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Subpart F—Manual Brachytherapy

35.400 Use of sources for manual brachytherapy.
(summarized by Tiffany Lin)
A licensee must use a brachytherapy source that is approved in the Sealed Source and Device
Registry for manual brachytherapy medical use. The source can be used for other manual
brachytherapy uses not listed in the Sealed Source and Delivery Registry, if used in accordance
with safety conditions and limitations. The source can also be used for research to deliver
therapeutic doses for medical use with an accepted Investigational Device Exemption (IDE)
application accepted by the US. Food and Drug Administration.
35.404 Surveys after source implant and removal.
(summarized by Tiffany Lin)
After implantation of a source, the licensee shall survey to locate and account for all sources that
have not been implanted. For temporary implants, the licensee shall survey the patient to confirm
that sources have been removed. Licensee needs to keep record of the surveys.
35.406 Brachytherapy sources accountability.
(summarized by Tiffany Lin)
Licensee needs to maintain accountability at all times for brachytherapy sources in storage or in
use. Sources must be returned to secure storage areas after being removed from a patient, and the
licensee must keep a record of the brachytherapy source accountability.
35.410 Safety instruction.
(summarized by Tiffany Lin)
The licensee needs to provide radiation safety instruction to personnel caring for patients
receiving brachytherapy, initially and at least annually. Safety training should include duties of
the personnel, size and appearance of the sources, safe handling and shielding instructions,
patient control, visitor control, and notifying the Radiation Safety Officer and authorized user if
the patient has a medical emergency or dies. The licensee shall have a record of individuals who
have received these safety instructions.
35.415 Safety precautions.
(summarized by Tiffany Lin)
The patient cannot be in a room with other individuals who are not receiving brachytherapy, and
a “Radioactive Materials” sign must visibly posted in the patient’s room, along with a time limit
notice on the room or patient chart for how long visitors can be in the room. A licensee must
have applicable emergency response equipment near the treatment room in case the source
dislodges from the patient or stays lodged within the patient following removal of source
applicators. A licensee shall notify the Radiation Safety Officer and authorized user if patient has
a medical emergency.
35.432 Calibration measurements of brachytherapy sources.
(summarized by Nicolette Sawicki)
A licensee should determine the source output or activity using a dosimetry system as well as
making sure the source is positioned accurately within the applicators. When taking
measurements, the licensee may use measurements provided by a source manufacturer or by an
accredited calibration laboratory. Mathematical corrections of the outputs or activities for
physical decay at intervals consistent with 1 percent physical decay are also determined by a
licensee. A licensee must also keep a record of each calibration.
35.433 Strontium-90 sources for ophthalmic treatments.
(summarized by Liz McGinnis)
A licensee who uses Strontium-90 for ophthalmic treatments must ensure that certain activities
are performed by a medial physicist or an ophthalmic physicist who is identified as such on a
specific or broad scope medical use license issued by the Commission or Agreement state, or
have a permit issued by a Commission or Agreement state master material licensee or broad
scope medical use licensee. Any person identified as such must also hold a master’s or doctor’s
degree in medical physics, physics, other physical sciences, engineering, or applied mathematics
from accredited college or university. This individual must also complete 1 full year of medical
physics training and an additional year of full-time work experience under the supervision of a
medical physicist. The training must include the creation, modification, and implementation of
written directives, procedures for administrations requiring written directives, and performing
calibration of brachytherapy sources. The licensee must calculate the activity of each strontium-
90 source that is used to determine treatment times of ophthalmic treatments. The decay must be
based on the activity determined during the calibration measurement. Assist in developing and
maintaining quality assurance procedures to ensure administration is following written directives
by observing treatments, review treatment methodology, calculate treatment time for prescribed
dose, and verify records to ensure accordance of written directives.
35.457 Therapy-related computer systems.
(summarized by Liz McGinnis)
A licensee must perform acceptance testing on therapy-related treatment planning systems in
accordance of protocols established by national accrediting bodies. At minimum, acceptance
testing must include verification of the source-specific input parameters required by dose
calculation algorithm, the accuracy of dose, dwell time, and treatment time calculations at
representative points, accuracy of isodose plots and graphic displays, accuracy of software used
to determine sealed source positions on radiographic images.
35.490 Training for use of manual brachytherapy sources.
(summarized by Nicolette Sawicki)
To have its certification process recognized, a specialty board shall require all physician
candidates for certification to successfully complete a minimum of 3 years of residency training
in an approved radiation oncology program. Each candidate must also pass a board examination
that tests the competence in radiation safety, radionuclide handling, treatment planning, quality
assurance and clinical use of manual brachytherapy.
A structured educational program in basic radionuclide handling techniques must be completed.
To be considered complete, 200 hours of classroom and laboratory training in radiation physics
and instrumentation, radiation protection, mathematics to the use and measurement of
radioactivity, radiation biology is required. Under the supervision of an authorized user, 500
hours of work experience is also a requirement. The work experience includes ordering,
receiving and unpacking radioactive materials safely, checking survey meters, preparing,
implanting and removing brachytherapy sources. Using administrative controls to prevent a
medical event as well as using emergency procedures is also a part of the work experience.
Supervised clinical experience in radiation oncology under an authorized user for three years
also needs to be obtained. A written attestation from an authorized preceptor, or residency
program director stating the individual has satisfactorily achieved all the above requirements
must be completed.
35.491 Training for ophthalmic use of strontium-90.
(Liz McGinnis)
The licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a
physician who is an authorized user under the training for manual brachytherapy sources
requirements (35.490) or Agreement state requirements equivalent or has completed 24 hours
classroom and lab training in medical use of strontium-90 for ophthalmic radiotherapy. The
training must include radiation physics and instrumentation, radiation protection, math
calculations pertaining to the use and measurement of radioactivity, radiobiology. The training
must also include supervised clinical training in ophthalmic radiotherapy in a medical institution,
clinic, or private practice that uses strontium-90 for ophthalmic treatment for 5 individuals. The
clinical training must include examination of each patient treated, dose calculation that is to be
administered, administration of dose, follow-up and review of each patient’s case history.
Written attestation by clinical preceptor that all clinical requirements set forth by the agreement
state were satisfactorily met by the individual and is now able to independently fulfill radiation
safety-related duties as an authorized user of strontium-90 for ophthalmic use.
Subpart H—Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma
Stereotactic Radiosurgery Units
35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma
stereotactic radiosurgery unit.
(summarized by Catherine Sanders)

The licensee can use only sealed sources in photon emitting remote afterloader units, teletherapy
units, or gamma stereotactic radiosurgery (SRS) units, and only for two purposes: for therapeutic
medicine or research. In the case of the former, the sealed sources and the units must be
approved and in accordance with the Sealed Source and Device Registry; in the case of the latter,
the sources and the units must be used as described in an active Investigational Device
Exemption (IDE) application. This IDE application must have met two conditions: to be
accepted by the U.S. FDA, and to follow 10 CFR 35.49 (“Suppliers for sealed sources or devices
for medical use”, which describes requirements for sealed sources or medical devices).

35.604 Surveys of patients and human research subjects treated with a remote afterloader unit.
(summarized by Catherine Sanders)
Prior to the release of a patient or a research subject, the licensee must confirm two items: the
source has been removed from the patient or subject, and the source has been returned to a
location that is safe and shielded. The licensee will confirm these two items by surveying both
the patient (or subject) and the remote afterloader unit with a portable radiation detection survey
instrument. A record of these surveys, per 10 CFR 35.2404 (“Records of surveys after source
implant and removal”) must be kept by the licensee. Section 35.2404 states that the records must
be kept for 3 years and include the date, the name of the person who performed the survey, the
survey instrument used, and survey results.

35.605 Installation, maintenance, adjustment, and repair.

(Summarized by Carli Doerr)
When any type of work is being performed on a radiation source unit, it is to be done only by a
person specifically licensed by the Commission or an Agreement State. This can include
installations, any kind of maintenance, adjustments or repairs that need to be done on units such
as remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units. This
regulation has been put into place so that any work on the source shielding, driving unit, or other
electronic or mechanical component won’t compromise radiation safety or expose the source in
any way. This licensee is also required to retain a record of the installation or other work
performed on the units in accordance with § 35.2605.
A licensee of the Commission or an Agreement State is the only person allowed to install,
replace, relocate, or remove a sealed source or one that is contained in remote afterloader units,
teletherapy units, or gamma stereotactic radiosurgery units. However, for a low dose-rate remote
afterloader unit, it has to be done by a licensee or an authorized medical physicist.
35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and
gamma stereotactic radiosurgery units.
(Summarized by Carli Doerr)
There are certain safety procedures and instructions that must be followed by the designated
professional who is licensed by the Commission or an Agreement State. This licensee is required
to secure the unit, the console area, any console keys, and the treatment room when it is not in
use as well as control who goes into and out of the treatment room during treatments. Only
individuals approved by the authorized user, Radiation Safety Officer, or authorized medical
physicist are permitted to be in the treatment room during treatment with the source. The licensee
must also prevent dual operation of more than one radiation producing device in the treatment
room.
The licensee must contain written procedures for responding to situations when the operator
might be unable to place the source in the shielded position or remove the patient from the
radiation field with controls from outside the treatment room. These written procedures must
include how to respond to equipment failures and the names of those that perform these actions,
what to do when restricting access to the treatment area to minimize the risk of exposure, and the
contact information of who is an authorized user, authorized medical physicist, and the Radiation
Safety Officer for when units or consoles don’t function properly. A copy of these written
procedures must be at the unit console with instructions to inform the operator as well as the
contact information of the authorized people for when the equipment malfunctions.
For a new unit or one that has been upgraded by the manufacturer, a licensee is required to
ensure that the vendor operational and safety training is provided by the manufacturer to anyone
who will be operating the unit. This must be done before the first treatment is performed. This
includes providing operational and safety instructions initially and annually to all of these users.
The licensee oversees emergency drills and procedures for all authorized users performed
initially and annually. Names and records of all of these procedures and drills must be retained
by the licensee in accordance with § 35.2310 and § 35.2610.
35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units.
(Summarized by Carli Doerr)
A licensee is required to control the doors that access the treatment room by equipping each
entrance with an electrical interlock system. This system prevents the operator from beginning
treatment until the doors are closed as well as prevents the source from being exposed when the
doors are opened or when there is an interlock interruption. They are also in control of making
sure anyone that entered the treatment room is monitored and checked that radiation levels have
returned to ambient levels.
Just like radiation therapy consoles, unit console areas must include viewing and intercom
systems of the treatment room to monitor the patient at all times. These treatments can only be
conducted if expeditious removal of a source is available. In addition, the licensee must have an
authorized physicist and user present during the entire process of the treatment.
A Radiation Safety Officer and an authorized user must be notified right away if the patient has a
medical emergency or dies. Emergency equipment must be made readily available by the
licensee for situations where the source is left unshielded or lodged in the patient following
treatment.
35.630 Dosimetry equipment.
(summarized by Catherine Sanders)
With the exception of low dose remote afterloader sources (for which the manufacturer has
determined its source output or activity), the dosimetry system available for use by the licensee
must be calibrated by one of two methods: using a NIST-traceable system or source and
protocols that have been accepted by nationally recognized organizations, or calibrated within
the past 4 years and intercompared with a separate, calibrated dosimetry system 18 to 30 months
after the calibration of the licensee’s system. If using the first method, the calibration must have
been performed within the past 2 years and after any servicing of the system that may have
impacted its calibration. If using the second method, there are requirements for the separate,
calibrated dosimetry system used for the intercomparison, the intercomparison itself, and for the
results of the intercomparison. This separate dosimetry system used for the intercomparison must
have been calibrated within the preceding 24 months by NIST or an AAPM-accredited
calibration lab, and it must be a unit comparable to the licensee’s unit (including collimators or
beam attenuators as needed). The intercomparison units must use the same radionuclide source
as the licensee’s unit. Finally, the results of the intercomparison must find that the calibration
factor of the licensee’s unit has not changed by more than 2%, and the licensee’s unit is not to
have its calibration factor altered as a result of the intercomparison.
If spot-checking output measurements is performed by the licensee, then the licensee must have
an appropriately-calibrated dosimetry system to perform this spot checking. This spot-checking
dosimetry system may be the same one described in the previous paragraph. This dosimetry
system must be compared with another unit that has been calibrated using either of the two
methods stated in the previous paragraph, and this comparison must have occurred within the
past year and after any servicing that may impact its calibration.
Finally, all calibration, intercomparison, and comparison records must be kept by the licensee per
10 CFR 35.2630 (“Records of dosimetry equipment used with remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units“). Section 35.2630 states that the
records must be kept for the duration of the license and include the date, the name of the person
who performed the work, the manufacturer, model and serial numbers of the unit, and the
resulting correction factor.
35.632 Full calibration measurements on teletherapy units.
(Summarized by Rob Rohe)
A licensee who is authorized to use a teletherapy machine for medical purposes is required to
perform calibration measurements on each machine before the first medical use as well as if
specific events occur. Some of the conditions requiring full calibration measurements include
when output differs by more than 5 percent of the last full calibration, source replacement,
reinstallation of a teletherapy unit to a new location, any repair is completed that requires the
removal of the source or major components associated with it, and if one year has elapsed since
the last full calibration.
Measurements taken to satisfy the full calibration requirement include output within +/- 3
percent for the full range of field sizes and distances used medically, agreement between the
radiation field and the field produced by the light beam localizing device, beam uniformity, timer
accuracy, on-off error, and the accuracy of distance measuring devices. The licensee is required
to use an acceptable dosimetry system and make measurements following published protocols
accepted by national regulating bodies. Monthly corrections must be made for physical decay of
cobalt-60, biannually for cesium-137. Other nuclides will follow correction intervals consistent
with 1 percent decay. All full calibration measurements must be performed by a licensed medical
physicist and records must be kept.
35.633 Full calibration measurements on remote afterloader units.
(Summarized by Chris Maurino)
A licensee authorized to use a remote afterloader unit must perform full calibration checks at
multiple time points by an authorized medical physicist using a dosimetry system described in §
35.630(a) and in accordance with published protocols. The unit must be calibrated before the
first medical use of the unit, following the reinstallation at a new facility, following the
replacement of the source, or following the major repair of the unit. The unit must also be
calibrated periodically. For high, medium, and pulsed dose-rate afterloader units, whose half-life
exceeds 75 days, the units need to be calibrated every 3 months. Low dose-rate remote
afterloader units need to be calibrated yearly and the source inventory need verified quarterly.
In order to meet full calibration requirements, several factors need to be measured and met. The
output of the machine must be within ± 5 percent, the source positioning accuracy must be
within ±1 millimeter, and the source retraction with the backup battery must be operational in
case of power failure. The output of the machine may be mathematically corrected for physical
decay at intervals consistent with 1 percent physical decay. In addition, the length and function
of the source transfer tubes, length and function of the applicators, and timer accuracy and
linearity over the typical range of use must be measured.
35.635 Full calibration measurements on gamma stereotactic radiosurgery units.
(summarized by Cory Tuzzo)
The authorized licensee must perform full calibration measurements on each gamma stereotactic
radiosurgery unit before the following instances: (i) the first medical use, (ii) whenever spot
checks indicate the output differs by more than 5% from calibration standards corrected for
radioactive decay, (iii) after replacing the source or reinstallation, (iv) after any sort of repair that
may require reassembly or removal of certain parts, and (v) at 1 year intervals and following any
damage to the helmet.
Full calibration measurements must include the output within + 3%, relative helmet factors,
isocenter coincidence, timer accuracy, on-off error, treatment table mechanisms, helmet
microswitches, emergency controls, and stereotactic frames and localization.
These standards and protocols are set by nationally recognized bodies. Corrected outputs should
be done at intervals not exceeding 1 month for cobalt-60 and 1% decay for other radionuclides.
These corrections must be performed by the authorized medical physicist and record each
calibration.
35.642 Periodic spot-checks for teletherapy units.
(Summarized by Rob Rohe)
Spot checks are required monthly on teletherapy units used for medical purposes. Spot checks
must determine timer accuracy and linearity, on-off error, the agreement of the radiation field
and light field, accuracy of distance measuring devices, and output of typical operating
conditions. Although it is required that output measuring procedures be created by an authorized
medical physicist, they do not need to be the one to actually perform them. Results of spot
checks must be reviewed by a medical physicist within 15 days.
Safety spot checks are required monthly as well and cover the proper operation of electrical
interlocks at room entrance, electrical and mechanical stops, source exposure indicator lights,
video and audio systems, and treatment room doors. If any safety checks do not meet standards,
the teletherapy machine is to be locked in the off position and not used unless for repair,
replacement, or to check the failing system. Records of each spot check must be kept with a copy
of procedures performed.
35.643 Periodic spot-checks for remote afterloader units.
(Summarized by Chris Maurino)
Spot checks are required to be performed on remote afterloader units in accordance with written
procedures established by an authorized medical physicist. A medical physicist is not required to
be present for a spot check, but must review the results within 15 days. Each spot check must be
recorded and retained. Spot checks are required before the first use of a high, medium, and
pulsed dose-rate remote afterloader unit each day. Spot checks are required before each patient
treatment for low dose-rate remote afterloader units. Spot checks are also required after each
source installation.
In order to satisfy the requirements of a periodic spot check, spot checks at a minimum must
assure the operation of electrical interlocks at each remote afterloader unit room entrance and
source exposure indicator lights on the remote afterloader unit, on the control console, and in the
facility. In addition, the emergency response equipment, radiation monitors used to indicate the
source position, timer accuracy, clock in the unit’s computer and the decayed source(s) activity
in the unit’s computer must be checked. In the event that a spot check indicates a malfunction,
the unit shall not be used until the necessary correction is made.
35.645 Periodic spot-checks for gamma stereotactic radiosurgery units.
(summarized by Cory Tuzzo)
Spot checks must be performed by an authorized licensee (does not have to be the actual medical
physicist) on each facility and unit; (i) monthly, (ii) before the first use of the unit on a given
day, and (iii) after each source installation. The authorized physicist must check the results of
each spot check within 15 days. These checks include table retraction mechanisms, helmet
microswitches, emergency timing circuits, stereotactic frames and localization, the output for one
typical set of operating conditions compared to the expected output (expressed as a percentage),
timer accuracy, on-off error, electrical interlocks for radiosurgery room entrance, source
indicator lights, audio and video communication, radiation monitors, and emergency on/off. If
any of these are damaged or not working, they must be fixed as soon as possible and recorded
correctly.

35.647 Additional technical requirements for mobile remote afterloader units.

(Summarized by Chris Maurino)
A licensee providing mobile remote afterloader service shall check survey instruments before
medical use at each address of use or on each day of use, whichever is more frequent and
account for all sources before departure from a client’s address. In addition, as with remote
afterloader, mobile remote afterloader services are required to perform periodic spot-checks.
Mobile remote afterloader units are required to ensure the operation of electrical interlocks on
treatment area access points, ensure viewing and intercom systems are operational, and ensure
the source exposure indicator lights on the remote afterloader unit, on the control console, and in
the facility are operational. Additional checks including applicator, source transfer tubes, and
transfer tube applicator interfaces, radiation monitors used to indicate the room exposures, source
positioning (accuracy), and radiation monitors used to indicate whether the source has returned
to a safe shielded position need to be checked. In the event that a spot check indicates a
malfunction, the unit shall not be used until the necessary correction is made. Each spot check
must be recorded and retained.
35.652 Radiation surveys.
(Summarized by Carli Doerr)
A licensee must make surveys to ensure that the maximum and average radiation levels from the
shielded position of the source do not exceed the levels stated in the Sealed Source and Device
Registry. These surveys must be made following installation or repairs that could lead to
exposure of the source, reducing shielding, or compromising radiation safety. A record of these
surveys must be kept by the licensee.
35.655 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
(Summarized by Rob Rohe)
Full inspection servicing must be completed within 5-year intervals for teletherapy units and 7
years for gamma stereotactic units. These inspections are also required after source replacement
for both teletherapy and gamma stereotactic units to ensure correct operation regarding the
source exposure mechanism as well as other safety components. Full inspection servicing must
be completed by a licensed personal and records must be kept.
35.657 Therapy-related computer systems.
(summarized by Cory Tuzzo)
The authorized licensee must perform acceptance testing on the TPS of therapy-related computer
systems in accordance with protocols set forth by nationally recognized bodies. These tests must
include; the source-specific input parameters required by the dose calculation algorithm; The
accuracy of dose, dwell time, and treatment time calculations, the accuracy of isodose plots and
graphs, the accuracy of the software used to determine sealed source positions and the accuracy
of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the
TPS.
35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units.
(summarized by Catherine Sanders)
The authorized user of sealed sources in photon emitting remote afterloader units, teletherapy
units, or gamma stereotactic radiosurgery (SRS) must be a physician who meets one of two
major criteria: (1) is certified by a recognized medical specialty board (which requires the
physician to undergo at least a 3 year residency in radiation therapy and pass a radiation therapy
board exam); or (2) has completed a structured educational program for use of sealed sources for
medical therapeutics (which includes didactics, lab training, and work experience under an
authorized user), 3 years of practice supervised by an authorized user (which may be concurrent
with the aforementioned supervised work experience), and has a written record provided by
either a residency program director or a supervisor who is an authorized user that states the
physician has completed requirements (per 35.57, 35.690, or those of an Agreement State), is
capable of performing necessary duties related to safety, and has received appropriate safety
training and instruction in equipment operation.
Finally, the physician must have been trained in safety, device use, and in clinical application(s)
appropriate to the authorization. In situation (2) above, such training would be documented in the
written record provided by the residency program director or supervising authorized user.