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Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held UseDocument issued on: December 24, 2008For questions regarding this document contact CDR Sean Boyd at 301-796-5895.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthDiagnostic Devices BranchDivision of Mammography Quality and Radiation ProgramsOffice of Communication, Education, and Radiation ProgramsContains Nonbinding Recommendations Preface Public CommentWritten comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.
When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional CopiesYou may also send an e-mail request to to receive a copy of the guidance. Please use the document number (1680) to identify the guidance you are requesting. Guidance for Industry and FDA Staff Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use IntroductionThe intent of this guidance is to advise manufacturers and FDA staff about safety procedures and recommendations that should be provided to the end user to promote safe use of hand-held x-ray equipment. In general, there are a number of regulations, consensus safety standards, and radiation protection guidelines governing the performance and use of diagnostic x-ray equipment. Diagnostic x-ray equipment manufactured for the US market must meet the performance requirements described in Title 21 of the Code of Federal Regulations, sections 1020.30 through 1020.33, which require manufacturers to provide users with operational and safety information as well as to meet standards for equipment performance.Internationally, radiation safety standards are provided by the International Electrotechnical Commission (IEC) in its collateral standard 60601-1-3.
Voluntary guidelines, particularly relevant to handheld equipment, have been provided by the National Council on Radiation Protection and Measurement (NCRP) for radiation protection in dentistry. Many states regulate the use of x-ray equipment under their own regulations based on the Suggested State Regulations for the Control of Radiation, published by the Conference of Radiation Control Program Directors (CRCPD).FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. The Least Burdensome ApproachWe believe we should consider the least burdensome approach in all areas of medical device and electronic product regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view.
You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman., including ways to contact him, can be found on the Internet. IssueThere are two basic sources of potential x-ray exposure to operators that should be addressed during the use of hand-held x-ray diagnostic equipment:. Leakage radiation transmitted through the equipment housing and shielding that surrounds the source assembly. Backscatter radiation from the patient and nearby structures.2.
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GuidanceA primary consideration in any radiographic procedure is to reduce the dose to the patient as well as to the operator as much as possible while still achieving the diagnostic goals. This guidance briefly discusses the hazards unique to hand-held medical x-ray equipment, clarifies applicable requirements, and makes recommendations for safe use of the equipment. What are the exposure concerns with handheld x-ray systems?The federal performance standard for diagnostic x-ray systems and their major components did not anticipate hand-held x-ray systems at the time it was written. It therefore does not address system performance attributes or protective measures in light of the operator’s proximity to the source assembly and the patient. Because of such proximity, hand-held x-ray systems pose increased operator exposure concerns due to leakage radiation and backscatter radiation. Submit comments on this guidance document electronically via docket ID: - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)If unable to submit comments online, please mail written comments to:Division of Dockets Management (HFA- 305)Food and Drug Administration5630 Fishers Lane, Rm.
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1061Rockville, MD 20852All comments should be identified with the title of the guidance.