FY 2005 OCER Annual Report - Message from the Director

The Office of Communication, Education, and Radiation Programs (OCER) provides services that directly affect the lives of millions of Americans. As one of the Offices within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), our mission is to collaboratively support the Center and Agency in assuring the safety and effectiveness of medical devices and radiation-emitting electronic products and in assuring high quality mammography. We specialize in program-based communication, education, radiological health, mammography quality, and reduction of use error. To accomplish this goal, we use our unique and diverse expertise to enhance the effectiveness and efficiency of Center programs.

Overall, the CDRH mission and vision guide OCER’s work. During Fiscal Year (FY) 2005, OCER worked toward the CDRH mission, vision, and strategic goals. These goals include:

• to apply the total product life cycle model across all CDRH activities;
• to serve as a magnet for excellence in attracting and retaining a diverse workforce who want to help us fulfill our public health mission;
• to manage knowledge in support of the total product life cycle model; and
• measure and communicate our public health impact.

Because of our role within CDRH, we serve a wide variety of customers. Our customers include:

• domestic and foreign manufacturers of medical devices and radiation-emitting electronic products;
• domestic and foreign government agencies engaged in public health and the regulation of medical devices;
• healthcare professionals and healthcare facilities, as well as the organizations that represent them;
• consumers and patients, including all women in the United States who receive mammograms; and,
• CDRH staff that benefit from our training and professional development activities.

FY 2005 was noteworthy for OCER in many program areas and presented unexpected challenges in others. Hurricane Katrina presented us with an enormous challenge. Our staff responded quickly by assisting the Department of Health and Human Services (HHS) medical staff in the affected areas. OCER staff also assisted the HHS emergency assistance call centers in Washington DC by responding to questions related to medical devices and radiological products. I am proud of all of the CDRH staff that rose to this challenge, and especially proud of the volunteers in OCER who assisted in the overall disaster recovery effort which in many cases included traveling to New Orleans and other hard-hit areas to provide expertise and a helping hand.

Another of our more notable accomplishments was OCER’s Division of Mammography Quality and Radiation Programs (DMQRP) commemorating 10 years of Mammography Quality Standards Act (MQSA) inspections. Since the inception of this valuable program, MQSA inspectors have completed over 99,000 inspections of mammography facilities. During that time, the percentage of inspections without adverse observations has increased significantly, and continues to do so. We also published amendments to the mandatory medical x-ray performance standards that should significantly reduce patient radiation exposure from fluoroscopy.

Throughout this report, you will see that communication and education are in all aspects of our work. This is evident whether we are producing teleconferences, training CDRH staff, working with patients/consumers/health professionals, assuring high quality mammography, conducting radiation safety surveys, answering device industry questions or writing regulations. Radiation, the other component in our name, is also a large part of what we do in OCER. The majority of staff that work on radiation and radiological issues are within OCER. Whether it is the regulation of mammography facilities or compliance of electronic product manufacturers of lasers, microwaves, or diagnostic devices such as x-ray equipment, we ensure all of these products are safe for the consumer.

As we carry out our programs, we emphasize collaboration both within and outside CDRH. Coalition building, public participation, and information exchange allow us to obtain input from all relevant and concerned sources and to leverage and multiply our resources to protect the public health.

We think that each of our customers will find programs of interest in this report. We welcome your review and your comments on our efforts and our future directions.

Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs