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Office of Device Evaluation Annual Report Fiscal Year 2006 and Fiscal Year 2007
(Part 3 - Magnet for Excellence)

In ODE, our staff is our most valuable resource. We are very proud of the accomplishments of our highly trained and dedicated staff of scientists, engineers, physicians, nurses, and other health professionals. ODE staff are routinely asked to participate and lead government working groups and consensus standards committees, to present at professional conferences and at academic institutions, and to prepare articles for publication in journals and other publications.

The complete list of publications and presentations by ODE staff are given in Appendix B and the complete list of all ODE staff who serve as liaisons to standards committees is also in Appendix B. A few highlights of our activities are described below.

Leadership Readiness Program

In FY 06, ODE initiated a Leadership Readiness Program to create a pool of employees with skills necessary for transitioning into projected first-level supervisory vacancies within the Office.

This one year cohort program includes training in conflict resolution, facilitation, group dynamics, FDA administrative policies, and communication skills. Participants have also been provided several opportunities for learning about themselves through assessment instruments such as Myers-Briggs, Emotional Intelligence, and a 360 profile.

Each participant was also matched with a mentor from ODE or OIVD who individually assists their mentoree (participants) to identify crucial developmental opportunities that will enhance their learning and provide skills that cannot be learned in the classroom.

Thirteen employees from ODE and three employees from OIVD were competitively selected to participate in the program. Fourteen ultimately completed the program, and five of those individuals have been promoted into permanent management positions at CDRH. This ODE/OIVD program was so successful in developing our future leaders that it has been adapted for use in all of CDRH.

ODE Staff Receive Outside Honors

Several ODE staff members were honored this past year with awards from outside organizations.

DAGID Awards and Special Recognition:

Harry Sauberman received the IEEE Washington Section 2005 Volunteer-of-the-Year Award for his work with the University of Maryland graduate engineering students. 

William M. Burdick has been accepted for inclusion in the 2007 edition of Marquis’ Who’s Who in America.

DGRND Awards and Special Recognition:

During FY 06, Binita Ashar, M.D., M.B.A., of the General Surgical Devices Branch served as an Advisor for Medicine and Public Health for Homeland Security Affairs in the Office of the Vice President for the United States.  Dr. Ashar’s service was honored with appreciation letters from the Chief of Staff to the President,  Mr. Andrew Card,and, the other from Vice President Dick Cheney.

DOED Awards and Special Recognition:

Teresa Cygnarowicz received her doctorate degree in audiology (AuD) from the Pennsylvania College of Optometry-School of Audiology on April 16, 2006.

Bruce Drum is in the 2007 edition of Marquis’ Who’s Who in America (61 st Edition, Marquis’ Who’s Who LLC, Providence, NJ).

DRARD Awards and Special Recognition:

Ewa Czerska , MD , Ph.D., is president of the Bioelectromagnetic Society (BEMS) for 2007-2008.

Gema Gonzalez , as a member of the Renal Diseases and Detoxification Committee, received an AAMI Standards Technical Committee Award in 2007.

Raju Kammula , DVM, Ph.D., was commended for his long service to the American Veterinary Medical Association (AVMA) on July 15, 2006.

Pam Weinel , RN, MS, MBA, was accepted for inclusion in the 2005-2006 editions of Marquis’ Who’s Who in American Women and in the 2006-2007 editions in Who’s Who in Medicine and Healthcare.

Standards

ODE staff continue to play a significant role in both domestic and international standards committees. Our staff members are liaisons and often, chairpersons of standards committees for a wide range of devices for a variety of standards organizations including ISO, AAMI, ASTM, ANSI and IEC. ODE is committed to the standards development process, and we believe that the development of scientifically sound standards will allow us to efficiently review premarket applications for both existing and innovative technologies. A complete list of ODE staff involved in standards activities is in Appendix B.

International Outreach

In FY 06 and FY 07, ODE staff members continued their efforts in international outreach and global harmonization activities. Several staff served on the Global Harmonization Task Force (GHTF). Their efforts were directed towards harmonizing medical device regulation on a global basis. In addition, the office participated in several meetings with government regulators, academicians and representatives from many countries. These meetings, hosted by DSMICA, included:

In FY 06 --

(1) Health Canada – Regulations for Single Use Devices – March 16, 2006;

(2) China, Jiangsu Province, Food and Drug – Premarket Regulatory Processes – May 17, 2006; and

(3) China, Jiang Test and Research Institute for the Control of Medical Devices – Devices 101 and Specifically Contact Lenses – June 2006.

In FY 07 –

(1)   Taiwan, National Cheng Kung Univ. – Innovation and Development of Medical Devices – Feb. 5–7, 2007;    

(2)   Singapore, Health Science Agency – Overview of Medical Device Regulations – June 13, 2007.

Updated June 19, 2008

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