Top Compliance Issues around Fluid Storage
on 5/17/2022 10:00:00 AM
There always seems to be a buzz around the storage of IV fluids. How long can they be out of their protective overwraps, can we warm them, can we cool them, can they go back on the shelf after we heat them, why do I have to waste them… the list of questions goes on and on. In this article, we will try to clarify all the questions you may have regarding proper storage around IV fluids and irrigations and what surveyors will be looking for when tracers are performed. One disclaimer before we start – this is intended to be a reference guide and NOT a substitute for checking with the manufacturer of your product. Your product’s manufacturer will be the ultimate source for allowable temperatures and timeframes for storage.
Most IV fluids are packaged in a protective overwrap. When removed from the overwrap, it shortens the storage life of the packaged product. Manufacturers generally agree that once the overwrap is removed, IV fluids for injection that are greater than 100mL may be stored for 30 days at normal room temperature. 25-50mL bags may only be stored for 15 days. This includes IV fluids (piggyback solutions) that come in packages of four or more per overwrap. Large irrigation bags (2000-3000mL) are only approved for storage outside of the overwrap for 7 days. Organizations need to have a process to identify the beyond use date so the 7 to 30-day timeframe is not violated. In all cases, the fluids must not be dated past their manufacturer’s expiration date.
Can fluids be warmed? Most manufacturer’s instructions for use (MIFU) allow the fluids to be warmed to a temperature no greater than 104 degrees Fahrenheit (40 degrees Celsius), however the length of time they may be warmed varies according to the manufacturer and type of material used to manufacture the bags. Generally, IV fluids for injection greater than 150mL and irrigation fluid bags of 2000-3000 mL may be stored in their protective overwrap for 14 days at a temperature no greater than 104° F (40°C). The exception to this rule is B. Braun. Fluids for injection in the E3 containers (packaged without overwrap) and the Excel IV containers (packaged in overwrap) may be stored 6 months or 180 days at 104° F (40°C). Irrigation pour bottles may be warmed to 104° F (40°C) for a period of 60 days or at 122° F (50°C) for 72 hours. After warming, most fluids must be discarded rather than returned to common storage even if the manufacturer’s expiration date has not been reached.
How about chilling fluids? Again, the answer is yes, fluids may be held chilled at defined timeframes and temperatures. Most MIFU allow fluids to be held at 36 – 46 degrees Fahrenheit (2-8 degrees Celsius) for at least 30 days, depending on the manufacturer. B. Braun again, allows for a longer storage period of 90 days. There is some conflicting information regarding whether fluids may be returned to storage and used until their printed expiration date or if they must be discarded, so organizations are encouraged to check with the manufacturer to determine the most current recommendation.
What will your regulatory surveyors be looking for when it comes to storage? Any intravenous fluid bag found out of the overwrap should be marked with an adjusted expiration date. Even if the overwrap is opened but still in place, the fluids should be labeled with a revised date. All fluids placed into a warming cabinet or refrigerator are expected to be labeled with the adjusted expiration date allowed by the manufacturer for that type of storage. Make sure the adjusted date is not beyond the manufacturer’s expiration date or what is allowed by your organization’s policy.
For warmed or cooled fluids, the temperature of the warming cabinet or refrigerator needs to be recorded at least daily to assure that it remains within the recommended temperature range. When the temperature is out of range, the organization’s policy should define what is required, but it must, at a minimum, include adjustment and a recheck of the temperature to assure it returns to the recommended range. If fluids remain in warming cabinets or refrigerators over a weekend when a daily temperature is not documented, then there should be a memory thermometer or continuous monitoring device so the temperature can be verified when staff are present. When you have fluids from different manufacturers in your warmer and the MIFU specifies different warming temperatures, the fluid warming cabinet temperature must be set to the lowest maximum temperature of the fluids maintained therein.
Lastly, fluids should be stored in a dedicated warmer. Since various items hold heat at different rates, it is important that your fluids are not co-mingled with linens or other supplies. It is acceptable to have a single warming cabinet with dual chambers that hold linens in one chamber and fluids in a different chamber. It is not ok to store fluids and linens and blankets together in a single chamber, even if they are stored on different shelves.
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