Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2150 - Additional Technical Requirements for Intravascular Brachytherapy Units

Current through Register Vol. 48, No. 28, July 12, 2024
In addition to other provisions required by this Part, the
				  licensee authorized to use an intravascular brachytherapy unit for medical use
				  shall:
a) Have a treatment team
				consisting of, at a minimum, an interventional cardiologist, an authorized user
				and an authorized medical physicist and that, at a minimum, an interventional
				cardiologist and an authorized user will be physically present in the treatment
				suite during all radioactive procedures.
AGENCY NOTE: The requirements of 32 Ill. Adm. Code 401
				  regarding radiation therapists must also be met.
b) Independently verify source strength and
				uniformity. Dwell time at the treatment location must be monitored and
				recorded. Source uniformity or strength must not differ by more that 10 percent
				of the expected values.
c) For
				devices requiring additional shielding, demonstrate compliance with 32 Ill.
				Adm. Code
				340.210
				and
				340.310
				requirements.
d) Inspect sealed
				sources, source trains or ribbons after each use and ensure sources are removed
				from service at intervals established by the manufacturer (i.e., confirm that
				source trains will not be used after the "use by" date, at intervals not to
				exceed 2 months from the date of shipment, or when evidence of degradation is
				observed, whichever comes first).
e) Inspect and service devices containing
				sealed sources at intervals established by the manufacturer, and ensure that
				maintenance and repair of the device is performed only by the manufacturer or
				persons specifically authorized by the Agency, the U.S. Nuclear Regulatory
				Commission, an Agreement State or a Licensing State to perform such
				service.
f) Prohibit cuts,
				alterations or splicing of the sealed sources, source trains or ribbons, except
				in situations involving an emergency where the source wire cannot be returned
				to its normal safe position. If such cuts, alterations or splicing are
				necessary, notification in accordance with Section
				335.1080
				or 32 Ill. Adm. Code
				340.1220
				shall be made to the Agency.
g) Use
				only manufacturer provided inducer sheaths, catheters and accessories to ensure
				their demonstrated equivalents will be used with the devices.
h) Ensure the daily operational checks will
				be performed prior to patient treatment. At a minimum, they should include
				position verification, source uniformity, dwell time function, indicator lamps
				and other status/operational displays, and visual inspection for integrity of
				all applicators and catheters to be used for the treatment.
i) Perform tests following source or device
				exchange in accordance with the manufacturer's instruction manual for:
1) Timer accuracy/constancy, if
				appropriate;
2) Calibration of the
				source output following the manufacturer's instructions; and
3) Interlock/interrupt checks (i.e.,
				interrupt test, cartridge lock test, emergency retraction test and catheter
				connection test), if appropriate.