Appendix

Publications and Presentations

A Patient’s Path to Understanding Medical Devices. Presentation (poster) at the American Academy of Family Physicians/Society of Teachers of Family Medicine Annual Conference on Patient Education; and at the FDA/National Patient Safety Consumer Forum. John J. Crowley, Patricia A. Kingsley.

CDRH Hot Topics for 2000 and Navigating and Retrieving Valuable Information from the FDA Website. Presentation (booth) at The Medical Design and Manufacturing (MD&M) East 2000 Conference, New York, NY. William M. Sutton, Carol M. Fedorchak.

CDRH Overview. Presentation at Baltimore District Conference, Annapolis, MD. August 21, 2000. Nancy M. Leonard.

CDRH Webpage and Overview of Medical Device Regulations. Presentations at the Pan American Health Organization (PAHO), Washington, DC. October 22, 1999. Frederick B. Winston, Thomas E. Cardamone, William M. Sutton, John F. Stigi.

Central Venous Catheter Tip Placement and Catheter Occlusion. American Journal of Surgery; 108(1):78-79 (2000). Walter L. Scott.

Challenges for FDA (in regard to electronic records and electronic signatures). Presentation at the Drug Information Association Conference, Washington, DC. September 13, 2000. Christine Nelson.

Condoms-Standards and Regulations. Presentation at the International Glove/Barrier Shippers Association, Long Beach, CA. May 1, 2000. Arthur K. Yellin.

Current Issues in Federal Sector Healthcare Law. Presentation at Medical Jurisprudence of the Uniformed Services University of the Health Sciences Section of Medical Jurisprudence and the Air Force Judge Advocate General School, Bethesda, MD. May 2000. Melvin Greberman.

Doses in Radiology: How and Why They Vary. Presentation at the Annual Meeting of the National Council of Radiation Protection (NCRP), Bethesda, MD. Orhan H. Suleiman.

Electronic Imaging in the Health Care Enterprise: Roles of the FDA. Presentation at the American Medical Informatics Association (AMIA), Washington, DC. November 1999. Melvin Greberman.

Electronic Records and Signatures. Presentation at AdvaMed Workshop, Washington, DC. September 26-27, 2000. Christine Nelson.

FDA Guidance for I. V. Catheter Market Clearance. The Journal of Vascular Access Devices; 5(3):18-19 (2000). Walter L. Scott.

FDA International Activities and FDA/EU Mutual Recognition Agreement Update. Presentations at the Global Harmonization Task Force (GHTF) Annual Conference, Ottawa, Canada. September 2000. Christine Nelson.

Human Factors Considerations in Infusion Pump Use Safety. Presentation at the Infusion Pump Workshop, Minneapolis, MN. September 26-28, 2000. John J. Crowley, Ronald D. Kaye.

Human Factors in Medical Device Use Safety: How to Meet the New Challenges. Presentation at the International Mini-Symposium on Global Challenges for Human Factors and Medical Systems, Conference of the International Ergonomics Association and the Human Factors and Ergonomics Society Annual Meeting. August 2000. Susan K. Meadows, Ronald D. Kaye, C. Richard Sawyer, Peter B. Carstensen, Cornelia B. Rooks.

IDE Process and Expected Information in Protocols. Presentation for the U.S. Army Medical Material Command, Bethesda, MD. October 29, 1999. Frederick B. Winston.

Making Medical Devices Safer. Nursing Spectrum; 11A:21, 20 (1999). Patricia A. Kingsley, C. Richard Sawyer, Peter B. Carstensen.

Mammography in the 1990’s: The United States and Canada. Radiology; 210:345-351 (1999). Orhan H. Suleiman, David C. Spelic, John L. McCrohan, Gordon R. Symonds, Florence Houn.

Medical Glove Regulation Overview and Quality System Regulation Overview. Presentations at the India Latex Conference, Wellington Island, Cochin, India. December 6-8, 1999. Arthur K. Yellin, Anthony E. Rodgers.

Medical Device Update. Presentation at the Latin American Conference, Alexandria, VA. July 11, 2000. Christine Nelson.

Navigating and Retrieving Valuable Information from the FDA Website. Presentation (booth) at The Medical Design and Manufacturing West 2000 Conference, Anaheim, CA. January 17-20, 2000. William M. Sutton.

NEXT Update. Presentation at the 31st Annual Meeting of the Conference of Radiation Control Program Directors, Louisville, KY. David C. Spelic.

Optimization of Viewing Conditions and Phantom Image Quality Evaluations on GE DMR and Full Field Digital Mammography System. Journal of Digital Imaging Vol 13, No.2, Suppl 1, May 2000, pp 226-227. Kishalaya Chakrabarti, Jerry Thomas, Richard V. Kaczmarek, Ronald W. Waynant, Michelle Loscocco.

Overview of the Division of Small Manufacturers Assistance. Presentation at the Association of Medical Diagnostic Manufacturers Meeting, Rockville, MD. September 20, 2000. William M. Sutton.

Overview of FDA; Design Controls Process Validation; Acceptance Activities; and Corrective and Preventive Actions. Presentations at Association for Advancement of Medical Instrumentation GMP Quality System Requirements and Industry Practice Course, Roslyn, VA. February 28-March 2, 2000. Christine Nelson.

Overview of Medical Device Regulations and Export Requirements. Presentations at Department of Commerce Seminar, Washington, DC. June 29, 2000. Lynne L. Rice, Thomas E. Cardamone.

Overview of US and European Medical Device Regulations. Presentation at Department of Commerce Seminar, Russia and Ukraine. April 1-9, 2000. Lireka P. Joseph, Lynne L. Rice.

Overview of the Quality System Regulations. Presentation at the Quality Systems Workshop, Mexico City, Mexico. April 11-12, 2000. Joseph V. Puleo, Christine Nelson.

Patient Dosimetry Activities in the United States: the Nationwide Evaluation of X-ray Trends (NEXT) and Tissue Dose Handbooks. Applied Radiation and Isotopes 50 (1999) 247-259. Orhan H. Suleiman, Stanley H. Stern, David C. Spelic.

Phantoms Used for Evaluation of Full Field Digital Mammography Systems. Presentation (poster) at World Congress on Medical Physics & Biomedical Engineering, Chicago, IL. Richard V. Kaczmarek, Jerry Thomas, Kishalaya Chakrabarti.

Preference Studies of Workstation Monitor Performance. Presentation at the Fifth International Workshop on Digital Mammography, Toronto, Canada. June 2000. Jerry Thomas, Kishalaya Chakrabarti, Richard V. Kaczmarek, Michelle Loscocco, Jerry Gaskill.

Preliminary Results of the 1998 Nationwide Evaluation of X-ray Trends Pediatric Survey. Presentation at the American Association of Physicists in Medicine Meeting, Nashville, TN. Albert E. Moyal.

Quality Control Phantoms for Full Field Digital Mammographic Systems. Presentation at Fifth International Workshop on Digital Mammography, Toronto, Canada. June 2000. Jerry Thomas, Kishalaya Chakrabarti, Richard V. Kaczmarek, Michelle Loscocco, Jerry Gaskill.

Radiographic Trends of Dental Offices and Dental Schools. Journal of the American Dental Association; Vol. 130: 1104-1110 (July 1999). Orhan H. Suleiman, David C. Spelic, Burton J. Conway, June C. Hart, Penny R. Boyce, Robert G. Antonsen.

Regulatory Overview; Quality Systems Inspection Technique; Corrective and Preventive Actions; Case Studies; 21 CFR: Part 11; Electronic Records and Signatures; Financial Disclosure for Clinical Investigators; and The 510(k) Paradigm. Presentations at the Cooperative Workshop with Western New York Technical Development Center, Buffalo, NY. September 26-27, 2000. William M. Sutton; Frederick B. Winston, Joseph V. Puleo.

Regulatory Requirements for Medical Gloves and Overview of Quality Systems. Presentations at the Medical Glove Symposium, Taipei, Taiwan. March 27-31, 2000. Judith L. Strojny.

Results of a Nationwide Survey of Chest Radiography: Comparison with Results of a Previous Study. Radiology; 215:891-896 (2000). Richard V. Kaczmarek, Burton J. Conway, Robert J. Slayton, Orhan H. Suleiman.

Roles of the FDA: Telemedicine and Website Linkages. Presentations at Mitretek Systems Seminar, McLean, VA; at Washington Metropolitan Distance Learning Association, Washington, DC; and at University at Buffalo Schools of Law, Medicine, and Pharmacy, Amherst, NY. Melvin Greberman.

510(k) and Registration and Listing Requirements for Medical Devices. Presentations at the International Latex Conference, Akron, Ohio, July 25, 2000. Arthur K. Yellin.

      OHIP Staffing and Organization

      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

      Staff College

• develops and delivers training programs, courses, seminars and lectures
• provides satellite telecasts and distance learning programs on a variety of topics

     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

      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

      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

      Division of Small Manufacturers 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