This page contains a Flash digital edition of a book.
conditional. Later this year we intend to add a new section giving advice when there is a need to perform an MR examination in the following scenarios:


• the patient has an MR-conditional device but the manufacturer’s guidance cannot be met; • the patient has an implanted device whose compatibility is unknown; • the patient is implanted with a device known to be MR-unsafe.


Fixed parameter option: Basic (FPO:B) scanning mode At an international level, active implantable medical device manufacturers and MRI scanner manufacturers have been working on an agreed standard operating mode that can be used to safely scan MR conditional implants. This will be known as FPO scanning. In this mode, MRI output will be limited for peak and average radiofrequency power, and peak and average


gradient switching fields. The initial agreed option, basic, is for 1.5T scanners only. Implant manufacturers can now design devices that can be scanned safely without risk to the patient within these defined limits, and label them as such.


Conclusion The new guidance produced by MHRA is up to date, consistent and relevant to MRI units today. It provides clarity and may alleviate some previously held concerns. The ability to publish online will allow us to provide relevant and timely advice to MRI healthcare professionals.


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ABOUT THE AUTHOR David Grainger is a Senior Medical Device Specialist (MR and x-ray imaging) in the devices division, at the Medicines and Healthcare Products Regulatory Agency.


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