FDA MRI Safety Public Workshop
 

AS: Please tell us about your past experiences in MRI safety and the work you do at the FDA's CDRH.

TW: I have been involved in the area of MRI safety at FDA since the early 1990s, working to develop FDA guidance as well as national and international standards addressing the safety of medical devices in the MR environment. I am the chair of the CDRH MR Working Group that is a cross divisional group involving people from across CDRH to address MRI safety issues in applications for new medical devices and for issues involving devices that are on the market. I initiated and chair the ASTM standards group that has written and published 5 standards addressing testing and labeling medical devices and other objects for safety in the MR environment and participate in other IEC and ISO MRI related standards groups.

AS: What was the motivation to hold this MRI safety public workshop now or is it a regularly held meeting?

TW: The workshop is not a recurring meeting. We held it to obtain feedback on a number of questions regarding general MRI safe use and to identify areas where we can work together to prevent very preventable accidents. We also held the workshop to learn about the challenges that MR Technologists and health care providers face with regard to existing medical device labeling and their conditions of use.

AS: How important is it to the FDA that in addition to clinicians, scientists and those from industry that technologists and radiographers attend these public workshops on MRI safety? If so, why?

TW: We find your attendance critical. We need your feedback because you are the individuals who are presented with MR safety challenges in the field every day. You are the front lines who ensure that patients are safely scanned and that MR safety protocols are followed in your facility. You are the ones who read medical device labeling every day and you are the ones that have to make an immediate decision about how that labeling impacts the proposed scan the patient needs. It is important that we understand what labeling information you need so that we can work with device manufacturers to construct labeling that clearly provides the information you need to determine if it is safe to scan a patient with a given medical device.

AS: Among the many presentations that were given during this two-day public workshop, were there any surprises for you in the information that was shared?

TW: I was a little surprised to learn that many audience members and workshop participants are unaware of FDA’s regulatory authority. FDA regulates the medical device industry. We do not regulate the practice of medicine, nor do we require initial and ongoing education for clinical staff. There were numerous comments indicating that FDA should encourage or mandate ongoing education, certification, and licensure for MR technologists and other medical professionals as well as requests that we impose requirements for accreditation and reimbursement, all of which are outside the scope of FDA’s mission.

AS: Was there any information presented that supports new directions in which you would like to see the FDA and CDRH engage?

TW: For some time, I have wondered how useful MR safety labeling is for medical professionals at MR sites. We heard a request for more clear and consistent MR safety labeling for implants and accessory devices and are currently exploring different ways we can address that concern. We are also working to improve MR safety education for premarket reviewers at the FDA to ensure consistency in reviews of medical device MR safety information. We are also exploring ways we can reach out to MR professionals, other health care providers, and hospital staff to increase their awareness of the safety issues that may occur in the MRI environment with the goal of preventing the many preventable incidents that occur each year.

AS: There seemed to be a consensus among several of the participating attendees that thermal burns and injuries are the most common adverse events that occur during MRI examinations. Do you agree with this and how do we work towards reducing these incidents?

TW: I would like to emphasize that MRI is a very safe imaging modality, with the majority of patients experiencing no adverse events. Burns are an adverse event we continue to see for a small minority of patients. I think having an established MR safety program with well defined procedures coupled with continuing education are the best ways to minimize burns and other incidents, especially those that result from incorrect positioning and padding techniques or lapses in screening.

AS: The importance of continuing education for technologists and radiographers as a means to reduce MR safety incidents was emphasized by presenters and attendees. Is there anything the FDA and CDRH can do to support this?

TW: As I mentioned earlier, continuing education is not something for which FDA has jurisdiction. However, the Agency recognizes the need to develop targeted education to increase provider and patient awareness of the safety issues that may occur in the MRI environment as it relates to device use.

AS: Do you believe that the current MRI safety labeling terminology (MR Unsafe, MR Conditional and MR safe) will remain in its current form or change in the future to be more specific with regards to items that may be affected ferromagnetically or electrically?

TW: The current terms were developed over many years with input from many parts of the MR community, including the MR technologists who were polled to give their opinions on possible terms and icons. We have been working since 2005 to spread awareness and use of these terms, and I do not anticipate any changes in the current terms. I think we should consider making more use of the optional supplementary information sign that can be used with the MR Conditional term and icon to provide additional information about potential hazards like projectile hazards.

AS: How likely is it that the FDA and CDRH will seek out continued dialogue and information from the SMRT going forward?

TW: FDA welcomes input from our stakeholders. I think it is critical that MR safety labeling be useful for MR technologists and other MR professionals, so feedback from the SMRT is very important to us as we continue to work with the medical device manufacturers to construct MR Conditional labeling.

AS: For many years now I have had the opportunity to attend and participate in MRI Safety Workshops conducted by the parent society of the SMRT, the ISMRM. I have been impressed by the number of individuals from the FDA that are in attendance at these meetings. What do you learn from those workshops and how is it valuable to the FDA and the CDRH?

TW: Since I spend most of my time working with medical device manufacturers and my colleagues in CDRH, I find the feedback from MR technologists and other members of the clinical community on how things work ‘in the real world’ to be invaluable. This helps us understand the critical information that should be in MR safety labeling and lets us know what technologists actually do with the labeling. The workshops also provide a wonderful opportunity to talk to other people in the MR safety community in a neutral setting where we can proactively discuss the current issues, hear possible solutions and learn about potential issues.

(Note: ISMRM Safety Workshops are typically conducted biennially. For more information, please see http://www.ismrm.org/meetings-workshops/future-ismrm-workshops/)

AS: Personally and professionally, I learned a great deal during this two-day public workshop conducted in Silver Spring, MD on MRI safety. If the SMRT hosted a similar workshop inviting clinicians, scientists and industry, would the FDA and CDRH think it valuable enough for you to attend?

TW: As a cost-saving measure, the government has instituted travel restrictions. However, if funds were available, I and others from the CDRH MR Working Group would be eager to attend an SMRT workshop on MR safety.

In conclusion, thank you very much to Dr. Terry Woods from the FDA's Center for Devices & Radiological Health for taking the time from her busy schedule to speak to us. Given her long history engaged in MRI safety, we are greatly appreciative for sharing her thoughts and opinions regarding the recent MRI safety public workshop and MR safety overall. We believe that keeping the lines of communications not only open but active; will ensure a safer MRI environment for patients and health care professionals worldwide.

Anne Marie Sawyer, Charles McIntyre, Carolyn Roth
 

Charles McIntyre
 

Ashok Saraswat, Vera Kimbrell, Maureen Hood, Sonja Boiteaux, Charles Stanley
 

Ellen Lipman (ASRT), Charles Stanley, Christine Harris