Water Circulating Hot/Cold Therapy Problems Result in FDA Warning Over Injury Risk

Federal regulators warn that problems with the cold-therapy mode of water-circulating hot/cold therapy devices may result in serious injuries.

In a safety communication issued on September 9, the FDA urges consumers to carefully follow instructions for the cold-therapy mode of water-circulating hot/cold therapy devices, warning about a potential risk of tissue damage and other cold-related injuries linked to the devices if used incorrectly.

Water-circulating hot/cold therapy devices pump chilled or heated water through tubes over an injured part of the body, typically following surgery or recovery from injury. Some provide both heated and cold therapy while others only provide one or the other. In addition, some inflate to provide compression to the treated area. They are used to provide temporary relief from pain and swelling.

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According to the FDA, between January 2015 and December 2019, the agency has received at least 15 reports of injuries associated with using the cold therapy modes. These injuries include frostbite, second and third degree burns, and necrotic cell death which led to serious medical procedures such as amputations and skin grafts.

As a result of the hot/cold therapy problems, the FDA issued a list of recommendations for patients and caregivers using the devices. The agency calls for patients to discuss the type of therapy, how often it should be used and applied, how long to wait between uses and the total time of treatment with their health care provider.

In addition, the FDA also recommends using a barrier, such as a cloth or bandage, between bare skin and the device, warning that no part of the device’s wrap should touch the skin for any period of time. The agency also recommends checking the skin under the wrap frequently, and making sure your doctor knows about conditions such as diabetes, peripheral neuropathy, sciatica, stroke, spinal cord injury, circulatory disorders like sickle cell anemia, and the use of medications which negatively affect peripheral vascular circulation, as well as a history of cold-related injuries.

The agency advises consumers stop using the device if they experience adverse reactions, including:

  • Increase pain
  • Burning
  • Increased swelling
  • Itching
  • Blisters
  • Increased redness
  • Discoloration
  • Welts
  • Changes in skin appearance.

The FDA advises doctors with patients using the devices to review the agency’s recommendations for patients and caregivers, look to the device’s labeling for prescribing instructions on different therapy modes, and to screen patients for risk factors which may increase their risk of injury from the devices.

Doctors and patients are encouraged to report any adverse events related to water-circulating hot-cold therapy devices to its MedWatch adverse event reporting program.


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