Regulatory requirements for Refrigerators and Freezers (in the USA)

The main purpose of medical refrigerators and freezers is to keep medical and biological products safe. They are often used to store sensitive yet vital material such as vaccines, lifesaving medication, blood and lab samples. 

These medical components require special care when being stored or transported. Hence, regulatory bodies such as the CDC have shared certain guidelines that, when followed appropriately, can increase the shelf life as well as maintain the potency of the products. 

The appliance in which medical articles are being stored needs to be compliant with certain standards and requirements put into place to keep them safe. Most medical refrigerators are designed with features that fulfil all these requirements, and hence, are preferred for medical usage.

Listed below are some of the important requirements by regulatory bodies aimed at proper storage and transportation of medical assets:

1. Centers for Disease Control and Prevention (CDC)

The Centers for Disease Control and Prevention is a government agency focused on health promotion strategies, protection against deadly diseases and improvement of health of the public in the USA. They have provided a set of guidelines on the requirements for refrigerators as well as freezers for storage of vaccines, blood and medication. Access them using the following links:

• https://www.cdc.gov/vaccines/hcp/admin/storage/downloads/storage-fridge.pdf 
• https://www.cdc.gov/vaccines/hcp/admin/storage/downloads/temp-fridge.pdf 
• https://www.cdc.gov/vaccines/covid-19/downloads/transport-temperature-log.pdf 
• https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf  

Read about how to appropriately store vaccines.

2. Code of Federal Regulations:

The Code of Federal Regulations (CFR) refers to the general and permanent rules published in the federal register by the Federal Government departments and agencies. It has also provided instructions and guidelines for the storage and handling of prescription drugs; how the storage establishment should look like, as well as the maintenance of prescription drug distribution records. These suggestions are catered towards wholesale drug distributors and their officers and representatives.

https://www.govinfo.gov/content/pkg/CFR-2021-title21-vol4/pdf/CFR-2021-title21-vol4-sec205-50.pdf 

Learn about appropriate storage of drugs and medication,

3. Food and Drug Administration (FDA)

The FDA is a federal agency of the Department of Health and Human Services. It has shared regulatory requirements for appropriate storage and transportation of blood and blood components. The Centre for Biologics Evaluation and Research (CBER) is a center within the FDA that focuses on regulation of blood, blood components and biological products.

https://www.govinfo.gov/content/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-sec640-5.pdf

Learn more about appropriate storage of blood and blood components.

4. American Red Cross

The American Red Cross is a non-profit organization that focuses on emergency assistance, disaster management and education in the USA. It also focuses on the blood donation process right from its collection to its appropriate storage and finally transfusion. It has also provided guidelines for appropriate storage of blood throughout this process.

https://www.redcrossblood.org/donate-blood/blood-donation-process/what-happens-to-donated-blood.html

By taking cognizance and adhering to the suggestions and guidelines shared by the above government bodies and organizations, medical professionals can ensure longevity, safety and potency of medical components and articles.