For questions regarding this document contact CDR Sean Boyd at 240-276-3287.
Written 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 copies are available from the Internet at: http://www.fda.gov/cdrh/ocer/guidance/1680.pdf. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number (1680) to identify the guidance you are requesting.
The 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.1
Internationally, radiation safety standards are provided by the International Electrotechnical Commission (IEC) in its collateral standard 60601-1-3.2 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.3 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).4
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.
We 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. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.
There 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:
A 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.
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. The radiation exposure to the operator will be the sum of any radiation leaking from the x-ray tube source assembly (leakage radiation) and any radiation that scatters from the patient or any objects in the room that are in the x-ray field (backscattered radiation.)
The applicable performance standard for a diagnostic source assembly, under 21 CFR 1020.30(k), limits radiation leakage from the x-ray source assembly to an air kerma of 0.88 mGy (corresponding to an exposure of 100 mR) in one hour at a distance of one meter from the x-ray source when measured as specified in the standard.
For additional information on state requirements applicable to hand-held x-ray systems, refer to your state’s radiation control program regulations. The CRCPD website has a list of contacts for each state (http://www.crcpd.org/links.asp). Please contact your state officials on this subject. Another resource to consider is the Suggested State Regulations for the Control of Radiation. Some state programs do not allow the use of hand-held x-ray equipment.
If you have any questions about this guidance, contact CDR Sean Boyd in the Division of Mammography Quality and Radiation Programs, Office of Communication, Education and Radiation Programs, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850 at 240-276-3332 or sean.boyd@fda.hhs.gov.
Updated January 8, 2009
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