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Thomas B. ShopeOffice of Science and Technology
Center for Devices and Radiological HealthU.S. Food and Drug Administration
Rockville, Maryland
tbs@cdrh.fda.gov301-443-3314 ext. 132
Update on Proposed Amendments
to the Performance Standard for Diagnostic X-ray Systems
(21 CFR 1020.30 - .33)(The Fluoroscopic System Amendments)
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Outline
Background on amendment development.
Status of comments.
Estimated schedule for completion.
Future role of international standards?
Advice or comment from the committee
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Background
Community recognized need for amendments to address changes in technology in early 1990s• Increased radiation output capability and new imaging
modes• Digital subtraction angiography, lithotripsy systems• 1992 ACR/FDA Workshop on Fluoroscopy
► Consensus on need for display of patient dose info Development of IEC Standard 60601-2-43: Particular
requirements for the safety of X-ray equipment for interventional procedures
Concerns over radiation injuries from fluoroscopy
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FDA’s Actions Regarding Fluoroscopic X-ray
Systems 1993 - Proposed rule regarding limit on maximum
exposure rate during high-level control mode 1995 - Final rule effective, other amendments needed 1997 - ANPR for additional amendments published Discussion of concepts for amendments and proposed
rule with TEPRSSC at 1997 and 1998 meetings “Year 2000 Problem” diverts resources/delays
progress
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FDA’s Actions Regarding Fluoroscopic X-ray
Systems December 2002 - Proposed rule published following
development of impact analysis, estimates of costs and benefits
Comment period ended April 10, 2003
FDA consideration of comments
Preparation of Final Rule
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Comments on proposed rule
Comments from 12 individuals or organizations• Two state agencies• Three professional associations• One industry association• Two x-ray equipment manufacturers• Four individuals, including one medical physicist
and one radiation effects researcher Comments, in general, were in favor of
amendments
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Comments on proposed rule
Some objections to specific proposals or details Changes suggested to the standard that were not
part of FDA’s proposal - Such changes would generally require an additional proposal for comment• Definitions, clarifications, significant changes
Several comments urged “harmoniztion” with IEC standards for x-ray equipment
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Examples of specific comments
Modify definitions Desire to consult/confer with FDA on development
of additional requirements• Dose limits for input to the image receptor• Imaging performance• Characterization and requirements for solid state
x-ray imaging devices
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Comments on Definitions
Attenuation block - size, thickness Mode of operation - single control in IEC standard C-arm fluoroscope Exposure - definition of second meaning (loading) Isocenter Solid state x-ray imaging device Visible area Others
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Critiques of proposed requirements
Manufacturer description of intended uses for specific modes of operation in user information
Manner and accuracy of dose display data Ultimate responsibility for modifications initiated by
user/owner Audible signal during fluoroscopy - conflict with
current IEC standard 60601-2-7 for generators Application of dose display and last image hold to
mini C-arm systems (SID < 45 cm)
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Reference location for system with isocenter
Shield
Shield
Monitor
15 cm
Dose rate orcumulative doseat reference point
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8.3mGy/minmGy
During irradiationAir kerma rate
mGy/minmGy66.8
Following irradiationCumulative air kerma
Proposed display of dose information
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mGy/min
mGy
Air kerma rate
Cumulative air kerma
Display of air kerma rate during irradiation.
Continuous display of cumulative air kerma.
Alternative display of dose information
4.8
127.5
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Accuracy of dose display?
Proposed accuracy of display of 25%
IEC Standard 60601-2-43 requires 50%
Is an accuracy of better than 50% necessary?
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Critiques of proposed requirements
Manufacturer description of intended uses for specific modes of operation in user information
Manner and accuracy of dose display data Ultimate responsibility for modifications initiated by
user/owner Audible signal during fluoroscopy - conflict with
current IEC standard 60601-2-7 for generators Application of dose display and last image hold to
mini C-arm systems (SID < 45 cm)
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Additional changes not in NPR
Require info and tools for troubleshooting, repair, service, and testing
Specification of voltage (kVp) waveform Use specific IEC requirements - dose info, test
procedures, primary protective barrier Display peak skin dose and “skin dose map” Display of collimation without irradiation Indication of x-ray beam-on and “live image” Post-exposure “image cropping” of digital images
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Skin dose “mapping” system
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Additional changes not in NPR
Require info and tools for troubleshooting, repair, service, and testing
Specification of voltage (kVp) waveform Use specific IEC requirements - dose info, test
procedures, primary protective barrier Display peak skin dose and “skin dose map” Display of collimation without irradiation Indication of x-ray beam-on and “live image” Post-exposure “image cropping” of digital images
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Electronic “cropping” of digital images
Area of imagereceptor
X-ray field area
Area of stored image
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Electronic “cropping” of digital images
Stored and displayed image
X-ray field
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“Cropping” of poorly collimated image
Area of imagereceptor
X-ray field
Area of stored image
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X-ray field border
Stored and displayed image
“Cropping” of poorly collimated image
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Question?
Are requirements about “electronic cropping” of digital images needed in performance standards for digital diagnostic x-ray systems?
Initial display versus storage of images?
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Errors and omissions noted
Discussion of “unique” modes of operation and dose information for them
Omission of effective date for 1020.32(m)(2) and clarification of requirement to indicate filtration used
Attenuation of material between patient and image receptor
Tolerance on dose display data - 1020.30(h)(6)(i) Typo in proposed 1020.32(k)(5)(ii) describing the
alternate location of the reference point
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Schedule for completion
Finalize decisions regarding regulatory wording
Draft Federal Register notice for final rule that responds to comments
CDRH, FDA, HHS and OMB review of FR notice
Anticipate completion by end of calendar 2003, rule would be effective in late 2004 or early 2005.
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Future role of international (IEC)
standards? Relationship between U.S. and IEC standards needs attention in global economy?• No IEC standards when U.S. std. Developed• Process for developing IEC standards different from
the regulatory process►Consensus of national committees►Maintenance teams - structure being revised
• Are IEC standards “enforced” on manufacturers?• FDA standards address only radiation safety
performance
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Future role of international (IEC)
standards? Could IEC standards be used in place of U.S.
standards (for medical x-ray, for other electronic products)?• How could they be enforced?• Impact on State radiation control programs?• Impact on Federal preemption?• Could medical device authorities be used to
assure compliance with “voluntary” IEC stds?
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Future role of international (IEC)
standards?• Could IEC standards be used without legislative
changes?• Would public health be protected if reliance
placed on IEC standards?• Could FDA or U.S. national committee play
effective role in maintenance of IEC standards? • Do current problems with Dx x-ray systems
warrant continued mandatory standard?• Would greater public health impact be obtained
through other FDA activities?
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Comments & Questions
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