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. CDRH’s Radiological Health Council has continued efforts to revitalize our radiological health programs. The Council pursues 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

Detailed information on all aspects of the MQSA program can be found at the Mammography Program website. Examples of documents currently available on the webpage include:

• an overview of FDA’s Mammography Program;
• the Mammography Quality Standards Act;
• Federal Register Notices;
• a listing of certified mammography facilities, searchable by zipcode;
• Mammography Facility Performance Reports;
• MQSA Program Accomplishments;
• consumer-specific information; and
• the MQSA Policy Guidance Help System.

The MQSA Policy Guidance Help System (PGHS) is an information resource that is structured like a Windows help system. It is organized by main topics, or books. Each book includes a list of subtopics, or pages, that contain guidance. Many of the pages begin with the regulatory citation related to the selected topic, followed by questions and answers offering guidance on how to comply with the regulations.

Assuring Quality Mammography

Approximately 9,100 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 FY 2003, the five accreditation bodies and the number of facilities they accredit were:

• American College of Radiology (8,288)
• State of Arkansas (71)
• State of California (466)
• State of Iowa (141)
• State of Texas (150)

To assure mammographic quality, mammography facilities undergo annual inspections by FDA trained inspectors¹. Approximately 9,000 inspections take place each year. Nearly two-thirds of the facilities (65.5%) had no adverse observations during their inspections this fiscal year. About 9% of facilities had nothing worse than minor (Level 3) observations, while 23% had moderate (Level 2) observations as their most significant result. Finally, about 2% had serious (Level 1) observations during their inspection.

Figure 1. Preliminary FY 2003 Inspection Results
	Inspectors can issue three levels of findings. Level 1 represents the most serious noncompliance with MQSA standards. Level 2 represents moderate noncompliance. Level 3 represents minor noncompliance. Regardless of the level, a facility must correct all deficiencies found during an inspection.

The percentage of facilities with significant inspection observations continues to decrease compared with previous years and CDRH is confident that mammography facilities will continue to improve their performance.

 ¹The MQSA inspection program includes FDA inspections of federal facilities performing mammography. MQSA-like inspections are also performed for the Veterans Health Administration (VHA) through an Interagency Agreement.

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 FY 2003 are listed below.

• Digital Mammography: This 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. To date, CDRH’s Office of Device Evaluation (ODE) has approved the following Full Field Digital Mammography (FFDM) systems for commercial use: the General Electric (GE) Senographe 2000D, January 2000; the Fischer SenoScan, September 2001; the Lorad Digital Breast Imager, March 2002; and the Lorad Holgic Selenia FFDM System, October 2002.

Currently, there are 413 FFDM units accredited in the U.S. Also, in FY 2003, FDA approved the following Accreditation Bodies to accredit FFDM units as follows:

• American College of Radiology
  - GE Senographe 2000D (approved 12/18/02; became effective 02/15/03)
  - Fischer SenoScan (approved 07/24/03; became effective 08/15/03)
  - Lorad Selenia (approved 09/05/03; became effective 09/15/03)
• State of Iowa
  - GE Senographe 2000D (approval date 08/28/03; effective 10/01/03)
  - Lorad Selenia (approval date 08/28/03; effective 10/01/03)

• States as Certification Agencies (“States as Certifiers” or SACs): This project successfully transferred certain key MQSA responsibilities to the states of Illinois and Iowa under a demonstration program during the summer of 1998. The program authorizes qualified states to certify mammography facilities within their jurisdiction, to conduct annual inspections, and to enforce the MQSA quality standards under FDA oversight. In the first half of 2004, FDA expects to transition these SACs from the demonstration program under the interim regulations to the final regulations, which were published by the Department of Health and Human Services on January 18, 2002.

• Inspection Demonstration Program: Under the MQSA Reauthorization Act, Congress authorized the Food and Drug Administration (FDA) to undertake an inspection demonstration program (IDP) to assess the results of conducting some mammography inspections less frequently than annually. The purpose of the program is to evaluate whether selected mammography facilities can maintain the same level of quality without FDA's current scrutiny through its annual inspections. In its final form, the IDP includes approximately 160 study group facilities and an equal number of controls in 14 States or other governmental jurisdictions that have agreed not to inspect these facilities under their own authority during the study period. The first half of these facilities were selected and notified in November 2001 and the second half were selected and notified in May 2002. Each facility was randomly selected from a set of eligible facilities on a jurisdiction-by-jurisdiction basis. The facilities must have had a clean inspection history for the last two inspections to be eligible. The facilities in the study group are undergoing biennial inspections during the demonstration program and the inspection process will look at the same areas as the current annual inspections but records will be reviewed for the entire period since the last inspection date. Approximately one half of these facilities have now received their delayed inspection. All study group facilities should be inspected by the end of August 2004 and results should be available by early FY 2005.

• MQSA Compliance Activity: FDA is preparing to implement a new enforcement strategy effective October 1, 2003. Under the new strategy, facilities with the most significant observations will be directed to respond in writing within 15 days of the inspection, rather than almost always being sent a Warning Letter. That response will be reviewed by the FDA prior to taking any further action. If there is no response or if the response is inadequate, then a Warning Letter could be issued. If the response appears adequate but the facility has a history of violations, then a fee-based follow-up inspection could be scheduled. In addition, Warning Letters may be followed by a non-fee-based follow-up inspection within a few months to assure that correction has been made.
  This new strategy will focus more attention on facilities with a history of violations. CDRH also is looking at whether changes may be needed on how repeated inspection violations are defined.
  In parallel with the new enforcement strategy, CDRH will increase the rate of enforcement actions to direct appropriate attention to those facilities that exhibit significant problems that they can not or will not correct. During FY 2003, CDRH issued 2 directed plans of correction (DPC), 1 civil money penalty (CMP), and 1 patient notification.

• Additional Mammography Review Process (AMR): CDRH is also beginning a review of AMR process and procedures. An AMR is a review of clinical images and other relevant information to assure that the facility is in compliance with MQSA. CDRH has had preliminary discussions about AMRs internally and with approved accreditation bodies. It is examining a number of issues specific to AMRs and Patient and Physician Notifications (PPNs) that include:
• reasons for requesting AMRs;
• procedures for performing AMRs (number of cases and number of reviewers);
• criteria used to evaluate AMRs;
• methods for evaluating the effectiveness of Corrective Action Plans and/or PPNs; and.
• role of medical outcomes and other evidence in the AMR/PPN process.

NMQAAC

NEXT

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 this page shows the status of the 1998 through 2003 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.

Selecting 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 periodically repeating NEXT surveys for a particular x-ray examination, the data can be used to identify trends or changes over the course of time.

NEXT Survey Results

OHIP prepares a comprehensive report summarizing statistical results for each survey. 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 and medical journals.

During FY 2002-2003, OHIP gave presentations related to NEXT at several professional meetings including the FDA Science Forum, the annual meeting of the Conference of Radiation Control Program Directors, and the annual meeting of the American Association of Physicists in Medicine (AAPM). 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 safety concerns about patient exposure.

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

• provide a standard of practice against which clinical facilities can compare their patient exposure levels in order to maintain a safe and beneficial practice;
• have been used as a standard for comparison during inspections by the Joint Commission on Healthcare Organizations (JCAHO);
• are currently being referenced by the American Association of Physicists in Medicine (AAPM) and the ACR in efforts to develop patient exposure reference values for standards of clinical practice; and
• are gaining international attention from such agencies as the IAEA (International Atomic Energy Agency) as a model program for collecting population exposure data from diagnostic x-ray exams.

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 many electronic products. Examples of these products include lasers, sunlamps, microwave ovens, ultrasound medical equipment, cabinet x-ray systems and diagnostic x-ray systems. In addition to the 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.

D uring the October 1, 2003 TEPRSSC meeting, Lillian Gill, Senior Associate Director, CDRH, presented an update on a number of issues. This was followed by presentations and discussion on a number of topics, including sunlamps, security systems, and fluoroscopy.

Dental X-Ray Examinations

During FY 2003, the RSO and OHIP accomplished the following:

• 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; and
• facilitated and chaired quarterly radiation safety committee meetings.

Also, during FY 2003, 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, have led to continuing, significant reductions in the amounts of hazardous materials stored by CDRH (see table below). 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.

²“Decay-in-Storage” is a standard practice to store containers of short-lived radioactive waste until the radioactive materials have decayed so that the waste can be released as non-radioactive.

³Does not include generally licensed sources that do not require NRC (Nuclear Regulatory Commission) approval.