NEMA Provides Quality Control Standards for X-ray Imaging
September 19, 2006 // Published as a news service by IHS
The National Electrical Manufacturers Association (NEMA) published two standards, NEMA XR 22-2006 - Quality Control Manual: Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-Field Digital Mammography, and NEMA XR 23-2006 - Quality Control Manual: Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography.
"These documents include templates providing both a consistent presentation format and a minimum set of QC tests that should be included as part of the quality assurance plan of a display or workstation or hardcopy output device (e.g., printer) labeled for final interpretation in a full field digital mammography (FFDM) system," said Kish Chakrabarti of the U.S. Food and Drug Administration (FDA) Office of Device Evaluation.
"When FFDM systems were first introduced, all components (e.g., image receptor, acquisition workstation, diagnostic workstation hardcopy output device) were provided or qualified for use by the image receptor manufacturer, which also provided a comprehensive quality control (QC) plan to enable mammography facilities to meet their responsibilities under the Quality Mammography Standards of the Mammography Quality Standards Act (MQSA). Subsequently, the U.S. FDA approved other manufacturers to market hardcopy and softcopy displays for FFDM images," said Dr. Charles Finder of the FDA MQSA program.
This has made system QC more difficult since, under MQSA regulations, the facility is required to follow a quality assurance program substantially the same as the one recommended by the image receptor manufacturer. However, according to NEMA, that QC plan might not adequately address the needs of components developed by other manufacturers.
With the entry of additional hardcopy and display manufacturers into the market, the responsibility for developing QC procedures for these individual system components falls to the manufacturers of those components.
According to NEMA, FDA suggested that the Mammography Group of the NEMA X-ray Imaging Section develop templates that provide both a consistent presentation format and a minimum set of QC tests that should be included as part of the quality assurance plans of displays, workstations and hard copy output devices labeled for final interpretation in an FFDM system.
"Display, workstation and hard copy output device manufacturers who follow these templates when developing their quality assurance programs and include at least the tests listed, will have incorporated the essential aspects of quality assurance that the image receptor manufacturers have included in their recommended quality assurance programs," said Ralph Schaetzing, chair of the XR-23 task force.
"This will ease the burden of the mammography facility to establish and maintain a quality assurance program substantially the same as the one recommended by the image receptor manufacturer."
Source: National Electrical Manufacturers Association (NEMA).