Radiological Health Reengineering Workshop - November 15-16, 2000

Introduction

The Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH) is interested in meeting with stakeholders to hear whether certain radiological health programs and processes would benefit from changes and, if so, which changes would be most effective. The open public workshop is intended to bring together persons representing industry, the health professions and other users of radiation-emitting electronic products, government agencies, instrumentation manufacturers, product testing laboratories, and scientific and standards organizations to develop practical plans for reengineering. This meeting is in keeping with the outreach provisions of the Radiation Control for Health and Safety Act and the Food and Drug Administration Modernization Act.

Workshop Purpose

The purpose of reengineering the radiological health processes is to make the best use of FDA expertise and resources in performing activities that best fulfill the FDA role in radiation protection. In partnership with stakeholders, CDRH wants to implement:.

• a prioritization process to assure that limited resources are allocated effectively and efficiently to address critical radiation problems.
• an efficient and effective information exchange process on public health concerns, safety information and manufacturer data.
• an optimized process for the development and implementation of radiation product standards and recommendations.
• a consolidated process for gathering, storing, analyzing, and disseminating product test data.

The workshop will include presentations on CDRH radiological health reengineering activities and proposals, a town hall forum for participant comments, and four breakout sessions. Participants will be asked to participate in two breakout sessions on November 15, and then to concentrate on one of the four topics on November 16. The four breakout topics are prioritization, information exchange, standards, and product testing. 

Conference Objectives

1. Develop practical solutions to the following questions.

• How should CDRH choose and implement specific radiological health activities and set priorities? (Constraints include low budget and 60 full-time equivalent personnel.)
• How can CDRH better communicate and network with stakeholders (states, other federal agencies, industry, health professionals, standards organizations, etc.) regarding its radiological health program?
• How can CDRH optimize and improve the development/administration of electronic product radiation standards, recommendations, and guidances?
• How can CDRH optimize and improve the evaluation of radiation emissions/exposures from electronic products?

2. Seek collaboration via leveraging to enhance the overall effectiveness of the FDA/CDRH radiological health program in light of modern technology, fewer resources, competing priorities, and reduced public concern about exposure to radiation sources.
3. Get stakeholders’ reaction and buy-in to proposed changes in the FDA/CDRH radiological health program.

Breakout Topic 1: Prioritization

CDRH must prioritize the use of limited resources to effectively and efficiently identify and address public health concerns. CDRH wants to partner with stakeholders to assure the best allocation of these limited resources. We are seeking a practical plan to be implemented jointly by FDA and stakeholders. The workshop will address the following questions:

Day 1

• For the purposes of a prioritization scheme, what products and technologies are of most concern and why?
• Who are we (CDRH and stakeholders) trying to protect and from what? (Consider what health effects we are trying to prevent from modern-day products and technologies, e.g., burns, cancer.
• How should the prioritization scheme be used?

Day 2

• How should we (CDRH and stakeholders) prioritize these products and technologies?
• How and when should CDRH communicate the prioritized products and technologies to our stakeholders?
• What measures of success should CDRH use for this prioritization scheme? (Consider stakeholder needs, communications and the impact on improved public health.)
• How should FDA and stakeholders develop, maintain and implement a risk based program?
• What partners should participate and how?

Breakout Topic 2: Information Exchange

FDA and stakeholders need information on product emissions, exposure, use and health effects to make public health decisions. When FDA and stakeholders exchange information, such as identification of public health concerns, dissemination of safety information, and reports from manufacturers, FDA’s public health effort is enhanced. CDRH is seeking a practical plan to improve the efficiency and effectiveness of communications tools and processes. The workshop will address the following questions:

Day 1

• What are the criteria for identifying a public health concern?
• When there is a public health concern, what information do we need to collect/analyze and why? (Consider injury data, risk prevention, and stakeholder fears).
• When there is a public health concern what does each stakeholder group need to know? (When brainstorming consider emergency information, long-term information, trends data versus descriptions, and training versus literature).
• What surveillance data needs to be obtained and why? How should the surveillance data be used? (Consider data on new technologies, monitoring compliance with standards and guidances, and adverse events).

Day 2

• How should stakeholders and FDA communicate and network about public health concerns? (Consider what tools and technologies should be used.)
• How should stakeholders and FDA collect and disseminate public health data and information? (Consider what tools and technologies should be used. This includes the submission of manufacturer reports to CDRH and reports of adverse events.)
• How should we format the information? (Consider trend analysis, charts, graphs and general presentations.)
• What measures of success should we use to evaluate the information exchange process?
• How should we implement an information exchange process? What partners should participate? 

Breakout Topic 3: Standards

CDRH develops and enforces regulatory performance standards for radiation-emitting electronic products to minimize exposures to unnecessary radiation. In addition, CDRH makes recommendations relating to hazards and control of radiation. CDRH is seeking a practical plan to optimize the maintenance, development and implementation of standards and recommendations. The workshop will address the following questions:

Day 1

• What are the principles (e.g., informing patients about the benefits of radiation, protecting children, or providing controls to allow users to minimize exposures) CDRH and stakeholders are trying to achieve in radiation protection standards? (Consider what exposure or use conditions we are trying to prevent).
• When are mandatory performance requirements necessary and when is it acceptable for performance specifications to be in consensus standards (including international standards)? (Consider purpose, use and compliance with standards.)
• When should CDRH use guidances in place of standards?

Day 2

• What measures of success should CDRH use for determining when product performance criteria improves public health? (Consider implementation, distribution, use, effectiveness and harmonization of regulatory and consensus standards and guidances.)
• How should CDRH and stakeholders work smarter to develop and maintain regulatory and consensus standards? What partners should participate?
• How should the process of developing and implementing guidances differ from the process for standards?
• How should CDRH format standards and guidances so stakeholders can easily read, understand and implement them?

Breakout Topic 4: Product Testing

CDRH develops and enforces regulatory performance standards for radiation-emitting electronic products to minimize exposures to unnecessary radiation. In addition, CDRH makes recommendations relating to hazards and control of radiation. CDRH is seeking a practical plan to optimize the maintenance, development and implementation of standards and recommendations. The workshop will address the following questions:

Day 1

• What aspects of radiation emissions and safety can be obtained only by a test of a product? (Consider all types of radiation and applications, including consumer, medical, and industrial.)
• Who needs the testing information? Why and how will the testing information be used?
• What instrumentation and test methodologies are needed to achieve product testing?

Day 2

• How should CDRH and stakeholders work smarter to test products? (Consider all types of radiation and applications, including consumer, medical, and industrial.)
• How should CDRH work with others to obtain reliable testing information and what partners should participate? (Consider industry monitoring and assessment of user practices.)
• What measures of success should CDRH use for determining when product testing improves public health?
• How should CDRH consolidate and present the information so that it is useful to stakeholders? (Consider consumer information, exposure trends, industry noncompliance rates or types of outlyers.)