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. Since October 2000, OHIP’s Director has served as chairperson of the Council. The Council is pursuing a variety of initiatives to assure and enhance the cost-effectiveness and public health benefits of CDRH’s 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 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

Approximately 10,000 certified mammography facilities operate in the United States, including federal and military. To be certified to conduct mammography, each facility must be accredited by an FDA-approved accreditation body. At the end of FY2000, the five accreditation bodies and the number of facilities they accredit were: American College of Radiology (9,178)
State of Arkansas (71)
State of California (464)
State of Iowa (134)State of Texas (85)

To assure mammographic quality, mammography facilities undergo annual inspections by FDA credentialed inspectors¹. Nearly 10,000 inspections take place each year. Preliminary results from FY2000 are shown in Figure 1:

• fifty-three percent of the mammography facilities had no adverse findings;
• only four percent of the inspections found the most serious type of problems ("Level 1 finding") – facilities must correct problems or lose their certification; and
• since the beginning of the MQSA program, significant problems at four 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 left). 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.)

Improving the MQSA Program

The mammography program strives to provide better value, improved customer service, and improved public health. Some of the major innovations during FY2000 are listed below.

Digital Mammography: CDRH’s Office of Device Evaluation approved the first Full Field Digital Mammography (FFDM) system for commercial use on January 28, 2000. Digital mammography allows interpreting physicians to quickly and easily manipulate the images and may reduce the need for some women to have additional exposures. Digital units are exempt from MQSA accreditation requirements until the accreditation bodies have developed a process for accrediting them. However, in order for a 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"): The States as Certifiers (SAC) Demonstration Project is in its third year. In this project, certain key MQSA responsibilities have been transferred successfully to the States of Illinois and Iowa. The SAC program authorizes qualified States to certify mammography facilities within their jurisdiction, conduct inspections, and enforce the MQSA quality standards under FDA oversight. The proposed rule to institutionalize the program on a national scale was published on March 30, 2000. Final regulations are expected in 2001.

NMQAAC

• issuance of guidance on the MQSA final regulations;
• FDA’s role in evaluating the competency of mammography personnel;
• implementation of a demonstration project evaluating the feasibility of performing less than annual mammography facility inspections in high quality facilities; and
• certification of Full Field Digital Mammography facilities.

NEXT

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 tabulations of the results and graphical summaries. These reports

are then published by the CRCPD. CRCPD publishes the reports without conclusions or other analyses in order to make the reports widely available and as timely aspossible. Instead, the data are available to the radiation community for their own in-depth analysis and publication in technical journals.

During FY1999 and FY2000, OHIP published six analytical works on the NEXT data in peer-reviewed journals and conference proceedings. These included articles in Radiology, the Journal of the American Dental Association, and the Proceedings of the Thirty-fifth Annual Meeting of the National Council on Radiation Protection and Measurements (NCRP)². A review of the NEXT findings was published in a special edition of the international journal, Applied Radiation and Isotopes in January 1999 (Vol. 50, pp. 247-259).

The uses of NEXT data and its impact are illustrated in the figure on the next page. Data points through 1992 were generated using data 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 NEXT developed protocol for determining the radiation dose and phantom image quality score.

As a result of NEXT and these actions, the radiation dose women receive from mammography is generally lower and the image quality is 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.

• 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); and
• are currently being adopted by the American Association of Physicists in Medicine (AAPM) and the ACR as Reference Values (RV) for standards of practice for patient radiation exposure.

TEPRSSC

The Technical Electronic Products 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. During FY1999-2000, TEPRSSC discussions included the following important health and safety issues:

• Electronic Article Surveillance Systems and their potential interference with implanted medical devices;
• the use of ionizing radiation to scan people for concealed weapons and other contraband;
• wireless medical telemetry and interference with medical devices;
• the development of sunlamp standards associated with international harmonization;
• proposed rulemaking for lasers;
• proposed amendments for computed tomography fluoroscopy;
• NEXT computed tomography survey;
• radiological health re-engineering; and
• ultrasound diathermy.

Federal Facilities Inspections

• Department of Justice (Bureau of Prisons);
• U.S. Coast Guard;
• DOE (Department of Energy);
• HRSA (Health Resources and Services Administration); 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 radiation surveys in these facilities with FDA’s Office of Regulatory Affairs (ORA). 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 100 surveys were completed in FY2000. Most were conducted in 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

• developed and implemented a new CDRH Policy for physical security in rooms where radioactive material is stored;
• updated a CDRH policy on the decommissioning³ of CDRH buildings where radioactive materials were stored or used, and worked with other CDRH staff in decommissioning the Wilkins Avenue building;
• updated CDRH’s inventory of electronic generators of ionizing radiation and non-ionizing radiation used for research purposes;
• 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;
• conducted the annual training required of all licensed materials users, as well as training on safety procedures for other CDRH and contract janitorial staff who occasionally work in radiation laboratories;
• facilitated and chaired quarterly radiation safety committee meetings;
• amended CDRH’s Nuclear Regulatory Commission (NRC) license from a broad to a specific license;
• disposed of approximately 200 sealed radioactive sources no longer needed for CDRH research programs, four 55 gallon drums of dry waste, and 40 carboys⁴ of liquid radioactive waste;
• instituted a program of bi-monthly disposal of liquid radioactive wastes; and
• successfully passed the NRC inspection in early FY2000.

During FY1999 and FY2000, 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 or procedural violations 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.