Date Issued: September 9, 2020

The FDA monitors reports of adverse events and other problems with medical devices and alerts the public when needed to ensure proper use of devices and protect the health and safety of patients and users. The FDA is issuing this safety communication to inform patients and health care providers about the importance of following the instructions for the cold-therapy mode of water-circulating hot/cold therapy devices. This information is timely as patients may be recovering from surgery or an injury at home during the COVID-19 pandemic.

The U.S. Food and Drug Administration (FDA) wants patients and health care providers to know about the risk of injury that may happen to patients if the cold-therapy mode of water-circulating hot/cold therapy devices is not used correctly. Patients who use these devices may get injuries from the cold, such as temporary (transient) numbness or discoloration, or frostbite and cell death (necrosis), which may require skin grafts, muscle/skin flap reconstruction, or amputation. The FDA issued this safety communication to help remind health care providers and patients of important instructions for use, warnings, and precautions.

Recommendations for Patients and Caregivers Using Water-Circulating Hot/Cold Therapy Devices

• Before using water-circulating hot/cold therapy devices, discuss with your health care provider:
  • The type of therapy (that is, hot,cold, and compression) you should use.
  • How often and how long therapy should be applied.
  • The length of breaks between uses.
  • Total time of treatment.
• When applying the device wrap to the skin, apply a barrier (for example, cloth or bandage) between the wrap and your skin, and do not wrap it around the area tightly. No part of the wrap should touch the skin for any period of time.
• Check the skin under the wrap frequently and try to keep the treatment site dry.
• Stop using the device and contact your health care provider if you experience any negative (adverse) reactions such as:
  • Increased pain
  • Burning
  • Increased swelling
  • Itching
  • Blisters
  • Increased redness
  • Discoloration
  • Welts
  • Other changes in skin appearance
• Be aware that if you have any of the following conditions, you should talk with your health care provider to determine if you should use these devices:
  • Diabetes.
  • Any condition that may decrease your skin sensation, such as peripheral neuropathy, sciatica, stroke, or spinal cord injury.
  • Circulatory disorders, including: Raynaud’s disease, Buerger’s disease, peripheral vascular disease, vasospastic disorders, sickle cell anemia, and hypercoagulable clotting disorders.
  • Taking medications that may have a negative effect on peripheral vascular circulation, including: beta adrenergic blockers and local epinephrine use (such as local anesthetics).
  • History of cold injury, frostbite, or adverse reactions to local cold application.

Recommendations for Health Care Providers With Patients Using Water-Circulating Hot/Cold Therapy Devices

• Review the Recommendations for Patients and Caregivers Using Water-Circulating Cold Therapy Devices listed above and the labeled precautions and warnings with your patients who use these devices.
• Refer to the device labeling for prescribing instructions on the different therapy modes (for example, cold, hot, and compression).
• Screen patients for risk factors that may decrease sensation and increase risk of injury from use of the device.

Device Description

A water-circulating hot/cold therapy device pumps heated or chilled water or other liquid through tubing and wraps to provide hot or cold therapy to a patient’s body part. Some devices only deliver cold therapy and no other treatment modes. Some devices deliver both cold and hot therapy. And, some devices have an additional treatment mode that inflates the limb wrap to temporarily apply compression therapy alone or at the same time as hot or cold therapy. The devices are intended to provide temporary relief of swelling and pain from surgical procedures or sudden injuries (for example, minor sprains and strains). These devices are used in hospitals, outpatient clinics, athletic training settings or home settings.

Between January, 2015 and December, 2019, the FDA has received 15 reports of injuries associated with using the cold therapy mode of these devices, including more serious injuries such as frostbite, second and third degree burns, and cell death requiring medical intervention (for example, skin grafts or amputation). All therapy modes (cold, heat, or compression therapy modes) that may be available on water-circulating hot/cold therapy devices have some risk associated with them. For instance, some tissue injuries, like second degree burns, discomfort, and blisters can occur when using the hot therapy mode of the device. Pain has also been reported with the compression therapy mode. Some devices have additional features, such as programmable settings for temperatures and treatment time, limitations on treatment times, and auto-shut off features.

When used correctly, these devices should not cause pain or skin damage.

FDA Actions

The FDA will continue to monitor adverse events associated with the use of water-circulating hot/cold therapy devices. The FDA will keep the public informed if signifigant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.