FDA Issues Warning to Doctors About Dangerous Magnetic Interaction Between Hearing Devices and CSF Shunt Systems
UNITED STATES – As reported in an online news article published by medicaldevice-network.com, the FDA has issued a warning identifying a potentially dangerous magnetic interaction with the use of both a magnetic hearing device as well as a programmable cerebrospinal fluid (CSF) shunt system.
The United States Food and Drug Administration (FDA) issued a statement to health care providers warning them about potential complications resulting from a patient’s simultaneous use of both a magnetic hearing device and a CSF shunt system. A CSF shunt system is used to treat patients with hydrocephalus (swelling of the brain resulting from excess fluid build-up). The purpose of the shunt is to redirect excess cerebrospinal fluid to the abdomen or heart where the fluid can be absorbed.
According to the FDA, magnetic interactions may occur between the hearing device and the CSF shunt system when implanted near one another. The magnetic interaction may cause unintended changes to the CSF shunt system valve settings. Such an interaction may be experienced by patients with cochlear implants, bone conduction hearing devices, or middle ear hearing devices.
If a patient’s magnetic hearing device interacts with the patient’s CSF shunt system, a change in the shunt’s valve settings may result in over or under-drainage of cerebrospinal fluid. Patients may then suffer symptoms that include, but may not be limited to, the following:
- Altered mental state;
- Visual changes; and
- Difficulty walking.
If these symptoms are not treated, patients may subsequently experience loss of consciousness, seizures, hemorrhage, or death. As such, the consequences of the magnetic interaction between two medical devices is potentially dangerous for patients.
The FDA’s warning letter to health care providers advises them to take certain steps to avoid a magnetic interaction between a magnetic hearing device and CSF shunt system. Such steps include, but may not be limited to, the following:
- Place the CSF shunt system on the opposite side of the head to increase the distance between the shunt system and a patient’s magnetic hearing device;
- Place the CSF shunt system and magnetic hearing devices as far away from each other as possible if a patient has magnetic hearing devices in both ears;
- Check the CSF shunt settings after placement or adjustment of any other medical device; and
- Educate patients about the potential risk of complications associated with a magnetic interaction between magnetic hearing devices and CSF shunt systems and warn patients about symptoms that may be signs of a complication.
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