January 28, 2008

Scalable Digital Mammography — Solis Women’s Health Finds Flexibility in CR Mammography
By Dan Harvey
Radiology Today
Vol. 9 No. 2 P. 14

Solis Women’s Health decided to implement Fujifilm’s Computed Radiography for Mammography (FCRm) system in its eight Dallas-Fort Worth area breast imaging centers in 2006. The project provides an example of how CR mammography can fit into a large, distributed private practice environment.

“We adhere to the hub-and-spoke concept to extend our geographic reach,” says Gerald R. Kolb, JD, the organization’s chief knowledge officer. “We will have comprehensive breast centers, as well as mammography-only centers.”

Solis first implemented Fuji’s FCRm system at its Denton, Tex., site. “We started there because it was a new facility with no existing mammography technology, so it provided us an opportunity to equip a new site with digital technology,” says Kolb.

Solis’ decision to go digital was motivated by several factors; first and foremost, the time had come for such a move. “Many competing facilities had already gone digital,” Kolb says.

Also, the technology was strongly validated by the Digital Mammographic Imaging Screening Trial (DMIST) study. Findings from this landmark study published in 2005 indicated that digital mammography more accurately detects breast cancer than film mammography in significant subsets of the screening population. CR mammography was one of four digital mammography technologies used in the trial, and Fuji’s FCRm—the second most-used—produced 30% of its studies.

Attainable Solution
While Solis’ management acted after DMIST findings provided compelling evidence, many women’s healthcare professionals still perceive full-field digital mammography (FFDM) implementation as something that’s presently unattainable at their facilities. Often, that assumption arises from the costs and conversion complexities related to going digital. But CR mammography can be a less-expensive and more easily implemented alternative that better integrates with existing mammography systems, making digital mammography a cost-effective option, even for facilities with modest volumes.

In selecting a digital solution, Solis evaluated all available FFDM systems in search of the technology that provided optimal image quality, and physicians were encouraged to provide input. “The ‘go/no-go’ decision for all technologies was based on physician acceptance as far as image quality,” says Kolb. “We wanted them to be comfortable with the images. FCRm more than met physician requirements. Some did not expect to be wowed by CR, but they were.”

Evaluation also included how the system would impact technologists, particularly concerning ergonomics and mammogram delivery. “We wanted our technologists to be completely comfortable with the ergonomics and acquisition process,” says Kolb. “One of the great benefits of CR is that there is little in the way of transition, as the basic mammography platforms are retained.”

Solis also evaluated the economics of implementation, which included a detailed financial analysis involving elements such as service contracts and the potential impact of downtime on productivity. As Kolb points out, increased dependence on technology is an unintended consequence of going digital. “If a digital room goes down, you have to reschedule all of those patients who cannot be served for at least the period of equipment downtime. With the volume of patients we see, this can mean a great inconvenience to a large number of patients,” he explains.

In this regard, Solis felt comfortable with Fujifilm’s track record. The system has a history of successful overseas implementations, with more than 4,000 FCRm units worldwide.

Solis’ financial analysis also included life cycle costing projections. “We costed the units by projecting maintenance and capital expense over the life of the equipment,” says Kolb. “With a new technology like this, that included the cost of the service contract.”

In the final analysis, Solis deemed Fuji’s FCRm solution to be the most cost-effective. “However, I must stress that cost was not our primary decision point,” says Kolb. “Image quality must meet clinical expectations, or you will sacrifice clinical quality. We would never consider doing anything that would compromise our patients’ care in any way.”

Digital Transition Challenges
Once the system decision had been made, Solis faced several implementation challenges, including infrastructure. “We converted to a completely digital infrastructure, including the radiology information system [RIS], at the same time that we went to digital mammography,” relates Kolb. “This was somewhat difficult in an environment where computer literacy levels varied. It was a big leap, but we successfully moved through the challenges.”

Image interpretation posed a substantial hurdle. According to Kolb, Solis’ physicians specialize in breast imaging and had absolutely no experience with interpreting in a digital environment. This presented a learning curve, as digital technology enables more interpretive opportunities than film. “It took our physicians between two to six months before they felt truly comfortable utilizing digital workstations,” recalls Kolb.

But he’s quick to point out that the learning curve for technologists was practically nonexistent. “They’re still using conventional equipment while processing images in FCRm,” he says. “They were ecstatic because digital made everything so much more efficient for them, and they could review the images without leaving the mammography room.”

Checking Priors
A major challenge in the digital transition—whether a facility selects CR or DR mammography—involves reviewing and comparing prior exams that are part of screening and diagnostic mammography. Solis tackled this problem by digitizing images acquired in the analog format and placing them into storage.

“Because of the nature of our organization—we’re an expansive network—we simply did not want to maintain film library architecture along with the new electronic infrastructure,” explains Kolb. “We needed to move to a completely electronic infrastructure as quickly as we could. It’s difficult for a physician to use an alternator and a soft-copy monitor in the same room at the same time because of the different light levels produced by each viewing platform.”

Digital infrastructure allows the movement of images and information to the physician rather than moving the physician to the data. “In our diverse network, we need to be able to move images quickly. Digital infrastructure removes the tyranny of the physical file, making for a much more efficient, productive, and clinically excellent environment,” says Kolb.

Solis manages digitized images with PACS and handles mammography priors by digitizing two years’ worth of priors for its patients. “Before the patient’s visit, we digitize two years of priors, so they’re in the PACS when the new, digital images are taken,” says Kolb.

So when a patient arrives for her first digital mammogram, her priors are available at the technologists’ workstation for viewing by the technologists and on the PACS network for comparisons by the physicians.

“We utilize a robust but breast-specific PACS,” Kolb says. “We store all of our images locally until we are done with them for the year and then they go into archival storage until we recall them to the local system for use when the patient returns the next year.”

Further, Solis also integrated its PACS and RIS to enable physicians to easily access patient data from either system. While the two systems involve separate software, people involved in the clinical process have seamless access to all the information, according to Kolb.

Acceptance Pattern
The other potential sticking point is user acceptance. As Kolb indicates, Solis’ technologists readily accepted the change. “They took to it very quickly,” he says. “Reducing the walking they had to do everyday, as well as eliminating the smell of developer chemicals, were great rewards.”

But radiologist acceptance was slower. “The transition represented a major change in how they read images,” Kolb says. “Initially some were more accepting than others, but we’ve reached a point where all of them have accepted the technology. Looking back on the experience, the change for the physicians was much greater than we had anticipated during the planning process. The good news is that everyone made the transition in fine shape, and [they] are amazed at the increase in information that they find in the digital mammogram.”

Generally, this is the pattern with Fuji’s FRCm implementation, says Andrew Vandergrift, national marketing manager of women’s healthcare imaging for Fujifilm Medical Systems USA.

“Once they’ve completed the necessary education, technologists love it,” he adds. “They don’t have to deal with any more film, and their work becomes so much more efficient. Plus, because the images can be immediately viewed, they can release patients with much more confidence. It doesn’t take long for them to perceive the advantages of digital.”

Vandergrift agrees with Kolb that radiologists face the bigger transition challenge because of the need to view priors on film. But this problem will fade as the relevant priors go online and the entire imaging world completes the transition to a digital environment. “Eventually all images are going to be digital, and, inevitably, film images of priors will be eliminated,” he says.

— Dan Harvey is a freelance writer based in Wilmington, Del., and a frequent contributor to Radiology Today.

For The Big Show?
Many view CR as an option best applicable to the smallest facilities that can’t afford DR.

“In reality, that’s simply not the case,” contends Andrew Vandergrift, national marketing manager of women’s healthcare imaging for Fujifilm Medical Systems USA. Currently, Fujifilm offers the only FDA-approved CR mammography system available in the United States. Carestream Health (formerly Kodak) is waiting for final approval for its CR mammography detector that can be used with several of its existing general CR readers.

“We’ve witnessed CR mammography implementation in settings that range from academic centers to hospitals and to individual imaging centers,” Vandergrift says.

While the Fuji Computed Radiography for Mammography system costs less than direct digital mammography and is more economically viable for single-room, lower-volume imaging facilities, it can also work well in larger organizations, especially centralized imaging centers with multiple satellite locations.

Since receiving FDA approval in 2006, nearly 300 units have been installed throughout the country, including the Greenville Hospital System in South Carolina, a five-campus, 1,110-bed healthcare system that screens 25,000 mammograms annually at its main women’s center and satellite facilities, and the University of North Carolina, a large, high-volume facility.

“Essentially, there are 8,800 accredited sites doing mammography in the United States, and any one of them—whether they’re in a university setting or a breast imaging center in Idaho—can consider CR mammography for full-field digital mammography,” says Vandergrift.

“Digital radiography is typically characterized by an electronic imaging plate,” he adds. “On the other hand, CR has a removable detector in the form of the cassette and imaging plate. That’s the major difference.”

Typically, FFDM DR systems have flat-panel detectors comprised of amorphous selenium or silicon that convert x-rays into digital images. With Fujifilm’s CR, a reusable phosphorescent imaging plate replaces the existing film screen cassette and film in a conventional analog mammography unit.

“The plate is inserted into the existing mammography bucky and it captures the image,” explains Vandergrift. “The technologist then inserts the cassette into a reader, and the information captured on the plate appears on the technologist’s PC acquisition console for image review.”

With DR, he continues, the already existing mammography unit is replaced with a digital mammography unit that contains an electronic detector. The image then comes up on the acquisition console.

Fuji’s ClearView CR image reader device, into which cassettes are inserted, come in two versions: a multiplate reader that addresses the volume of multiple rooms and a single-plate reader that can be installed inside an exam room.

— DH