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U.S. Department of Health and Human Services

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OCD FY2003: Radiological Health: NEXT

The Nationwide Evaluation of X-ray Trends (NEXT)

The CRCPD and FDA conduct the Nationwide Evaluation of X-ray Trends (NEXT) survey program, a federal-state collaboration that is the sole mechanism in the U.S. for capturing significant indicators of the state of practice in diagnostic radiology. Each survey collects data on patient exposure, radiographic equipment, image quality, and population workload from a randomly selected sample of facilities performing selected radiographic procedures. Selected exams for survey include adult chest, abdomen, spine, and pediatric chest radiography, fluoroscopy, computed tomography, and dental radiography. Digital x-ray imaging is becoming a significant player in the x-ray field and recent surveys are capturing baseline data with which to observe trends over time. NEXT also is focusing attention on emerging diagnostic procedures and technologies such as computed tomography which is being used for an increasingly diverse array of examinations, coupled with substantially high patient doses compared with conventional film x-ray procedures. NEXT recently completed a survey of computed tomography in 2000, and plans another for 2005 to document not only trends in patient exposure and technology, but also to assist the sectors of the professional community involved with public health efforts and regulatory activities.

Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC)

During the January 10, 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.

Counter-terrorism/Emergency Response Activities

CDRH continues updating emergency plans (including those related to electronic product emergencies and radioactive material emergencies) and integrating these plans with those of FDA and HHS. Training for CDRH personnel in this area has been conducted and additional training is planned as well as in-house radiation emergency response exercises. The Center has developed a Continuity of Operations Plan (COOP) which identifies radiological health and safety as a key element. CDRH has maintained a role in the federal emergency response program through continued involvement in subcommittees of the Federal Radiological Preparedness Coordinating Committee (FRPCC), membership on the Advisory Team for the Environment, Food and Health and the Federal Radiological Monitoring and Assessment Center (FRMAC) Operations Working Group and participation in exercises. The Center participates in interagency working groups which are developing strategies for responding to acts of radiological terrorism. CDRH also has maintained liaison with the states through the Conference of Radiation Control Program Directors E-6 Committee. CDRH participated in the Top Officials II exercise (TOPOFF II), providing technical input to other groups within the FDA and HHS as part of the overall response to the radiological dispersal device (RDD) attack scenario in Seattle.

 Mammography Quality

The goal of the Mammography Quality Standards Act (MQSA) is to enhance the detection of breast disease through high quality mammography services. Under the law, mammography facilities must be certified by the FDA and accredited by a non-profit body by meeting federally established quality standards and undergoing annual inspections. For detailed information on the items below, visit FDA’s Mammography Program (see http://www.fda.gov/Radiation-EmittingProducts/ MammographyQualityStandardsActandProgram/default.htm). The site includes a search engine that enables users to search by subject matter.

MQSA Policy Guidance Help System (PGHS)

All MQSA regulatory guidance materials and documents are compiled into one system—the PGHS. Mammography facilities and other interested parties now have access to a comprehensive online resource accessible via MQSA’s webpage on the Internet. PGHS users can search for answers to specific 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 see the regulatory citation, any relevant guidance documents, and any other appropriate information and references.

The National Mammography Quality Assurance Advisory Committee

The Committee met on April 28, 2003 and reviewed and suggested revisions to two MQSA guidance documents. The Committee also discussed how MQSA reauthorization might impact current regulations and possible ways to streamline the regulations and facility inspection procedures.

MQSA Reauthorization

The MQSA reauthorization of appropriation expired in 2002, but the FDA’s authority to inspect and certify facilities does not expire. The MQSA is expected to be reauthorized in 2004.

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
  • Role of medical outcomes and other evidence in the AMR/PPN process

Digital Mammography

To date, CDRH’s Office of Device Evaluation (ODE) has approved the following Full Field Digital Mammography (FFDM) systems for commercial use since January 2000:

  • The GE Senographe 2000D in January 2000
  • The Fischer SenoScan in September 2001
  • The Lorad Digital Breast Imager in March 2002
  • The Lorad Holgic Selenia FFDM System in October 2002

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. FDA approved the following two Accreditation Bodies (ABs) to accredit FFDM units:

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

As of September 30, 2003, there are 413 FFDM units accredited in the U.S.

States as Certifiers (SAC)

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.

 Inspections and Compliance

To assure mammography quality, mammography facilities undergo annual inspections by FDA credentialed inspectors. Nearly 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. 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.

Inspection Demonstration Program

Under the Mammography Quality Standards Reauthorization Act, Congress authorized the 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 has been to evaluate whether selected mammography facilities could maintain the same level of quality without FDA’s current scrutiny through annual inspections. In final form, the IDP included approximately 160 study group facilities and an equal number of controls in 14 states or other governmental jurisdictions that had 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. To be eligible, the facilities had to have a clean inspection history for the last two inspections. The facilities in the study group were undergoing biennial inspections during the demonstration program and the inspection process looks at the same areas as the current annual inspections but records are reviewed for the entire period since the last inspection date. Most of these facilities have now received their biennial inspection. All study group facilities should be inspected by the end of May 2004 and results should be available by early in FY 05.

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 03, CDRH issued 2 directed plans of correction (DPC), 1 civil money penalty (CMP), and 1 patient notification.