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.

Did You Know? Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

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.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Direct Filing of NEC Lawsuits Against Similac, Enfamil Manufacturers To Be Permitted in MDL
Direct Filing of NEC Lawsuits Against Similac, Enfamil Manufacturers To Be Permitted in MDL (Posted 6 days ago)

A federal judge plans to approve direct filing of future NEC lawsuits straight to the MDL court, streamlining the process for parents pursuing claims against the makers of Similac and Enfamil cow's milk-based formula.