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FY 2001 OHIP Annual Report - Appendix
Publications and Presentations
OHIP’s programs may involve formal publications or presentations in various scientific and professional settings. This listing reflects the variety and diversity of our programs.
Activities of NEXT – Past, Current, and Future. Presented to the 33rd Annual meeting of the Conference of Radiation Control Program Directors, Anchorage, Alaska, April 29-May 2, 2001. Companion paper published in Proceedings of the 33rd National Conference on Radiation Control, CRCPD Publication 01-7, August, 2001; pg 88. PowerPoint document available at http://www.crcpd.org/proceedings.asp. Mary Ann Spohrer, David Spelic.
Breast Implant Risks. FDA Brochure. November 2000. Nancy Leonard, Mary Ann Wollerton
CDRH Regulatory Requirements and Quality Systems. 8 Presentations at the FDA Medical Device Reuse Workshop; Orlando, FL.; May 10-11, 2001; Joseph Puleo; Frederick B. Winston
CDRH Regulatory Requirements and Quality Systems. 8 Presentations at the FDA Medical Device Reuse Workshop; Phoenix, AZ.; May 30-31, 2001; Joseph Puleo; Frederick B. Winston
Chapter 2, Radiation Safety. Efficacy and Radiation Safety in Interventional Radiology, (World Health Organization, Geneva, 2000). P. Shrimpton (Rapporteur), C. Sharp (Chairman), D. Mohlkert, V. Neofotistou, H. Schibilla, T. Schmidt, S. Stern, R. Veit, and M. Zankl.
Comparison of Photometers in Measuring DICOM Part 14 Conformance. Medical Physics, 28, 1248(2001). B. Drinkwine, J. Thomas, M. Loscocco, K. Chakrabarti, R. Kaczmarek, I. Ilev, R. Waynant.
Comparison of Photometers in Measuring DICOM Part 14 Conformance. Scientific exhibit presented at the 2001 meeting of the American Association of Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 2001 (Abstract), p. 1248. B. Drinkwine, J.Thomas (USUHS), K. Chakrabarti, R. Kaczmarek (CDRH), M. Loscocco (JRCAB, Ft Detrick, MD).
Continual Quality Control Monitoring of High Resolution Diagnostic Monitors. Medical Physics, 28, 1248(2001). M. Loscocco, J. Thomas, B. Drinkwine, K. Chakrabarti, R. Kaczmarek, D. Davis.
Continuous Quality Control Monitoring of High Resolution Diagnostic Monitors. Scientific exhibit presented at the 2001 meeting of the American Association of Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 2001 (Abstract); p. 1248. M. Loscocco (JRCAB, Ft Detrick, MD), J. Thomas, B. Drinkwine (USUHS), R. Kaczmarek, K. Chakrabarti, (CDRH) D. Davis (Naval Medical Center, San Diego, CA).
Division of Small Manufacturers, International and Consumer Assistance (DSMICA) Overview. Presentation at the Association of Medical Diagnostic Manufacturers (AMDA) Workshop; Rockville, MD.; April 25, 2001; William Sutton
Effect of CNR and SNR on Phantom Image Quality in GE Senographe Full Field Digital Mammography System. Medical Physics, 28, 1247(2001). K. Chakrabarti, R. Kaczmarek, J. Thomas, B. Drinkwine, M. Loscocco.
Effects of CNR and SNR on Phantom Image Quality in the G.E. Senograph 2000D FFDM System. Med. Phys. Vol. 28, No. 6, June 2001 (Abstract); p. 1247. Scientific exhibit presented at the 2001 meeting of the American Association of Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 2001 (Abstract), p. 1247. K. Chakrabarti, R. Kaczmarek (CDRH), J. Thomas, B. Drinkwine (USUHS).
Establishment Registration and Medical Device Listing. CDRH User Facility Reporting Bulletin, Issue 34, Spring 2001; Frederick B. Winston
Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-Ray Equipment. Poster S3, 2001 FDA Science Forum: Science Across the Boundaries, Washington, DC, February 15-16, 2001 (Abstract no. 189, entire paper). S.H. Stern, S.A. Tucker, R.M. Gagne, and T.B. Shope, Jr.
Equipment Evaluation and QC Test Requirements for Full Field Digital Mammography Systems Invited Presentation at the Digital Mammography Workshop. Nov. 15, 2001, University of California, Los Angeles, CA. Published in Newsletter of American Association of Physicists in Medicine. K. Chakrabarti.
FDA Launches a Tool to Create Effective Medical Device Patient Labeling: Seeks FDA-Industry Partnership in Its Use. Food and Drug Law Institute Update Magazine, Volume 56, Issue 4, Page 13-15. July/August 2001. Silberberg, Paula G.
Global Harmonization. 6 Presentations for the Asian Harmonization Working Party; Malaysia; September 6-7, 2001; Christine Nelson; Judy Strojny
Guidance on Medical Device Patient Labeling; Final Guidance for Industry and Reviewers. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm070782.htm. April 19, 2001. Silberberg, Paula G.
Hospital Bed Safety Work Group: Highlights. Article in User Facility Bulletin, Summer 2001, Issue Number 35, pages 5-6; M. Pijar & M. Wollerton.
The Impact of MQSA On the General Practice of Radiology: Regulated versus Unregulated Environments. Scientific paper and exhibit presented at the 2001 meeting of the American Association of Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 2001 (Abstract); p. 1257. O.H. Suleiman.
Issues Relevant to Medical Physicists Under MQSA’s Final Regulations. Presentation at the Medical Technology Management Institute workshops, Feb. 18, June 10, and Sept. 30, 2001. Mourad, W.
Medical Device Regulatory Requirements. Presentations at Hood College, Frederick, MD.; July 11, 2001; William Sutton
Mammography Equipment Evaluations (MEE) Under MQSA’s Final Regulations, poster presentation at the American College of Medical Physicists Meeting in Hershey, PA, June 4-6, 2001. Mourad, W.
Medical Physicists Role in Full Field Digital Mammography Facilities. Presentation at the American Association of Physicists in Medicine 43rd Annual Meeting, July 22-26, 2001, Salt Lake City, UT. Medical Physics, 28, 1243(2001). K. Chakrabarti.
MPRIS Overview and Demonstration. Presentation to CRCPD, April 2001. Haran, T.,
MQSA Update. Continuing education presentation for radiologic technologists at the "A Day of MQSA" meeting in Atlanta, GA, July 31, 2001. M. Divine.
Nationwide Evaluation of X-ray Trends: Summary of the 1996 Fluoroscopy Survey. Submitted to CRCPD for publication. Richard Kaczmarek.
The Nationwide Evaluation of X-ray Trends: Twenty-five Years of NEXT. Scientific exhibit presented at the 2001 FDA Science Forum: Science Across the Boundaries, (abstract no. 249, February 15-16, 2001, Washington DC.). D. Spelic, R. Kaczmarek, O. Suleiman, S. Stern.
Navigating the CDRH Website. Presentation at the Medical Alley: Managing your Submissions and Web Presence Workshop; Minneapolis, MN.; December 13, 2000; Frederick B. Winston
Navigating the CDRH Website. Presentation (booth) at the Medical Design and Manufacturing (MD&M) West 2000 Conference; Anaheim, CA.; January 8-10, 2001; Frederick B. Winston; Carol Fedorchak
Navigating the CDRH Website. Presentation (booth) at the Medical Design and Manufacturing (MD&M) East Conference; New York, New York, June 5-7, 2001; William Sutton, Carol Fedorchak
NEXT 2000 Protocol for Survey of Computed Tomography (CT). December 18, 2000. (CRCPD publication available at http://www.crcpd.org/, posted August 3, 2001). S.H. Stern, D.C. Spelic, R.V. Kaczmarek.
Optimization of Viewing Conditions and Phantom Image Quality Evaluations on GE DMR and Full Field Digital Mammography (FFDM) System. J. Digital Imaging, 13, 226(2000). K. Chakrabarti, J. A. Thomas, R. V. Kaczmarek, R.W.Waynant and M. F. Loscocco.
Overview of Medical Device Regulations. 8 Presentations for the Canadian Manufacturers; November 14, 2000; Montreal, Canada; Frederick B. Winston, William Sutton
Overview of Medical Device Regulations. 8 Presentations for the Canadian Manufacturers; November 16, 2000; Halifax, Canada; Frederick B. Winston, William Sutton
Overview of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA); Global Harmonization; Mutual Recognition Agreement. Presentations for San Diego Graduate Students; Rockville, MD.; August 27, 2001; Christine Nelson
Overview of Medical Device Regulations; CDRH Electronic Communications Systems. 8 Presentations for the Canadian Government; Ottawa, Canada; May 31, 2001; Ron Parr, Christine Nelson
Overview of Medical Device Regulations; Global Harmonization; Mutual Recognition and Overview of Radiological Health. Presentations for Embassy Seminar (Representatives for Medical Device Industry); Rockville, MD.; October 2000; William Sutton; Christine Nelson, Walter Snesko
Overview of Medical Device Regulations and Quality Systems Presentations at Hood College, Frederick, MD.; July 9, 2001; Frederick B. Winston
Overview of Quality Systems. 17 Presentations for the Government of Singapore; November 2-3, 2000; Singapore; Judy Strojny
Overview of Quality Systems Requirements for Process Validation.. Presentation at the Association for the Advancement of Medical Instrumentation (AAMI) Process Validation Workshop; Dallas, TX; December 13-15, 2000; Christine Nelson
Overview of Quality Systems Regulations. Presentation at the Association for the Advancement of Medical Instrumentation (AAMI) GMP/QS Requirements and Industry Practice Workshop; Sanibel Island, Fl.; October 16-19, 2000; Christine Nelson
Overview of Quality Systems. Presentation at the Association for the Advancement of Medical Instrumentation (AAMI); Frankfurt, Germany; April 23-27, 2001; Christine Nelson
Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. Presentation at the Medical Design and Manufacturing (MD&M) East Conference; New York, New York, June 6, 2001; William Sutton
Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. Presentation at the Mass MEDIC Exporting Medical Devices to Europe; New Frontiers and Opportunities Workshop; Boston, MA; June 7, 2001; Christine Nelson
Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. Presentation at the Regulatory Professional Society (RAPS) and the Department of Commerce Workshop; San Francisco, CA; June 12, 2001; William Sutton
Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex. Presentation at the Medical Alley: Exporting Medical Devices to Europe; Minneapolis MN.; June 14, 2001; Christine Nelson
Overview of Quality Systems. Presentation at the American Society for Quality (ASQ) Workshop; St. Paul, MN.; July 16-17, 2001; Christine Nelson
Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex and Where do IVD’s Fit In. Presentation at the FDA/IVD Roundtable, Rockville, MD.; July 24, 2001; Christine Nelson
Overview of U.S./EC Mutual Recognition Agreement Medical Device Annex and Where Do IVD’s Fit In. Presentation at the AdvaMed Conference; Washington, D.C., August 23, 2001; Christine Nelson
Overview of the U.S./EC Mutual Recognition Agreement; Presentation at the Japan Association for the Advancement of Medical Equipment (JAMME) International Seminar; August 27-31, 2001; John Stigi
Preference Studies of Workstation Monitor Performance. Proceedings of the 5th International Workshop on Digital Mammography, June 11-14, 2000, p 612-616, Medical Physics (2001). M.F. Loscocco, J.A. Thomas, K.Chakrabarti, and R.V. Kaczmarek.
Radiation Dosimetry in X-Ray Computed Tomography (CT): Standardization and Regulation. Presentation at 28th Meeting of the Technical Electronic Product Radiation Safety Standards Committee, Advisory Committee to the Food and Drug Administration, Rockville, Maryland, May 17, 2001, (transcript pages 68-110, http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3751t1_01.pdf and http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3751t1_02.pdf). Stanley H. Stern.
Reports of Corrections and Removals. CDRH User Facility Reporting Bulletin, Issue 34, Spring 2001; Frederick B. Winston
Tabulation and Graphical Summary of 1998 NEXT Survey of Pediatric Chest Radiography. Submitted to CRCPD for publication. Albert Moyal.
Twenty-seven Years of the Nationwide Evaluation of X-Ray Trends. Scientific paper presented at the 2001 meeting of the American Association of Physicists in Medicine, Salt Lake City, UT. Medical Physics, Vol. 28, No. 6, June 2001, (Abstract), p. 1257. D. Spelic, O. Suleiman, R. Kaczmarek, S. Stern, A. Moyal.
Update of FDA Part 11 Activities. Presentation at the AdvaMed; Electronic Records and Electronic Signatures; Boulder, CO; March 1-2. 2001; Christine Nelson
Update of U.S./EC Mutual Recognition Agreement. Presentation at the American Council of Independent Laboratories; February 26, 2001; Alexandria, VA; Christine Nelson
U.S. Regulatory Requirements and U.S./EC Mutual Recognition Agreement. Presentation for Government of China; April 16-21, 2001; China; John Stigi
U.S. Regulatory Requirements. 24 Presentations for the Department of Commerce and State Drug Administration; Kunming, China; September 10 -12, 2001; Christine Nelson; Judy Strojny.
The Vessel Dilator for Central Venous Catheter Placement: Forerunner for Success or Vascular Misadventure? Journal of Intensive Care Medicine, Volume 16 – No.6 November/December 2001, pages 263-269; W. Scott, P. Collier.
OHIP Staffing and Organization
OHIP includes the Office of the Director, two Staffs and four Divisions.
Office of the Director
- provides overall leadership and direction
- provides administrative and ADP support to all OHIP programs
Regulations Staff
- develops and advises on the preparation of Federal Register documents, including proposed and final regulations and notices
- coordinates the preparation, review and processing of responses to citizen petitions
Cassis, Domini H. Hanna, Myrna A. Olson, Jean * Fischer, Ruth A. Knight, Jacqueline E. Sheehan, Joseph M. Gilmore, Rosa M. Noland, Bernice E. Wade, Jennette Staff College
- develops and delivers training programs, courses, seminars and lectures
- provides satellite telecasts and distance learning programs on a variety of topics
Brier, Marjory F. Kramer, Mark D.* Nakon, Kimberly K. Gerhold, Susan H. Morch, Cecile, A. Sauer, Patrice A. Hanna, Mary R. Nesseler, Steven E. Stewart, Laura L. Division of Communication Media
- produces videotapes and teleconferences – from script development to completed program – using in-house resources
- delivers satellite productions to CDRH, FDA, and national audiences to promote the mission and messages of CDRH and FDA
Bailey, David W. Jefferson, Arnette L. Rose, Stanley C. Boyce, Wallace C. Kogok, Richard A.* Scimonelli, Glenn M. Butler, Bruce E. McCleary, Robert F. Silverman, Laurie Fatula, Robert H. Monica, Stefan F. Vinson, Jeanine M. Frederic, Kenton P. Richards, Barbara A. Division of Mammography Quality and Radiation Programs
- implements the Mammography Quality Standards Act, including the certification and annual inspection of all mammography facilities
- supports collaborative activities that help protect the public from unnecessary exposure to electronic product radiation
- administers the CDRH radiation safety office
Abernethy, Scott D. Divine, Michael P. Ratskoff, Ellyce F. Akey, Catherine L. Finder, Charles A. Robinson, Denise J. Ali, Fiad M. Flanagan, Margaret Shandruk, Petro Appleby, Suzanne E. Franke, Kathleen A. Sheridan, Kathleen M. Ashby, Kimberly A. Friend, Wesley A. Spelic, David C. Barr, Helen J. Gunzburg, Charles R. Stern, Stanley H. Belella, Stephanie L. Haran, Timothy J. Suleiman, Orhan H. Bennaugh, Nancy T. Hoage, Patricia A. Thompson, Donald L. Boyce, Penny R. Jernigan, Vickie H. Trammell, Dennis L. Burkhart, Roger L. Kaczmarek, Richard V. Wandell, Evelyn P. Chakrabarti, Kishalaya McCrohan, John L. Wei, Stella D. Chesemore, Kaye F. Mourad, Walid G. Wynne, Nancy M. Chissler, Pamela G. Moyal, Albert E. Choy, Joanne K. Pack, Randy F. Division of Device User Programs and Systems Analysis
- provides human factors and systems analysis to reduce use error by evaluating device design, instructions for use, and patient labeling in premarket and postmarket reviews
- conducts and advises on qualitative research to help construct risk messages and analyze internal processes
- develops information and outreach for health professionals and consumers
Appel, Sherrie McCracken, Jack E. Scott, Walter L. Cangelosi, Robert J. Meadows, Susan K. Seligson, Edith D. Carstensen, Peter B. Mendelson, Laurel S. Silberberg, Paula G. Clayton, Carol M. Mendelson, Michael Thomas, Alvin W. Houchins, Donna E.* Pijar, Mary Lou Tolbert, Margaret T. Lowe, Nancy S. Rachlin, Jay A. Weiss, Ruth Kaye, Ronald D. Rooks, Cornelia B. Wollerton, Mary Ann Kingsley, Patricia A.* Sawyer, C. Richard Division of Small Manufacturers, International and Consumer Assistance
- educates industry and helps them comply with FDA regulations
- educates consumers on medical device and radiation emitting product issues and problems
- educates foreign governments on the U.S. regulatory process
- supports global harmonization and MRA (Mutual Recognition Agreement) activities
Alderton, Bonnie J. Lucas, James E. Stigi, John F. Alford, Shirley * Nelson, Marie C. Strojny, Judith L. Allen, Gene E. Park, James J. Sutton, William M. Auerbach, Jessica B. Parr, Ronald P. Taylor, Tawana V. Barcome, Althea L. Pritchard, Lisa M. Watts, Crystal Bracey, Alfred Puleo, Joseph V. Weller, Phyllis S. Cardamone Thomas E. Raines, Joyce A. Weiner, Deborah C. * Clark, Geoffrey S. Rice, Lynne L. Willis, Marcellus E. * Fedorchak, Carol M. Rodgers, Anthony E. Winston, Frederick B. * Freeman, Nancy J.* Snesko, Walter M. Yellin, Arthur K. Greberman, Melvyn* Stellar, Barbara P. Leonard, Nancy M.
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*No longer with OHIP as of 3/31/02
OHIP Organization Chart
