FDA advice about medical devices that have been exposed to unusually high storage temperatures
Many medical devices require specific storage conditions. The manufacturer’s instructions, in the product labeling will explain specific needs for refrigeration, freezing, or controlled room temperature.
Medical devices that have specific storage requirements are not safe if those requirements have been violated. But do not necessarily discard working devices without specific storage requirements, because this may cause product shortages.
If the power goes out:
- Do not open refrigerators or freezers until the power is restored. Most refrigerators and freezers will maintain their temperatures for at least one day if they have not been opened.
- If you must remove products from a refrigerator or freezer, keep the products on ice or dry ice at the required temperature until use.
When the power is restored:
- Measure the temperature of the refrigerator or freezer. Discard products if the temperature has risen above the safe storage temperature.
- If you are not sure whether or not a product is safe to use, run quality control checks (when appropriate) and contact the manufacturer.
The majority of reagents used for laboratory testing are temperature sensitive, with most requiring routine refrigeration.
A small subset of materials require freezer, or below freezer-level conditions (ranging from freezing to 70 degrees below freezing).
Without refrigeration, most reagents will deteriorate within hours. No reagents that require refrigeration will last more than 2-3 days without it.
Run control solutions to determine whether or not your reagent is still potent.
See product labeling/manufacturers instructions for specific storage temperature information.
When using glucose meters, always run controls to make sure the meter is functioning properly. Make sure control strips and solutions are appropriate for your meter. Both moisture and heat may compromise the performance of test strips. Users should check manufacturer’s instructions to determine if their testing materials will be safe for use.
In some cases, dialyzers are reprocessed or re-used for the same patient. Any used dialyzer that is not reprocessed immediately after use should be refrigerated. If you cannot reprocess or refrigerate the dialyzer immediately, you should discard it.
Disinfectants and Sterilants
Store all sterilant and disinfectant products according to the manufacturers' instructions, as indicated in the product labeling.
Many sterilants and disinfectants must be stored below 30° C (86° F). Storage above this temperature for more than a short time could jeopardize their stability and activity.
This includes most liquid chemical sterilants and high level disinfectants (used to reprocess reusable critical or semi-critical medical devices between patient uses) and general purpose disinfectants (used to disinfect non-critical medical devices and medical equipment surfaces).
Before each use of a liquid chemical sterilant/high level disinfectant solution, use a test strip or chemical monitoring device to ensure that the concentration of active ingredient(s) in the solution is adequate. Always use the specific test strip or chemical monitoring device recommended by the manufacturer or an equivalent strip or device. Be sure to follow the manufacturer's instructions for using the test strip or monitoring device.
Discard any solutions that do not have an adequate concentration of active ingredient(s).
Skin Substitutes and Burn Products
Skin substitutes and burn treatment products have specific requirements for storage times and temperatures. Do not use any skin substitutes or burn treatment products if they have been stored at inappropriate temperatures.
Follow the manufacturer’s instructions in the product labeling for specific refrigeration requirements.
Organ Preservation/Storage Solutions
Organ preservation and storage solutions require refrigeration prior to use and during organ transport and storage.
These solutions are used to hold organs after they are harvested from the donor and while they are transported to the implant hospital.
Always follow specific manufacturer’s instructions in the product labeling to identify safe storage temperatures for organ preservation and storage solutions. If temperatures have risen above safe levels, you should discard the solutions.
Most dental restorative and impression materials should last until the expiration date at controlled room temperatures. Higher room temperatures (80º F - 90º F) may reduce the working times for the materials, making them unacceptable for use.
Before using dental restorative materials, make sure that they are setting properly. Discard any products that do not set properly.
Many biologic based combination products (such as bone filling materials) require refrigeration of one or both components. Do not use these products if they have been without refrigeration.
Lock Flush Solutions
Store all lock flush solutions according to the manufacturer’s instructions, as indicated in the product labeling.
Lock flush solutions that contain heparin (used to keep catheters patent) must be stored below 30° C (86° F) and away from direct light. Storage above this temperature for more than a short time can jeopardize their stability and activity.
Human Heart Valve Allografts
Cryovalve human heart valve allografts are transported in a shipping container that can serve as a temporary holding container for up to 72 hours, providing the temperature does not exceed -70 degrees C (dry ice temperature).
Store all human heart valve allografts according to the manufacturer’s instructions, as indicated in the product labeling.
Ophthalmic Viscosurgical Devices OVDs
Refrigerate all ophthalmic viscosurgical devices (OVDs), except those made from hydroxypropyl methylcellulose (HPMC), to prevent breakdown of the material.
OVDs that must be refrigerated include:
- Alcon - DuoVisc, Viscoat, ProVisc
- AMO - Healon, Healon 5, Healon GV, Vitrax
- Bausch & Lomb - Amvisc, Amvisc Plus
Do not use OVD products that require refrigeration if they have been without refrigeration.
Intra-Ocular Lenses (IOLs)
The Ciba Vision MemoryLens intra-ocular lens requires refrigeration. Do not use this lens if it has been without refrigeration.
The Bard Contigen Collagen Implant (an injectable bulking agent used for the treatment of urinary incontinence) requires refrigeration. Do not use this product if it has been without refrigeration.
Assisted Reproduction Media Products
Assisted reproduction media products require refrigeration. Do not use these products if they have been without refrigeration for more than 1-2 days.