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U.S. Department of Health and Human Services

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FY 2005 ODE Annual Report - Part 3 - Magnet for Excellence

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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. This past year posed difficult challenges to the U.S. in the wake of Hurricanes Katrina and Rita. ODE staff who are commissioned officers in the Public Health Service responded and many were deployed to serve critical needs in the nation’s public health system.

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.

ODE Staff Receive Outside Honors

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

Kish Chakrabarti of DRARD was named as one of the 100 physicians, administrators and thought leaders in the June issue of Health Imaging & IT.

Several ODE staff were honored by awards from the ASTM Committee on Medical and Surgical Materials and Devices (F04). John Goode of DGRND was awarded the 2005 LeRoy Wyman Award for outstanding contributions as an engineer, Vivianne Holt of DCD was awarded the 2005 Robert Fairer Award for her work on the Interventional Cardiology Task Group, and Mark Melkerson of DGRND received the 2005 Patrick G. Laing Award for distinguished service and outstanding technical contributions.

An article recently published by Malvina Eydelman and Bruce Drum of DOED entitled "Systematic evaluation of wavefront-guided outcomes" has been selected as one of the most important papers recently published in Ophthalmology by OphthoLinx Refractive / Eye Surgery Newsletter as well as by Optics/Refraction/Lenses Newsletter.

Humanitarian Efforts

Many of our staff were called upon to assist the nation during this past year of significant and devastating national disasters. Several ODE staff were deployed to help in the Gulf area to care for victims of Hurricanes Katrina and Rita. In addition to helping in direct patient care, ODE staff also helped to set up systems to care and manage the large number of patients needing services, as well as assessing infrastructure needs for health care and handling logistics for the large number of PHS officers being deployed to the area. In addition to disaster relief, ODE PHS officers also provided aid and services for Native Americans as well as for international relief efforts.

The ODE PHS officers deployed over the past year were:

Name Division
LCDR Brian Lewis DCD
LCDR Nina Mezu-Nwaba DCD
CDR Victoria Hampshire DCD
CAPT. Bette Lemperle DCD
CDR Stephen Rhodes DGRND
CDR Samie Allen DGRND
CAPT. Susan Runner DAGID
LT Scott Colburn DAGID
LT Mary Brooks DAGID
LCDR Lori Austin-Hansberry DOED
LTJG Brad Cunningham DOED
LCDR Nicole Wolanski POS
CAPT. Paula Simenauer POS

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 05, ODE staff continued our efforts in international outreach and harmonization. Several of our staff members serve on the Global Harmonization Task Force, an effort to standardize and harmonize medical device regulation around the world. Our office also hosted fellow regulators from around the world, including representatives from Korea, Finland, Canada, and Taiwan to share information and our experiences in medical device regulation.