NRC: 10 CFR Part 35 – Medical Use of Byproduct Material

The Title 10, Code of Federal Regulations (CFR) Part 35 documentation provided by the
Nuclear Regulatory Commission (NRC) discusses the requirements for the medical use of
byproduct material.1 The subparts that will be discussed below include Subpart F- Manual
Brachytherapy and Subpart H- Photon Emitting Remote Afterloader Units, Teletherapy Units,
and Gamma Stereotactic units:

Subpart F – Manual Brachytherapy

Christina Ong

35.400 Use of sources for manual brachytherapy

Brachytherapy sources shall only be used as approved in the Sealed Source and Device
Registry or with an active Investigational Device Exemption (IDE) application accepted the FDA
in research.

35.404 Surveys after source implant and removal

Surveys shall be done immediately after implanting brachytherapy sources to locate for
all sources that have not been implanted and removing brachytherapy sources to confirm that all
sources have been removed—a record of the surveys (in accordance with 35.2404 as follows)
shall be retained for 3 years to include the date and results of the survey, the survey instrument
used, and the name of the individual who made the survey.

35.406 Brachytherapy sources accountability

All brachytherapy sources shall be accounted for at all times (in storage or use) and
returned to a secured storage as soon as the sources are removed from a patient/human research
subject. A record of the brachytherapy sources accountability (in accordance with 35.2406 as
follows) shall be maintained for 3 years. For temporary implants, the record must include the
number and activity of sources removed/returned from/to storage, the time and date they were
removed/returned from/to storage, the location of use, and the name of the individual who
removed/returned them from/to storage; for permanent implants, the record must include the
number and activity of sources removed from storage, not implanted, and permanently implanted
in a patient/human research subject, the date they were removed/returned from/to storage, and
the name of the individual who removed/returned them from/to storage.

Jacquelyn Palermino

35.410 Safety Instruction

This section requires that licensees provide radiation safety instructions to personnel who
are involved in caring for patients and human research subjects receiving brachytherapy. 1 These
safety instructions, in addition to the requirements specified in section 10 CFR section 19.12
“Instruction to workers”, are to be given initially and at least annually. Instruction must be
consistent with the duties of the personnel and should include the size and appearance of the
brachytherapy sources, safe handling and shielding instructions, and patient or human research
subject control. This section also includes visitation regulations of hospitalized individuals in
accordance with 10 CFR section 20.1301 “Radiation Dose Limits for Individual Members of the
Public” and the notification of the Radiation Safety Officer and authorized user if the patient
experiences a medical emergency or dies. Lastly, records should be maintained of the individuals
receiving safety instructions, stating the names of the attendees, the names of the individual who
provided the instruction, as well as the topics reviewed. The records should follow in agreement
with 10 CFR section 35.2310.

35.415 Safety Precautions

This section states that licensees should not hold patients or human research subjects
receiving brachytherapy who cannot be released according to section 10 CFR 35.75 in a room
with other individuals not receiving brachytherapy.1 A “Radioactive Materials” sign must visibly
be posted outside the patient’s or human research subject’s room along with a note stating where
and for how long visitors may stay in the patient’s or subject’s room. Appropriate emergency
response equipment should be available nearby in case a source becomes dislodged from the
patient or becomes fixed within the patient after removal of the source applicators. This section
also specifies the requirement for the licensee to the notify the Radiation Safety Officer and
authorized user if the patient experiences a medical emergency or dies.

35.432 Calibration measurements of brachytherapy sources

 This section explains calibration measurements for brachytherapy sources used on or
after October 24, 2002.1 Prior to the first use of a brachytherapy source, the source output or
activity must be determined using a dosimetry system that meets the requirements specified in
section 10 CFR 35.630(a). The source positioning accuracy within the applicators must also be
determined. In addition, measurements supplied by the source manufacturer or by a calibration
laboratory accredited by the American Association of Physicists in Medicine (AAPM) may be
used to determine the source output or activity. For the outputs or activities determined,
mathematical corrections should be completed for physical decay, and documentation of each
calibration should be recorded in accordance with 10 CFR section 35.2432.

Julie Puzzonia

35.433

This portion of the document discusses the decay of Sr-90 sources for ophthalmic
treatments. It states that the authorized medical physicist is responsible for the calculation of the
activity of the source for all ophthalmic treatments and calculations should be completed in
accordance with section 35.432. This should be done to determine the amount of treatment time
needed for each patient. In addition, a record of the activity of the Sr-source should be
maintained by a licensed individual as per section 35.2433.

35.457

This section states that acceptance testing is needed for all treatment planning systems
and therapy-related computer systems. The acceptance testing should follow guidelines provided
by national governing bodies and include: source specific input parameters, the accuracy of dose,
dwell time, and treatment time calculations, the accuracy of isodose displays, and the accuracy of
software to determine sealed source positions on radiographs.

35.490

The training required for physicians wishing to use manual brachytherapy sources
requires the following credentials: certification by a medical specialty board that is recognized
by the Commission or Agreement State, completion of a 3-year residency training in an
accredited radiation oncology program, successful completion of an exam encompassing
radiation safety and radionuclide planning, QA, and manual brachytherapy.

The education program that is required must include 200 hours of class and lab training
in: radiation physics, radiation protection, calculations for radioactivity, and radiation biology.
The physician also must have 500 hours of work experience under an authorized user
performing: safe handling of materials and radiation surveys, implanting and removing
brachytherapy sources, taking inventory of materials, practicing safe procedures to prevent
medical events, and using emergency procedures when necessary. Upon completion of the
program, a written attestation must be given stating that the individual has successfully
completed all necessary education and clinical experiences and is competent as an authorized
user of manual brachytherapy sources.

Jade Reihart

35.491

Section 35.491 presents training requirements for authorized users of strontium-90 for
ophthalmic radiotherapy. Authorized users are physicians who have completed 24 hours of
classroom and laboratory training for the medical use of strontium-90 for ophthalmic
radiotherapy. The training must include –

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity; and

(iv) Radiation biology

The candidate physician must also complete clinical training under the supervision of a
current authorized user at a medical institution, clinic, or private practice. The clinical training
must include five clinical competencies with the candidate physician examining each patient,
calculating the dose, administering the dose, and providing follow-up for each case.
 Finally, the preceptor-authorized user must provide documentation that the candidate
physician has satisfactorily completed the requirements and is able to function independently as
an authorized user of strontium-90 for ophthalmic use.

Subpart H - Photon Emitting Remote

Afterloader Units, Teletherapy Units, and
Gamma Radiosurgery Units
35.600

Section 35.600 provides direction on how sealed sources in photon emitting remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery units can be used. The
licensed facility can operate the devices for therapeutic medicine as approved in the Sealed
Source and Device Registry. The devices may also be used in research in accordance with an
active Investigational Device Exemption (IDE) application accepted by the FDA.

35.604

Section 35.604 specifics that patients treated with remote afterloader units must be
surveyed with a portable radiation detection instrument prior to release to confirm the source has
been removed from the patient. A survey of the afterloader is also required to ensure the source
returned to the safe and shielded position. Finally, all survey records must be recorded and
retained by the licensed facility.

Ryan Salem

35.605

Section 35.605 covers installation, maintenance, adjustment, and repair of these units. A
person specifically licensed by the U.S.NRC or an agreement state can install, repair, or maintain
any of the above units if the work is related to the source shielding, driving unit, or electronic
component that could lead to exposure from the source. If radiation safety can be compromised
in any way when handling the units, only a licensed person may partake in handling of the
situation. In HDR units, only a licensed person can install, replace, relocate, or remove a sealed
source in a unit. In LDR units, a licensed person or authorized medical physicist can perform
these tasks. A record of installation, maintenance, adjustment, or repair of all units must be
maintained in accordance with 35.2605.

35.610

Section 35.610 discusses safety procedures and instructions for the units. To minimize
risk of inadvertent exposure, only individuals approved by the RSO or other authorized person
can be present during treatment with sources. When not in use, the unit, console, and keys must
be secured. All procedures regarding abnormal situations should be recorded, developed, and
implemented. They must include equipment failures and the removal of the patient from the
radiation field. A licensee must provide instruction initially and annually to anybody who will
operate the unit. Records must be kept of instruction, and all operators must participate in drills
of emergency procedures.

35.615

Section 35.615 explains safety precautions for these units. The treatment room must be
controlled by a door equipped with an electrical interlock system that both prevents treatment
and shields the source when the entrance door is opened. Nobody may enter the room until
radiation levels have been returned to ambient levels by use of radiation monitors. For all units
except LDR, the treatment room must be equipped with viewing and intercom systems from the
treatment console. Quick removal of a jammed source must be possible for brachytherapy
treatments as well. For medium, pulsed, and high dose-rate units, an authorized medical physicist
and an authorized user or physician must be physically present during the initiation and must be
immediately available in the event of an emergency for all patient treatments. For gamma SRS
units, at least a medical physicist must be present throughout all patient treatments. In any
emergency or fatal situation, the RSO or the designee and an authorized user must be notified.
Equipment must be available to respond to sources that remain in the unshielded position or is
lodged within a patient following treatment completion.

Adam Schwartz

35.630
 According to section 35.630, a calibrated dosimetry system must be available to analyze
any sources outside those used in low dose-rate remote after-loader systems, where output is pre-
determined by the manufacturer. To satisfy this requirement, 1 of 2 conditions must be met. The
first condition requires a dosimety system be calibrated using a categorized source or system
calibrated by the National Institute of Standards and Technology (NIST) or by an American
Association of Physicists in Medicine (AAPM) accredited calibration lab. These dosimetry
systems must be calibrated every 2 years and following any servicing that may affect system
calibration. The second condition requires dosimetry systems be calibrated every four years and
inter-compared every 18-30 months following the original calibration using another NIST or
AAPM accredited system independently calibrated no more than 24 months before. The result of
this inter-comparison must indicate variation of less than 2% to be considered acceptable and
may not be used to change the calibration factor of a dosimetry system. Any unit used for inter-
comparison of sealed therapeutic sources must be comparable to the facilities clinical unit with
beam attenuators, collimators, and the same source radionuclide. In regards to spot-check output
measurements, a licensee should possess a dosimetry system that has been compared with a
system calibrated in accordance to any of the conditions mentioned above. The comparison must
be performed within a year of the calibration of the comparing system and following any
servicing that may have affected system calibration. To remain in accordance with 35.2630, the
licensee must retain and record all information pertaining to calibration and inter-comparison.

35.632

Section 35.632 discusses full calibration measurements on teletherapy units. A licensed

medical physicist authorized to therapeutically operate a teletherapy unit must perform full
calibration measurements on each of the units in accordance to published protocols recognized
by national entities. These measurements must be taken prior to initial medical use, annually,
following replacement of a source or relocation of a teletherapy unit, following repairs related to
source or source exposure assembly, and following a spot-measurement deviating greater than
5% from the previous output reading correcting for radioactive decay. These outputs are to be
mathematically corrected for physical decay in intervals not exceeding 1 month for cobalt-60, 6
months for cesium-137, or intervals consistent with 1% with all other radionuclides. All
calibration measurements must include output within 3% for range of field sizes and distances
used medically, coincidence of radiation field and dependence on beam orientation, timer
accuracy and linearity, on-off error, and accuracy of all distance measuring and localization. A
dosimetry system described in section 35.630 must be used to measure output at one set of
exposure conditions, while the remaining measurements listed above may be analyzed using a
system that indicates relative dose rates. All records of calibration must be kept to accord with
section 35.2632.

35.633

Full calibration measurements on remote after-loader units are discussed in section

35.633. Full calibration measurements on each unit must be performed by a licensed medical
physicist prior to the first medical use, following source replacement or transfer of the unit to a
new facility, and any repair that involved removal of the source or repair of source exposure
assembly. These calibration measurements must be performed at interval not exceeding 1 quarter
for high, medium, and pulsed dose-rate after-loader units containing sources with whose half-life
exceeds 75 days and at intervals not exceeding 1 year for low dose-rate after-loaders. To satisfy
these requirements, full calibration measurements must be done using a system described in
Section 35.630, following recognized protocols. These measurements are to include output
within 5% (corrected for physical decay intervals consistent with 1% decay), source positioning
accuracy within 1 millimeter, source retraction using back-up battery following power failure,
length of source transfer tubes, timer accuracy and linearity, length of applicators, and function
of source transfer tubes, applicators, and transfer tube-applicator interfaces. The licensee should
perform an autoradiograph of sources to verify inventory and source arrangement at intervals not
exceeding 1 quarter. Low dose-rate remote after-loader units allow for the use of manufacturer
measurements and all records of calibration must be kept to accord with section 35.2632.

Ruha Siddiqui

35.635

This section pertains to the use of calibrating measurements on gamma stereotactic radiosurgery
units. It states an authorized user that is licensed is in charge of calibrating gamma radiosurgery
units. It also states conditions in which it can be used before medical use, such as: different
output, source replacement, need of gamma stereotactic radiosurgery unit repair, and at intervals
more than a year in which damage may also occur. The full calibration measurements
determinants are also written to satisfy requirements.

35.642

This sub-section pertains to the periodic spot check that is required for teletherapy units
once a month. This check must include timer accuracy, on/off error, light-beam localizing device
that demonstrates the coincidence of the radiation field, and the output found under a set of
operating conditions and etc. This section also verbalizes the need for a licensee to perform
measurements based off a medical physicist’s authorization. Other criteria for periodic spot-
checks include checking the treatment room doors (inside, outside, and electrically assisted
treatment rooms). If any form of malfunction is established, then a licensee is responsible for
locking the control console. A record of spot-check conducted must be retained each time.

35.643

This sub-section summarizes the need for periodic spot-checks after the medical use of a
remote afterloader. This periodic spot check must be done under certain conditions, such as:
before the use of varying dose-rate afterloader, before a patient is treated with a low dose-rate
afterloader remote, and after each source installation. These measurements must take place with
accordance to a medical physicist’s written guidelines and be checked by him/her for
verification. The spot-checks performed must assure certain operations are proper and in place
such as: electrical interlocks at the remote afterloader unit room entrance, indicator lights are on
for each remote afterloader, viewing and intercom systems for each dose-rate afterloader are
properly in place, and emergency response equipment is in check. If for any reason, there is any
indication of a malfunction the control console should be locked in the off position and not used
until further notice. All checks must be recorded as well.

Zach Stauch
35.645

In 10 CFR, part 35.645 describes the requirement for periodic spot checks for gamma
SRS units. This part describes that a spot check should be performed on each gamma SRS unit
once a month, before the units first use on that given day, and after each source installation. A
licensee shall also perform measurements required by paragraph (a) of the section, and an
authorized medical physicist must review the spot check within 15 days. The spot check must
assure the proper function of the treatment table’s retraction mechanism, helmet microswitches,
emergency microswitches, and SRS frames and localizing devices. It must also determine the
output for one set of operating conditions, the source output against computer calculation, and
timer accuracy. Electrical interlocks, source exposure indicator lights, intercom and video
systems, timer termination, and emergency off buttons must all pass in the spot check as well. If
something in the spot check does not pass, the console must be locked until proper repair is
performed.

35.647

Part 35.647 has to do with the additional technical requirements for mobile remote
afterloader units. A licensed facility that provides remote afterloader service must check the
survey instruments before each medical use, as well as account for all sources used before the
patient departs. Like the spot checks in part 35.645, checks should be performed after each use.
At a minimum, the electrical interlocks, source exposure indicator lights, video and intercom
systems, applicator interfaces, source positioning, and monitors used to indicate if the source has
returned safely to the shielded position should all be checked. Before each use, a simulated cycle
must be performed with the afterloader for safety purposes. If there is any malfunction, the
console must be locked in the off position until proper repair is performed. For both parts,
records must be kept of every spot check.

Kayla Tedrick

35.652 Radiation Surveys

Section 35.652 narrows down to radiation surveys and is in addition to section 20.1501
detailing the use of surveying in areas of radiological hazards or possible residual radioactivity
and the records that must be kept and calibration needed for the instruments. Section 35.652
requires any dosimetry processor licensed under the National Voluntary Laboratory
Accreditation Program (NVLAP) of the National Institute of Standards and Technology shall 1:

1. Survey to ensure that the maximum and average radiation levels stated in the Sealed
Source and Device Registry not be exceeded when surveying from the surface of the
main source safe with the source(s) in the shielded position.

2. This survey stated above is required to be done at installation of a new source and
following repairs to any component of the source, such as the shielding or anything that
could reduce the shielding around the source, driving unit, or anything that could expose
or compromise the radiation safety of the unit or the source(s).

3. This survey stated above should be recorded by the standards of Section 35.2652.

35.655 "Five-year inspection for teletherapy and gamma stereotactic radiosurgery units"

(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully
inspected and serviced to assure the source exposure mechanism is working correctly at times of
at least every five years or when a source is replaced, whichever occurs first.

(b) A licensee by the Commission or an Agreement State must perform this inspection and
service.

(c) A record with requirements stated in Section 35.2655 must be kept of this inspection and
service.

Bianca Tester

35.657

Subparts H (35.657) summarizes what quality assurance (QA) items that must be tested
on the treatment planning system (TPS) for brachytherapy treatments. There is a minimum of 5
items that must be tested including: the accuracy of dose, dwell time, and treatment time
calculations at specific points; the accuracy of isodose plots and graphic displays; and the
accuracy of transferring the treatment parameters to the brachytherapy unit from the TPS. 1

35.690
 Subparts H (35.690) summarizes who is considered an authorized user of remote
afterloader units, teletherapy units and gamma stereotactic radiosurgery units and the specific
training the licensee shall be required to complete in order to become an authorized user. Some
examples from subparts H (35.690) include: the authorized user must be a physician that has
completed a minimum of 3 years of residency training in a radiation therapy program approved
by the Residency Review Committee of the Accreditation Council for Graduate Medical
Education (or the Royal College of Physicians and Surgeons of Canada or the Committee on
Post-Graduate Training of the American Osteopathic Association). The authorized user must
also have 500 hours of work experience under the supervision of another authorized user that
meets the requirements in sections 35.57, 35.690 or equivalent requirements at the particular
medical institution.1

References

1. The United States Nuclear Regulatory Committee. Part 35—Medical Use of Byproduct
Material. The United States Nuclear Regulatory Committee webpage.
https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/. Last updated June 4, 2018.
Accessed July 15, 2018.