Cerebrospinal Fluid Shunts: Magnets
The question
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential impact of high strength retail sold magnets, including those imported outside of the UK and EU regulatory frameworks, on the safety and functioning of cerebrospinal fluid shunts.
Answered by Dr Zubir Ahmed
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 (MDR 2002) established the statutory framework that medical devices, including cerebrospinal fluid shunts, must meet in order to comply with these standards.
The manufacturer is legally responsible for obtaining the necessary certification, registering their medical devices with the MHRA, the UK Competent Authority, and undertaking post-market surveillance. Higher risk medical devices are assessed and approved by Approved Bodies, for UKCA marking, or Notified Bodies, for CE marking. Manufacturers consider anticipated conditions within intended environments of use, such as those with high magnet fields, for instance magnetic resonance imaging, when designing and manufacturing devices. As part of meeting the requirements of the MDR 2002, manufacturers must provide instructions for use, including implant cards and implant information, any special operating instructions, any warnings and/or precautions to take, and precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields.
The MHRA has published guidance on how electromagnetic interference can affect several types of medical devices that have electrical or electronic systems and mitigation steps. This guidance is available at the following link:
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