The Food and Drug Administration (FDA) on Wednesday said that electrotherapy devices are medical devices that need to obtain a license from the FDA and contain a warning that it is unsuitable for people with six types of conditions, as electrotherapy is commonly used in physiotherapy to reduce pain and strengthen muscles.
The FDA’s Division of Medical Devices and Cosmetics section head Yeh Shiu-huei (葉旭輝) yesterday at the Ministry of Health and Welfare said that electrotherapy is a type of electrical muscle stimulation — the application of electrical currents across the surface of the skin to activate motor nerves and create muscle contractions.
Electrotherapy is a commonly used non-invasive treatment for relieving muscle pain or neuromuscular retraining therapy for helping people with nerve or muscle damage or injury for the purpose of restoring muscular mobility, he said.
Photo: Chiu Chih-jou, Taipei Times
Chiayi Chang Gung Memorial Hospital’s Department of Physical Medicine and Rehabilitation physician Hsu Hung-chih (許宏志) said many people may have the misconception that “turning the electric frequency higher provides better therapeutic effects,” but people should start “from low to high” and “from shorter to longer periods of time.”
As elderly people usually have thinner layers of skin and fat, and are less sensitive to stimuli, sometimes using a high electric frequency might cause electric shock or burn injuries, so it is better for healthcare professionals to operate the medical devices for patients, Hsu said.
In addition, people with any of the six conditions — people with electronic implantable medical devices (such as a pacemaker or a cardioverter defibrillator), open wounds on the skin where the electrode pads are placed, epilepsy or diabetes, and pregnant women and children — are unsuitable for receiving electrotherapy , Hsu said.
If patients use electrotherapy at home, they should stick the electrode pads or patches on their skin appropriately following the device instructions, Hsu said, adding that the size of the pads or patches should not be too small to avoid overstimulation, the skin where they are placed should be clean and dry, and the therapy should not be used for long durations.
Electrotherapy devices are listed as a class II medical device in Taiwan, so they must pass the FDA’s safety, effectiveness and quality reviews, and obtain a license before being sold, Yeh said.
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