Radiological health is an important part of CDRH’s public health mission. We assure the safety of consumer and industrial radiation-emitting electronic products. We promote the safe use of radiation in medicine by reducing unnecessary radiation exposure and by improving diagnostic image quality. However, CDRH resources for radiological health are at an all-time low. Reallocation to medical devices, personnel attrition and changes in product technology are just some of the factors involved. Within CDRH, a Radiological Health Council has been formed to revitalize our radiological health programs. The Council continues to pursue a variety of initiatives to assure and enhance the cost-effectiveness and public health benefits of CDRH radiological health programs.

Within OHIP, nearly one-third of our staff are involved in radiological health programs. As described below, we are using third parties, cooperative programs with the States, leveraging and other innovative approaches to address important public health problems.

Mammography Quality

MQSA Webpage

There are many facets to enforcement of the Mammography Quality Standards Act. Detailed information on all aspects of the MQSA program can be found at the Mammography Program website. This includes a list of all certified mammography facilities that is searchable by zipcode or State.

Examples of documents currently available on the webpage (link on previous page) include:

• FDA’s Mammography Program: An Overview;
• Mammography Quality Standards Act;
• Federal Register Notices;
• Mammography Quality Standards Reauthorization Act of 1998;
• Mammography Matters newsletters;
• policy guidance documents;
• listing of certified mammography facilities;
• Mammography Facility Performance Reports;
• Speaker’s kit: MQSA Final Regulations;
• MQSA Program Accomplishments; and
• consumer-specific information.

Assuring Quality Mammography

• American College of Radiology (8,752)
• State of Arkansas (75)
• State of California (465)
• State of Iowa (140)
• State of Texas (126)

To assure mammographic quality, mammography facilities undergo annual inspections by FDA trained inspectors¹. FY2001 was the second full year of inspections under the MQSA Final Regulations. Nearly 9,300 inspections take place each year. Results from FY 2001 are shown in Figure 1 on the following page.

• 58.5% of the mammography facilities had no adverse findings;
• about 3.4% of the inspections found the most serious type of problems ("Level 1 finding") – facilities must correct problems or lose their certification; and
• Level 1 and Level 2 percentages were lower, the Level 3 remained constant, and the "no findings" percentages were higher than the previous year.

Since the beginning of the MQSA program, significant problems at eleven facilities led FDA to require that patients and physicians be notified of concerns related to the quality of their mammographic examinations (see link to Mammography Facility Performance Report at right). In each case, the patients and referring physicians served by these facilities were notified about the image quality problems at the facilities and were advised of the health risk. As a result, the patients and referring physicians were able to arrange for appropriate healthcare followup. (Note: State actions against mammography facilities are reported separately.)

As part of its continued efforts to assist MQSA inspectors to maintain consistent and uniform performance, FDA established an Inspector Quality Assurance Program. This program requires inspectors to conduct a minimum of 12 inspections yearly, obtain 15 continuing education units in mammography-related training (MEU’s) over a three-year period, and undergo an annual audit by an FDA MQSA-certified auditor. In FY2001, FDA completed audits of every certified inspector.

Improving the MQSA Program

• Digital Mammography: CDRH’s Office of Device Evaluation approved the first Full Field Digital Mammography (FFDM) system, the GE Senographe 2000D, for commercial use in January 2000. A second FFDM unit, the Fischer SenoScan, was approved in September 2001. The new technology promises to enhance mammography by reducing the need for some women to have additional exposures, while allowing interpreting physicians to quickly and easily manipulate the images. At this time digital units are exempt from MQSA accreditation requirements. However, the accreditation bodies are developing a process for accrediting FFDM units. For an MQSA certified facility to lawfully use the FFDM system, it must:
• maintain its accreditation status for at least one screen-film unit;
• submit an application with required information to FDA;
• ensure that any interpreting physician, medical physicist, or radiologic technologist has eight hours of initial training in the new modality before using it clinically;
• provide a satisfactory FFDM equipment evaluation;
• follow the manufacturer’s guidelines for quality assurance and quality control tests; and
• receive approval from FDA

• States as Certification Agencies ("States as Certifiers"): This project successfully transferred certain key MQSA responsibilities to the States of Illinois and Iowa. The program authorizes qualified States to certify mammography facilities within their jurisdiction, conduct inspections, and enforce the MQSA quality standards under FDA oversight. The Department of Health and Human Services (DHHS) released the final regulations for publication on January 18, 2002.

• Comprehensive electronic guidance: All MQSA regulatory guidance materials and documents are now compiled into the MQSA Policy Guidance Help System (PGHS). Mammography facilities and other interested parties now have access to a comprehensive online resource accessible through MQSA’s web page. Users of the PGHS can search for answers to specific policy questions through an indexed list of topics and key words. For example, by selecting a particular subject, such as "revocation of accreditation" or "accreditation and certification," the user will find the regulatory citation, any relevant guidance documents, and any other appropriate information and references.

MPRIS Web Applications

In response to numerous requests from State programs to provide more open access to the Mammography Program Reporting Information System (MPRIS) database, we developed ‘modified view-only’ versions of the two web-based MPRIS applications: (1) the Certification Accreditation Support System (CASS); and (2) the Facility Noncompliance Tracking and Management System (FaNTMS).

Using the CASS web application, current facility and unit certification and accreditation information and reports are now available to the States and the Districts on-line at any time. The State Facility Listing Report in CASS, which can be exported, replaced the monthly printed report that became rapidly outdated and was expensive for the Division to print and mail. The user is also able to print reports for an individual facility.

FaNTMS was also modified especially for view-only use. Using FaNTMS, a State inspector or supervisor is able to search for inspections in their State using several criteria. They may also view noncompliance and general inspection information and print or export a variety of reports such as the Inspection Detail and Post-Inspection Reports. FaNTMS provides complete descriptions of each report and on-line help is also available. In the Spring of 2001, a third version of FaNTMS was released designed for use by SAC States. This version has all the features of the FDA version, such as entering and editing correspondence and closing out noncompliances and inspections, except that the view of MPRIS data is limited to the SAC State.

NMQAAC

• certification of Full Field Digital Mammography facilities;
• facility satisfaction survey; and
• current facility inspection findings.

NEXT

CRCPD’s NEXT Committee serves as the steering and coordinating group for the program, exercising general oversight andproviding a cadre of State radiation control staff who conduct the annual surveys.OHIP provides scientific and technical support for all phases of NEXT. This support includes training of surveyors, including presentations from CDRH staff on new technologies and survey procedures and hands-on surveyor training at local clinical facilities.

The NEXT program represents a twenty-seven year partnership between FDA and the States. Since 1998, NEXT training for State surveyors has been partially supported by the American College of Radiology through funding to the CRCPD.

Annual Surveys

Under NEXT, the surveys for a given year are directed at a single x-ray procedure and are conducted in a national cross section of clinical facilities. Thus, the survey results for a given year represent a statistically valid "snapshot" of x-ray exposure and related factors for that examination in the U.S. The table on the previous page shows the status of the 1995 through 2002 NEXT surveys. During each survey, specific information is collected, including radiographic technique factors, patient x-ray exposure, x-ray beam quality, image quality, film processing quality and darkroom fog.

Choosing a different x-ray examination from year to year provides data on a variety of radiographic procedures while minimizing the workload during any one year. By repeating NEXT surveys for a particular x-ray examination every few years, the data can be used to identify trends or changes over the course of time.

NEXT Survey Results

OHIP prepares a comprehensive report on a given year’s data that includes statistical tabulations and graphical summaries. These reports are then published by the CRCPD without conclusions or other analyses in order to make the reports widely available and as timely as possible. OHIP also publishes interpretive analyses of NEXT data in peer-reviewed scientific, technical, and medical journals.

During FY 2001, OHIP gave presentations at several professional meetings including the FDA Science Forum, the annual meeting of the American Association of Physicists in Medicine (AAPM), and the annual meeting of the Radiological Society of North America (RSNA). Of special interest to the professional community were the results of the 2000 survey of computed tomography (CT). This modality has seen much technological advancement in the past decade as well as broader applications that have renewed concern about patient exposure safety.

The applications of NEXT data and their impact are illustrated in the figure on the next page. Data points through 1992 were generated from NEXT surveys supplemented with information from the literature. The data since 1995 has been collected using MQSA inspection data.

The results of the NEXT mammography surveys identified concerns with patient dose and image quality. These were factors in ACR’s development of its Mammography Accreditation Program in 1988 as well as FDA’s MQSA regulatory program in 1992. The MQSA inspection uses the protocol that had been developed in the NEXT program for determining the radiation dose and phantom image quality score.

Average patient dose and phantom image quality
scores during mammographic examinations.

As a result of the NEXT program and these ensuing developments, the radiation dose women receive from mammography is generally lower and the image quality better than at any other time since we began recording such information. Other data collected during these surveys show marked improvement in darkroom conditions, also contributing to improved image quality. While patient dose has been increasing slightly since 1995, that increase is primarily associated with changes in technical measures to improve image quality.

Overall, NEXT has established baseline data and long-term trends for seven diagnostic examinations. These data:

• provide a standard of practice against which facilities can compare their radiation levels in order to maintain safe and state-of-the-art radiation levels (It is a common practice for many State x-ray surveyors to provide x-ray facilities with a brochure so that the facility can compare its x-ray survey results with the NEXT data.).
• have been used as a standard for comparison during inspections by the Joint Commission on Healthcare Organizations (JCAHO);
• are currently being adopted by the American Association of Physicists in Medicine (AAPM) and the ACR as reference values for standards of practice in patient radiation exposure.

TEPRSSC

The Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) is an important advisory committee to CDRH and FDA. Established under the Radiation Control for Health and Safety Act of 1968, TEPRSSC is charged with providing advice and consultation to the Commissioner of Food and Drugs on the technical feasibility, reasonableness, and practicality of developing performance standards for electronic products. TEPRSSC may also recommend electronic product radiation safety standards to the Commissioner.

FDA has performance standards for lasers, sunlamps, microwave ovens, ultrasound medical equipment, and diagnostic x-ray systems. In addition to these existing standards, FDA has the authority to promulgate mandatory safety standards for a wide array of products for which mandatory standards do not exist, such as cellular telephones and x-ray people scanners.

OHIP provides the Executive Secretary for the committee as well as programmatic support. Summaries of recent TEPRSSC meetings are available on our website. In May 2001, the 28th Annual Meeting of TEPRSSC convened to discuss important health and safety issues associated with:

• digital medical x-ray modalities such as digital radiography, computerized radiography, and computed tomography;
• the use of ionizing radiation to scan people for concealed weapons and other contraband;
• cellular telephones;
• the development of sunlamp standards and international harmonization;
• proposed rulemaking for lasers;
• proposed amendments for fluoroscopy;
• computed tomography pediatric examinations, dose-index display, standardization of nomenclature, tube-current modulation, x-ray field limitation, possible regulatory approach, and whole-body screening;
• non-medical radiation products such as television sets, microwave ovens, and lasers.

Federal Facilities Inspections

• Department of Justice (Bureau of Prisons);
• U.S. Coast Guard; and
• NASA (National Aeronautics and Space Administration).

CDRH also has an Interagency Agreement with the Indian Health Service to provide survey equipment, calibration services, training, and assistance with technical issues related to radiation use and control.

OHIP coordinates with FDA’s Office of Regulatory Affairs (ORA) to conduct radiation surveys in all of these facilities. ORA staff, either the FDA Regional Radiological Health Representatives (RRHRs) or FDA x-ray auditors, perform the actual surveys. The ORA staff have special training and experience in radiation physics and are qualified to provide facilities with information on how to reduce radiation exposure during medical radiographic procedures. This information ranges from recommending x-ray techniques to methods for optimizing film processing and enhancing image quality. The RRHRs are also available for phone consultation to assist facilities with other problems that might arise in their x-ray facilities.

OHIP provides administrative support and overall coordination for the program. This support includes negotiating Interagency Agreements with the participating federal agencies. These Agreements fund FDA’s program implementation for the purchasing and inventorying of survey equipment and supplies, and for conducting surveys. Each radiation survey is followed up with a report to the x-ray facility and to the headquarters liaison for that federal agency. The report contains test results, cites deficiencies if any, and makes recommendations for improving the quality of the diagnostic x-ray services at the facility.

Approximately 90 surveys were completed in FY2001. Most were conducted in the Bureau of Prisons or U.S. Coast Guard facilities. Almost all surveys recommended minor changes that resulted in a reduction in unnecessary radiation exposure and improved image quality.

All of the participating federal agencies review these reports and require their x-ray facilities to make changes and improvements as recommended by the FDA. At Bureau of Prisons facilities, these reports become an integral part of the records reviewed by auditors from the Joint Commission on Accreditation of Healthcare Organizations when they evaluate and accredit the facility.

Radiation Safety

• conducted quarterly surveys of all radiation laboratories, annual audits of all radiation programs and licensees and unannounced surveys of CDRH radiation laboratories;
• calibrated 22 radiation survey instruments on a semi-annual basis;
• conducted the annual training required for all licensed materials users;
• facilitated and chaired quarterly radiation safety committee meetings.

During FY2001, there were no incidents that resulted in harm or overexposure to individuals working in CDRH laboratories. Our laboratory inspections and audits also indicate that we are meeting our goals. Where minor problems were identified, corrective actions have been taken and will be monitored during future reviews.

The improvements in CDRH’s radioactive waste practices, begun in FY1999, were particularly important accomplishments. As shown in the following table, they have led to continuing, significant reductions in the amounts of hazardous materials stored by CDRH. These practices have resulted in improved radiation safety, better accountability of radioactive materials, reduced workload for monitoring sealed radiation sources, and reduced costs for physical storage.