Sponsored by AUE
By Jim Carr
Unfortunately, many of us have had one or more family members or loved ones that have been affected by breast cancer. Female breast cancer is the most common cancer, with more than 1.5 million new cases worldwide each year. It is the second leading cause of all cancer deaths in the USA. It’s generally recognized that mammography screenings find breast cancer early and increase the odds of survival. U.S. law requires private insurers to cover biennial testing of women age 40 to 74 and U.S. guidelines require the use of digital mammography systems. Those requirements, as well as favorable CMS reimbursement policies for digital mammography procedures and improvements in the designs of new scanners, have helped lead to the installation of many new full field digital and 3D mammography systems (and the de-installation of many analog systems). In the USA, there are almost 9,000 facilities with approximately 19,000 accredited mammography units. Market analysts say the OEMs with the largest market shares for new mammography systems are Hologic, the big 3 (GE, Philips and Siemens) and FujiFILM.
Each scanner requires maintenance and servicing as specified by the OEM. Mammography systems emit ionizing radiation and fall under Part 1020 of FDA law. In addition, because it is recognized that the quality of the images is critical to proper diagnosis, mammography facilities, personnel and scanners are also regulated by a federal law passed almost 20 years ago, the Mammography Quality Standards Act (21 CFR Part 900). Inspection and accreditation of facilities and scanners are required, and certification can be performed by any of four FDA-approved accreditation bodies; The American College of Radiology (ACR), and the states of Arkansas, Iowa and Texas. The FDA gives high priority to mammography, and the inspections are generally the toughest. Although 85 percent of inspections result in no violation, many result in findings that require corrective actions. A little less than 1 percent result in a “violation” which is posted almost immediately on the FDA website. If you browse some Adverse Event and Action Reports, you will find many that say “The facility is believed to be closed.” This is a big reason that a large percentage of facilities use the OEM for servicing their mammo systems. The OEMs tend to further capitalize on this “fear, uncertainty and doubt” advantage by providing advanced tools to their FSEs and trying to restrict access to assemble, install, adjust, test (AIAT) information.
The ongoing medical research regarding the effectiveness of various imaging modalities and recent technological developments are all factors that have helped drive the sales of other types of scanners. Laws that have been passed in almost every state over the past few years require that the patient be notified if they have dense breast tissue, which has led to an increased use of ultrasound for breast exams. Elastography, the most recent ultrasound mode to be approved by the FDA, is virtually 100 percent accurate in determining benign versus malignant tumors. Lots of upgrades, probes and new systems are being sold with that feature, which is typically only available on higher-end models. Magnetic Resonance Electrography (MRE) research has been going on for many years and MRI may provide the best way to distinguish pre-malignant tissue. The combination of non-invasive ultrasound elastography (UE) and MRE promises to eliminate the need for most breast biopsies. Currently, those are often done using stereotactic biopsy systems that shoot a needle into the breast, a rather risky and grisly procedure.
Radiography of the breast, X-ray mammography, is still the primary screening tool for cancer. The most common systems being used in the USA are Full Field Digital Mammography (FFDM) systems. The latest FFDM systems have reduced radiation doses, advanced processing algorithms that produce highly detailed images, and computer-aided diagnosis using artificial intelligence (AI) that in some cases is more accurate than a radiologist. The latest premium systems produce 3D images using digital breast tomosynthesis (DBT). Many new scanners being sold are a combination of FFDM and DBT technologies.
The improved performance of these systems is helping to address an ongoing and huge debate about mammography, which has to do with the benefits of it versus the potential harm that could come from it. Many studies regarding the safety and efficacy of mammography have been done over the years. Years ago, studies revealed that radiation from analog mammography units were actually causing more cancers than they found. More recently, over-diagnosis and overtreatment have been the main concerns. “Overdiagnosis” refers to finding very small tumors that may or may not turn cancerous. Overtreatment results from overdiagnosis, and can be everything from biopsies, to radiation and chemotherapy, all the way to breast removal. The studies that conclude most of these are treating clinically insignificant tumors have led to controversial policy changes; raising the age when mammograms should start, and recommending the frequency be every two years instead of annually.
Those studies are based on years of retrospective data and older technology. The problem is figuring out whether the tumors seen in a specific exam are significant or not. Some patients will take severe preventive actions based on a slight indication of disease. Those are obviously difficult personal decisions. As imaging engineers, our responsibility is to make sure they have the best images possible to make that decision. We need to use the manufacturer’s AIAT information to assure the system is working correctly and safely. That is especially true in the case of mammography systems; the imaging engineer has to sign a 2579 form and submit it to the FDA affirming that the manufacturer’s information was used during servicing. Contact the regulatory department of the OEM to get what is needed, and involve the FDA district compliance officer if necessary. Making sure the correct and best diagnosis can be made is literally a matter of life and death.
Jim Carr is Director of Service and International Operations for AUE. He may be contacted via email at JCarr@auetulsa.com.