In the second quarter of 2013, the NCRP Board approved a proposal to establish SC 4-5 to write a revision of NCRP Report No. 145, Radiation Protection in Dentistry. The revision will address imaging modalities that have evolved over the past 10 y and update existing material as needed. New imaging modalities include, but are not limited to, cone-beam computed tomography (CBCT), digital radiography, and hand-held dental x-ray units. Other topics include the use of high-speed film (80 % of U.S. dental facilities continue to use film which requires twice the radiation dose to the patient compared to high-speed dental film) and new data from the Nationwide Evaluation of X-Ray Trends (NEXT) survey.
Targeted professional groups include:
- dentists working in primary care and their assistants;
- dental and maxillofacial radiologists;
- head and neck radiologists;
- ear, nose and throat physicians;
- medical physicists;
- radiologic technologists;
- dental radiologic technologists;
- dental assistants and dental hygienists;
- equipment manufacturers and suppliers;
- state regulators; and
- relevant federal agency representatives.
This report is urgently needed as there are no formal guidelines on the safe and effective use of these modalities in the United States. In addition, every dental practitioner acts as an independent radiologist. CBCT units are generally installed as plug-and-play devices and they are not perceived by most in dentistry as computed tomography (CT) units, but rather as exotic panoramic units. Many states consider these the same as simple, intraoral x-ray equipment for regulatory purposes. Hand-held dental x-ray units face a barrier with state regulators since long-term training emphasized to never hold the x-ray tube. (Hand-held units are specifically designed with sufficient shielding to eliminate significant radiation exposure to the operator—although this is not true of all units available for sale in the United States).
During the third quarter of 2013, SC 4-5 held three planning teleconference (webinars) (July 1, July 23, and August 29). At the August 29 webinar an overview presentation was made on NEXT and also on the U.S. Department of Veterans Affairs efforts relative to CBCT by Committee member experts in order to bring all Committee members up to date on these topics.
Drs. Lurie and Gray, and Mr. Pizzutiello sent a letter to Joseph Klinger, President of the Conference of Radiation Control Program Directors (CRCPD), recommending that CRCPD form a committee to consider Suggested State Regulations (SSRs) for CBCT systems. There are no activities within CRCPD at this time relative to CBCT and, as noted earlier, many states consider these units the same as simple, intraoral x-ray equipment for regulatory purposes. CRCPD responded positively indicating that they have formed a committee on CBCT and requested that Drs. Lurie and Gray, and Mr. Pizzutiello serve as advisors, which they have agreed to do. A detailed outline for the supplemental sections was developed and circulated to the Committee for comment.
During the fourth quarter of 2013 a final version of the supplemental outline was approved by the Committee and individual assignments were made for primary authorship of each section. Also during this quarter, a face-to-face meeting was held (November 18–19, 2013) resulting in completion of a gap analysis report submitted to the U.S. Food and Drug Administration (FDA) in fulfillment of the first of four deliverables. Additionally, a suggested revision of the 2014 NEXT survey form was completed by the Committee and submitted to FDA for consideration.
In the first quarter of 2014, a detailed outline of the report was provided to FDA in fulfillment of the second of four deliverables. Also in the first quarter of 2014, four small section phone conferences were held [CBCT (2), digital (1), handheld (1)] and one full SC 4-5 phone conference was held to deliberate over the first rough draft. During the second quarter of 2014, three subsection and two full-group teleconferences/webinars were held. A complete section/subsection outline and a draft of the report was completed that contained contributions from all Committee members. The third FDA contract deliverable was submitted to include a risk benefit analysis for CBCT, digital, and hand-held dental imaging devices. Data from over 11,000 film and digital oral images are to be analyzed and summarized for the report.
Dr. Gray and Mr. Pizzutiello now serve on two national committees on CBCT: (1) as advisors on the CRCPD committee dealing with regulatory issues and producing a white paper on CBCT; and (2) a new American Association of Physicists in Medicine committee formed to address medical physics aspects of CBCT including siting, acceptance testing, quality control, etc.
A new draft of the SSRs has become available and was reviewed. The SSRs now require quality control for CBCT units as well as training for the operator. The SSRs include a stipulation that CBCT systems must be evaluated by a qualified medical physicist within 30 d of installation and annually. A discussion with Sean Boyd, Deputy Director of CDRH, clarified that CBCT will be treated the same as CT equipment from the regulatory point of view. All CT regulations apply to CBCT, including requirements for manufacturers to provide test phantoms and recommended procedures for quality control by the facility.
During the third quarter of 2014, SC 4-5 held one teleconference (webinar, August 22) for a small group consisting of the Co-Chairs, the NCRP Staff Consultant, Rob Sauer (FDA), Don Miller (FDA), and Executive Directors (James Cassata and David Smith). The purpose of the meeting was to review the status of the draft and provide a smooth transition between the Executive Directors.
SC 4-5 had a 2 d meeting on November 11–12, 2014 at the NCRP offices in Bethesda, Maryland. The goal of this meeting was to finalize the draft and prepare it for review.
The draft report was reviewed by PAC/SME review during the fourth quarter of 2015. The Committee is revising the report based on that review and Council review is anticipated in the second quarter of 2016.
NCRP gratefully acknowledges the endorsement and financial support by the American Academy of Oral and Maxillofacial Radiology, the American Board of Radiology Foundation, the American Dental Education Association, and the U.S. Food and Drug Administration.
The membership of SC 4-5 is:
Mel L. Kantor
is a professor in the Department of Oral Health Practice in the College of Dentistry with a joint appointment as professor in the Department of Epidemiology in the College of Public Health.
Dr. Kantor served on the faculties of University of North Carolina and University of Connecticut before moving in 1993 to University of Medicine and Dentistry of New Jersey where he was Professor of Diagnostic Science, New Jersey Dental School, and Professor of Epidemiology, School of Public Health prior to moving to the University of Kentucky in August 2011. He is a Diplomate and past-president of the American Board of Oral and Maxillofacial Radiology and a former member of the Board of Directors of the American Association for Dental Research. Dr. Kantor serves on several editorial boards and recently completed his term as a member of the Commission on Dental Accreditation. His research interests involve population-based and survey research, specifically radiology practice behaviors and use of selection criteria guidelines, quality and level of evidence in the radiology literature, and screening for medical conditions in a dental setting.
Alan G. Lurie
Alan G. Lurie is professor and chair of the Division of Oral and Maxillofacial Diagnostic Sciences and chair of the Section of Oral and Maxillofacial Radiology, Department of Oral Health and Diagnostic Sciences, at the University of Connecticut School of Dental Medicine. He has John Dempsey Hospital appointments in the Departments of Dentistry and Diagnostic Imaging and Therapeutics. He has been a full-time member of the dental school faculty since 1973, during which time he has done R0-1 research on radiation carcinogenesis, administered predoctoral and graduate educational programs, performed clinical research, and performed imaging care on patients in both dental and medical radiology settings.
He is past president and a current member of the School of Dental Medicine Council, co-founder of the University of Connecticut Multidisciplinary Head and Neck Cancer Clinic, and a member of numerous dental school and institutional committees. He is also an active member of his specialty nationally, having served as Councilor for Public Policy and Scientific Affairs of the American Academy of Oral and Maxillofacial Radiology, and Past President of the American Board of Oral and Maxillofacial Radiology. Dr. Lurie has more than 100 publications in the refereed literature, and numerous presentations to local, state, national and international organizations.
is an Associate Professor at the University of Iowa (UI). He joined UI College of Dentistry and Dental Clinics in 2008 as a faculty member after completing his residency there and having spent a little more than a year as a consultant to a private imaging company.
He is currently the Program Director for the Advanced Education Program in Oral and Maxillofacial Radiology (AAOMR) and the Director of Radiology at the College of Dentistry. He serves on several collegiate, university, national and international committees and is currently the American Dental Association and American Academy of Oral and Maxillofacial Radiology representative to the Digital Imaging and Communication in Medicine (DICOM) standards committee. Dr. Allareddy is the co-chair for Working Group 22 (Dentistry) of the DICOM Standards committee, where he also serves on the Leadership, Outreach, and Educations Committee, and is the co-chair of the Standards and Codes Committee for the AAOMR.
Dr. Allareddy is a reviewer for nine peer-reviewed dentistry and radiology journals. His main expertise and interest is in the use of technology in dentistry. His research areas are related to reduction of the radiation dose to the patient, healthcare outcomes, dental education, big data share, and the role of advanced imaging in the oral and maxillofacial regions as it applies to dentistry.
John B. Ludlow
is a Professor in the Radiology Section of the Department of Diagnostic Sciences at the University of North Carolina (UNC) - Oral Health Institute. He received his DDS from the University of Michigan in 1978 and MS in Oral Diagnosis and Radiology in 1983. He joined the UNC faculty in 1989. He is a past president of the American Board of Oral Maxillofacial Radiology, and past secretary of the American Board of Oral Medicine. He is a member of the State of North Carolina Radiation Protection Commission, and a member of the American Dental Association Council on Scientific Affairs. He is a member of Omicron Kappa Upsilon National Dental Honor Society, a Fellow of the American College of Dentists, and a Fellow of the Royal College of Surgeons, Edinburgh. His current research is focused on dose and risk from maxillofacial radiography. Dr. Ludlow has published over 90 scientific manuscripts and was an American Academy of Oral and Maxillofacial Radiology Weurhmann Prize winner for the best radiology research paper in 2006/07 and 2010/11.
Edwin T. Parks
received his DMD from the University of Kentucky College of Dentistry and his MS in Dental Diagnostic Sciences from Indiana University School of Dentistry. He is currently a Professor of Diagnostic Sciences in the Department of Oral Pathology, Medicine and Radiology at Indiana University School of Dentistry. Dr. Parks is the division director for Oral and Maxillofacial Radiology. He is a Diplomate of the American Board of Oral and Maxillofacial Radiology and the American Board of Oral Medicine. Dr. Parks has presented over 100 continuing education courses and authored numerous journal articles and book chapters. He currently serves as the forensic dental consultant for the Marion County Coroner’s Office and directs the facial pain clinic at University Hospital. Dr. Parks is active in the American Academy of Oral and Maxillofacial Radiology, the American Academy of Forensic Sciences and the American Dental Education Association.
|Eleonore D. Paunovich|
Robert J. Pizzutiello
began practicing medical physics in the Cancer Center at the University of Rochester Medical Center in 1977. In 1979 he became Director of Medical Physics at Rochester General Hospital, where his areas of interest and expertise broadened to include diagnostic imaging physics and teaching medical physics to physicians. Dr. Pizzutiello formed Upstate Medical Physics, Inc. in 1983, to provide medical physics services to facilities that could not support their own full-time medical physicist. Since 1989, he has been the full-time president of Upstate Medical Physics, the largest private practice diagnostic medical physics group in New York State – leading a group of 10 professionals who serve well over 100 facilities across New York, Connecticut, Pennsylvania and Massachusetts. He has also served as consultant to many major imaging manufacturers, contributing his knowledge of imaging and broad practical experience to the manufacturing sector.
In the early 1990s Dr. Pizzutiello became a medical physicist reviewer for phantom images for the American College of Radiology (ACR)-MAP. After more than a decade of work with the ACR and the Conference of Radiation Control Program Directors, he was appointed to the Food and Drug Administration’s Mammography Quality Standards Advisory Committee. When Stereotactic Breast Biopsy was introduced in the early 1990s, he worked with ACR to develop the Stereotactic Breast Biopsy Accreditation program and co-authored the SBB QC manual. He continues to serve on several key committees of the American Association of Physicists in Medicine , ACR, and ACMP.
Bob is an active lecturer, and has been invited to speak at over 100 programs in the last decade across the United States, in South America, and in China. His current special interests include breast imaging, MRI, and cone-beam computed tomography imaging.
is currently a Regulatory Physicist in the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. As a Regulatory Physicist, Dr. Sauer conducts premarket reviews of diagnostic x-ray systems, accessories, and post-processing software; develops regulatory and scientific guidance for FDA staff and industry; performs medical device and electronic product recall classifications; and serves as FDA point of contact for dental radiological safety outreach activities with industry and professional organizations. He holds a BS in Physics from the University of Delaware and an MS in Physics from the University of Arizona. Past research experience includes atomic and molecular ionization in ultrastrong fields and photoelectron dynamics in relativistic laser fields.
David C. Spelic
is a physicist with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. On his arrival at the FDA in 1994, Dr. Spelic became involved with the Agency’s implementation of the Mammography Quality Standards Act (MQSA), particularly focusing on mammography physics testing and the training of MQSA inspectors.
Presently Dr. Spelic conducts premarket reviews of diagnostic x-ray devices, and directs most technical aspects of the Nationwide Evaluation of X-Ray Trends (NEXT) program, an FDA collaboration with the Conference of Radiation Control Program Directors to document trends in patient dose and image quality for selected diagnostic x-ray exams and procedures.
EDWIN M. LEIDHOLDT, JR.
is a program manager in the National Health Physics Program, Veterans Health Administration, U.S. Department of Veterans Affairs (VA). His areas of interest include technical quality assurance and dose reduction in medical imaging and medical response to radiological incidents. He is certified by the American Board of Radiology in Medical Nuclear Physics and Diagnostic Radiological Physics. He received a PhD in Nuclear Engineering, a Master of Applied Mathematics, a Master of Engineering in Nuclear Engineering, and a BS in Nuclear Engineering, all from the University of Virginia. He has served as a Radiation Safety Officer at two VA medical centers, as technical director of nuclear medicine at one, and as the Radiation Safety Program Manager for the former Veterans Health Administration Western Region.
He is a Clinical Associate Professor of Radiology at the University of California, Davis, and a Clinical Adjunct Professor of Radiology at the University of Texas Health Science Center at San Antonio. He is a co-author of six scientific papers and abstracts, one textbook chapter, and one textbook, in its third edition. He served on the scientific committee that wrote NCRP Report No. 165. Dr. Leidholdt served as a surface line officer in the U.S. Navy from 1971 until 1975.
|W. Doss McDavid, Consultant|
DONALD L. MILLER
is the Chief Medical Officer for Radiological Health in the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. He was previously Professor of Radiology and Radiological Sciences at the Uniformed Services University of the Health Sciences in Bethesda, Maryland and an adjunct investigator in the Radiation Epidemiology Branch of the National Cancer Institute.
Dr. Miller earned a BA in Molecular Biophysics and Biochemistry from Yale University in 1972 and an MD from the New York University School of Medicine in 1976. He holds Board certification in both Diagnostic Radiology and Interventional Radiology. Prior to joining FDA, he engaged in the clinical practice of interventional radiology for nearly three decades.
He is a Fellow of the Society of Interventional Radiology and of the American College of Radiology, and is an Honorary Member of the American Association of Physicists in Medicine. He has served as a consultant to the International Atomic Energy Agency and the World Health Organization on issues related to radiation protection in medicine.
Dr. Miller was elected to NCRP in 2006. He serves currently as Co-Chair of Program Area Committee 4 (radiation protection in medicine), Chair of the Nominating Committee, and as a member or consultant to several scientific committees. He was Vice-Chair for NCRP Report No. 168 (Radiation Dose Management for X-Ray Guided Interventional Medical Procedures) and a consultant for NCRP Report No. 172 (Reference Levels and Achievable Doses in Medical and Dental Imaging: Recommendations for the United States).
He became a member of ICRP Committee 3 (Protection in Medicine) in 2010, and since 2013 has served as Vice-Chair of the Committee. He was an author of ICRP Publication 117 (Radiological Protection in Fluoroscopically Guided Procedures Performed Outside the Imaging Department) and Co-Chair for ICRP Publication 120 (Radiological Protection in Cardiology). He currently serves on three working parties of Committee 3.
Dr. Miller has authored more than 180 publications in peer-reviewed journals and more than 30 book chapters and reports. His research interests center on radiation protection in medicine, and include occupational radiation protection for interventional fluoroscopy, patient radiation doses and radiation protection in interventional procedures, and the development of U.S. national diagnostic reference levels for medical exposures.
JOEL E. GRAY
is Professor Emeritus, Mayo Clinic College of Medicine and President of DIQUAD, LLC (Dental Image Quality and Dose), a firm that evaluates dental image quality and dose through the mail. Dr. Gray received his BS in Photographic Science and Instrumentation in 1970, an MS in Optical Sciences in 1974, and a PhD in Radiological Sciences from the Institute of Medical Sciences, University of Toronto in 1977.
He served as a Diagnostic Medical Physicist at Mayo Clinic Rochester for 20 y, helped develop and obtain U.S. Food and Drug Administration (FDA) approval for Lorad's (now Hologic) first digital mammography system, and assisted in the development of the microStar patient dosimetry system using optically stimulated dosimetry material while at Landauer, Inc. After leaving Landauer, Dr. Gray founded DIQUAD and continues to operate that business today.
Dr. Gray published the first two books on quality control in medical imaging in 1976 under contract to FDA while in graduate school. Dr. Gray is the primary author of the first quality control text (Quality Control in Diagnostic Imaging—A Quality Control Cookbook) which is in use worldwide and has been translated into Chinese.
His primary areas of interest include image quality in medical and dental imaging, and optimization of image quality and radiation dose. He serves as a consultant to healthcare organizations and industry. Dr. Gray has served on many national and international advisory committees, including the International Commission Radiological Protection (Committee 3, Radiation Protection in Medicine) and is active in projects with the International Atomic Energy Agency (IAEA) and the World Health Organization. He has co-authored eight publications for the IAEA including educational programs and taught courses for the IAEA in several countries. He has over 170 publications in refereed journals and numerous book chapters, and presented lectures and refresher courses in the United States and overseas. He has visited over 40 countries for both business and pleasure.
Dr. Gray was responsible for starting the first Medical Physics Residency Program at Mayo Clinic in 1990. He has mentored masters and doctoral students, and Medical Physics residents.
He was elected to NCRP in 1986 and has served on numerous committees producing NCRP Report No. 99, Quality Assurance for Diagnostic Imaging; Report No. 147, Structural Shielding Design for Medical Imaging Facilities; and Report No. 160, Ionizing Radiation Exposure of the Population of the United States. He has served as a Technical Consultant for NCRP Commentary No. 20, Radiation Protection and Measurement Issues Related to Cargo Scanning with Accelerator-Produced High-Energy X Rays; NCRP Report No. 172, Reference Levels and Achievable Doses in Medical and Dental Imaging: Recommendations for the United States; and is presently serving on Scientific Committee 4-5 on radiation protection in dentistry supplement, in that capacity. After serving 18 y on the Council he was named a Distinguished Emeritus Member in 2005.
Dr. Gray is a Fellow of the American Association of Physicists in Medicine (AAPM) and the American College of Medical Physics. In 2010 he received the Lifetime Achievement Award from the Upstate New York Association of Medical Physicists and in 2011 the Edith Quimby Lifetime Achievement Award from the AAPM.