GRC is here to help implant / product manufacturers make their devices safer, and instruction more comprehensive, to benefit patients and MRI providers.
When 10% of the US population gets an MRI exam in any given year, poor testing, labeling, or documentation may mean many of your device patients are delayed or denied MRI services.
New MR Conditional Labeling
While GRC does not provide testing services, directly, we do manage the process of testing per ASTM F2503 for clients. This includes recommending testing (where possible) to define the safe limits of MR examinations, and not simply the default reporting of test conditions. Properly coordinated and competitively-selected testing organizations will mean cost-effective testing, and will result in proposed MR Conditional language and product documentation that will significantly clarify the safety of scanning patients with your products.
A prime illustration is the fact that most contemporary MR Conditional labels presume that the MRI provider is scanning the immediate anatomy of the implant, and offers no guidance for MRI scanning of remote / distal anatomy. This leads to confusion on the part of the MRI provider, frustration on the part of the patient and referring physicians, with the product manufacturer caught in the middle. GRC can help you minimize client frustration by improving your testing, labeling, and IFU for MR Conditional products and devices.
Do you know what bits of technical information about your products tell customers about their relative MRI safety? Even if you’re not in a position to submit new or revised MR Conditional for FDA approval, would you want to make available those specific technical details of your devices that could help inform safe decision making about whether / when / how to scan patients with your devices?
If you don’t have formal MR Conditional test data, you have options beyond the boilerplate “this device has not been tested for MR safety”, or remaining totally silent on the safety of your product for one of the most frequently-prescribed imaging studies in the US. Yes, GRC encourages full formal MR Conditional statements, but this doesn’t have to be an ‘all or none’ proposition. We can help you develop product information language that can help MRI providers make the appropriate risk assessments to provide safe MRI scans to your device customers.
Magnetic Spatial Gradient Extrapolation Tool
GRC offers this unique deflection angle extrapolation calculator for manufactures (and skilled MR safety personnel) to extrapolate ASTM magnetic spatial gradient fail points based on initial deflection angle and tested MSG condition.
If you know the deflection angle of a tested object (in degrees), and the magnetic spatial gradient (in G/cm) at which a magnetically-saturated object was tested, you can determine the MSG that would be required for the object to deflect 45-degrees. Do not use this calculator on deflection test results at magnetic field strengths of less than 1.5 Tesla. If deflection test results exist for multiple field strengths, use results from highest field strength for this calculator.
MR Conditional Device Q&A
What are the benefits to manufacturers of labels with more information?
Researching implant / device information for an individual patient MRI exam can take hours of the provider’s time, and much of that involves manufacturers’ customer support staff. Providing more comprehensive information in the product literature means less burden on your customer support staff.
What if we have products with ‘bare bones’ MR Conditional labels?
The FDA encourages updating MR Conditional labels and IFUs. In fact, they have a review program specifically for bulk review of ‘familial’ devices from one manufacturer. For example, if a manufacturer makes an orthopedic implant that comes in multiple sizes / configurations, GRC can help get the product family reviewed together, reducing time and expense for re-labeling.
Why doesn’t GRC do their own MR Conditional testing?
By managing a competitive testing procurement, GRC can provide client partners with a broader array of options: high-field testing, vertical-field testing, expedited testing, and even adverse-event replication testing. No one testing body has all of these options in-house, so GRC’s decision to use third-party services is intended to preserve flexibility for our clients.
Doesn’t the FDA prohibit the release of product information not approved by them?
If you’re providing usage information (‘you can use our product in this way’), then yes, the FDA does strictly restrict distribution of product information. If, however, you present objective data about your products – that might also be very helpful to a radiologist trying to categorize the relative risks of an MRI exam on a patient with your implant – that’s a different story. Partial information (in lieu of a formal MR Conditional label) won’t stop end-user questions, but it will help them.
What’s an example of how default labeling still leaves provider questions?
Magnetic Spatial Gradient is a good example. As described in this paper (jointly authored by GRC founder T. Gilk, along with E. Kanal, and F. Shellock), standard ASTM test protocol only reports the conditions under which a device is tested. It doesn’t describe the theoretical ‘fail point’ of the particular device, nor does it describe suitability to MRI scanners with magnetic fields with different orientation. Many device IFUs also only describe scanning the anatomy with the implant, leading many providers to avoid scanning distal regions. This may mean that – due to incomplete / inaccurate information on product labeling – patients with your implants are being turned away from safe scans, either because of the MRI scanner type, or the exam.
What about products / devices that are still in development?
GRC can help manufacturers prospectively identify MRI-specific risks, and product design approaches that may help reduce these risks, facilitating safe MR imaging of patients who receive your products. Both in terms of product design, and testing / labeling for MRI safety, GRC assists implant and device manufacturers minimize risks otherwise inherent in the products, and improve the information that may facilitate safe and effective imaging of the patients who use these products.