FY 2005 OCER Annual Report - Radiation Programs
Assuring Quality Mammography
The Division of Mammography Quality and Radiation Programs (DMQRP) commemorated 10 years of Mammography Quality Standards Act (MQSA) Inspections from 1995 – 2005. Warren Freier, a newly trained and FDA-certified MQSA inspector with the North Dakota Radiation Control Program, performed the first inspection on January 16, 1995. More than 10 years later, FDA has trained 436 inspectors. Currently, there are 241 active MQSA inspectors (206 state inspectors and 34 FDA inspectors). As of September 30, 2005, MQSA inspectors had completed 99,954 facility inspections nationwide. More than ten years after its inception, FDA’s goal for the MQSA program remains, “to improve the quality of the nation’s mammography services.” Annual inspections of over 8,850 mammography facilities nationwide now find that only 2.4% of facilities are not in compliance with MQSA standards.
Improving the MQSA Program
Based on over a decade of inspection results, DMQRP is reviewing the necessity of some of the physical measurements performed by inspectors during the inspection process and is planning enhancements to the MQSA program. The measurements, including Dose and Half Value Layer, are being reviewed and a decision about whether we should continue to perform these measurements should be made by mid FY 2006.
The Mammography Program Reporting and Information System (MPRIS) was developed to support FDA’s mission to improve the quality of mammography throughout the United States. MPRIS provides a reliable way for FDA to store a mammography facility’s MQSA certification, inspection, and compliance data that is reliable and accessible to our stakeholders. There were several developments with respect to MPRIS in FY 2005. Some of the major highlights include:
- The migration of the Certification/Accreditation Support System (CASS) modules and the MPRIS Reports module to a Web-based framework named MPRIS Web;
- The completion of a feasibility study to assess new technologies and an implementation strategy for the use of Advanced Encryption Standard (AES) to be implemented in 2006;
- Release of a version of the Field Inspection Support System (FISS) to include Full Field Digital Mammography questions;
- The modification to CASS to incorporate South Carolina as a State as Certifier; and
- The collection of information in support of the Center’s Hurricane Katrina efforts from MPRIS regarding mammography facility personnel qualifications. We were able to provide this information to personnel who worked in areas that were affected by Hurricane Katrina since most may have lost their qualification documents related to mammography during the storm.
The National Mammography Quality Assurance Advisory Committee (NMQAAC) is a committee established by MQSA to advise FDA on the implementation of the MQSA program. The committee met on September 26-27, 2005. Some of the issues discussed during this meeting were:
- The Institute of Medicine’s (IOM) recommendation to regulate Stereotactic Breast Biopsy The committee’s consensus was that FDA should proceed with further fact finding with the future goal of mandating requirements addressing specific problems.
- The committee agreed with many of the IOM’s recommendations designed to reduce the regulatory and inspection burden on facilities but only in those cases where quality would not be negatively impacted.
- The committee agreed with FDA’s recently issued guidance on Full Field Digital Mammography (FFDM) as it pertained to limiting the use of lossy compression and digitization of film screen mammograms.
The committee was given updates on the Center’s new approach to the Radiological Health Program, the American College of Radiology and the American College of Surgeon’s Voluntary Stereotactic Accreditation programs, and the State of Iowa’s mandatory Stereotactic program.
In FY 2005, new performance standards for fluoroscopy equipment were established to reduce unnecessary worker and patient exposure to x-rays. OCER staff participated in a cross-CDRH group working with FDA economics staff to publish amendments in June 2005 to the Federal radiation-safety standard improving the performance of diagnostic x-ray systems and their major components. The amended standards will require a number of new equipment features that will significantly reduce unnecessary exposure to x-rays, especially in fluoroscopy, while maintaining the level of image quality required for diagnostic efficacy. Over the decade following implementation of this final rule, the expected improvement in the quality of health care is projected to reduce the annual U.S. population dose by over 7,000 person-sievert, which is associated with a projected annual reduction in over 200 cancer deaths and annual savings of over $300 million.
OCER staff also assisted in updating draft standards covering the safety and constancy testing of equipment used in X-ray Computed Tomography (CT). An OCER representative serves as FDA liaison to Maintenance Team 30 (CT) of Subcommittee 62B (Diagnostic Imaging Equipment), Technical Committee 62 (Electrical Committee in Medical Practice), of the International Electrotechnical Commission (IEC). In written contributions and in meetings in Dublin, Ireland, and Shanghai, China, FDA positions were successfully advocated to require automatic exposure control; dose-index display, reporting, and recording; and an additional control in alerting operators of particularly dose-inefficient modes of operation associated with x-ray-field “over-beaming.”
Monitoring Compliance and Conformance
In FY 2005, OCER managed several compliance issues related to the MQSA and the Electronic Product Radiation Control (EPRC) sections of the Food, Drug and Cosmetic Act. A few of the issues were:
- MQSA Programs
- On July 22, 2004, Mr. Perry Beale plead guilty to 38 counts of mail fraud in connection with providing medical physicist services to over 50 hospitals and mammography facilities in Virginia, Maryland, West Virginia, North Carolina, Pennsylvania, and the District of Columbia. On May 12, 2005, Mr. Beale was sentenced to 54 months in prison followed by three years probation. Mr. Beale also must pay restitution of $375,831.20.
- On June 10, 2005, DMQRP posted the 2004 Mammography Facility Adverse Event and Action Report. This is a congressionally mandated report to enable consumers and other stakeholders to evaluate mammography facility performance.
- On September 26, 2005, in a case against Baltimore Imaging Centers (BIC) for performing mammography without a certificate, the DHHS Departmental Appeals Board (DAB) Appellate Division issued a Final Decision on Review of FDA’s Administrative Law Judge (ALJ) Decision, upholding in its entirety the December 17, 2004 Initial Decision of the ALJ in this case brought by the FDA seeking civil money penalties (CMPs) against Amile A. Korangy, M.D. and Korangy Radiology Associates, the corporation name for BIC, for violations of the MQSA. The Respondents are each liable for 193 violations of the MQSA and the ALJ's imposition of CMPs of $3,000 per violation per Respondent, for a total CMP of $1,158,000.
- EPRC Programs
DMQRP manages and administers the Field Compliance Testing of Diagnostic (Medical) X-ray Equipment Compliance Program (CP7386.003). This is a continuing, non-statistical compliance program intended to identify certified diagnostic x-ray systems that fail to comply with applicable performance standard requirements; obtain correction of noncompliant systems, and; to identify assemblers and manufacturers responsible for violative x-ray installations and take appropriate administrative/enforcement actions necessary to prevent further installations of noncompliant products.
- In FY 2005, FDA District Office’s and Partnership Agreement State inspectors surveyed 1,341 medical diagnostic x-ray systems nationwide. Of the systems surveyed, 152 systems (11%) were found to be noncompliant with one or more federal performance standards. A Notice of Noncompliance letter was issued to the assembler of record for each violative system. This letter requests the respective assembler to correct noncompliances observed during the equipment survey. As of September 30, 2005, assemblers corrected 109 of the violative systems the remaining 43 were pending correction.
OCER also issued several compliance-related letters to industry related to their practices. Some of the actions that were taken were:
- A Warning Letter was issued to a manufacturer firm for marketing software for intended uses beyond the scope of the FDA clearance for the product;
- A Request for Exemption was granted from labeling requirements;
- Two variances were granted for minimum-source-to-skin distance provisions;
- One Notice of Noncompliance was issued for labeling violations; and
- Four Corrective Action Plans (CAP) were approved and classified as recalls.
Monitoring Usage and Exposures
The National Evaluation for X-Ray Trends (NEXT) program is a world-recognized collaboration of FDA with the Conference of Radiation Control Program Directors (CRCPD), the umbrella organization of state radiation control agencies, to monitor the radiation doses patients receive during selected diagnostic x-ray examinations. In April 2005, FDA posted an article on its Radiological Health Web site titled "Dental Radiography: Doses and Film Speed". This article is a result of the 1999 NEXT Dental Survey and research on the technical performance of major brand dental products, and it documents that dentists who use a higher film speed during dental x-rays can reduce patient radiation exposure by 60 percent while maintaining acceptable clinical image quality.
The NEXT program is currently conducting a survey of facilities that perform computed tomography (CT) examinations. DMQRP staff developed a phantom to test the response of present CT equipment that is equipped with a form of automatic exposure control (AEC). This feature modulates the CT unit’s x-ray output according to the size of the patient similar to conventional AEC systems on radiographic equipment. Preliminary results of the survey will be presented at the May 2006 annual meeting of the CRCPD.
OCER’s Division of Device User Programs and Systems Analysis (DDUPSA) is coordinating the redesign of the CDRH Radiological Health Web site. This is one of the Center’s stated goals in the report on new directions for the Radiological Health Program, The CDRH Radiological Health Program – Adapting to Current Public Health Needs, completed in April 2005. The redesign will coordinate information on all aspects of radiological health, including electronic products, MQSA, and medical devices.
The redesign team, which includes representatives from DDUPSA and DMQRP, began working in May 2005 on this project. To ensure that the new design reflects the needs of a variety of user audiences both internal and external to CDRH, the team has sought input from CDRH Subject Matter Experts and from CDRH staff with knowledge of the particular needs of specific audiences, such as radiological product manufacturers or patients and consumers of these products. The team has also been working with a contractor who has completed a mapping of the site and initial designs for the home page and lower pages. The contractor has also begun reorganizing the current content within the new structure of the site.
Radiation Emergency Preparedness and Response
In FY 2005, there were two major counter-terrorism related issues addressed within CDRH. They were:
- Unnecessary Radiation Exposure; and
- Radiation Safety Issues
CDRH continues to be involved in radiological emergency preparedness, including counterterrorism, through participation in the Federal Advisory Team for the Environment, Food and Health, which recommends protective actions to Federal, State, and local government organizations following a radiological emergency. CDRH also plays an active role in informing the public about protective measures to limit radiation exposure in the event of a radiological emergency and helps address public concerns by preparing public information statements for consumers. CDRH works with all Federal agencies that are signatories of the National Response Plan to protect the public from accidental or intentional releases of radiation.
FDA, in collaboration with CDRH, continues to consultwith other agencies to prevent unnecessary radiological exposure to security workers from non-intrusive security screening products (e.g., explosives detection systems, truck and cargo scanners, personnel security systems) that use ionizing radiation.
The National Institute for Occupational Safety and Health (NIOSH) study, which was requested by TSA to identify the appropriate methods for monitoring worker exposures and to reduce exposures by good work practices, is complete. CDRH expects to peer review the final report in early FY 2006. During the study, several potential problems with the explosive detection systems in use by TSA were revealed. CDRH is following up with the manufacturers to ensure that these products are compliant with the federal performance standard. CDRH is also working with the Interagency Steering Committee on Radiation Standards to assess the need for a federal guidance intended for use by Federal agencies to address the issue of workers’ and the public’s exposure to ionizing radiation and, specifically, how to determine when the use of ionizing radiation is justified. CDRH coordinated presentations from several other agencies that have examined or use ionizing radiation. CDRH is participating in radiation safety consensus standard work group ANSI N43.16, which is writing a standard for truck and cargo security screening systems. The safety of these products depends a great deal on the way they are used, in addition to designed-in safety features. Often these systems can be used for personnel security in addition to cargo security, which can complicate the safety issues.
CDRH Radiation Safety
OCER is responsible for all radioactive materials for CDRH. In April 2005, the Nuclear Regulatory Commission (NRC) performed its routine inspection of the Center's licensed use of radioactive materials. The Center successfully passed the inspection. The NRC officially approved the decommissioning and removal of 12709 Twinbrook Parkway (the former Office of Science and Engineering Laboratories (OSEL) laboratory building) from the Center's NRC license.