With its lower cost, CR mammography opens the doors to the digital age
For the past few years, DR-enabled full-field digital mammography (FFDM) has been the breast imaging gold standard, transforming women’s health services. This transformation has delivered faster throughput and more accurate diagnostic results. However, its cost has made it a prohibitive modality for many facilities that have access to fewer resources and/or have multiple locations.
But that changed with the approval by the US Food and Drug Administration (FDA) of Fujifilm Medical’s CR mammography system, ClearView-CSm, in July 2006. With its lower cost, Fuji’s digital system is allowing health care systems around the country either to enter the digital realm for the first time or to expand their digital reach to lower-demand offices. Currently, Fujifilm Medical has the only FDA-approved CR device on the market.
Although it is opening the digital market to more health care organizations, there is a sense that CR mammography—as embodied by the ClearView-CSm—is not as good as the older FFDM. For instance, according to Rose Heller-Savoy, MD, of the Montclair Breast Center, Montclair, NJ, because it does not render an instantaneous image and has lower throughput, CR mammography has to be limited to screening and diagnostic procedures. “In a screening center, it’s not as big a deal [not to have instant results],” she said.
In reviewing the medical literature, Heller-Savoy said that DR-enabled FFDM seems
to have a slight edge over CR mammography in terms of image quality. However, she added that CR mammography is a great option for those who want to add digital mammography to their practices, particularly those who have low screening volumes. Because of its smaller size, the CR is also portable. “If you have the means, FFDM is the choice; otherwise, CR is a great first step,” she said.
While the literature may support this viewpoint, the reality may be a bit more complicated.
When McKee Medical Center, Loveland, Colo, introduced the ClearView in October 2006, it experienced a massive paradigm shift. Until that point, the organization’s six radiologists had been using film. And the results were “phenomenal,” said Cherlene Goodale, CRA, director of medical imaging. But with digital’s improvement over film, Goodale found that she had some hurdles to overcome, primarily with her radiologists.
“Because you can see the image so much more clearly, there was a fear that they may have missed something [in a past exam],” she said. “And for years the [radiologists] were used to hanging up the films on the light box, and then you had to go to a computer monitor. Some of the guys loved it from the beginning. For others, film is their security blanket.”
To that end, after the first week, Goodale had to put her foot down; she banned her physicians from using film, and they had to produce only digital images. And that forced those who were wary to adapt. The result: a happy ending. “Once [those resisting CR] got on board and made the adjustment, they loved it,” she said, adding that the technologists, as a group, were a little quicker to accept the CR than their radiologist counterparts.
While the research indicates that the speed of CR is not as good as that of DR-enabled FFDM, Goodale has found that it has increased the speed and efficiency of her department significantly. “We’ve seen some savings in time. The radiology technologists don’t have to handle the film or a film jacket, and don’t have to deliver it to the radiologist any longer. That saves a few seconds here and there, and it adds up,” she said. The facility does about 640 mammograms a month, and with its four ClearView devices, the backlog is only 3 to 4 days; Goodale said the average is about 6 weeks in many facilities.
Asked about the controversy over whether DR or CR is better, Goodale answered in the most pragmatic of terms: “The end result is a digital image—end of story.” And this attitude transcends Goodale’s perspective. Her radiologists use the ClearView for both screening and diagnostic procedures, and for all interventional procedures except those using the stereotactic breast biopsy table, which is also digital and feeds the digital image into its Fuji PACS system.
The comfort level that Goodale and her radiologists have with the technology is not surprising to Fujifilm Medical.
Although the ClearView is a new product on the US market, Fuji introduced the device worldwide in 2004. But the ClearView is not as new as it seems, noted Andy Vandergrift, Fuji’s national marketing manager, women’s health care imaging. The company has had CR mammography systems in place since the 1980s, making it a “proven technology,” according to him.
And, echoing Goodale, he notes that CR is a digital technology. “It’s really about image processing. [Fuji and its competitors] do a good job capturing the image,” he said. “The multiple plate reader ? offers a very DR-like workflow.”
The ClearView reader comes in two models. The Dual Side features a 50-micron display with a throughput of between 65 and 80 images per hour, depending on the image size, with a cycle time of 75 to 85 seconds. The HQ features a 100 micron display, a wider variety of image sizes to choose from, and a higher throughput rate of 103 to 165 images per hour, with a cycle time of 40 to 60 seconds. The footprint is relatively small at 24 inches by 29 inches, and can fit in the smallest examination rooms. The unit looks much like a standard computer.
As for the ClearView being best suited for small or rural facilities, Vandergrift says that several large organizations, among them the University of North Carolina, have purchased the viewer. He does admit that the lower price point is a contributing factor to its growing popularity. Since introducing it to the US market, Fuji has sold more than 100 units; it has 3,600 units in place throughout the world.
Price was an issue that Goodale considered when converting to digital. “I could convert the entire center to CR—and that made a lot of sense to me,” she said. This meant that she would be able to use all four of her mammography rooms and keep her backlog down to just a few days.
But performance and lower price may not be the only issue driving sales. The ClearView is also very easy to install.
The ClearView runs off a standard 110-volt wall socket and can be connected directly to an existing computer network. Although, theoretically, it could be taken out of its packing box and plugged right into the wall, the installation process is a little more involved and precise. Fuji sends out a full team of technicians and application trainers. The technicians work with the facility’s physicist and IT staff to get the system online.
In the case of McKee Medical Center, the process took more than a week and involved a staged installation, with two rooms installed at a time. As part of the process, the technicians had to take an image and transmit it to the American College of Radiology (ACR) in order to get certified. The system then had to be unplugged until approval from the ACR was obtained.
The company supports the system in a number of ways. It has an 800 number clients can call and troubleshoot problems. It also can provide remote assistance through the PACS.
Installing the CR has meant an immediate increase in space for McKee Medical Center, said Goodale. The film processing equipment has been removed, and each year old films will be taken out of the film storage system until, eventually, all patients’ past studies will be digital.
McKee also has a Fuji PACS system, which allows all of the images to be archived and easily accessed by staff. The elimination of lost films is another benefit of moving to digital, said Goodale. “That’s a huge issue, and [when it happens,] it’s horrendous for the patient and us,” she said.
While the Fujifilm Medical technology has been a boon for McKee Medical Center, it is the only CR mammo system available on the market. And that could spell trouble for facilities using other imaging modalities and PACS systems from other vendors. Fortunately, there is a vendor-neutral solution that leverages the ClearView even further.
|Fujifilm’s FCRm ClearView-CSm is a multi-plate digital mammography image reader and is ideal for centralized locations.|
Along with the worldwide introduction of ClearView comes Merge Healthcare, Milwaukee, introducing Merge Mammo. This vendor-neutral interface allows facilities to implement and integrate multiple vendor solutions.
Merge Mammo is a reading solution housed in a simple computer tower and includes a 5-megapixel flat screen monitor, either a standard or 10-button mouse, and a keyboard. The system is based on a Windows interface and can be configured according to the user’s needs. Merge offers a first-year warranty, which includes regular system upgrades.
When it installed Fuji ClearView in its new outpatient clinic in May 2007, Milwaukee-based Aurora Health Care needed a vendor-neutral solution to interface with its Emageon PACS system and other imaging modalities. Being in a multivendor situation, it was imperative that the health system, which includes 13 hospitals and 120 clinics, could interface the ClearView with its other imaging equipment.
Jay Lundberg, manager of capital equipment technology at Aurora Health Care, explained that, in addition to offering a vendor-neutral product, there were other reasons Aurora chose Merge. “It’s a local company and has [good] service support,” he said. “It could bring all of the [mammography vendor] images together and [uniformly resolve] the different image sizes of each system. If you can’t resize, that adds a lot of complexity for the clinician.”
Before implementing Merge, Lundberg arranged a demonstration for six of Aurora’s radiologists. “It was very intuitive, and they seemed to pick it up pretty readily,” he said.
Merge’s experience with Fuji in Europe was another deciding factor in Aurora’s decision to purchase the viewing station. “I had hoped that [the spirit of cooperation] would continue,” he said, and it did.
Installation was a bit more complex than it was at McKee Medical Center. There were technicians from the analog imaging vendor, Fuji, Merge, Emageon, and Aurora’s IT department. “It was a complex process, but a good experience,” said Lundberg. “Everybody was willing to work together to be successful.” After installing the Merge system, the radiologists received 3 days of applications training.
The move from analog to digital has been readily accepted by the radiologists and staff as they settle into their new facility. “They’re excited about it—the step from the past to the present has been a positive one,” said Lundberg.
There’s no doubt that digital is here to stay, but the bigger question is whether CR will be a sustainable technology.
The Future of Digital Technology
|Fujifilm’s FCRm ClearView-1m is a single-plate digital mammography image reader.|
For a multivendor site such as Aurora, the issue will continue to be about the ability to handle interoperability. And that means having a very particular perspective. “Digital imaging is still an emerging technology, and we have to be cautious,” said Lundberg. “We have to make sure that we pick the right partners. That’s critical. You have to be flexible.”
He adds an optimistic note for the future for facilities that may be struggling with a multivendor situation. “I have talked with other display companies, and everyone is working toward a vendor-neutral [solution],” he said.
Looking back on her move to digital radiology, Goodale said that the one thing she would have changed was working harder to prepare her radiologists for the shift from handling film to looking at a computer monitor and manipulating a more sophisticated image. “The learning curve was huge, and I didn’t understand that until we did it,” she said.
In terms of sticking with the technology, Goodale said that she will probably transition from CR to DR-enabled FFDM when the ClearView machines wear out, but she noted that they “last a long time.”
She also foresees ClearView helping smaller organizations by pushing down the price of DR, making that another affordable option.
Heller-Savoy believes that “digital mammography is the future” in terms of screening and diagnosis. She also believes that “CR will always be around.”
C.A. Wolski is a contributing writer for Medical Imaging. For more information, contact .