MRI Safety in 2018

10 Experts share their predictions of the top trends to watch out for in 2018

MRI Safety in 2018

10 Experts share their predictions of the top trends to watch out for in 2018

What will be the key trends in MRI Safety in 2018?

That’s the question we asked 10 leading MRI safety experts. Their responses, published below in full, show the many and varied challenges and opportunities that those working in MRI will face in coming months.

From implants and further questions around gadolinium accumulation through to a continued increase in demand for training and MRI safety data analytics – a wide range of trends are discussed. However, as shown in the word cloud of the article below, some common themes shine through:

 

Take a read through what the experts think but we’re also keen to hear your views. Send your predictions to us or join the conversation on Twitter using #MRISafety2018.

Contributors include:

The views expressed in this article are those of the individual contributors and not of Metrasens.

“Countless MRI projectile incidents will continue to occur across the globe. Each of them could be prevented…”

Barbara Nugent BSc(Hons), PgC (MRI), DCR(R), Radiographer, Lecturer, MRI Safety Project lead for NHS National Education for Scotland and MRI Safety Matters™ Consultant, Edinburgh, UK

My predictions for 2018 are:

1. While MRI radiographers/technologists appreciate the wonders of new technology, such as pill-sized endoscopy cameras, they need to recognise them as a huge risk to the patient undergoing an MRI scan. However, referrers are unlikely to have the appropriate education to alert radiographers to this hazard when requesting a scan. Patients will forget to tell us if they have ingested but not passed these capsules. Therefore, such wonderful electronic wizardry, designed to help, will hinder safety in an MRI unit. Education can help but humans are forgetful creatures. We need tools to detect such items.

2. That more patients will undergo permanent cosmetic surgery. However, their beauticians will be highly unlikely to know the fact that such ferrous cosmetics can potentially burn their clients if they undergo an MRI scan. MRI screening forms need to include this question.

3. That countless MRI projectile incidents will continue to occur across the globe. Each of them could be prevented from happening by a zero tolerance of ferrous items, complemented by having ferrous detection systems and minimum standards of MRI safety education.

“We see a trend in the desire to create an effective culture of safety in MRI.”

Bill Faulkner & Kristan Harrington of William Faulkner & Associates, LLC

From our clients at William Faulkner & Associates, we see a trend in the desire to create an effective culture of safety in MRI. Creating this culture requires a commitment from all parties. This means that administration, radiologists, MR technologists and support personnel are committed to working together to create and maintain an effective MR safety program.

Technologists shouldn’t be the only line of defense

Although the FDA’s MAUDE database is not an accurate reflection of the number of MR safety incidents, over the last year, there were multiple projectile incidents reported. Several of these incidents resulted in staff and/or patient injuries.

It’s still not uncommon, however, to hear technologists attending our MR Safety Officer (MRSO) courses state they feel like they are alone in trying to keep the patients and staff safe. Technologists are indeed the last line of defense when it comes to MRI safety. However, significant problems exist when they are the only line of defense.

“FMDS are sometimes not effectively utilized”

There is a significant difference between simply “checking boxes” and building an effective culture of safety. For example, we have performed several MRI safety audits and risk assessments surveys in facilities with Ferromagnetic Detection Systems (FMDS) installed.

However, the FMDS are sometimes not effectively utilized. For example, if an FMD alarms constantly because the staff does not dress in a ferrous-free fashion, alarm fatigue sets in and all alarms are eventually ignored. At one facility we visited, ineffective FMD utilization had resulted in a near-fatal incident for a technologist. Since that incident, however, significant changes have been made to the sites safety practices. We hope the trend of building an effective MR safety culture continues to be proactive rather than reactive.

Read more

Increased funding for training

Over the last year, we have seen larger institutions finance extensive MR safety training for their staff. We have personally participated in several MR Safety Officer / MR Medical Director courses presented solely for the MR personnel at those institutions. One large organization, which operates and/or manages over 150 magnets nation-wide has had us provide an MRSO/MRMD course for the past 2 years in a row. We believe this is due to the growing interest in the MR safety credentialing made available through the American Board of Magnetic Resonance Safety (ABMRS).

Finally, the number of clothing items with embedded metallic fibers is increasing. It is therefore critical that all patients be changed from street clothes into MR-appropriate attire prior to an MR exam.

“With the explosion of new implantable medical and non-medical devices and implants there will be increasing demand for standardization in approaches to implant MR safety evaluation and assessment, as well as demand for more objective analysis and assessment of risk quantification.”

Dr. Emanuel Kanal MD, FACR, FISMRM, MRMD, MRSE, AANG

Founder and Past Chair, American Board of MR Safety (ABMRS); Developer/Author, MagnetVision™ MR Safety app; Director, Magnetic Resonance Services; Professor of Radiology and Neuroradiology, Department of Radiology, University of Pittsburgh Medical Center.

Since roughly 2014 there has been a substantial global awakening of interest in all matters pertaining to MR safety by predominantly the practitioners of MRI, namely, MR technologists/radiographers. As a result, we will likely see the following activities in MR safety in 2018:

1. An increased focus of MR safety on the part of radiologists and perhaps even MR physicists, largely as a result of the continued increased focus and attention on this topic by MR technologists/radiographers who continue to lead the drive for professional growth and focus on this topic.

2. With the recent CMS relaxation of reimbursement criteria for cardiovascular implanted electrical devices (CIED) there will be a notable surge in requests for MR scans of patients with various CIEDs that are not labeled for MR scanning. This will generate substantial pressures on radiology personnel to accept device patients for MRI scans – personnel who are not familiar with how to do so safely. This, in turn, will further increase awareness and interest in formal MR safety education and ABMRS credentialing among US radiologists and technologists alike.

3. On a similar note, I predict that 2018 will usher in a budding international interest in formal MR safety accreditation/certification for MR radiographers, which might even awaken interest in formal MR safety education and certification among radiologists and physicists worldwide.

4. With the explosion of new implantable medical and non-medical devices and implants there will be increasing demand for standardization in approaches to implant MR safety evaluation and assessment, as well as demand for more objective analysis and assessment of risk quantification. 2018 will see the introduction of new software tools that will propel the entire MR community worldwide into more standardized approaches to risk quantification, analysis, and clinical decision making for patients with implants, devices, and foreign bodies.

5. For better AND for worse, the public’s eye has now been sharply focused on gadolinium-based contrast agent safety and the topic of retained/residual gadolinium. The recent FDA meeting on this issue, the recent well-publicized activities and lawsuit by Chuck and Gena Norris, and the recent FDA announcements regarding mandatory patient education regarding residual gadolinium promise to make 2018 a year filled with questions from our patients regarding GBCA usage, type, and dosing. This, in turn, will stimulate more formal educational efforts for at least US radiologists regarding this topic, and significant new research in this field will doubtless be forthcoming during this year.

“There will be a substantial increase in the number of investigations published in peer-reviewed journals that address the important topic of gadolinium deposition.”

Dr. Frank G. Shellock Ph.D., FACR, FISMRM, FACC, FACSM

Frank is Adjunct Clinical Professor of Radiology and Medicine at Keck School of Medicine, University of Southern California; Director for MRI Studies of Biomimetic MicroElectronic Systems at National Science Foundation, Engineering Research Center, University of Southern California; and President, Shellock R & D Services, Inc. www.MRIsafety.com

My predictions for 2018 are:

1. More active implants that are used for important therapeutic applications will receive MR Conditional labeling, including additional cardiac devices, cochlear implants, neurostimulation systems, and others.

For those active devices that currently have limited MR Conditional labeling, updated labeling will involve fewer limitations as well as the use of 3-Tesla/128-MHz MR systems for clinical MRI exams. The requirements that must be followed to ensure patient safety will continue to be unique to each particular active device, presenting further challenges for MRI Technologists/Radiographers.

2. There will be a substantial increase in the number of investigations published in peer-reviewed journals that address the important topic of gadolinium deposition. The question of whether there are adverse clinical effects related to this phenomenon will remain unanswered.

3. A growing number of MRI facilities will become attentive to the topic of MRI safety, focusing on yearly, comprehensive training, updating their policies and procedures in consideration of the latest information, and encouraging their radiologists/supervising physicians to become more engaged.

“MR safety must be focused on patient and public safety in the context of medical benefits from the examinations.”

Greg Brown MRSO, MRSE (MRSC™), FSMRT, Researcher & Lecturer, University of South Australia

The topic that I think will dominate attention, effort and discussion in the United States, and possibly elsewhere, is managing the public’s concerns over gadolinium accumulation.

In the USA in early 2018, the action of the FDA, and the “nothing to see here” attitude of radiology will really start to clash with public information. When all patients have to be given new drug information acknowledging the biochemical accumulation of gadolinium compounds in the bone, skin, and brain tissues occurring regardless of renal function, radiologists & staff needs to be ready to answer a wave of new questions accurately.

More to the point, the edict from the FDA following September 2017’s public and scientific hearings is that each patient will be required to read the new information before they are given any GBCA. I think the implications of that course of action can be huge.

More information needed on potential harm

The FDA has recognized a potential toxicity issue, recognized the concern and possible harm to the public, recognizes the potential benefits of GBCA when used judiciously, and recognizes that more information on potential harm is needed but will take a long time to obtain.

Their response, motivated perhaps by a duty to protect the public, is to require that before a gadolinium-based contrast agent is administered, the patient is informed that all GBCA leave trace amounts of GBCA in the body of all patients for the long term, (regardless of renal function), that some agents leave a lot more in the body than other. Now there’s a conversation starter…

Read more

Need to focus on the answers

Radiology will have to be ready for all the obvious questions that will follow: “Do you have the one that leaves the least gadolinium in me?”; “Is there something else we can use?”; “How toxic is this stuff? What can I do to get the gadolinium out of me? If it’s harmless how come Chuck Noriss’s wife is suing the companies?

Radiology, and specifically Radiologists, will be judged on the answers they provide. I think a lot of conversations in 2018 will focus on what the answers will be. I hope we don’t continue to neglect the critical question that has been often passed over in the past decades: What medical benefit will this use, of this GBCA have for this patient, in this examination?

The answer to that question is the justification for the development of this class of drug. I hope that in 2018 this central justification is recognized directly and converts to practice.

Other safety issues

Scanning active implants and decisions around passive implants will continue to trouble MR practitioners. In 2018, I expect we will see the rollout of Siemens’ software to assist sites to keep scanner outputs within defined ranges. It has taken three years for any manufacturer to respond to Philips’ ScanWise, suggesting a reluctance to enter this arena.

We can expect to see the increasing prominence of RF measured in B1+ RMS on scanner consoles, and the appearance of the FPO mode. Active devices designed to work with that mode may still be a few years away.

Things I’d like to see in 2018

RF burns will continue to be the major mechanisms of injury in MRI, and sites will continue to be surprised by them. In 2018, any patient reporting heating after a scan, or the appearance of lesions must be referred to the radiologists and get some medical examination.

Hearing-related injuries will continue. The Quiet suites and SilentScan tool won’t have changed the noise exposure. In 2018, I want to see all patients receiving ear bud hearing protection, with supervised fitting and recognition that MR safety must be focused on patient and public safety in the context of medical benefits from the examinations.

I’d also like to see Radiologists stepping into the conversation about MR safety, by becoming better educated, by delegating responsibilities explicitly to well-educated staff, and by taking the central role on medical decisions and the balance of risk for benefits.

“I think social media will continue to be very important as a venue for discussing and promoting MRI safety.”

John Posh R.T.(R)(MR), Metrasens’ Director of Education, MRI Safety Officer

My predictions for 2018 are:

1. The ACR has re-formed the MRI safety committee and we will likely see an updated 2018 version of the ACR Guidance Document as a result. I believe that the new version will be amendment heavy with stronger language for screening, including the recommendation for increased use of ferromagnetic detection, staffing (maintaining 2 trained staff at all times), and overall recommendations for MRI safety.

2. I see the MRI Safety Officer Accreditation continuing to grow. There has been an increase in job postings specifically requesting this certification and I think that trend will increase in 2018. Additionally, I predict a cottage industry of review and prep courses to deploy in 2018.

3. I believe the Joint Commission will continue to evolve to become more granular with respect to MRI safety. There have been social media postings where they have dived down to the patient prep level to make recommendations regarding what the patients wear on their feet in the scan room. In my opinion, this portends an awakening on their part to the real dangers associated with MRI and it will be interesting to watch their reaction as the year progresses.

Read more

4. I see 2018 as a big year for the MRI Contrast industry. The European agencies are banning certain linear agents for all but limited and specialized use (intra-articular). In the US there will be a push for greater clinical review of patient need before administration as well as greater accountability for misuse. This largely stems from the recent high-profile case of Chuck Norris and his wife. That case will also cause a ripple into the radar of patients needing MRI who will be more cognizant of the fact that contrast can cause problems.

5. 2018 will be the first full year of the traveling roadshow for the ISMRM/SMRT’s Joint Safety Committee’s MRI safety Committee’s MRI Safety Day. I believe that the regional 1-day safety focused seminars will grow in popularity and that these will continue beyond 2018.

6. I think social media will continue to be very important as a venue for discussing and promoting MRI safety. There are several MRI centric boards on Facebook and discussions are frequently heated debates on how the industry is responding to safety changes.

7. I do not see 2018 as the year that the vendors do much in the way of MRI Safety initiatives. There has been some small movement by the vendors to improve safety for users of their equipment. Some vendors have been paying for customers to attend MRI Safety Certification classes and others have been developing products to help in that regard such as ScanWise from Philips. I think dedicated MRI safety inititives will continue to be a low priority for the vendors in 2018.

“There seems to be a huge upsurge in imaging implanted patients. This will no doubt increase indefinitely.”

Dr. Mark Keene Metrasens’ Chief Technology Officer

Safety thinking around the increasing use of multi-modal assets, as well as inter-operable and interventional MRI, is still largely wooly without any accepted, defined or published ‘best practice.’ I believe that this year will see an increasing accident rate with such diagnostic assets. Along with this, will be progress toward defining best safety practices. Although these will have some level of commonality, there will be bespoke aspects for each type of asset.

More early adopters will install 7T magnets. A significant level increase in safety procedures around these will be required.

There seems to be a huge upsurge in imaging implanted patients. This will no doubt increase indefinitely. Data and advice for imaging assets to enable this is increasing and will take big leaps forward next year. Implant-present scanning will be conducted by increasing numbers of non-specialist facilities.

The implementation of ferromagnetic detection systems will also increase. In addition to warning people at the door, the most advanced entry control FMDS also collect and report statistical data on ferromagnetic materials entering Zone IV. This data will increasingly be used to manage the ferromagnetic safety levels in facilities, allowing controlled and measured reduction of unnecessarily ferrous material entering Zone IV.

“2018 is likely to be the year we see an explosion of individuals seeking accreditation”

Tobias Gilk M.Arch., MRSO, MRSE (MRSC™), Founding Principal, Gilk Radiology Consultants

MRI safety is now a rapidly evolving part of radiology. In just the past few years we’ve seen new safety accreditation requirements from both the Joint Commission (TJC) and the American College of Radiology (ACR). 2018 promises to bring us even more…

The ACR’s MRI Safety Committee has reconstituted and I expect that 2018 will see an updated version of the ACR Guidance Document on MR Safe Practices which will address some of the recent technical changes (hello, 7T), and changes in how MR is used, clinically (including interventional / intraoperative settings).

2018 will also see a new version of the Facilities Guidelines Institute (FGI) publication on design standards for healthcare facilities. While the clarifications on MR safety (including explicit language on the requirement for FMDS) will be limited, the structure of the design criteria for all of imaging (including MRI) will focus on patient acuity and level of intervention. It will also make clear that MRI safety standards should be applied to mobile (trailer based) settings, just as they are to permanent, brick-and-mortar, environments.

At the end of 2017 the American Board of Magnetic Resonance Safety (ABMRS) announced that they had surpassed 1,000 MR Safety Certified™ professionals. The number of certifications (for MRMD, MRSO, and MRSE) is likely to have passed a crucial ‘tipping point’ and 2018 is likely to be the year we see an explosion of individuals seeking accreditation, as well as job listings specifically requiring these credentials.

“My hope is that in 2018 we get better tools for researching implants.”

Vera Kimbrell BSRT R MR FSMRT, SMRT Safety Committee Chair

As we head into 2018, MR safety education has had a very good year. There are multiple seminars around the world and more hospitals are being proactive to get their staff trained. We still have a long way to go and we need to push hard to keep the momentum. Good quality education is the key to maintaining a safe MR environment for our staff and patients.

Better tools for researching implants

The implant world has exploded with so many new implants and devices that our heads spin! Most but not all have MR conditions and slowly those conditions are better written and more easily translated in “MR lingo”. The issue for sites now is the time it takes to screen, research and scan these appropriately. It’s become a full-time job in busy sites to do this work. My hope is that in 2018 we get better tools for researching implants.

MR scanners are getting “smarter” and have tools for MR safety now. Several of the manufacturers have stepped up to the plate with software that “limits” parameters, allowing us to stay within conditional guidelines. I believe this trend will continue with more companies taking this on and making their scanners with MR safety software.

High field MR safety issues

Higher field scanners are here to stay and soon to be used for clinical patients. We will see more implants tested and approved at 7 Tesla with new RF conditions. Words like Dual Transmit, Parallel transmit will become part of our lingo soon. There may be other MR safety issues with high field and we will watch and learn in the next couple years.

The push to go back and look at areas once thought to be Unsafe is gaining momentum. We may have to reevaluate our policies and learn how to scan devices that have less defined safety criteria. We need our MR MD’s to guide us thru this very stressful time when the old rules may be changing.

In general, I am very optimistic but we must never stop learning, questioning and educating. MR remains a modality that while safe for most can have fatal results.

© 2018 Metrasens, All rights reserved.





Free Guide to MRI Safety & Ferromagnetic Detection Regulations

With multiple professional and accrediting bodies involved, it can be difficult to keep track of what the various published safety recommendations and guidelines in the US say. Metrasens is pleased to assist by providing this summary of the present status as it relates to the growing adoption of ferromagnetic detection systems (FMDS) for the prevention of MRI projectile incidents.

Menu
X