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FDA issues safety reminder to patients and healthcare providers on the use of hot/cold therapy devices

September 14, 2020 · Clinical Team

The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding the use of hot/cold therapy devices. The September 9, 2020 communication reminds patients and healthcare providers about the importance of following the instructions when providing cold therapy through a water-circulating hot/cold therapy device.

Hot/cold therapy devices may be prescribed to treat musculoskeletal pain conditions or to assist in the recovery from certain surgeries. However, if instructions and precautions are not carefully followed, additional injury related to excessive cold exposure, such as frostbite, may occur. In severe cases, cold-induced skin injuries may result in the need for skin grafting surgery or amputation.

Before using a hot/cold therapy device, patients should clearly understand their individualized instructions for using the device, e.g., how to apply the device to their skin, the specific duration and frequency of use for the device, and symptoms that should be reported to their healthcare provider.

Patients should also inform their healthcare provider of any underlying comorbid conditions that may increase their risk of complications while using the device. Comorbid conditions that may be of concern include, but are not limited to, diabetes, vascular disorders, and nervous system injuries that can result in decreased skin sensation, such as traumatic brain injury, spinal cord injury and sciatica.

Impact on workers’ compensation and auto no-fault  

Hot/cold therapy devices are commonly seen in workers’ compensation and auto no-fault claims. While recommended by evidence-based treatment guidelines2 to be appropriate for the short-term treatment of some conditions, such as major knee surgeries, other injuries and pain conditions may not require the use of hot/cold therapy devices.

Lower-cost alternatives to hot/cold therapy devices, such as heating pads and refrigerated cold packs, may be clinically appropriate for the treatment of the majority of musculoskeletal injuries. Therefore, a review for the medical necessity, as well as for the appropriate duration of use, is recommended before authorizing a hot/cold therapy device.

For more detailed information on the FDA’s safety reminder, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

  1. U.S. Food and Drug Administration (FDA). Medical Devices. Medical Device Safety. Safety Communications. FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication. September 9, 2020.  Available at:
  2. ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. September 2020.

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