Important Safety Alerts

The United States Food and Drug Administration (FDA) has posted a safety communication concerning water-circulating hot/cold therapy devices. 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.

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.

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.

Recommendations for patients and caregivers using water-circulating hot/cold therapy devices:

• Before using water-circulating hot/cold therapy devices, patients should discuss with their health care providers:
  • The type of therapy (that is, hot, cold, and compression) patients 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 their skin, patient should not wrap it around the area tightly. No part of the wrap should touch the skin for any period of time.
• Patients should check the skin under the wrap frequently and try to keep the treatment site dry.
• Patients should stop using the device and contact their health care provider if they experience any negative (adverse) reactions such as: increased pain, burning, increased swelling, itching, blisters, increased redness, discoloration, welts, and other changes in skin appearance.
• Patients should be aware that if they have any of the following conditions, they should talk with their health care provider to determine if they should use these devices:
  • Diabetes.
  • Any condition that may decrease their 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:

• Review the 'FDA Recommendations for Patients and Caregivers Using Water-Circulating Cold Therapy Devices' and the labeled precautions and warnings with their 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.

For details, please refer to the following link:
https://www.fda.gov/medical-devices/safety-communications/fda-reminds-users-about-importance-following-instructions-cold-therapy-mode-water-circulating

Posted on 10 September 2020