible for handling vaccines.  When storing vaccines, only select CDC-recommended units to prevent costly vaccine losses or use of compromised vaccines. The federal agency recommends stand-alone, self-contained medical refrigerator and freezer units. They should be designed to store vaccines.

Medical refrigeration units available on the market include compact, counter-top, under-the-counter, and pharmaceutical grade units. Research studies found that stand-alone units maintain the required temperatures better than combination household freezer/refrigerator units.

If a medical facility currently uses a combination unit, please follow these suggestions. These protocols apply to both temporary and long-term storage.

• Only use the refrigerator area for vaccine storage.

• Use a stand-alone freezer for frozen vaccines.

• Refrigerators and freezers must maintain the required temperature range throughout the year.

• It should be a dedicated storage unit for biologics.

• Medical refrigerators and freezers must be large enough to hold a one-year supply the provider needs at their busiest time (usually flu season).

• There should be no crowding of vials inside the refrigerator.

There should be enough room to store water bottles in the refrigerator (or frozen water bottles in the freezer). These containers will stabilize the temperature and maintain it longer when power outages occur.

If your medical freezer is a stand-alone model, you must defrost it regularly. When defrosting this storage unit, make sure another one available (with the appropriate temperature setting) is ready to house your vials temporarily. Facilities storing frozen vaccines can use their preference between units that use frost-free or automatic defrost cycles.

 

Proper Air Circulation for Medical Refrigerator Units

Good air circulation will help your medical refrigerator work well. To improve it, place storage units in well-ventilated rooms with space around the sides. There should be at least four inches of clearance.  Make sure debris does not block the motor compartment's cover. Refrigerator must be level and stand firmly with one or two inches between its bottom and the floor.

 

Prohibited Medical Refrigerators and Freezers

The CDC prohibits storing vaccines in dormitory-style, bar-style, or combined refrigerator/freezer units under all circumstances, even temporarily.

Dorm-style refrigerators have one exterior door and an evaporator plate (cooling coil) located in the ice maker compartment. The units also exhibit extreme temperature stability issues in storage areas. They also pose a risk for short and long-term freezing. Facilities cannot use these appliances to store VFC vaccines or others bought with public funds.

 

Improper Temperatures Can Compromise Vaccines

Manufacturers must correctly store vaccines when they produce them. Additionally, healthcare providers must store them at the recommended range, or they lose their effectiveness.

• The ideal temperature range for most vaccines is between 36 ° F or 46 ° F (or 2 ° C and 8 ° C).

• Medical refrigerators should maintain an average of 40 F (5 C). Report out of range temperatures to a director immediately to prevent doses from becoming ineffective.

• Freezers should remain between -58° F and +5° F (or -50 ° C and -15° C)

Out-of-range temperatures can affect vaccines' effectiveness. Several events can compromise their quality.  They may include the following situations:

• A medical professional leaves a vaccine on a countertop.

• Storage of vaccines at improper temperature due to unit failures.

• The storage unit temporarily stops working due to a power outage.

• Overcrowding causes temperature fluctuations inside the unit.

• Temperatures inside the refrigerator rise because staff members open it too often.

Medical facilities shouldn't use compromised vaccines on patients. Protocol after these events will differ depending on state and federal law. Contact your health department and the vaccine manufacturer to learn the appropriate guidelines to follow. Don't throw away vaccines, unless an immunization official or manufacturer orders it. Tell them the total amount of time the refrigerator temperature was out of range.

Providers should never freeze refrigerated vaccines. The only exception to this rule is the Measles, Mumps, and Rubella (MMR) vaccine, which can be refrigerated or frozen.

 

Temperature Monitoring

The CDC recommends reviewing and recording temperatures in both refrigerator and freezer units at least two times each workday, once in the morning and before leaving at the end of the day. This best practice applies to all vaccine storage units regardless of whether or not there are devices that continually records temperatures like a digital data logger or temperature alarm.

1. Min/Max Temperature - Record the coldest and warmest temperatures in the refrigerator since the thermometer was previously reset. If the device doesn't display the min/max temperature, then check and record the current temperature a minimum of 2 times (at the start and end of each workday). Leave the space blank if min/max temperatures didn't get recorded.

2. Reset - Push this button after recording the minimum and maximum temperature.

3. Record the current temperature – After accessing vaccines, record the refrigerator's temperature every time.

Temperature Monitoring Devices

Vaccines must stay within a critical range to remain viable. Temperature monitoring is a crucial step that ensures vaccines remain safe and potent when used. 

Providers should track temperatures using calibrated digital data logger with a current, valid certificate of calibration testing (also known as a Report of Calibration). It notifies users of the temperature monitoring device's level of accuracy compared to a recognized standard. The CDC requires providers, who receive VFC vaccines (or those purchased with public funds), to use calibrated temperature monitoring devices.

Over time, the accuracy of devices declines due to use. Systems should undergo periodic calibration testing every one to two years from their prior testing date. Standards should meet those listed in the CDC's Vaccine Storage and Handling Toolkit. Immediately replace the device if calibration testing indicates the device is no longer accurate.

 

Recommended Temperature Monitoring Devices

Use digital data loggers to ensure your medical refrigerator maintains the right temperature range. These devices should have easy-to-read digital displays that show vaccine temperatures rather than the unit's air temperature. They should also have alarms for out-of-range temperatures and a current minimum and maximum temperature accuracy within +/-1° F (+/-.5 ° C). Additionally, units must have user-programmable logging intervals, low battery indicators, and memories that store at least 4000 readings.

Facilities should have a back-up digital data loggers for each storage unit. Train all staff on how to recognize, set, read, and analyze the data logger's data.

 

Temperature Monitor Placement

Temperature monitor device placement is important as the type of device used. Place the buffered probe with the vaccines. It should be in the storage's central unit, away from walls, ceilings, cooling vents, doors, floors, and its rear area. Allow the medical refrigerator's temperature to stabilize before storing any vaccines.

 

Staff Training

At your health care facility, a vaccine coordinator should regularly monitor your medical refrigeration unit's temperatures. Routine checks should occur twice a day. Record all temperatures on a readings log.

During daily inspections, the coordinator should check how well the unit works. The coordinator must rotate stock so vaccines (closest to their expiration date) will be used first.

The vaccine coordinator should remove expired vaccines and diluents from storage. This step will prevent them from being used on patients. They must notify the administrator about any potential temperature fluctuations that could damage vaccines and oversee proper vaccine transport. They should maintain all records, including temperature excursion responses and equipment maintenance records.

 

Storage and Handling Protocols

Medical facilities should have written protocols to tell staff how to handle refrigerated vaccine vials during routine hours and emergencies. Always update these plans annually, and make them an easily accessible reference for all staff. Each detailed plan should discuss how to:

• Order and accept vaccine deliveries

• Properly store and handle vaccines

• Manage vaccination inventory

• Handle compromised vaccines

Providers must create emergency plans for vaccine storage and retrieval. First, select a back-up area (with support capabilities) to house vials. The area must have enough storage units, temperature monitoring, and power to support vaccine units. Viable alternatives include local hospitals, pharmacies, long-term care facilities, and the Red Cross.

Additionally, provide packing materials, portable refrigerators, medical freezers, and qualified containers to store vaccines on site. It should be enough to handle the largest annual vaccine inventory (flu season). Transporting the vaccines using a refrigerated truck may be necessary.

 

Preparing Vaccine Deliveries for Refrigeration

Every medical facility should have trained staff, on hand, to handle vaccine deliveries upon arrival.  The front desk staff, or receptionist, should notify the vaccine coordinator when a delivery person appears.

Don't allow untrained staff to accept deliveries. They may not understand how necessary it is to store vaccines properly.

Your coordinator must sign for vaccine packages and schedule them to arrive during business office hours. Always update delivery times to reflect when there are office closures, vacation days, and holidays.

Upon arrival, the coordinator should examine the delivery, remove any damaged vials, and then store the rest. Use the following protocol to ensure the vaccines are viable.

1. Check for signs of damage to vials.

2. Next, confirm that the contents align with the packing slip.

3. Verify heat and temperature monitors for reading and reporting

4. If a monitor reading indicates a temperature excursion occurred during shipping, record the number immediately. Notify your health department and follow the CDC's recommendations for temperature excursion events.

5. Report the reading to the distributor within the recommended time frame if the medical facility purchased VFC vaccines (or others) with public funds.

Some manufacturers send vaccines, in specially designed boxes, that may not contain heat or temperature monitors.

For more information about vaccine storage, read the Vaccine Storage and Handling Toolkit.

Your health care facility deserves a high-quality medical refrigerator or freezer to store your vaccines. American BioTech Supply has a full range of temperature controlled appliances that can serve your needs. We have more than 25 years of experience serving customers across the medical and pharmaceutical industry.  Our company has an exceptional portfolio of small capacity countertop refrigerators, freezers, and application-specific models. Contact us today for details on our models.

 

Primary Reference

• https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-storage.pdf