Product Spotlight: Value of Medical-Grade Refrigeration

April 2016 - Vol.5 No. 3 - Page #8

All clinical laboratories require refrigerators and freezers in addition to other analyzers and equipment in order to operate and meet regulatory requirements. As the sophistication of refrigeration devices has grown significantly in the past 15 years, most clinical labs and hospital facilities now require medical-grade refrigeration in order to ensure the integrity of sensitive controls and reagents, as well as vaccines, blood and blood products, and other patient specimens.

Approximately eight years ago, Kaiser Permanente San Rafael Medical Center remodeled the clinical laboratory and the decision was made to replace all refrigerators and freezers with medical-grade products.

Ensure the Integrity of Lab Products

In order to produce accurate test results, all reagents, controls, and samples must be stored within the manufacturers’ recommended temperature ranges. Likewise, the storage of blood products requires sensitive and reliable temperature control mechanisms that not only control and maintain uniform temperature, but also have visual indicators and data recorders to document that proper storage conditions are being maintained over time. The laboratory at San Rafael Medical Center has stored blood products in medical-grade refrigerators and freezers with visual temperature-monitoring devices for many years.

Whether the refrigeration devices used in the lab and throughout the facility have built-in temperature monitoring and remote notification, or the lab or facility utilizes a third party system for this activity, it is important to incorporate a system that provides alarming notifications if the devices go out of temperature range. The performance of refrigeration units cannot be physically monitored at all times, so in order to ensure these devices continue to function properly in perpetuity, a continuous monitoring system should be in place. Accreditation and regulatory bodies require such documentation as well.

Make the Best Use of Space

The type or size of refrigerator selected (eg, full size or undercounter; single or double door) and physical placement within the lab will be unique to the needs and layout of each lab, but consideration should be given to efficient user access and proper segregation of products and specimens.

In our lab, we have two upright refrigerators in chemistry and two additional upright units in the blood bank. We also have multiple undercounter refrigerators and freezers. As is common in many clinical labs, space is at a premium, hence the necessity for incorporating numerous undercounter refrigerators and freezers. Given that the placement and utilization of undercounter refrigerators differs from full-size devices, consideration should be given to the end-user experience. The smaller overall storage space of undercounter units requires an efficient plan for how products will be stored within them. Furthermore, as undercounter refrigerators require bending down for access or restocking, care must be taken to avoid repetitive stress injury.


As with any technology acquisition, it is important to find the best refrigeration type and configuration unique to the individual lab. With this in mind, the lab should determine its core needs and then incorporate and arrange the devices accordingly. For a small lab with limited space, having a greater number of smaller, undercounter units may be preferable to fewer upright units. For larger labs with more space flexibility, the opposite may be true. Regardless, all clinical labs that utilize refrigerated products should seek to acquire medical-grade devices in order to ensure product and specimen integrity. Doing so provides the peace of mind that your critical products are kept in consistent and stable temperatures.


Margaret Mak, MT(ASCP), is the laboratory administrative director at Kaiser Permanente Medical Center in San Rafael, California.



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