This month, the experts weigh in on readers’ concerns over purchasing and servicing mammography equipment amid today’s advancing technology and slow economic recovery. Responders include Regina Earnest , senior director of women’s health at Siemens Healthcare; Kenn Dickinson, Diagnostic Imaging QA Product Manager for Fluke Biomedical and Sameer Kankitar , an in-house biomed at Saint Clares Hospital who has worked on mammography equipment for 15 years.

TechNation: What are the biggest trends right now in the mammography equipment market?

Dickinson: Mammography equipment is being influenced by four main innovations in the market today. First, multiple target filter combinations are now able to customize beam hardness by utilizing new materials like Tungsten-Silver and Tungsten-Rodium. Mammo machines have also gone digital, which has enhanced full field shots and allowed for 3D imaging. Another recent advancement is FDA approval of the new Hologic Dimensions Tomosynthesis 3D imaging technology. With tomosynthesis 3D imaging, a technician or radiologist can create images at different angles and planes similar to CT scans. By combining the powers of mammography and CT, hybrid imaging is creating more anatomical and structural imaging, resulting in more and better information.

Earnest: : I think you have two trends that are in parallel. The first is an ongoing transition from analog to digital. About 30 percent are still operating with analog equipment. The rural hospitals are still on analog, and because of the economy I think the transition actually got slowed down in the last two to three years. Related to that trend, you do have the transition to going to a PACS environment. In the past when you looked at the early mammography equipment, you always had a dedicated workstation with it. Over the last two to three years, the PACS vendors have made much more of an effort to offer a mammography module on the PACS, which is what the customers are looking for. The module allows them to use the PACS system that they have in place already (cost savings) and are used to.

Looking at what is happening right now and going to the future is obviously the 3D mammography application, so I’m talking about tomosynthesis. It’s going to be a lengthy process. We currently have one vendor in the U.S. approved to offer tomosynthesis. Siemens offers a product outside of the US and we have about 150 sites using tomosynthesis clinically. The reason it is a slow trend is first because there is no reimbursement here in the U.S. for tomosynthesis. We are probably looking at 2013 or 2014 for that, so this is one point that is holding up the general adoption of tomosynthesis in the U.S.

The second is the clinicians are not all in agreement on how to use tomosynthesis, and who to use it on. There are many opinions in the U.S. clinician world on how to use and apply tomosynthesis, and I think it is the vendors’ responsibility to prove superior clinical information of one method vs. another. Out approval process is to take all these different varying opinions into account and offer a product that can be used most versatile. However, this requires a fairly large sample size and therefore takes much longer to get approved.

Kankitar: : Digital Mammography has evolved, and OEMs are capitalizing on full field digital mammography technology. The latest trends are as follows: reducing the radiation dose to the patient without affecting the image quality and better diagnosis tools for radiologist with intelligent computer aided diagnosis (CAD) software.

TechNation: How will the market for mammography equipment evolve in the next five years? How will that affect service of the equipment?

Dickinson: Advancing technology will soon allow machines to utilize on-board dose measurements, which will increase user confidence and patient safety. Machines will become better at self-monitoring and testing, but independent quality assurance will continue to be vital to validating machine integrity. MQSA guidelines aren’t expect to change in the near future, but with the advent of 3D imaging it’s possible new guidelines focused on testing protocols for tomosynthesis 3D imaging may be on the horizon.

Earnest: : I think you’re going to have early adopters, who for whatever reason think they have to have the new technology right now. It is probably below 3 percent, but [these facilities] are used to having the top-notch procedure and application available, or they fear competition down the road. They will purchase tomosynthesis right now. But typically the adoption bell is going to apply for tomosynthesis as well, where I don’t think you will see a general adoption until three years from now, until reimbursement is established. So for service engineers, I don’t think on a general basis they have to worry about it right now, but they do need to be ready for two years from now where you’re probably going to see more adoption.

In the PACS environment, I think service needs to definitely be better prepared than what we are today in how the data management, specifically of mammography data, works in a PACS environment. You re dealing with large amounts of data. Taking the digital transition and tomosynthesis into account, we are moving into very large data sets. To give an example, a typical mammogram today has a size of about 100 megabytes. However, going into the 3D world, we’re looking at 2 gigabytes or more. So for service engineers, there definitely needs to be some awareness and training on the data management piece.

Kankitar: : The cost of ownership is the main driving factor. The digital mammography needs following components/hardware: digital mammography system; review/processing workstation like Advantage, Mammoreport, etc.; PACS (PACS systems have to be IHE compliant to be considered as a review station for mammography. Very few PACS vendors are IHE compliant. A lot of companies claim but are not truly IHE compliant); a hardcopy camera for diagnosis, recordkeeping and patient records.

The market is sectorial/regional: North America is used to digital evolution, and many customers will be changing over to DR. South America is high on CR for mammography; DR is yet to pick up in that region due to high cost of ownership. Doctors are using CR cassettes with analog mammography and CR reader. Asian countries like India, Philippines are warming up to DR, even though cost remains to be the main concern.

The concerns for an in-house biomed department are cost of flat panel detector. There are not many resources/vendors other than OEMs to purchase the detector. It means you will have to either sign the service contract with detector coverage or use insurance to cover the same. Some OEMs are showing flexibility to offer shared service agreements with shared labor and parts liability.
OEMs protect the service software with license and you may require service key for even changing the IP address of the machine. This is another way of forcing the end user to buy the service contract. This is the benefit of purchasing GE mammography compared to Siemens. You have lot of freedom with GE service software compared to Siemens.

TechNation: What are some of the biggest challenges of purchasing and servicing mammography equipment today?

Dickinson: Facilities first need to understand their use model so they can determine which form, fit, and function will accommodate them, and whether new or used machines are required to adequately meet their needs. Regardless of machine age, service is a key – and sometimes difficult – component in the buying decision. Service may either be included in a package deal with the machine from the manufacturer or in-housed in partnership with the biomedical or clinical engineering team – a model that can potentially save facilities significant money. In-house clinical engineers and biomedical equipment technicians can be key in keeping radiology on time and profitable because they allow for swift first-call response, eliminate costly field-service expenses and can dramatically decrease down time. However, this hybrid-type service model may require investments in training and technology in order to be successful.

Earnest: : I would look at three areas. One, there definitely needs to be research done on the data compression being done by each vendor, and that’s more on the PACS side than actual mammography equipment side. Data compression can make a huge difference on how large a data file is, because keep in mind a mammogram file must be stored by law for 10 years. So it’s important to do the proper research on the amount of data and how the compression is being done.

Another is how the images are being routed, so connectivity is really the big piece behind that, and there are different pieces when it comes to dedicated stations versus PACS. Proper routing and viewing (image quality) is dependent on DICOM standards and IHE compliance. Both pieces have to be researched properly.

The third area is around workflow, and that goes for either transitioning from analog to digital, or from 2D to 3D, because your workflow is going to change, so you may have to consider the setup of the equipment, and you may have to consider the virtual routing. Originally the clinician had to be on site, but we’re far from that now with virtual reading capabilities. So I think those are new concepts that again are not necessarily knowledge that is available.

Do research in these three areas. The first two are more questions to the vendors. The third involves getting a group of people internally together and asking questions around the workflow.

Kankitar: : Cost of ownership is high; you need IHE compliant PACS with 5MP or higher resolution monitors for diagnostic capabilities of mammography; you will need a hardcopy camera to print images to give it to Patient or radiologist for review and you may need a processing station or dedicated review station from the vendor based on radiologist preference. A lot of hospitals have dedicated review station from the vendor like the Advantage workstation, Mammoreport workstation, etc.

TechNation: Please share your advice for people in hospitals that are faced with these challenges.

Dickinson: Bring your medical physicists and biomedical/clinical engineering experts together to discuss the service model that is best for your facility. The right service model should protect your investment, profitability and caseloads, and of course patient safety. If you decide an in-house or hybrid service model is best for your facility, a good tip is to include the service manual and any needed training as part of your equipment purchase order.

Earnest: : The biggest advice I have is to include your PACS administrator. I am involved in so many projects where the PACS administrator might be a technologist who has never received proper training and is completely overwhelmed, and rightfully so, if these standards are not available and not given. Make sure ultimately that the images are seen on the PACS are DICOM and IHE compliant are shown in the right settings. In mammography we are looking at tiny lesions, so if any of the settings are not appropriate we will miss a diagnosis, and that becomes obviously a legal matter.

I think the other consideration is knowing what you want to offer in the future, so for example, if you have a large health care network that has five satellite clinics and one hospital, understand where you want to be five years from now. For example, if you will be doing only screening mammograms today but add 3D capabilities in the future in clinics, understand that and with that understand what platform you will require to be able to add future applications as they become available. To be more specific, some vendors offer platforms that cannot be upgraded to support tomosynthesis in the future.

Kankitar: : It is advisable for upgrade to DR. It has its advantages, even though cost of ownership is high. If you have PACS, please verify that PACS vendor is IHE compliant. It will save you money from buying dedicated processing station from the OEM. If you have Hardcopy Camera, please verify that it can be configured for use with Mammo. Please check with the vendor about service training, and contract offerings. Hospital always saves money with less dependency of OEM contract. Please consult your In-house biomedical/Clinical engineering before signing the deal. Please check the pricing, and life expectancy of flat detector, software, and other hardware. Please assign the super user for performing the QA, and other regulatory documentation process.

TechNation: What else do you want TechNation readers (biomeds) to know about purchasing and servicing mammography equipment?

Dickinson: If you’re looking for a hybrid service solution between radiology and biomedical/clinical engineering, Fluke Biomedical is available to assist. We have a long history of serving the needs of medical physicists and hospital radiation safety professionals. Fluke Biomedical offers a full line of diagnostic imaging test and measurement products, including X-ray test devices, dosimeters, ion chambers and phantoms.

Earnest: : With the economy being the way it is, the lifecycle for mammography equipment has increased substantially. We’ve estimated seven years in the past, but I truly believe it is more like 10 or maybe 11 years in today’s world. Know that what you buy today, you’re stuck with because of a cost prohibitive approach of a forklift replacement later. So investing in the research about the data management, workflow, projects and future visions within your health care network is definitely worth taking the time. Go on site visits and talk to the users. Have the potential customer or end user talk to the biomed engineers at the hosting site and ask what the serviceability of the equipment is. Ask the vendor if there is a site available that has the same PACS setup [as your facility], and visit that site. This is critical.

The last piece is research the programs vendors offer for biomed engineer training. At Siemens, we offer biomed engineer training, and they sit in the same classroom as our service engineers, so there’s no hidden agenda or hidden information.

Kankitar: : There are not many third party providers for Digital Mammogrpahy. It is in the best interest to negotiate with the OEM to support the In-house program. We have 5 GE digital Mammogrpahy machines from GE. We support them In-house without any service contract. Readers are more than welcome to contact me at sameerangio@gmail.com for any more questions or concerns.