Cerebrospinal Fluid Shunts
The question
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential impact of retail sold magnets on the safety of cerebrospinal fluid shunts programmable externally by magnets.
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) establish the statutory framework that medical devices must meet in order to comply with these standards.
All medical devices, including cerebrospinal fluid shunts programmable externally by magnets, must comply with the MDR 2002, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers or their UK representatives must monitor use of these devices when used in the UK. The manufacturer holds the legal responsibility for obtaining the necessary certification and registering their medical devices with the MHRA, the UK Competent Authority. Higher risk medical devices are assessed and approved by Approved Bodies in the UK or Notified Bodies in the European Union.
As part of meeting the requirements of the regulations, manufacturers have to provide instructions which would include 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. In addition, some manufacturers provide further standalone information on this topic, an example of which is available at the following link:
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