Tag: Medical Imaging

It’s 11am. Do You Know Where Your MRI Safety Officer Is?

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“Each time we have a bed, compressed gas cylinder, wheelchair, or floor polisher go flying into an MRI scanner there’s this collective wish to explain the event as some sort of freakish aberration. But how many of these freakish aberrations do we need to see before we come to terms with the fact that -to date- the radiology profession has proven unwilling to require the changes that we know would be effective in reducing these accidents?”

Tobias Gilk, MRSO, MRSE, MRI Safety Expert
Image Credit: Shutterstock.com

Well, it has happened again. Twice actually. Two recent news stories highlighted the fact that we’ve sent another object flying into an MRI scanner with disastrous and, in one case, fatal results.

The first case reported in numerous news stories was about a Brazilian man killed by his own handgun while accompanying his mother for her MRI. On Jan. 16, lawyer Leandro Mathias de Novaes was wearing a registered firearm on his waistband while assisting his mother in the MRI suite when the scanner’s powerful magnet pulled the gun away from his body. The gun subsequently discharged and shot the 40-year-old lawyer in his stomach, landing him in an intensive care unit until Feb. 6, when he passed away.

Image Credit: Tobias Gilk, MRSO, MRSE, LinkedIn post

The facts as we understand them – The site didn’t have a policy against companions going into the MRI scanner room, and they didn’t require people to change out of their street clothes. They did have a policy that people were to sign attestations that they didn’t have any metal (an attestation that the man purportedly signed but didn’t comply with). The man had a concealed pistol which, when he got close to the MRI scanner, the powerful magnetic energy of the MRI pulled from him and helped cause the gun to fire. The gunshot hit the man in the abdomen, and he died of the injuries several days later. As Professor Gilk (my go-to resource for all things MRI safety-related) outlines in his LinkedIn post:

“We’ve all heard (and probably repeated) tropes about the MRI technologist having ultimate responsibility for MRI safety. Those arise from the incredibly-long list of stories of techs whose training and observational skills have stopped off-duty police officer with a firearm, or transport with the wrong wheelchair, or anesthesia with a steel oxygen cylinder, or the patient with the lifelike prosthesis, just before the door into the MRI scanner. These ‘good catch’ happy accidents are so well known in our profession we’ve built de facto practices around the unblinking vigilance of MRI techs (often in lieu of system-level MRI safety practices).”

Tobias Gilk, MRSO, MRSE

The second example was reported just this week and happened in a hospital in the United States. In this case, the object was a hospital bed/gurney with multiple injuries.

Image Credit: Tobias Gilk, MRSO, MRSE, LinkedIn post

The facts as we understand them –
• A senior MR tech was on duty but not immediately in the magnet room.
• The MRI’s undockable table was out of the magnet room to allow the transfer of the bed-bound patient.
• A nurse and tech aide brought patient-on-gurney into the magnet room.
• Patient was thrown off the gurney as it was drawn to and struck the MRI scanner (patient relatively unharmed).
• Nurse was struck by the gurney, and is reported to have suffered a broken femur and fractured pelvis.

The prevailing opinion shared extensively in most public relations campaigns is that MRI is the “safe modality. As Professor Gilk points out:

“To be clear, MRI injury accidents have been, and remain, rare, but in nearly every case of MRI injury accident there was an existing, well known and widely promulgated best practice prevention that wasn’t used. In other words, we could -if we so chose- prevent nearly every MRI injury accident that occurs… we just choose not to.

Tobias Gilk, MRSO, MRSE

To support his statement, Professor Gilk has created a chart that depicts the current state of MRI safety by looking at MRI accident rates.

Image Graphic: Tobias Gilk, MRSO, MRSE

The red line represents growth in MRI adverse events, and the blue line represents growth in MRI exam volume. If you apply ‘best fit’ slopes to each of these two datasets, you learn that reported MRI adverse events are growing at rates between 2x and 4x the rate of growth of MRI procedure volume (depending on the weighting given to the 2008 – 2012 ‘hump’ of MRI adverse events in the data). To quote Professor Gilk:

“Put simply, this data indicates that MRI adverse events are both greater in number, and represent a greater proportion of MRI exams, than twenty years ago. An MRI patient, today, appears to have a greater likelihood of an adverse event than an MRI patient in 2001. Despite more experience and more knowledge, we’re producing more MRI adverse events… Facts that shouldn’t coexist.”

Tobias Gilk, MRSO, MRSE

So what should be done to correct this problem? The industry, and each MRI provider, need to take long hard looks at their practices and identify ways in which their assumptions and ‘the way we’ve always done things’ might contribute to our national growth in MRI adverse events. Professor Gilk has studied how effective existing, established best practice standards can be at preventing MRI projectile accident injuries. In the most recent study for Metrasens, the more current data found that -for the two years studied- these same three existing best practice protections would have prevented 100% of the patient injuries from MRI projectiles.

In addition to the nine steps highlighted in the Metrasens study cited above, I always recommend the following to imaging providers:

  • Appoint an MRI Safety Officer for your organization – That person is charged with reviewing, revising, and communicating all MRI safety protocols throughout the organization. Recommended responsibilities for management of MR safety guidelines can be found here: https://www.ismrm.org/smrt/safety_page/Recommended_Responsibilities_for_Management_of_MR_Safety_JMRI2016.pdf
  • Review your MRI safety protocols annually and whenever equipment changes are made – This is an important step often glossed over by many organizations. It is critically important to do an extensive review if a new scanner is purchased.
  • Conduct regular MRI safety training for all staff involved with patient care, including transport, nursing, etc. Training is available through AppliedRadiology.com. Programs for MR personnel include: “Introduction to MRI Safety,” “Basic MRI Safety Training,” and “Advanced MRI Safety Training For Healthcare Professionals.” Please visit appliedradiology.org/MRISafety/. Videos Available on IMRSER include MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. Visit: IMRSER Videos.
  • Keep a continuously updated list of MRI-safe implants and devices – A sample list can be found here: http://www.mrisafety.com/TMDL_list.php
  • Ensure you have implemented the 4-Zone MRI safety system linking screening/supervision.
Image Credit: Metrasens

Until we take the well-known steps which prevent those injury accidents, we’re going to continue to experience these head-scratching moments every time another missile-effect injury (or worse, death) is reported.

Additional resources:

Random Thoughts On RSNA 2022 From A Forty-Plus Year Industry Veteran Attendee

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“If we expand our thinking to the patient’s perspective, we will find that imaging’s value extends beyond the tight focus of the radiologist or radiation oncologist.”

Bruce G. Haffty, MD., RSNA President
Image Credit: RSNA.org

For medical imaging professionals, Thanksgiving weekend is usually an abbreviated affair. After enjoying dinner with family and friends on Thanksgiving day, they pack their bags, brave the busy travel issues, and head to Chicago for the annual Radiological Society of North America Conference and Exhibition. For over forty-five years, that was part of my schedule every year too. Now I follow the conference virtually and thought I’d share some thoughts on what’s being featured this year.

Attendance

Based on the early figures released by the RSNA, total attendance returns to typical figures, although they are still slightly below pre-pandemic levels. Total advance registration this year was 34,385, a 61.4-percent increase over the 21,300 registered on this equivalent day in the conference in 2021. Among the 34,385, 19,485 were registered as professionals. Last year, COVID-19 was still impacting attendance, while the 2020 conference had to be made entirely virtual because of the pandemic. The attendance figure for RSNA 2019, the last year before the pandemic hit, was 47,011 (with 21,837 professional registrants); in 2018, that number was 48,615 (with 21,837 professional registrants), while in 2018, the figure was 48,615, and in 2017, total attendance had been 48,445. There is still a mix of in-person and virtual attendees, and the international attendance figures appear to be closer to normal numbers, even with outbreaks happening in China and other countries at the current time. So, RSNA still lives up to its reputation as the largest medical conference in the world.

Exhibitors

The number of vendor companies was up considerably as well. This year, 647 vendors are exhibiting at McCormick Place, a 13.3-percent increase over the 571 vendors that exhibited last year. Back in 2019, the last pre-pandemic year, 789 vendors had exhibited, while in 2018, 693 had exhibited.

The virtual vendor experience

I spent some time exploring the various vendors’ online virtual booths to try and understand what was new and how they were positioning their products this year. Virtual RSNA evolved from the years when COVID prevented onsite meetings. The first year left a lot to be desired, but it has evolved and become much better since then. But the user experience is decidedly mixed. Some of the interfaces are unintuitive, and the loading times are really slow – surprising in this day and age. Several websites give you information that is untainted by fluff, but so many are poor at best and abysmal at worst. I wish I had a nickel for every vendor who “developed the DICOM standard” or “is leading the charge in AI in medical imaging.” I could fund a vacation with the money.

What was being featured this year

A.I. Again – Once again, this year, there’s a big focus on A.I. applications in medical imaging. AI has applications across the radiology spectrum, including using natural language processing algorithms to help collect and process data for clinical research. Using the Gartner Hype Cycle framework, I think we’ve reached the point where AI is exiting the “peak of inflated expectations” phase and heading down to the “trough of disillusionment.” Practical experience in everyday practice has exposed the challenges of implementing AI. The biggest challenge is integration – at every step in the imaging value chain.

Which algorithms should be used and for which applications? How does the AI fit into the radiologist’s workflow? How does AI complement the radiologist’s diagnosis? And how does it impact the care pathway? These essential questions must be answered to allow for the widespread adoption of the technology.

Cloud, Cloud, and more Cloud – The benefits of Cloud solutions, such as their cost-effectiveness and predictability, unlimited scalability, and deployment flexibility, have started to outweigh the perceived risks. This is especially true in medical imaging, where the unending growth in image data volumes, coupled with long-term data retention policies in place, makes traditional storage upgrades and scale-up mechanisms unsustainable over the long run. This is why, since the early 2000s, Cloud-based solutions have provided a viable alternative to tape- and truck-based solutions for the long-term archival of medical image studies.

Two simultaneous and complementary market trends are advancing Cloud-based imaging informatics into new use cases: the continuous expansion of medical imaging applications into niche subspecialty clinical areas and the ongoing diversification in the points of care where medical multimedia content is produced and consumed by various enterprise imaging stakeholders.

Every major vendor of cloud solutions exhibited at RSNA this year: Microsoft. Google, Nuance, and NVIDIA all had major exhibits.

Photon counting CT – Photon-counting detector (PCD) CT is a new CT technology utilizing a direct conversion X-ray detector, where incident X-ray photon energies are directly recorded as electronic signals. The design of the photon-counting detector itself facilitates improvements in spatial resolution (via smaller detector pixel design) and iodine signal (via count weighting) while still permitting multi-energy imaging. PCD-CT can eliminate electronic noise and reduce artifacts due to the use of energy thresholds. Improved dose efficiency is vital for low-dose CT and pediatric imaging. The ultra-high spatial resolution of PCD-CT design permits lower dose scanning for all body regions. It is particularly helpful in identifying important imaging findings in thoracic and musculoskeletal CT. Improved iodine signal may be helpful for low-contrast tasks in abdominal imaging. Virtual monoenergetic images and material classification will assist with numerous diagnostic studies in abdominal, musculoskeletal, and cardiovascular imaging. Dual-source PCD-CT permits multi-energy CT images of the heart and coronary arteries at high temporal resolution.

Multiple presentations at RSNA this year highlighted the benefits of photon-counting CT in medical imaging. For example, PCCT is feasible for the imaging of heart defects in neonates and infants, offering a superior signal-to-noise ratio and image quality than conventional CT.

Empowering Patients – I was pleased to see this topic as a focus this year. To the patient, imaging can remove uncertainty, decrease anxiety and give hope. A significant challenge is objectively quantifying the patient’s perception of value to demonstrate its importance to the greater medical community. From the time a patient schedules an appointment through every follow-up, effort should be made to ensure they feel comfortable, informed, supported, seen, and heard. Image results are the tip of the iceberg. Imaging’s actual value through the lens of the patient—quality of life, comfort, peace of mind, certainty, hope, and trust— all lies below the surface for us to explore together.

What we didn’t see – There were no significant new product introductions at the meeting this year. Vendors essentially rounded out their product portfolios with missing elements at lower price points. I think that reflects the current market conditions where health systems are under intense margin pressure, meaning less capital is available for purchasing big-ticket items like MRI scanners. The case vendors need to make is all around efficiency, throughput, clinical benefit, and cost reduction.

Final thoughts – RSNA is still my favorite conference to follow during the year. It’s the one place where medical imaging professionals gather to review the state of the industry, explore new products and technologies that are entering the market, share clinical applications that broaden the use of medical imaging throughout the care continuum, and celebrate the contribution that imaging makes for improving the lives of the patients we serve.

More Supply Chain Woes as Contrast Agents for Medical Imaging in Short Supply

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“There has been no improvement to any extent within the U.S.market to manufacture items, so we still predominantly rely on international supply. In addition, the distributors are allocating supply by their individual customers, and at times that can lead to other outages.”

Christopher O’Connor. President and Incoming CEO of Yale New Haven (Conn.) Health, Becker’s Healthcare Interview
Image Credit: Shutterstock.com

In what should probably be categorized in the “we never learn our lesson” department, we now hear of a temporary shortage of GE Healthcare’s iodinated contrast media—specifically, all concentrations and formulations of its Omnipaque™ (iohexol) products that are manufactured in a single facility in Shanghai, China (Shanghai is currently under COVID-19 lockdown). While the facility has reopened and ramped up production, GE anticipates an 80% reduction in supplies for the next 6-8 weeks. General Electric’s (GE.N) healthcare unit said on Tuesday it had increased output of contrast media used for medical scans and tests at its factory in Ireland and shipped products by air to help combat shortages caused by the suspension of its Shanghai factory.

Supply chain issues have dominated the news for months now as the pandemic slowed international trade and applied pressure on critical items. Usually only felt if it goes wrong, supply chain management has become an increasingly important consideration. Hospitals and health systems have faced significant issues with their supply chains, from personal protective equipment shortages at the start of the pandemic to a lack of crutches now. According to a Kaufman Hall study, ninety-nine percent of hospitals and health systems report challenges in supply procurement as of October 2021.

“I truly believe that we’re probably going to be faced with these challenges for another 12 to 24 months. I would suggest that the trend is that there’s going to be price pressures, we’re anticipating energy challenges throughout the next six to eight months.”

Michael McCullough. Senior Vice President of Supply Chain at Wellstar Health System, Becker’s Healthcare Interview

The vitality of the supply chain is undoubtedly among the top concerns facing hospitals and medical providers today. ECRI’s Top 10 Health Technology Hazards for 2022 rank supply chain shortages among the top three risks facing healthcare organizations. Unfortunately, it’s a multifaceted issue with no easy solutions. We are all aware of the backlog of cargo ships waiting to be unloaded on the West Coast. On top of that, we see COVID-19-related manufacturing disruptions in some Asian countries that produce many of the everyday items we use in the healthcare setting. We also have pressure on the trucking industry in this country due to the increase in e-commerce over the past two years. Traditional reliance on industry partners (manufacturers and distributors) for product availability and order fill can no longer be the norm. The list of scarce items is long. It includes latex and vinyl examination gloves, surgical gowns, laboratory reagents, specimen-collection testing supplies, saline-flush syringes, and dialysis-related products, according to the U.S. Food and Drug Administration.

“We’ve got the wrong products in the wrong location with the wrong shipping. It’s not one disruption; it’s a series of disruptions.”

Abe Eshkenazi, CEO, Association for Supply Chain Management

But what’s frustrating to me is that this latest problem feels a lot like a scene from the movie Groundhog Day. We keep repeating the same patterns over and over again. Today it’s iodinated contrast media. In the past, it’s been a shortage of radioisotopes for nuclear medicine studies. Or a previous shortage of gadolinium-based contrast agents for MRI studies. In each instance, critical imaging studies had to be postponed, and patient care suffered. The American College of Radiology (ACR) has published a list of recommendations on dealing with the current shortage, which is commendable. But, as before, we are not trying to solve the root causes of the problem.

Moving manufacturing offshore – Drugs used in the U.S. involve inputs from all over the world. Many of those chemical inputs are manufactured in India and China, and they’re shipped to the U.S. That gets tied up in all of the disruptions around shipping affecting all industries right now. A factory shutdown caused the current contrast media shortage in Shanghai. China’s shutdowns have a lag time of 45 to 90 days before their effects show up in the U.S., so supply-chain challenges will most likely continue well into 2023. The radioisotope shortage was caused by the decommissioning of the Chalk River reactor in Canada. Shortages in aluminum, semiconductors, wood and paper pulp, and resin disrupt medical devices’ supplies. Those shortages have led to uneven supplies of medical monitors, CT scan devices, packaging for medical supplies, and gloves.

The “single-point-of-failure” effect – Shortages among pharmaceuticals tend to primarily affect sterile injectable drugs and usually drugs that are older and less profitable. They tend to be drugs manufactured in and around the U.S., where companies maybe, over time, didn’t find it as profitable to make these older injectable drugs. They got out of the business, to the point where there’s just one manufacturer left. Any disruption happens there, and then the supply does dry up. Now there appears to be no end in sight to America’s baby formula shortage, according to the most recent data from a retail tracking group. The share of baby formula out of stock across the U.S. hit 40 percent on April 24, according to Datasembly. That’s up from 29 percent in March. The shortages were prompted in part by the shutdown of a key production facility in Michigan this year. The plant, owned by Abbott Nutrition, has been the subject of an FDA and CDC investigation following reports of contaminated formula that was linked to the deaths of at least two infants.

“Unfortunately, we don’t see this (shortage of baby formula) slowing down any time soon.”

Ben Reich, CEO, Datasembly

Time to rethink “Just in Time” ordering practices – For the often-used stocked items required to treat patients, the industry used to have fill rates of 96% to 98%, meaning that just a tiny percentage of orders remained unfilled. Today, the industry’s fill rate for these items is in the high 80s. According to industry experts, it used to be that hospitals would deal with 50 to 100 back-ordered items per day. Many institutions now deal with 800 to 1,000 backorders per day.

What’s the solution? – In 2020, the National Academies of Sciences, Engineering, and Medicine looked at the causes of medical-product shortages and ways to improve medical supply chains, both in normal times and in public health emergencies. Its 364-page report, Building Resilience into the Nation’s Medical Product Supply Chains, which came out earlier this year, called for the FDA to publicly track sourcing, quality, volume, and capacity information and to establish a public database; for health systems to include failure-to-supply penalties in contracts; and for the federal government to optimize inventory stockpiling to respond to medical-product shortages, among other things.

In their report, the NAS created a medical product supply chain resilience framework. They used this framework, which contains four tiers that address awareness, mitigation, preparedness, and response, to craft and inform their recommendations.

Under the awareness category, they proposed measures to collect, compile, and disseminate information about medical product supply chain risks and vulnerabilities. The committee recommends the U.S. Food and Drug Administration (FDA) make sourcing, quality, volume, and capacity information publicly available for all medical products approved or cleared for sale in the United States and establish a public database to share this information and to promote analyses of these data by interested parties

Under the mitigation category, they advocated steps to reduce the likelihood and magnitude of supply disruptions. The committee recommends that health systems deliberately incorporate quality and reliability, in addition to price, in contracting, purchasing, and inventory decisions

Under the preparedness category, they describe a range of options for preventing a supply shortage from impacting patients and medical personnel. The committee recommends the Office of the Assistant Secretary for Preparedness and Response (ASPR) modernize and optimize inventory stockpiling management as protection against medical product shortages at the national and regional levels and that ASPR and FDA complement stockpiling with capacity buffering policies to enhance cost efficiency and to improve protection in major emergencies.

Under the response category, they suggest policies for building organizational capabilities that protect health during emergency disruptions. The committee recommends negotiating an international, plurilateral treaty with other major medical product exporters to make more effective use of limited global supplies by ruling out export bans on vital medical products and components and that ASPR and the Centers for Disease Control and Prevention establish a domestic working group to examine ways to improve the effectiveness of the final delivery stage within the United States (“last mile”) of medical product supply chains and to engage end-users in planning for an emergency response to medical product shortages.

These are all excellent recommendations, to be sure. But none of these fixes will happen in the short term, and in the meantime, hospitals and health systems are trying to cope. Some of the best recommendations I’ve seen to date on how hospitals and health systems that want to improve their supply chains can manage the current situation come from the team at Kaufman Hall in their State of Healthcare Performance Improvement Report, 2021. Their key recommendations include:

  • They are identifying historically challenging supplies and developing acceptable substitutes.
  • They are diversifying suppliers and partnering with several alternative suppliers.
  • Focusing on inventory management and using technology to gain early insight into supply chain issues.
  • Gathering supply chain data and building supply-demand models per category or supply items, as well as sharing this data with vendors and requesting the same visibility from them.
  • Managing vendors and thoroughly vetting all vendors.

For the remainder of 2022 and potentially 2023, enhanced healthcare supply chain management will require transparency, collaboration, and frequent communication between distributors and suppliers. Organizations across the medical supply chain must work together to help improve production and smooth out problem areas to achieve a “new normal.” Flexibility, teamwork, and planning will prove critical components of effective supply chain management in the months ahead.

RSNA 2021 Journal – Observations from a Remote Attendee

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“It is important that we understand the importance of our role in a value-based system and leverage the tools that enhance our ability to provide subspecialized expertise to patients, the medical community and the public at large.”

Mary C. Mahoney, M.D., President, RSNA
Image credit: Shutterstock.com

Last week the annual Radiological Society of North America conference and exhibition was held in Chicago. As I highlighted in my previous post, this is the largest medical imaging conference in the world. And although the pandemic has forced some tough decisions to be made by the conference organizers, this year marked a return to in-person attendance – albeit with some significant modifications to the rules.

I decided to follow the conference remotely again this year. And, I must admit that I didn’t miss the trip to Chicago and the endless walking through the exhibit halls of McCormick Place to check out all the vendor offerings. But, since I’ve spent the bulk of my professional career in medical imaging, I’m still interested in the technology, the profession, and the clinical developments in the industry. So, after spending the past week reading all of the press releases, watching the virtual vendor presentations online, and talking with some of my former industry colleagues, I thought I would share some observations on both the educational and technical exhibitions.

General Observations

RSNA 2021 Attendance Sees 55% Drop from 2019 Level – The total in-person registration as of November 29th was 21,300, including 11,173 professionals registered. Final registration totals will be available in early January. That 21,300 figure is down 55% from the overall attendance figure for RSNA 2019, which was 47,011 (with 21,837 professional registrants). That figure had, in turn, represented a 3.3-percent drop from the 48,615 statistics from RSNA 2018, while in 2017, the total attendance had been 48,445. The advance registration for this conference was 26,348 (with professional advance registration at 16,028). The number of vendor companies of all types exhibiting this year has also declined significantly from two years ago. This year, 571 companies exhibited, down 27.63% from the 789 exhibited in 2019. That 789 figure at RSNA 2019 had represented a 13.8-percent jump over the 693 shown in 2018. As reported by on-site attendees, there were between 40 and 50 vendor no-shows where booths sat empty.

The RSNA did an admirable job creating a safe environment for attendees throughout the conference and exhibition. Registrants were required to show proof of vaccination before receiving their conference credentials. On-site registration was said to be very easy, taking only about five minutes, according to some reports. Masks were required at all times – a City of Chicago requirement. RSNA also offered two onsite COVID-19 testing options during RSNA 2021, with results available 60 minutes after testing.

Several colleagues I spoke to who attended in-person said this was the best RSNA they’ve attended. The lower attendance allowed for companies to present to those who were serious about implementing technology sooner than later. You could have a substantive conversation without having someone else crash your demonstration.

Educational Sessions

Addressing inequities in access to medical imaging – Radiologists are well-positioned to develop strategies for mitigating health disparities through the thoughtful application of radiologic technology. This includes utilizing electronic medical records and demographic data to identify individuals at an increased risk of missing screenings or missed follow-up imaging. Targeted outreach can then be offered to avoid these missed opportunities for care. The hope is that the coalition of patient-focused radiologists will collect and disseminate resources and best practices, advocate for and connect with patients and community members, and collaborate on programs and services that empower others to act.

AI in medical imaging – Applications that improve radiologist efficiency was not nearly as likely to attract investment as those that help organizations capture more patients. An AI application that helps bring more patients back for follow-up imaging, for instance, has the potential to add tens of thousands of dollars to an organization’s bottom line. Adoption remains low, however, with only one-third of organizations currently using AI in their practices. AI continues to demonstrate promise as a tool to speed up imaging exam times — up to 70% faster for spine MRI studies — and reduce dose, including 90% less dose needed for gadolinium-based contrast agents. More on AI in the technical exhibits section in a bit. Here’s a great graphic from Dr. Bertalan Mesko and his team at The Medical Futurist Institute showing the major milestones in AI development in healthcare:

Image Credit: Bertalan Mesko, M.D.

Radiomics role in medical imaging – Several sessions discussed the increasing use of radiomics in clinical practice. One session reviewed applying radiomics, and machine learning to FDG-PET/MRI can noninvasively assess nodal status and treatment planning for breast cancer patients. Out of the eight radiomics models the team developed, the one that had radiomics features extracted from dynamic contrast-enhanced images, antibody-drug conjugates, and PET images showed the highest accuracy for predicting lymph node status. Another presentation reviewed a combination of radiologist assessment and a radiomics classifier to significantly improve the accuracy of MRI for predicting treatment response in cases of rectal cancer. Presenter Mitchell Chen, Ph.D., of Imperial College London in the U.K., and colleagues assessed the utility of CT radiomics in a retrospective study involving 292 NSCLC patients diagnosed at their institution over four years. They presented clear evidence supporting the clinical utility of CT-based radiomic analysis in NSCLC.

Technical Exhibition

AI promoted heavily, but buyer beware – Over half of the vendors claimed to have some form of artificial intelligence (AI), including nearly all the major companies. That said, you needed to dig deeper to understand what they meant by AI versus the industry’s shared understanding of AI. While there are standards for AI, there still isn’t a uniform descriptor of what medical imaging AI is other than what is in the mind of some company’s marketing department. Yes, AI can help with improving signal-to-noise ratios and even with adapting hanging protocols, but that is not what most people are looking for when they look at AI. As reported by Michael Cannavo:

“Real AI” was out there, although anyone who says it is a developed marketplace is sadly mistaken. Fewer than a dozen vendors have more than 20 paying customers using their algorithms, even though they might claim to have 200. Alliances are being formed between several AI vendors who have decided to partner up after realizing the movie dialogue cliché, “this town ain’t big enough for two of us,” or in the case of radiology AI, the 200+ of them.

Michael J. Cannavo, Aunt Minnie.com article

Reimbursement is still an issue. New Technology Add-On Payments (NTAP) are a class of reimbursement meant to help pay for new technology that is not included in the diagnosis-related group (DRG) bundled payment. Unless something changes, NTAP payments for AI applications will expire next year. And, radiologists have finally realized that platforms are more important than point solutions for AI. As Mike points out in the quote above, there’s significant consolidation in the industry, and partnerships to create total AI platform solutions will become dominant in the next several years. Here’s a link to a video interview Brian Casey, Editor in Chief of Aunt Minnie, did with Dr. Paul Chang of the University of Chicago on AI in imaging at RSNA 2021.

Informatics – PACS, vendor-neutral archives (VNA), and enterprise imaging systems (EIS) were all displayed on the exhibit floor, with VNAs making a resurgence of sorts. But with a few exceptions, most of the excitement around PACS/EIS primarily involved upgrades for those using their existing products. PACS vendors continued to place a major emphasis on their respective cloud advantages, and there was a widespread consensus that cloud is on every imaging IT roadmap.

Photon-Counting CT is the talk of the exhibition – Siemens Healthineers executives touted the benefits of its photon-counting CT technology, which is finally reaching the market after 15 years of development work. There are currently over 20 scanners in operation in the U.S. and Europe, most at university hospitals, according to company executives. The fact that they were able to keep this under wraps until the RSNA had competitors scrambling to counter the announcement. In a press release, GE reported that researchers at Karolinska Institute in Sweden had begun clinical evaluations of a photon-counting CT scanner based on technology from GE Healthcare. And Canon Medical announced that they launched a project with the National Cancer Center Japan to evaluate a new photon-counting CT scanner. Both press releases were pretty much drowned out by the hoopla surrounding the Siemens product launch. Philips promoted their spectral CT scanner and had no mention of photon-counting.

Here’s a link to a video interview that Brian Casey, Editor in Chief of Aunt Minnie, did with Cynthia McCollough, Ph.D., of the Mayo Clinic about photon-counting CT.

Mobile imaging systems take center stage – I’ve discussed the topic of bringing medical imaging to the patient in a previous post. This year’s technical exhibition reinforced that message with several new product introductions and first-time exhibitors. Hyperfine had a booth at the conference to demonstrate their Swoop portable MRI system. Fifty organizations are currently using Swoop. A partial list of these organizations includes Yale-New Haven Hospital; North Shore University Hospital (part of New Hyde Park, New York-based Northwell Health); University of California Irvine; Massachusetts General Hospital; Danbury, Connecticut–based Nuvance Health; and Ohio State University. Samsung Neurologica introduced updated versions of their portable CT systems: OmniTom Elite and BodyTom 64 (FDA 510k pending). New versions of handheld ultrasound systems were on display at several vendors booths. Redesigned mobile digital x-ray systems with smaller profiles, lighter weight, and longer battery life were also shown. This trend will grow in importance as more patient care is delivered in the home, in retail settings, and other points of care outside of the hospital.

MRI: Hold the cryogens, please – While there were many updated products announced at this year’s RSNA, the big trend is toward reducing the need for cryogen refills on systems. The technology seals helium directly into the magnet, such that scanners do not require helium refills or quench pipes. Philips, GE, and Siemens promoted their versions as part of their press releases. Vendor portfolios continue to expand with configurations at 1.5, 3.0, and 7.0 Tesla field strengths. New introductions of permanent magnet open systems like the Velocity MRI from Fujifilm Healthcare were also demonstrated.

Some concluding thoughts:

The imaging industry made the most of RSNA 2021, and everyone seemed happy to be together again after two long years of working from home. As reported by Jake Fishman in The Imaging Wire, “almost every product message at RSNA focused on productivity and efficiency, often with greater emphasis than clinical effectiveness. The AI Showcase highlighted many trends we’ve been seeing all year, including larger vendors transitioning to AI platform strategies, an increased focus on workflow integration and care coordination, and a greater emphasis on radiologist efficiency.”

My one beef is with the marketing messages from some of the vendors. I know it’s tough to differentiate yourself in a mature market, but some of the messaging left me scratching my head. Some examples:

  • We’re going to “democratize data-driven medicine, together.” What does that mean exactly?
  • Our product is FDA approved. No. The FDA doesn’t approve products; they clear them to be marketed, but that’s it.
  • Companies that use numbering designations for their product portfolio. Really? Is 5500 better than 7500? Is the price different for a 3100 than an 8800? My head hurts….
  • Disney-esque knockoffs especially drive me crazy. You folks know who you are. “People Can Tell When You Imagine.” I’d rather not imagine it but actually do something.
  • I’d worry about a company that touts that their product addresses “clinically significant cancer.” Most patients who receive a cancer diagnosis think their condition is “clinically significant.”
  • The same goes for companies who use the “Patients are at the center of all we do” tagline. Maybe if we really were at the center of all you do you’d give us access to our medical data without requiring us to sign away our first-born child or re-mortgage our homes to get a digital copy. And don’t get me started about fax machines….
  • I can’t even count the number of press releases or online virtual exhibits that used the words paradigms, proliferation, future-proof, future-powered, pressing trends, and my personal favorite, ubiquitous. Perhaps spending $32.99 on the latest edition of Roget’s Thesaurus would be in order here?
  • And finally, companies who still insist on using stock photography showing a physician holding up a film of a CT or MRI scan in their promotional materials. News flash – it’s almost 2022, folks. A Shutterstock subscription doesn’t cost that much. But, if you’re serious, I think I still have a lightbox in my basement that I used to do slide editing. Yours free for the asking.

A couple of weeks ago, I wrote a post on what to expect from the conference. So, how did I do with my prognostications? Most were pretty obvious based on the information available at the time. My wild card guess didn’t get as much notice as I thought. And I was delighted to see that the PACSman Awards were featured again this year on Aunt Minnie.com. Looking forward to seeing what happens in 2022.

RSNA 2021 – What to Expect From the World’s Largest Medical Imaging Conference

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“After two challenging years, our attendees were ready to return to Chicago for the world’s leading imaging forum and to engage with the state-of-the-art technical exhibition.”

Mary Mahoney M.D., President, Radiological Society of North America
Image Credit: Radiological Society of North America

It’s Thanksgiving week. And medical imaging professionals know that generally means a terrific dinner with family, a short day of relaxation following all that food, and a Saturday trip to the Windy City to prepare for the opening of the world’s biggest medical imaging conference, the Annual Meeting and Exhibition of the Radiological Society of North America (RSNA).

In the past, that was my usual Thanksgiving routine throughout my time as a company representative and provider of imaging services. In all, I’ve attended 43 RSNA conferences. And it’s was both a grueling and fun experience. I know I don’t have the stamina today to handle a week of booth duty, customer meetings, presentations, and walking the halls of McCormick Place (for miles and miles) to scope out the competitive landscape. But, that doesn’t mean I’m not interested in what technology will be shown and what techniques will be discussed. So, I thought I’d dust off my crystal ball and take a shot at forecasting what this year’s conference will be like – for attendees and exhibitors. Here goes:

Attendance will be down considerably from pre-COVID-19 levels – An industry reporter acquaintance emailed me this week saying that his contacts told him that Professional registration is now at 9,200. This is approx. 50% of in-person professional registration from the same time in 2019. 31% of the professional, in-person registrants are from outside of N. America. This ratio is similar to 2019. There are 7,800 virtual RSNA meeting registrants, 56% of which have opted for both the in-person and virtual event (we’ll have to watch out for double-counting in the reported numbers), so they can access the RSNA educational program until April 30th, 2022. On Monday of this week, Aunt Minnie published an article that stated that the Society is expecting about 19,000 in-person attendees and about 4,000 virtual attendees. Pre-pandemic attendance was usually between 51,000 and 60,000 total attendees.

Exhibitor numbers and total exhibitor square footage is down – The number of exhibitors is down approximately 33% vs. 2019, with 495 in-person technical exhibits occupying 296,000 square feet (versus 740 technical exhibits occupying 452,000 square feet in 2019). I would expect that companies will send fewer staff to the conference this year. Some exhibitors have opted only to do virtual booths. Most major exhibitors will have a robust online component to their marketing efforts for 2021 – mirroring what they did last year – 52 virtual exhibits, including 32 virtual-only exhibits. (Numbers accurate as of 10/30/2021)

A.I. will be a significant focus again this year – As usual, AI research will be the focus of a variety of dedicated scientific sessions, as well as sprinkled throughout the scientific program at RSNA 2021. AI is increasingly being investigated for its potential utility in predicting patient outcomes and guiding treatment. The conference will also include an A.I. Showcase which will be located in the South Hall of McCormick Place this year. As of early November, 93 vendors were scheduled to showcase their wares in this dedicated area on the exhibit floor. Those visiting the AI Showcase in person will also have the opportunity to visit the RSNA’s Imaging AI in Practice interactive exhibit, which will feature 22 vendors demonstrating AI technologies and the integration standards needed to embed AI into the diagnostic radiology workflow. Featuring 32 different products, the interactive exhibit will showcase the use of AI and health IT standards throughout the radiology workflow in real-world scenarios.

Photon-Counting CT will be the talk of the exhibition – Just this past week, Siemens Healthineers’ Shape 22 pre-RSNA event featured an ambitious hardware announcement that stands to expand what can be done with CT exams. The new scanner has received clearance from the U.S. Food and Drug Administration (FDA), a move the FDA said was the “first major imaging device advancement” in CT in nearly a decade. Naeotom Alpha uses the emerging technology of photon-counting CT, in which each individual x-ray photon is measured as it passes through the patient’s body. This differs from existing CT instrumentation, in which the scanner’s detectors measure the total energy in many x-rays at once. Proponents of photon-counting CT believe the scanners can give radiologists much more detailed images at a lower radiation dose than conventional CT. Photon-counting images have a higher contrast-to-noise ratio, resulting in higher resolution and the correction of artifacts like beam hardening. Siemens claims that photon-counting CT will be the standard within ten years. So, that creates a fascinating thing to watch at this year’s RSNA. What’s the response from Siemens’ competitors like GE, Philips, and Canon? We are probably in for a treat listening to the marketing gurus spin their company messages. GE in 2020 made a major investment in the future of photon-counting CT by acquiring Prismatic Sensors, a Stockholm-based developer of the technology using silicon. But is “Deep Silicon design” enough to blunt the splash Siemens has made? Inquiring minds want to know…..

Mobile imaging solutions featured prominently – As I outlined in a previous post, the options for bringing medical imaging to the point of care have grown with the introduction of portable CT, MRI Ultrasound, and next-generation digital x-ray systems. Hyperfine will be exhibiting its Swoop mobile MRI system. Samsung and Siemens will be showing their portable CT systems. Butterfly, GE, Philips, and others will be highlighting their handheld ultrasound systems. And multiple vendors will be showing redesigned mobile digital x-ray systems. The COVID-19 pandemic and the Hospital@Home movement have prompted health systems to rethink their approach to point-of-care imaging. And, many are adding capabilities to their fleet of services to meet the expected demand.

My most anticipated RSNA reporting – Every year, I look forward to reading Michael Cannavo’s PACSman Awards article on AuntMinnie.com. Michael J. Cannavo is known industry-wide as the PACSman. After several decades as an independent PACS consultant, he worked as a strategic accounts manager and solutions architect with two major PACS vendors. He has now made it back safely from the dark side and is sharing his observations. I had the opportunity to work with Michael during my tenure at Philips Healthcare. And I love his irreverent but highly accurate look at the world of the RSNA technical exhibition. If you haven’t experienced Michael’s annual post, here’s a link to his 2020 RSNA PACSman Awards.

Wild cards – Lots of pre-RSNA online postings (primarily Twitter, Facebook, and Press Releases) from one company about a new system with a “novel x-ray source” that’s going to “revolutionize” digital radiography. (Hint to the vendor: using the term “cold cathode” in your marketing materials doesn’t mean there isn’t heat generated in creating x-rays. Electrons smash into the target/anode, and only less than 1% of the energy is converted into usable x-rays, while the rest gets wasted as heat. Isn’t it wonderful that the laws of physics apply to everyone?) As to the term “novel” x-ray source, perhaps the vendor in question should look at the portable x-ray machine from Carestream, which uses a carbon nanotube, cold-cathode x-ray source. Or, maybe a review of what Fuji and Micro-x are doing would be in order. I’ll reserve the final judgment on this vendor until after the conference. But perhaps I’ll nominate them for one of Mr. Cannavo’s PACSman awards this year.

So, how much of this will I get right? We’ll know after next week is over. I’ll be posting my highlights of the 2021 RSNA in early December. They might not be as entertaining as the annual PACSman Awards, but they’ll include what was discussed and why I think it’s important. Thanks for reading! My sincere best wishes to you and your families for a happy and safe Thanksgiving gathering.

Some Straight Talk on Bringing Medical Imaging to the Patient

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“We offload the equipment, roll it into the setting and we image at the location. At the end of the day, we roll it back into the van and drive away.”

Marty Shirley, President, Diagnostic Services, Digirad.
Image Credit: Shutterstock.com

Mobile medical imaging is certainly not a new phenomenon. Mobile x-ray systems were used on the battlefield in both World Wars. Mobile chest x-ray units could be found on many street corners during the 1950s as the country grappled with the TB epidemic. Even shoe stores had fluoroscopic units in place so customers could check the fit of a pair of shoes before purchase. (Really, I’m not making this up.)

TB unit image credit: American Lung Association
Shoe-fitting Fluoroscope Image Credit: Wired.com

The COVID-19 pandemic has posed many unprecedented challenges to the healthcare system. And imaging providers had to innovate new ways for imaging seriously ill COVID-19 patients while minimizing risk to staff. For example, a new chest x-ray technique implemented during the COVID-19 pandemic of imaging patients through glass produced diagnostic-quality radiographs while reducing hospital costs and infection risk.

Image Credit: RSNA

And health care systems have been providing mobile mammography, CT, MRI for years now.

Image Credit: USA Today

So why talk about this now? – Advances in technology, computerized imaging, AI, and networks have opened up new opportunities to bring medical imaging directly to patients, whether inpatient, outpatient, or in the home or workplace. Also, the cost of some of these systems has been reduced significantly, thus eliminating some of the traditional barriers to entry of other competitors in health care.

What imaging modalities can be delivered to the patient wherever they are? – We are used to providing portable x-ray, mobile c-arm fluoroscopy, and mammography to patients already. Recently, with the development of portable CT scanners, we’ve seen an increase in their use in ICUs, ERs, and ambulance services to help diagnose stroke patients and screen for lung cancer at the point of care.

Image Credit: UCLA Health

What’s new in this space is the development of low-cost technology like portable MRI and handheld ultrasound units. I’ve long been impressed with the work being done by Jonathan Rothberg and the companies he has spun out of his 4Catalyzer firm. Last year, Hyperfine, his portable MRI company, received FDA clearance for their Swoop system. This low-field MRI system can be easily moved, plugged into a conventional wall outlet, and run from an included tablet. Although the system is currently cleared for neuroimaging, the company has plans to expand its use to other areas in the future. Butterfly, his point-of-care ultrasound company, has demonstrated the use of their handheld systems in multiple clinical settings, including anesthesia, cardiology, critical care units, emergency medicine, musculoskeletal imaging, OB/GYN, and primary care.

Swoop Portable MRI Image Credit: Hyperfine, Inc.
Butterfly IQ Image Credit: Butterfly Network, Inc.

“Providing ultrasound at the bedside where the patient really needs it is a huge innovation and a step forward for health care.”

Gary Cohen, M.D., Diagnostic Imaging Chair and Professor, Radiology, Temple University Health System

Where are the business opportunities in mobile imaging services? – In addition to the traditional use cases in both inpatient and outpatient imaging, providers should explore potential business opportunities and partnerships in the following areas:

  • Nursing Homes & Assisted Living Facilities
  • Hospital at Home programs
  • Home Health & Hospice facilities
  • Urgent Care Centers
  • Physician Offices
  • LTAC & Rehabilitation Centers
  • Surgical Centers
  • Behavioral Health Centers
  • Sports Teams – Professional, College, High School, Community
  • Community Health Centers
  • Companies with on-site health clinics
  • Industrial Plants & Refineries
  • Correctional facilities

What are some of the qualifying reasons for mobile imaging services at the point of care? – Insurance carriers will generally reimburse for mobile imaging at the point of care for various reasons. Some of the most common are:

  • Bedridden due to illness
  • Chronic disease
  • Contact isolation
  • Continuous IV
  • Dementia
  • Fall risk/status post fall
  • Injury
  • Medication (adverse side effects)
  • Mentally challenged
  • Pneumonia
  • Oxygen dependent
  • Senile/confused
  • Unresponsive
  • Weakness/frail
  • Wheelchair bound

Benefits of mobile imaging services – Mobile imaging services help care providers conduct many kinds of essential screenings, actively monitor a patient’s condition, and are flexible enough to accommodate patients in any environment. Most importantly, mobile imaging is considerably faster and measurably cheaper than other alternatives. With 24 hour turnaround times and near-instant access to imaging scans through online portals, mobile imaging allows care providers to diagnose issues in a much faster timeframe than third-party providers. This shorter time frame, combined with the flexibility of mobile imaging, leads to less overall operational expenses for care providers.

“If there’s one thing we’ve learned through the hub-and-spoke model we’ve adopted for our health system, it’s that we need to meet people where they are rather than have them travel to us for their care.”

Albert Wright Jr., President and CEO, West Virginia University Health System

My take – I believe that we are at the beginning of a new growth phase in the deployment of mobile medical imaging. The mobile radiology trend is anticipated to receive a considerable push from increasing focus on point-of-care testing and ongoing advances in this direction. The concept is expected to play an essential role in complementing traditional imaging practices and enabling users to perform many radiology examinations effectively. Amid the COVID-19 crisis, the global market for Mobile Imaging Services, estimated at US$1.7 Billion in the year 2020, is projected to reach a revised size of US$2.2 Billion by 2026, growing at a CAGR of 4.5% over the analysis period. The Mobile Imaging Services market in the U.S. is estimated at US$542 Million in the year 2021.

If you take into account the rise in the elderly population, the COVID-19 impact, the increase in hospital at home programs, the increase in the prevalence of cardiovascular diseases, renal disorders, neurological disorders, and cancer, and the increase in the awareness among the people about these mobile services, health care providers should give serious thought to expanding these alternative options as part of their overall imaging strategy.