Previously tarnished by bad publicity surrounding safety scares, the computed tomography market has made major steps to get back into the public’s good graces. Learning from past mistakes, manufacturers, vendors, health care workers and patients are now better-informed and aware, with all eyes on dose reduction. A quick scan of the CT market reveals a number of positive, revolutionary advancements.
Make room: CT market balloons
CT’s use in the U.S. has increased more than twentyfold since 1980. Approximately 70 million CT scans were performed in 2009. Driven by low-dose and high-slice systems, the CT market – estimated in 2010 to be worth $3.4 billion – is predicted to reach $4.8 billion by 2017, with a compound annual growth rate of 5 percent, according to a report published last month by research firm GlobalData.
The expanding role of CT in the diagnoses and early triage of patients with acute and sometimes life-threatening illnesses may be responsible for this rise in utilization, states a study published in August by the American College of Emergency Physicians. CT use is particularly booming in the U.S. hospital emergency department, where one-third of CT scans take place daily.
“CT remains the highest volume advanced modality in the ED, because it’s a very rapid modality and its breadth and spectrum of applications is increasing every day,” says Murat Gungor, Siemens Healthcare’s senior director.
While CT utilization blossoms, new legislation surrounding the market, including the Deficit Reduction Act of 2005, has resulted in a “dramatic” decline in the purchase of new CT equipment, notes Joseph Cooper, director of Toshiba Medical Systems Corporation’s business unit.
“The DRA lowered reimbursement rates for imaging centers to that of the same rate hospitals would receive,” Cooper says. “That wiped out the outpatient CT market over night. After that, we had the recession, health care reform and that brings us to today’s more stable market.”
Meanwhile, Peter Kovamees, marketing manager for ContextVision, an OEM, attributes CT’s flat buyer’s market to its expensive equipment.
“It’s a mature, saturated market with purchases only taking place when CT equipment needs to be replaced,” says Kovamees.
Although it is initially expensive to purchase a digital CT system, a November report by research firm Kalorama states that with continued use, operating costs are lower than with standard radiology. Film and processing are not required with digital systems, the annual cost of which can be as great as the capital cost of standard radiographic equipment. Once a digital system is installed, large film storage facilities are no longer needed.
“Big buyers with large budgets are again starting to actively look into premium CT scanners at affordable prices,” Siemens’ Gungor says.
Four dragons dominate the consolidated global CT systems market, accounting for more than 74 percent of the market share: Siemens Healthcare, GE Healthcare, Toshiba Medical Systems Corporation and Philips Healthcare.
“After a lull, it seems interest in CT equipment is revving back up internationally,” says Ben Powell, marketing manager for medical equipment manufacturer, NeuroLogica. “Some countries that weren’t hurt by the economic turndown seem like they are pretty interested in purchasing CT equipment.”
While the United States had previously been the largest regional medical imaging market, that market –along with those of Europe and Japan – is experiencing a slowdown in growth. Concurrently, China, India and Brazil’s emerging economies are spending more on health care, with their CT systems market expected to grow at CAGRs of 9 percent and 12 percent between 2010 and 2017, according to GlobalData’s report. Over the past few years, the government partnerships between these developing countries and the manufacturers of diagnostic imaging equipment have significantly increased.
There is a strong link between the use of CT scans and a drop in mortality, according to a study published last year in the New England Journal of Medicine. However, improper use of CT can lead to patients getting much more than they bargained for.
In 2010, the Food and Drug Administration reported radiation overdoses that occurred at hospitals in California and Alabama from 2008 to 2010. For nearly two years, 260 patients undergoing CT brain perfusion scans at L.A.’s Cedars-Sinai Medical Center were exposed to eight times the expected level of radiation doses. In order to prevent similar incidents from occurring in the future, this month in California, the first phase of a law requiring providers to record CT radiation doses and receive state accreditation goes into effect.
More recently, a Sentinel Event alert issued by the Joint Commission noted that in the past 20 years the U.S. population’s total exposure to ionizing radiation has almost doubled. New actions were recommended for hospitals, including using ultrasound or MRI when similar imaging quality can be produced; adhering to guidelines set by the Nuclear Regulatory Commission, the Society for Pediatric Radiology, the American College of Radiology and the Radiological Society of North America; ensuring the proper dosing protocol is in place; establishing effective processes and protocols; evaluating the safety of equipment; and establishing a culture of safety and expanding the radiation safety officer’s role to include patient safety and education of dosing and equipment usage for physicians and technologists.
To scan or not to scan: risks and benefits
Unsurprisingly, in response to the negative publicity, many patients have become hesitant when it comes to getting CT scans.
“Because of a substantial increase in media coverage around medical radiation use and potential effects to the population, there is a generally heightened awareness which has resulted in individual patient concerns,” says Dr. Geoffrey Rubin, George Geller professor and chairman of radiology at Duke University.
Although the media’s attack on CT was “painful” for the sector, Dr. Elliot Fishman, a professor at Johns Hopkins University, notes that it was a good wakeup call, prompting both vendors and providers to be more vigilant about dose levels. He also suggests more patients are beginning to understand that the scans’ positives eclipse the negatives.
“The chance of getting cancer from a CT scan is a theoretical risk – you are more likely to get into an accident on the way to the scan,” he says. “The way you have to look at it is the risk of not getting a CT scan far outweighs the risk of getting a CT scan.”
Accidents aside, exposure-risks associated with standard CT procedures differ depending on the patient’s age, gender and size, along with what part of the body is being scanned.
“In general, young people are most at risk and this gradually diminishes with age,” says Rubin. “Risks are relatively greater for scans of the neck, chest, abdomen or pelvis and less for scans of the head and extremities.”
Additional concerns include potential discovery of incidental findings that require subsequent medical evaluations but may not improve outcomes. And understanding the relationship between hospitalization decision-making and CT use has implications for policy and health care system costs.
The Journal of the American Medical Association published in November by Stanford researchers claiming patients who had high-resolution CT scans to check for heart disease ended up having far more invasive tests and follow-up procedures for a cost of $4,000 more per patient than those who underwent basic stress tests. The study did not determine whether those extra tests and surgeries translated into healthier outcomes.
CT scans can also help to reduce the length of time a patient spends in the hospital and provide a net overall reduction in the cost of care by making diagnoses immediately available – this decreases the likelihood of other tasks or invasive procedures being required to determine what is wrong with the patient.
“When the public looks at the value proposition of CT scanning, it is critical to understand that the impact of the CT scan is very broad,” Rubin says.
Indoctrinating the doctors
Although the machines at Cedars-Sinai were functioning properly, the FDA found that improper use had resulted in the increased radiation doses. Fortunately, most companies that equip providers with CT equipment incorporate rigorous training programs and helpful resources.
“You can innovate until the cows come home, but if the CT equipment is not utilized and implemented in the best way, it will mean nothing,” says Gungor. “Long hours of professional training are needed to ensure the tools are utilized in the correct way.”
Fishman adds that just because a scanner can give a low dose, doesn’t mean it is actually giving the low dose.
“It’s like getting a Ferrari,” Fishman says. “First you need to know how to drive a Ferrari.”
Toshiba’s customers learn the ropes through free online courses available on the company’s website. CT equipment user manuals, along with scan protocol guides and case studies also provide users with information on best practices. Another company, NeuroLogica, says it sends a clinical application specialist to train hospital technicians for free with the purchase of its CT equipment. Training can take up to two weeks and NeuroLogica aims to make sure everyone understands the CT device before training is completed.
Trends and advancements
Rapid technological advancements have been made in the CT market, particularly in the areas of cardiovascular diseases and cancer. But until recently, progression was stifled due to the modality’s negative publicity, according to Fishman.
“Many vendors felt paralyzed, wondering if they should continue to invest in CT,” he says. “People began to realize that CT impacts and saves lives every day; a corner was finally turned and now we are working on the safest ways to implement CT scans.”
CT systems’ advancements include increased speed and additional safety features; but the biggest trend has been the focus on dose reduction.
“More and more vendors are offering solutions to minimize dose and optimize image quality,” says Heather Pierce, sales and marketing manager for Computerized Imaging Reference Systems Inc., a phantom manufacturer.
Dose reduction technology enables the separation of noise from structure through mathematical algorithms; thereafter, relevant structures and clinical areas are separately enhanced, without simultaneously creating more noise. This results in a clearer image with better clinical visualization. According to GlobalData’s report, positive clinical evidence of the benefits of using low-dose CT systems on cancer patients is expected to further fuel the market’s growth.
“In the past, it has been a slice war and customers have purchased more equipment than was truly needed,” says Chris McHan, business director and general manager of Neusoft Medical, a medical equipment supplier. “Today, customers are purchasing the equipment that is most appropriate for their clinical needs without all the extra software. The main concerns in the industry are dose and the continued hesitation to buy based on uncertainty regarding government spending and mandates.”
In an effort to reduce costs and increase workflow, NeuroLogica developed BodyTom, a portable full body CT scanner that can be wheeled around the hospital as needed. BodyTom received FDA clearance in early 2011.
“In the past, you had to have an expensive installation, which would involve crews coming in and disturbing workflow,” says Powell. “With our portable BodyTom, this is eliminated.”
Traditionally, patients were scanned with 120 kV; last year this went down to 100 kV; and now it has been reduced to 80 kV. Limiting kV from 120 to 100 reduces dose by 30 percent, while limiting kV from 120 to 80 reduces dose by 60 to 70 percent, according to Fishman.
“It’s easy to scan at low dose, but low dose becomes low information and then the study has not been at all worthwhile – it’s about getting the best of both worlds: the same information with lower dose,” he adds.
Dose levels can be minimized through hardware, such as active collimation or beam filters; and software, such as noise reduction tools and adaptive iterative dose reduction software, including Toshiba’s Boost3D and Quantum Denoising Software, which can achieve a dose savings of up to 50 percent.
Supporting the Medical Imaging & Technology Alliance’s Radiation Dose Reduction Plan and its CT Dose Check Initiative, Toshiba installed the first Aquilion ONE CT system featuring Toshiba’s Dose Check Software and additional low dose technologies last year. Computerized imaging reference systems also offer devices that can be used to measure the dose delivered during different CT protocols.
There are many different methods of iterative reconstruction currently implemented or in development, allowing comparable image quality at lower dose. One of the main challenges is that previous metrics of image quality used in the last 60 years have proven ineffective when it comes to assessing the image quality of CT images produced by IR.
In November, Siemens Healthcare’s iterative reconstruction algorithm SAFIRE – Sinogram Affirmed Iterative Reconstruction – received FDA clearance. This new generation of image reconstruction software and hardware aims to reduce radiation dose by up to 60 percent in CT exams and improve image quality.
“It has been difficult to properly evaluate the effectiveness of these iterative reconstruction methods or affirm manufacturers’ claims of improved quality or reduced dose,” says Ehsan Samei, a medical physicist at Duke University. “New metrics of image quality are needed for that purpose.”
Another increasing trend involves the utilization of hybrid modalities such as positron emission tomography/CT and computed tomography laser mammography, to enhance CT systems’ applications. Hybrid modality systems are medical practitioners’ preference when diagnosing cardiovascular disease, cancer and Alzheimer’s disease. GlobalData’s report notes images of increased metabolic activity in diseased tissues obtained through other modalities, such as PET and SPECT systems, can be superimposed onto the anatomical images produced by a CT system through use of hybrid modality systems.
High-slice CT systems capable of producing high quality cross-sectional images or slices of a whole organ in a single rotation are another recent advancement. This reduces diagnosis times and radiation exposure. Perfusion CT scans and colonoscopy CT scans are also growing in popularity.
“Moving forward, I think we are going to see a greater proliferation of advanced tools that will provide radiologists with the capability to more consistently reduce exposure,” says Rubin. “The potential opportunity over the next several years is to perform CT scans with four to five times less dose than has routinely been applied.”
Monitoring and tracking
In November, the American Medical Association House of Delegates endorsed new policies aimed at reducing radiation exposure from diagnostic imaging for all patients. The policies call for raising standards for technicians who use CT devices, increasing radiation risk awareness and tracking a patient’s lifetime exposures.
A patient’s previous number of CT scans is relevant, but the cumulative impact of multiple CT scans remains unknown. Regardless, the decision to perform a CT scan should be informed by the medical need at the time, according to Rubin.
“It is important to remember that the latency of cancer development from a CT scan is on the order of 15 to 20 years,” he says. “If we are trying to give a patient with a chronic disease another two or three years of life, then the number of CT scans they have had is really not relevant to this goal.”
To help monitor how much radiation patients actually receive, in an effort to provide the optimal radiation dose to each patient, Samei and his colleague Olav Christianson created software that matches data from CT scanning devices with information about the age, gender and body part scanned for every single scan. The database currently contains information from roughly 10,000 CT scans.
“We are still in the process of collecting data, but already the software has confirmed that [Duke] uses very low levels of radiation during CT imaging and has also identified several possibilities to improve the consistency of image quality from patient to patient,” Christianson says.
An initiative born out of Duke’s dose monitoring program is developing guidelines for target dose values for specific CT exams based on the patient size. This will enable the technologist to know prospectively whether the dose would be consistent with the patient’s characteristics before the exam’s initiation.
“CT will continue to play an increasing role in medicine, to the benefit of our patients,” says Samei. “With the use of smarter dose monitoring programs, we can ensure that the CT utilization is optimized in providing the highest level of benefit at the lowest possible dose, and to ensure that the radiological medicine remains the judicious steward of public trust.”
DOTmed Registered CT ISR 2011 Companies
Names in boldface are Premium Listings.
Doug Anderson, DGA Medical,LLC
David Denholtz, Integrity Medical Systems, Inc.
Ed Ruth, Managed Medical Imaging
John Pereira, United Medical Technologies Corp.
Todd King, KING Equipment Services, Inc
Bruce Hull, Network Imaging Systems
Eric Smith, SOS Medical Imaging
Albert Dennis, Tech Med
Christi Kukes, DMS Health Technologies
Sal Aidone, Deccaid Services Inc.
Paul Zahn, Shared Medical Services, Inc.
Mads Vittrup, AGITO Medical
Imad Muati, IMC
Marc Baldini, Link Medical Systems Europe
Osvaldo Lara, SMA
Haitham Khoury, MEDMACK
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Vasant Sohoni, Vasant Sohoni & Associates
Varun Bansal, ABDIEL BIOMEDICAL SERVICES
ali yousefi, tajhizgistar
Jose Morillo, J Morillo Sistemas Biomedicos