By Joan Ferlo Todd, RN
(Originally published May 2003)
A 38-year-old woman with an implantable cardioverter/defibrillator used an abdominal stimulator to try to flatten her belly. She got a jolt of electricity that knocked her unconscious. An abdominal muscle stimulator is a battery-powered belt worn around the waist, thighs, or arms. Electrodes connected by wires to the belt deliver current to the encircled area and cause muscle contraction. The higher the current setting, the stronger the contraction. The FDA has received reports of some muscle stimulators causing shocks, bums, bruising, skin irritation, pain, or-as in this case-interfering with critical electronic medical devices.
Many abdominal stimulators haven't undergone FDA review or met premarket requirements for design, manufacturing, and labeling. Teach your patients how to prevent problems with these devices:
- To find out if a device complies with FDA regulations; call 1-888-463- 6332: The FDA hasn't determined that abdominal muscle stimulators are safe or effective for weight loss or improving appearance.
- Don't use a muscle stimulator if you have an implanted cardiac pacemaker, defibrillator, insulin pump, or other medical device; it may interfere with proper operation.
- Don't use one if you're pregnant it may be unsafe.
- Don't place the device over inflamed or broken skin, a lesion, or a rash-it can cause more irritation.
- Eliminate gaps between the electrodes and your skin when you apply the device to reduce the risk of shocks or burns. Apply gel recommended by the manufacturer if it isn't built into the electrodes.
- Don't crush or bend the device. The wires inside could crack, risking malfunction and injury.
For further consumer information on abdominal stimulators, please see the FDA Web site on Electronic Muscle Stimulators.
Joan Ferlo Todd is a nurse-consultant at the Center for Devices and Radiological Health of the Food and Drug Administration in Rockville, Md. Beverly Albrecht Gallauresi coordinates Device Safety.