We, the undersigned, respectfully request of the Food and Drug Administration to henceforth require of MR device manufacturers more detailed three dimensional spatial distribution maps of transmitted RF (i.e., B1) energies associated with each of their RF coils designed for radiofrequency energy transmission. Access to this information should be considered a vital and necessary piece of information contributing to safe utilization of the MR scanning hardware for those charged with its safe operation, and could potentiate safer MR scans on at least some of our patients compared to the Z-axis-only two dimensional RF field data provided today. While we recognize that the information provided today is targeted to help clarify potential exposure levels for workers in the region of the MR scanner during active imaging, we believe that this information should be considered basic and necessary for all MR operators for routine safe usage of this equipment, and should be widely available to all who operate any and all MR imaging equipment for diagnostic and/or therapeutic human imaging objectives.
Updates
Reached 250 supporters
June 19, 2020
March 8, 2020
The technical complexity of this requirement has prompted significant dialogue with industry experts who understand the limitations of current two dimensional data. Our focus remains on securing a response from the agency regarding the necessity of these three dimensional field plots for patient safety.
March 6, 2020
The petition has now reached one hundred signatures from professionals concerned about imaging safety. This response confirms that the need for detailed three-dimensional radiofrequency data is a significant concern within our field.
Reached 100 supporters
March 6, 2020
March 5, 2020
The momentum behind this request for transparent RF field data is building steadily toward our first milestone. Please direct colleagues in the radiography field to this page so we may present a substantial consensus to the FDA.
143 Comments
Amsterdam, the Netherlands I agree with the need for more information. But on the issue of heating one needs the map of the E1 field, instead of B1. The E-field determines the RF induced heating, and close to the RF coil, in the near-field, is the E1 field more inhomogenous than the B1 field. Thus with the B1 field map essential information is still missing.
It would be great to have not only the 3D distribution of the fields but also the safety margins implemented by the vendors, if any, to understand (as we do EM simulations ourselves) the actual SAR values that occur in the scanner.
All MRI related injuries are preventable. Detailed three dimensional spatial distribution maps will provide a significant prevention measure for those operating MRI units imaging patients. The message imparted by a three dimensional representation is conceptualized and applied leaps and bounds beyond what a two dimensional graphic representation of data provides.
this information will greatly help MRI Technologists minimize risk of thermal injury to our patients.
As an advisor to the attending radiologist invoked in the risk vs benefit decision making process on scanning under various circumstances, this information is vital to ensure patient safety.
The Netherlands
New Zealand
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We, the undersigned, respectfully request of the Food and Drug Administration to henceforth require of MR device manufacturers more detailed three dimensional spatial distribution maps of transmitted RF (i.e., B1) energies associated with each of their RF coils designed for radiofrequency energy transmission. Access to this information should be considered a vital and necessary piece of information contributing to safe utilization of the MR scanning hardware for those charged with its safe operation, and could potentiate safer MR scans on at least some of our patients compared to the Z-axis-only two dimensional RF field data provided today. While we recognize that the information provided today is targeted to help clarify potential exposure levels for workers in the region of the MR scanner during active imaging, we believe that this information should be considered basic and necessary for all MR operators for routine safe usage of this equipment, and should be widely available to all who operate any and all MR imaging equipment for diagnostic and/or therapeutic human imaging objectives.
Updates
Reached 250 supporters
June 19, 2020
March 8, 2020
The technical complexity of this requirement has prompted significant dialogue with industry experts who understand the limitations of current two dimensional data. Our focus remains on securing a response from the agency regarding the necessity of these three dimensional field plots for patient safety.
March 6, 2020
The petition has now reached one hundred signatures from professionals concerned about imaging safety. This response confirms that the need for detailed three-dimensional radiofrequency data is a significant concern within our field.
Reached 100 supporters
March 6, 2020
March 5, 2020
The momentum behind this request for transparent RF field data is building steadily toward our first milestone. Please direct colleagues in the radiography field to this page so we may present a substantial consensus to the FDA.
143 Comments
Berlin, Germany Agree with previous comments. Full field Information needed (complex 3D vector of E and H/B field in 3D volume)
Amsterdam, the Netherlands I agree with the need for more information. But on the issue of heating one needs the map of the E1 field, instead of B1. The E-field determines the RF induced heating, and close to the RF coil, in the near-field, is the E1 field more inhomogenous than the B1 field. Thus with the B1 field map essential information is still missing.
It would be great to have not only the 3D distribution of the fields but also the safety margins implemented by the vendors, if any, to understand (as we do EM simulations ourselves) the actual SAR values that occur in the scanner.
All MRI related injuries are preventable. Detailed three dimensional spatial distribution maps will provide a significant prevention measure for those operating MRI units imaging patients. The message imparted by a three dimensional representation is conceptualized and applied leaps and bounds beyond what a two dimensional graphic representation of data provides.
this information will greatly help MRI Technologists minimize risk of thermal injury to our patients.
As an advisor to the attending radiologist invoked in the risk vs benefit decision making process on scanning under various circumstances, this information is vital to ensure patient safety.
The Netherlands
New Zealand
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Berlin, Germany Agree with previous comments. Full field Information needed (complex 3D vector of E and H/B field in 3D volume)