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Medical Devices that Have Been Exposed to Heat and Humidity

FDA advice about medical devices that have been exposed to unusual levels of heat and humidity

Many medical devices may not function correctly if they have been exposed to high levels of heat or humidity. The manufacturer’s instructions in the product labeling may describe the device’s tolerance levels for heat and humidity. Medical devices may not function properly outside the tolerance levels recommended in the product labeling.

Unusually high levels of heat and humidity may

• Cause instruments to operate in unexpected or unusual ways;
• Reduce shelf-lives or totally destroy products;
• Cause laboratory reagents to lose potency; or
• Compromise the sterility of packaged devices.

Many devices that require specific storage requirements are not safe if those requirements have been violated. If there are no specific storage requirements listed on the packaging, and the device appears to be working properly, you may continue using the device. If you have any questions about whether or not the device is working properly, or if you cannot locate the product labeling, contact the product manufacturer.

Electrical Equipment

Do not use electrical equipment if the power cord or device is wet!

If electronic devices are exposed to water or high levels of humidity, they may not operate properly. Before using the device, make sure to:

• Dry the device thoroughly. Wipe the outside of the device with a dry cloth and check that power cords and electronic components are dry.
  
• Check all settings and alarms to make sure that they are working properly. Some devices reset to a default mode when the power is interrupted.

Note: As area power networks are restored, voltage levels may continue to fluctuate even after electricity has returned. This may cause devices to reset or operate improperly.

• Run self-tests and quality control checks often to make sure the device is working properly.
  
• If a medical device is not working properly, turn it off and do not use it. Depending on the extent of the damage, the device may be able to be repaired or refurbished.

Laboratory Reagents and Test Kits

Most laboratory reagents and test kits require controlled levels of heat and humidity. If your reagents have been exposed to levels of heat or humidity that exceed those listed in the product packaging, the test results may not be accurate. Run quality control checks and follow all instructions on the product packaging. Do not use reagents or test kits that give inaccurate results.  

Packaged Devices

Always check devices before using them to make sure that seals and packaging are intact.

If there is any water damage or breaks in the package seal, you should assume that the sterility of the product has been compromised.

There are two types of medical devices: single-use devices and reusable devices.

Single Use Devices

• If the device is damaged or dirty (for example, a bandage or a pulse oximeter), you should discard the device and not use it.
  
• If the device packaging is open, but the device has not been used (i.e. sutures), you should check with the original manufacturer to see how to resterilize the device.

Reusable Devices

• If a reusable device is not visibly clean, it should be cleaned and dried before it is repackaged and sterilized.
  
• If you need to resterilize a reusable device, check the original device packaging to see how the device was originally sterilized. Always package and sterilize the device using the same methods that were used originally.

Updated September 3, 2005

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