Radiation-Emitting Products

Printers and the Evolution of Mammography

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. Some of the needs the printers served at that time 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.

Digital mammography was introduced into clinical use fifteen years ago, and today fewer than 350 screen-film units remain in use in the U.S. The nearly universal availability of computers for viewing of digital images diminishes the need for a facility to maintain a printer. 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. 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.

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 program benefits the facility that wants to provide the best possible quality in any hard copy mammography images it prints. Although the FDA’s 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.
 

Page Last Updated: 11/18/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.