jueves, 18 de julio de 2019

Update: Potential Magnetic Field Interference with Programmable CSF Shunts and Implanted Hearing Devices


Update: Potential Magnetic Field Interference with Programmable CSF Shunts and Implanted Hearing Devices

The U.S. Food and Drug Administration (FDA) wants to increase awareness about programmable cerebrospinal fluid (CSF) shunt valves and a potential for magnetic field interference with some hearing devices that contain magnets, such as cochlear implants, implantable bone conduction hearing devices, or implantable middle ear hearing devices. 

People who have implanted programmable CSF shunt systems may experience unintended changes in their CSF valve setting if exposed to magnets from some hearing implants. The magnetic interference may cause unintended CSF shunt systems pressure valve changes, which could lead to potential over- or under-drainage of CSF and subsequent symptoms such as altered mental status, headaches, lethargy, irritability, vomiting, changes in vision, difficulty walking, loss of consciousness, seizures, hemorrhage, or death.

Reduce the Risk of Unintended Setting Changes

With awareness and education, health care providers can reduce the risk of unintended changes in CSF shunt valve setting due to magnetic field inference. To help health care providers better understand the risks associated with CSF shunt valves and magnetic field interference by some hearing devices, the FDA issued a Letter to Health Care Providers with suggestions for preventing unintended setting changes.

Questions?

If you have questions about CSF Shunts and magnetic field interference with implanted hearing devices, contact the Division of Industry and Consumer Education.

No hay comentarios: