Pharmacists and Pharmacy owners: How to Purchase Medical-Grade Refrigerators and Freezers for Storing Children’s Vaccines

Making the right medical refrigeration purchase

Information on storage for children's vaccines vary by individual state recommendations, and some of the information found on state and manufacturer sites can be inaccurate and conflict with CDC regulations. It is essential to know the proper requirements to remain compliant and provide sufficient storage of vaccines for children. The CDC's Vaccines for Children (VFC) program offers millions of vaccines annually, and recent events will add to supplies and call for more resources.

When looking into adequate vaccine storage, suppliers should offer medical-grade refrigerator and freezer units that meet all CDC requirements. As you compare manufacturers with the latest designs, make sure they have added technology to make it easier to monitor temperatures and generate reports to minimize errors and make timely adjustments. Be sure they can explain the product specifications and how it will help you remain compliant.

A study in 2012 uncovered problems with storage temperatures not meeting the required ranges, and inappropriate temperatures lasting five hours or more. This reduced vaccine potency and increased the risk that children were not being protected. Also, expired vaccines were being stored together with non-expired vaccines creating confusion. As a result, providers must now maintain even more stringent processes and documentation, showing compliance.

Reevaluate your current pharmacy and laboratory medical refrigerators and freezers, vaccine supplies, processes, and staff. Do some research to find the correct solutions for your specific environment. Aside from storage space, staff may need additional training, and current processes updated or reorganized for accuracy and efficiency.

The CDC works with immunization program managers, professional organizations, and state health officials to improve compliance. Be prepared for a site visit to assess procedure and documentation requirements.

Officials will look for appropriate equipment that can store vaccines and maintain proper conditions. There are two types of requisite storage units:

• Refrigerator units with separate freezer compartments and individual exterior doors
• stand-alone refrigerators and freezers

These medical-grade refrigerators or freezers must be able to maintain required vaccine storage temperatures year-round and be large enough to hold peak inventory. They must have a working thermometer calibrated with a certificate following the National Institute of Standards and Technology (NIST) or the American Society for Testing and Materials (ASTM) guidelines inside each storage compartment with the manufacturer's recommended schedule for recalibration. Keep in mind, you may experience a dramatic change in your annual vaccine inventory this year.

7 Vaccine Storage Rules to Remember

1. Combination refrigerators with interior freezer compartments and a single door may not be used for permanent storage of Vaccines for Children (VFC). Only use them in limited conditions for temporary, short term use.
2. Store vaccines in the middle of the refrigerator or freezer compartment to let cold air circulate around the vaccine. Never store vaccines in the door of the storage unit or with food or drink.
3. Post a temperature log on the vaccine storage unit door or nearby. Record temperatures at the beginning and end of each day to check that refrigerators remain between 35°F and 46°F, and freezers are 5°F or lower. This is required even when using a graphing/recording thermometer or a digital data logger.
4. Review and update written routines and emergency storage and handling plans. Include guidance on what to do in the event of equipment malfunctions, natural disasters, and power failures.
5. Develop and maintain separate stock records for public and private purchases of vaccines. You may or may not need different storage units to track inventory accurately.
6. Immediately upon delivery of vaccines, check the temperature monitors and store vaccines according to manufacturers' product specifications.
7. Develop policies and processes for maintaining temperatures when transporting to offsite clinics or emergency storage areas. Only draw vaccine when administering to ensure that the cold chain is maintained and that vaccine is not unnecessarily exposed to light.

Printable Guidelines to Post for Employees

CDC, Healthcare providers/professionals, Vaccine Storage and Handling Toolkit, https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

There are many biomedical refrigerators and freezers to choose from. If you can find factory-direct products, including those found at K2 Scientific, you may be able to save quite a bit on costs. By having additional storage space, you can be sure new equipment meets CDC requirements, any expired vaccines are identified and separated from nonexpired vaccines, and inventories are better managed to meet all oversight regulations.