Amend rule language as necessary to meet current radiation machine produced technology standards. These changes were requested by the manufacturer of the equipment to assist the facilities using this equipment. The changes provide clarification on ...

 

DEPARTMENT OF HEALTH
Division of Environmental Health

RULE NO.: RULE TITLE:
64E-5.101: Definitions
64E-5.504: Fluoroscopic X-Ray Systems
PURPOSE AND EFFECT: Amend rule language as necessary to meet current radiation machine produced technology standards. These changes were requested by the manufacturer of the equipment to assist the facilities using this equipment. The changes provide clarification on the requirements for the facilities without affecting public health and safety.
SUMMARY: The Department determined that in the interest of protecting the public health, dose rates from fluoroscopes should not have unlimited radiation outputs but should be limited to outputs necessary to perform fluoroscopic medical procedures but no higher. The current language specifying the test points used to constrain fluoroscopic outputs is difficult for members of the public and the regulated community to understand. One of the test points discussed is incorrect. The proposed changes are being proposed to make the regulations accurate and easier to understand.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The proposed changes to the regulations are to help clarify requirements for the use of fluoroscopic machines without changing health and safety procedures. The regulations added for the extremity only fluoroscopes will prevent machines of this type from having to meet regulations they cannot meet by their design/manufacture and accommodate limits they were designed to meet by the approved Food and Drug Administration applications for the medical devices. Compliance with these changes will not impose additional costs. Therefore, this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
RULEMAKING AUTHORITY: 404.042, 404.051, 404.061, 404.22 FS.
LAW IMPLEMENTED: 404.031, 404.051, 404.061, 404.22 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Philip Thoma, 705 Wells Road, Orange Park, FL 32073, [phone], [e-mail]

THE FULL TEXT OF THE PROPOSED RULE IS:

64E-5.101 Definitions.

As used in these rules, these terms have the definitions set forth below. Additional definitions used only in a certain part are defined in that respective part.

(1) through (186) No change.

(187) “Mobile C-arm” means a mobile c-arm fluoroscopeic machine that is designed for and used without a specific patient support device such as a radiographic table, cradle or radiolucent stretcher. This would includes machines moved from room to room to assist in surgical procedures. Measurements of patient entrance exposure for this type of system will be measured in accordance with subparagraph 64E-5.504(3)(e)2., 3., and 4., F.A.C.

(188) “C-arm system” means a mobile C-arm used in the same room with the same patient support device. fluoroscopic C-arm routinely used with the same patient support device which will have interlocks, detents or positioning marks to allow reproducible geometry. Measurements of patient entrance exposure for this type of system will be measured in accordance with subparagraph 64E-5.504(3)(e)2., 3., and 5., F.A.C.

(189) through (192) No change.

(193) “C-arm fluoroscope” means a fluoroscopic machine where the image receptor and the x-ray tube housing assembly are ganged allowing a change in the direction of the beam axis with respect to the patient without moving the patient.

(194) “Extremity-use-only fluoroscope” means a fluoroscope manufactured after June 10, 2006 having a maximum source-image receptor distance of less than 45 centimeters and labeled “Extremity-use-only.”

Rulemaking Authority 404.042, 404.051, 404.061 FS. Law Implemented 404.031, 404.051, 404.061, 404.20, 404.22 FS. History–New 7-17-85, Amended 4-4-89, 5-12-93, 1-1-94, 5-15-96, Formerly 10D-91.102, Amended 5-18-98, 10-8-00, 8-6-01, 9-11-01, 12-18-01, 9-28-06, 8-16-07, 2-28-08, 2-11-10,               .

 

64E-5.504 Fluoroscopic X-Ray Systems.

All fluoroscopic x-ray systems shall meet the following requirements:

(1) through (2) No change.

(3) Allowable Entrance Exposure Rate Limits for Fluoroscopic Equipment.

(a) through (d) No change.

(e) Measuring Compliance of Entrance Exposure Rate Limits. Compliance with the dose limits will this subsection shall be determined as follows:

1. Movable grids and compression devices will shall be removed from the useful beam during the measurement.

2. The fluoroscope’s radiation output will be maximized.

a. Systems with automatic exposure controls such as automatic brightness control will have sufficient lead or lead equivalent materials placed in the useful beam to produce the maximum output.

b. Systems without automatic exposure controls or systems with a manual mode in addition to automatic exposure control modes will have the current and potential set to produce the maximum output.  Attenuating material will be placed in the useful beam to protect the imaging system.  If the registrant has a written radiation protection program restricting the range of current and potential the tests will be performed within the range of allowed values.

c. Patient support device height and SID, where adjustable, will be varied to produce the maximum output.  If the registrant has a written radiation protection program restricting the range of patient support device heights or SIDs the tests will be performed within the range of allowed values.

3. The exposure rate will be measured at the following points on the centerline of the beam unless the specified geometry is prohibited by a written radiation protection program.

a. At least one centimeter above the patient support device and corrected for distance to show the actual entrance exposure rate at the top surface of the patient support device for:

(I) Fluoroscopes where the x-ray tube is fixed under the patient support device.

(II) C-arm systems or stationary c-arm fluoroscopes where the x-ray tube can be rotated under the patient support device.  The x-ray tube will be positioned as close to the patient support device as possible.

b. At 30 centimeters above the patient support device with the end of the beam-limiting device or spacer assembly positioned as close as possible to the point of measurement for:

(I) Fluoroscopes where the x-ray tube is fixed above the patient support device.

(II) C-arm systems or stationary c-arm fluoroscopes where the x-ray tube can be rotated above the patient support device.

c. At a point 15 centimeters laterally from the centerline of the patient support device or from the centerline of the patient if the registrant has a written radiation protection program specifying placement of the patient not on the centerline of the patient support device in the direction of the x-ray tube with the input surface of the fluoroscopic imaging assembly positioned as close to the edge of the patient support device as possible but no closer than 15 cm for:

(I) Fluoroscopes where the x-ray tube is fixed laterally to the patient support device.

(II) C-arm systems or stationary c-arm fluoroscopes where the x-ray tube can be rotated lateral to the patient support device.

d. At 30 centimeters from the input surface of the fluoroscopic imaging assembly, provided that the end of the beam-liminting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly, for mobile c-arm fluoroscopes.  Spacers or other attachments normally used can not be removed to allow measuring from a point closer to the actual input surface.

2. If the source can be operated below the patient support device, the exposure rate shall be measured at least 1 centimeter above the patient support device and corrected for distance to show the actual entrance exposure rate.

3. If the source can be operated above the patient support device, the exposure rate shall be measured at 30 centimeters above the patient support device with the end of the beam-limiting device or spacer assembly positioned as closely as possible to the point of measurement.

4. In a mobile C-arm type of fluoroscope, not associated with a specific patient support device, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly.

5. If the source can be operated laterally to the patient support device, the exposure rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.

6. X-ray systems that incorporate automatic exposure controls such as automatic brightness control shall have sufficient lead or lead equivalent placed in the useful beam to produce the maximum output of the x-ray system.

7. X-ray systems that do not incorporate automatic exposure control shall use the maximum combination of current and potential to produce the highest output. Attenuating materials shall be placed in the useful beam to protect the imaging system.

(f) through (g) No change.

(4) through (5) No change.

(6) Source-to-Skin Distance.  Positive means shall be provided to assure the source-to-skin distance shall not be less than:

(a) Thirty-eight centimeters on stationary fluoroscopes installed after January 1, 1977,

(b) Thirty-five and one-half centimeters on stationary fluoroscopes installed prior to January 1, 1977,

(c) Thirty centimeters on all mobile fluoroscopes,

(d) Twenty centimeters for image intensified fluoroscopes used for specific surgical applications.  Written safety procedures must be provided to the operator of the fluoroscope and precautionary measures followed during the use of this device.

(e) Nineteen centimeters for extremity-use-only fluoroscopes.

(f) Ten centimeters for extremity-use-only fluoroscopes used for specific surgical applications.  Written safety procedures must be provided to the operator of the fluoroscope and precautionary measures followed during the use of this device.

(7) through (11) No change.

(12) For remotely operated fluoroscopic systems:

(a) The remote control panel shall be installed so as to require arranged or configured to allow the operator to stand behind a permanent protective barrier meeting the requirements of subsection 64E-5.502(2)(a)-(c), F.A.C. The barrier must be wide enough to prevent the secondary scatter radiation from striking the operator directly when the machine is operated from the remote control panel. have both auditory and visual communication with the patient during exposures.

(b) The operator’s protective barrier shall have a window or mirror system arranged so that the operator can keep the patient under constant visual surveillance during exposures. must be able to see and hear the patient when behind the barrier.

(c) The barrier shall be constructed of material of sufficient density to meet or exceed the barrier requirements of subsection 64E-5.502(1)(a)4b, F.A.C. Windows shall have lead equivalent shielding equal to that required in the operator’s protective barrier.

Rulemaking Authority 404.051, 404.22 FS. Law Implemented 404.051, 404.22 FS. History–New 7-17-85, Amended 4-4-89, 3-17-92, 1-5-95, Formerly 10D-91.605, Amended 5-18-98, 8-16-07,               .

NAME OF PERSON ORIGINATING PROPOSED RULE: Cynthia Becker, Bureau Chief, Bureau of Radiation Control.
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General & Secretary.
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 09, 2013
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 13, 2012