Feature | Breast Imaging | November 24, 2015 | Dave Fornell

FDA Offers Guidance on Printers for Mammography

In the digital age, there is little need for printers for hard copies of mammograms

The FDA said there is little need for hard copies of mammograms in the digital age, but it still provides guidelines for quality assurance if printers are maintained at breast imaging centers. 

November 24, 2015 — Over the past 20 years, there has been significant evolution in mammography, with the shift from screen-film to digital imaging being the most prominent change. As the technology has evolved, so has the role various peripheral devices played. The utilization of film printers by facilities was prevalent, especially when digital mammography first entered the market. However, the U.S. Food and Drug Administration (FDA) reported in November the need for mammography printers in the digital age has significantly dropped.

Some of the needs the printers served in the past were the provision of hard copy comparison images from digital facilities to requesting facilities that were not capable of viewing digital images, the submission of images for accreditation, and providing copies of mammograms to be viewed in the operating room. However, in the digital age, the FDA said the need for hardcopies has been significantly reduced. 

Digital mammography was introduced into clinical use 15 years ago, and today fewer than 350 screen-film units remain in use in the United States. The nearly universal availability of computers for viewing of digital images diminishes the need for a facility to maintain a printer, the FDA said. Another change in current practice was the introduction of digital breast tomosynthesis (DBT) in 2011 and its rapid clinical adoption. DBT images are intended solely for soft-copy interpretation.
Today, with many mammograms shared on computer media such as compact discs or via online access, the provision of printed hard copies is becoming obsolete, the FDA said. Many medical facilities have the ability to review images on monitors throughout their facilities. Please note that any exchange of images between requesting and image-providing facilities is to be accomplished in a mutually agreed-upon format since there is no regulation dictating format. Additionally, all FDA-approved accreditation bodies can accept images electronically needed for accreditation, additional mammography reviews, etc.

Therefore, in today’s world, the option to maintain a printer and/or the ability to print hard-copy images is a decision left to each individual facility, according to the FDA. 
 
If a facility chooses to maintain a printer, it must follow all the quality control requirements that are prescribed by the manufacturer of the printer and mammographic unit. The manufacturer’s quality control (QC) program benefits the facility that wants to provide the best possible quality in any hard copy mammography images it prints. Although the FDA’s Mammography Quality Standards Act and Program (MQSA) inspection program has removed printer QC questions from its inspection procedures, if a facility decides to maintain a printer, medical physicists must continue to include that printer QC in the mammography equipment evaluation upon installation, after a major repair, and annually, if required by the printer’s or image receptor’s manufacture quality control program.

For more information: www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActand...
 

Related Content

IBM collected a dataset of 52,936 images from 13,234 women who underwent at least one mammogram between 2013 and 2017.

IBM collected a dataset of 52,936 images from 13,234 women who underwent at least one mammogram between 2013 and 2017, and who had health records for at least one year prior to the mammogram. The algorithm was trained on 9,611 mammograms. Image courtesy of Radiology.

Feature | Artificial Intelligence | July 19, 2019 | Michal Chorev
Breast cancer is the global leading cause of cancer-related deaths in women, and the most commonly diagnosed cancer...
Paragon Biosciences Launches Qlarity Imaging to Advance FDA-cleared AI Breast Cancer Diagnosis System

Qlarity Imaging’s software is used to assist radiologists in the assessment and characterization of breast lesions. Imaging features are synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth. Image courtesy of Business Wire.

Technology | Artificial Intelligence | July 18, 2019
Paragon Biosciences LLC announced the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded...
FDA Clears Koios DS Breast 2.0 AI-based Software
News | Ultrasound Women's Health | July 11, 2019
Koios Medical announced its second 510(k) clearance from the U.S. Food and Drug Administration (FDA).
SimonMed Imaging Implements ProFound AI for 3-D Tomosynthesis
News | Mammography | July 10, 2019
Arizona-based SimonMed Imaging announced their implementation of the first U.S. Food and Drug Administration (FDA)-...
Therapixel Appoints Matthieu Leclerc-Chalvet as CEO
News | Artificial Intelligence | July 03, 2019
Artificial intelligence (AI) breast cancer screening specialist Therapixel announced the appointment of Matthieu...
GE Healthcare showcases Senographe Pristina Serena featuring its add-on-biopsy kit at the Breast Imaging Symposium. Photo by Greg Freiherr

GE Healthcare showcases Senographe Pristina Serena featuring its add-on-biopsy kit at the Breast Imaging Symposium. Photo by Greg Freiherr

Feature | Breast Imaging | July 03, 2019 | By Greg Freiherr
Productivity and its enabler — efficiency — guided the display of products at the April...
Countless possibilities can impact the future of global healthcare and AI is the first step toward breakthrough that will change the landscape of personalized medicine
Feature | Women's Health | July 03, 2019 | By Samir Parikh
Contrary to what many people believe,...

Image courtesy of GE Healthcare

Feature | Radiology Business | July 03, 2019 | By Jeffrey Hoffmeister, M.D.
Burnout in the medical profession is not uncommon, particularly as clinicians have become more overwhelmed by growing
iCAD ProFound AI

Image courtesy of iCAD

News | Breast Imaging | June 25, 2019
Use of...