OCD FY2000: Radiological health
Revitalization and Reengineering
In November 1999, we established a senior management Radiological Health Council to revitalize its radiological health program. In addition to overseeing reengineering efforts, the technical advisory committee agenda, and liaison with government agencies, the Council instituted activities to improve the radiological health web pages, coordination with the FDA field staff, assessment of our staffing and expertise resources and development of an internal training plan. Through contracts, the Council is investigating the possibility of a consortium for a training institute and locating internal materials to populate the web pages and include in training courses.
Several reengineering teams addressed the need to improve our radiological health processes. The Food and Drug Law Institute conducted a workshop in January 2000 where stakeholders concluded that our primary roles are leadership, expertise, information clearinghouse, guidance and training. They suggested that we conduct outreach, allow partners to help develop policy and philosophy, shift from conformance assessment activities to training, advertise the Top Ten priorities, and post all releasable information on the internet. At a November 15-16, 2000, open public meeting, stakeholders confirmed the proposed prioritization approach with minor modifications and suggested improvements in information exchange, product testing, standards and guidance development, and manufacturer reports and electronic submissions.
Emerging Technology and Re-emerging issues
We are developing a prioritization process to address the products and issues of greatest concern. Technology is growing rapidly and our staff is trying to monitor the safety of exposures from many new radiation-emitting products. Examples include: computed tomography (CT), green laser pointers, high powered light-emitting diodes (LEDs) and fiber-optic lasers, infrared and microwave local-area-networks, ophthalmic surgery illuminators, and laser, microwave, and ultrasound weapons and security equipment. In addition, we are concerned about how digital medical diagnostic imaging is affecting radiation exposures, particularly when image display systems provide no indication of x-ray overexposures. We are actively working on emerging issues involving mobile phones, security scanners, and electronic article surveillance equipment.
The re-emergence of radiation safety issues is posing challenges to our staff. Examples include: high doses from fluoroscopy, whole-body medical diagnostic x-ray procedures, inefficient x-ray image display systems, and the potential for x-ray emissions from globally-manufactured television receivers and monitors.
Partnerships and Leveraging
- Training on X-Ray Testing of Televisions
In a new and unique endeavor, we entered a co-sponsorship agreement with the Consumer Electronics Association (CEA) and FDA’s Winchester Engineering and Analytical Center (WEAC) to develop and sponsor a course to train manufacturers in the Federal requirements for television products. FDA and CEA developed videotapes for the course, which emphasize x-ray testing procedures and compliance with the performance standard for television receivers. The first offering of the course is expected in May 2001.
- Diagnostic X-Ray Compliance Tests
In an effort to salvage an existing program when contract money was unavailable, FDA negotiated partnerships with states to continue diagnostic x-ray compliance testing. In exchange for CDRH providing test instrumentation, calibrations, and training in test methodologies, 30 states agreed to continue testing equipment meeting our Center’s criteria at or near the same level as in the contracts. We revised the qualification exam, conducted training, and issued certificates upon completion of both didactic and survey modules. Together, FDA and the States tested 1500 systems, 15 percent of which had one or more noncompliances with the performance standard.
- Suggested State Regulations
We continued to assist the Conference of Radiation Control Program Directors (CRCPD) with revisions to the diagnostic x-ray suggested state regulations and with laser and microwave issues.
Other partnerships are evident in the research and studies listed below.
Radiation Emission, Exposure, and Risk Evaluations
- Medical X-Ray Exposures
The CRCPD and FDA conduct the Nationwide Evaluation of X-ray Trends (NEXT). This collaborative Federal-State survey program is the sole mechanism in the United States for acquiring and updating nationally representative baseline data on medical x-ray exposures, image quality, and related clinical practice. During the surveys, information is collected on radiographic technique factors, patient x-ray exposure, x-ray beam quality, image quality, film processing quality, and darkroom fog. The survey results for a given year represent a statistically valid "snapshot" of x-ray exposure and related factors for that type of examination in the U.S. In FY 2000, computed tomography (CT) surveys are underway incorporating major improvements in survey methodology (electronic submissions, etc.).
- Mobile Telephone Measurements
We are leading the development of an international standard for evaluating the radiofrequency (RF) radiation dose to users of hand-held wireless handsets, including cellular and personal communications service (PCS) telephones (see "Leveraging" section under "Postmarket Programs.").
- Mobile Telephone Bioeffects Research
In an effort to spur research on the possible health effects of RF emissions from wireless phones, we established a Cooperative Research and Development Agreement (CRADA). The focus of the research is on two study topics: epidemiology and mechanistic studies related to toxicity. We are seeking input from government, industry, and scientific and technical experts.
- Suntanning Cancer Risk
FDA established an inter-Center Photosciences Network to collaborate on ways to improve safety from exposures to ultraviolet (UV) radiation. Our Center established a research facility and, with a multi-disciplinary team from the National Cancer Institute, Washington Hospital Center, Philips Research Laboratories and FDA’s Center for Food Safety and Applied Nutrition, investigated biomarkers for testing and standardizing human skin response to UV. In addition, we are conducting research on cell death mechanisms from ultraviolet-A exposure and have calculated an average annual solar UV dose based on data from the Environmental Protection Agency. This information is necessary to assess the relative increased risk of skin cancer resulting from use of ultraviolet-emitting electronic products.
See the Regulatory Science and Standards section for the following:
- Information Disclosure to Diagnostic X-Ray Assemblers;
- Electronic Anti-Theft Systems;
- Amendments to Fluoroscopy and Laser Standards; and
- X-Ray Personnel Screening (People Scanners).
Surveillance and Compliance for Radiological Products
We reviewed approximately 63 percent of the nearly 6000 product reports and annual reports submitted by manufacturers documenting compliance with standards and radiation quality control and testing programs. Based on these reports, laboratory tests, field tests, and inspections, we issued over 60 noncompliance letters and disapprovals of radiation testing programs and assisted the field staff with over 30 import detentions.