A risk assessment needs to occur when deviations in your standard last for prolonged periods of time or when excursions are dramatic in nature. Hospitals often have issues with maintaining this humidity range throughout the seasonal changes in the U.S. Humidity ranges in the IFU’s almost always were listed at 30%-60%. Most sterile storage areas fall within that specified temperature range, although not being best practice as defined by ASHRAE. In my past reviews of IFU’s for sterile packages and packaging, the manufacturers listed a common theme of storage ranges from around 59 degrees F to approximately 86 degrees F with a caveat listed as "may be out of range for short durations." I have reached out too many manufacturers to define a short duration, and unfortunately, none would. To start, when making an assessment for environmental conditions and possible contaminates in the sterile storage areas the Joint Commission comments, "a small variance for a short period of time may not be of clinical concern, whereas a large variance for a longer period of time may have clinical significance." Water vapor may be much more a threat to sterility than temperature, also understanding that humidity is relative to temperature, and the higher the temperature, the more water vapor can be held in the air. When temperature and humidity excursions happen, there are a few considerations you must make.
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