Changes to CDC’s guidance on the Fahrenheit temperature range for storing refrigerated vaccines

The 2016 Vaccine Storage and Handling Toolkit, released last month, reflects an adjustment in CDC’s guidance on the Fahrenheit temperature range for storing refrigerated vaccines. The new recommended Fahrenheit temperature range is 36° F – 46° F (previously 35° F – 46° F). The Celsius temperature range (2° C – 8° C) remains unchanged, as stated in all manufacturer package inserts for routinely recommended vaccines. The conversion of 2°-8° Celsius equates to 35.6°-46.4° Fahrenheit. Among routinely recommended vaccines, most manufacturers’ package inserts note a Fahrenheit temperature range of 36° F-46°° F, while some note a temperature range of 35°°F-46° F. The Fahrenheit temperature range of 36° F-46° F aligns with guidance from the United States Pharmacopeia (USP), a scientific organization that sets federally recognized quality standards for food and drugs. By adjusting CDC’s guidance for the Fahrenheit temperature range from 35°°F-46° F to 36° F-46°°F, CDC is ensuring that its recommended Fahrenheit temperature range does not conflict with the package inserts of any routinely recommended vaccines. The CDC has recommended a set point of 5° C (40° F) and recommends that providers check their digital data logger’s current Fahrenheit temperature range settings and adjust them accordingly. During the remaining 2016 site visits, VFC inspectors will be helping to drive these changes, and beginning January 2017, all VFC program providers must comply with the adjusted Fahrenheit temperature range for refrigerated vaccines. For the full list of Q&A around the new recommended Fahrenheit temperature ranges, click...

Demystifying Medical Grade Refrigeration

To better protect precious or irreplaceable patient samples, safeguard expensive and sensitive vaccines/medications, or store reagents and controls that are critical to patient care, the adoption of Medical Grade equipment continues to increase in prevalence. Although there are many vendors that market their equipment as Medical Grade, there is no standard industry definition that dictates performance or features. In addition, terms like “Pharmaceutical Grade” or “Purpose Built” are also used interchangeably with Medical Grade when applying to cold storage options. These issues can lead to confusion and uncertainty when making important decisions related to equipment that is critical to the delivery of safe and quality patient care. For this reason, we want to help demystify Medical Grade cold storage. The difference between Medical Grade cold storage and other types of traditional/commercially available units starts with performance. The use of effective forced-air refrigeration not only ensures that all locations within a cabinet maintain a uniform temperature, but will also allow a refrigerator to recover back to set temperature quickly after door openings. Without proper uniformity and recovery, there is risk of exposing sensitive contents to inappropriate storage conditions. Medical Grade units also offer specific features, including microprocessor-based controls and displays, and temperature logging, designed to ensure and monitor precise temperature regulation over time. These units will also commonly include integrated alarms to notify users of risk-causing events; out of temperature range, door open, and loss of power alarms are just a few examples. Medical Grade cold storage units will incorporate specially designed drawers or shelves that allow for proper airflow, and some vendors allow for custom storage configuration to best...

The Importance of Reliable Ultra-Low Temperature Storage

Researchers and clinicians rely on their cold-storage equipment to maintain the integrity and quality of precious patient samples and other biological products.  The failure of a cold-storage unit can compromise samples, which disrupts critical research and has a significant impact on these institutions and individuals.  The failure of a storage unit such as an ultra-low temperature freezer can result not only in a substantial financial loss, but can also mean losing years of researchers’ time and effort.  This means that clinicians and investigators need to take great care in selecting brands and equipment critical to protecting research or enabling the delivery of patient care. An event that illustrates the importance of cold-storage occurred at the Harvard Brain Tissue Resource Center (HBTRC) at McLean Hospital in Belmont, MA.  A freezer containing brain samples that had been collected for autism research failed there in June 2012.  Unfortunately, the failure was discovered too late to prevent the brains from thawing.  The Boston Globe reported that, “Among those samples were the brains of 54 people who had autism – nearly a quarter of the autism brain samples available for research into a condition that now affects 1 in 88 American children.  At the time researchers said the collection, which took 14 years to amass, could set autism research back perhaps as long as a decade.” It’s clear that reliable cold-storage equipment plays a vital role in safeguarding precious (and in some cases irreplaceable) samples so that important research can continue without delay or disruption.  To help meet the challenge of providing equipment that researchers and clinicians can depend on, Helmer Scientific designed the...

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