Radiation Sources in Radiotherapy

Accidents in Radiotherapy

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International Atomic Energy Agency Day 7 – Lecture 6
 Objective

To become familiar with the contributing factors that can

led to unwanted exposure in radiotherapy.
To be aware of investigation of accidents; case studies of
accidental exposures in radiotherapy and lessons
learned.
Role of the Regulatory Body in case of accidents and
emergencies in radiotherapy.

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 Contents

• Potential for accidents in radiotherapy.

• Deviation from the prescribed dose.
• Potential exposures in external beam therapy.
• Potential exposures in brachytherapy.
• Case examples and lessons learned from accidental
exposures in radiotherapy.
• Role of the Regulatory Body.

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 Potential for accidents in radiotherapy

Radiotherapy is unique from the point of view of radiation

safety because:
• it is the only use of radiation sources in which very
high radiation doses are given deliberately to the
human body.
• not only the tumour, but also normal tissue receives
radiation doses comparable to the tumour dose.

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Potential for accidents in radiotherapy (cont)

Potential Exposure

“Prospective exposure that is not expected to be delivered with

certainty but that may result from an anticipated operational
occurrence, accident at a source or owing to an event or sequence
of events of a probabilistic nature, including equipment failures and
operating errors.”

[GSR Part 3 Definitions]

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 Deviations from the prescribed dose

Deviations from the prescribed dose:

• may involve severe or even fatal consequences;

• require prompt investigation by licensees in the event of

an accidental patient exposure.

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 Accidental Medical Exposure

“Any medical treatment delivered to the wrong individual or

the wrong tissue of the patient, or using the wrong
radiopharmaceutical, or with an activity, a dose or dose
fractionation differing substantially from (over or under) the
values prescribed by the radiological medical practitioner, or
that could lead to unduly severe secondary affects”

“Any failure of medical radiological equipment, software

failure or system failure, or accident error, mishap or other
unusual occurrence with the potential for subjecting the
patient to a medical exposure that is significantly different
from what was intended.”
[GSR Part 3 Requirement 41. 3.179]

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 Causes of accidents

For external beam therapy,

accidents may be related to:
• equipment design;
• beam calibration;
• maintenance;
• treatment planning;
• dose calculation;
• treatment simulation;
• treatment setup and delivery.

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 Examples – Equipment Design

An operator of a linear accelerator selected x-ray mode and then

quickly changed to electron mode. The machine was unable to
complete the first request (to operate in x-ray mode) and
subsequently operated with “hybrid” instructions.
The same accident occurred in 6 different hospitals and 2 patients
died due to doses ranging from 160 -180 Gy
Contributing factors
• The software controlled linear accelerators were not tested for
the conditions that occurred in practice at the hospitals.

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 Examples – Equipment Design (cont)

An operator of a linear accelerator selected x-ray mode and then

quickly changed to electron mode. The machine was unable to
complete the first request (to operate in x-ray mode) and
subsequently operated with “hybrid” instructions.

The same accident occurred in 6 different hospitals and 2 patients

died due to doses ranging from 160 -180 Gy.
Contributing factors (cont)
• The manufacturer took too long to identify the problem and to
disseminate the information. By then the 6 hospitals had
experienced the same failure and 2 patients had died from
their radiation exposure.
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 Examples – Beam Calibration

Accidents due to mistakes in properly determining the radiation

dose rate have led to patient over-exposure, in some cases by as
much as 60%.
Other reported accidents have concerned misinterpretation of a
calibration certificate and an atmospheric pressure correction
factor; incorrect use of a plane-parallel ionization chamber;
inadequate briefing of a replacement medical physicist.
Contributing factors
• Lack of understanding of beam calibration procedures,
calibration certificates, conversion factors and dosimetry
instruments.
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 Examples – Beam Calibration (cont)

Contributing factors (cont)

• Lack of training and expertise in radiotherapy physics;

• Lack of redundant and independent determination of

absorbed dose (mistakes were not detected);
• Lack of formal procedures for communication and
information exchange with new personnel.

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 Examples – Beam Calibration (cont)

In one case verification of a 60Co teletherapy beam had not

been undertaken for 22 months.

Contributing factors

• The physicist responsible was fully engaged with a new

linear accelerator and “ignored” the 60Co unit.
• Management did not review staffing needs when the new
accelerator was installed.

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 Examples – Maintenance problems

Incorrect adjustment of the electron energy of a linear accelerator

resulted in 27 patients being over exposed. Doses were between
3 and 10 times greater than intended, causing several deaths.
Contributing factors
• A repair was made by a maintenance technician who did not
understand the accelerator circuitry nor the consequences of
incorrectly adjusting the electron energy (i.e. insufficient or
incorrect training and experience).
• The repair was not communicated to the medical physicist and
patient treatments resumed without beam verification.

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 Examples – Maintenance problems (cont)

Contributing factors (cont)

• It was possible to operate the machine with the energy

selector disabled.

• Conflicting displays and signals on the control panel were

misinterpreted (the energy selector indicated a different
energy to the instrument on the control panel).

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 Examples – Maintenance problems (cont)

Operation of a linear accelerator in “physics” mode for

treatments resulted in one death.

Contributing factors

Repeated, intermittent and unresolved equipment faults were

interrupting treatments. The radiation oncologist took a
decision to operate the accelerator in “physics” mode which
bypassed safety interlocks.

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 Examples – Treatment planning

Accident relating to the commissioning of the Treatment

Planning System (TPS) leading to wrong doses to many
patients.
• A distance correction was applied manually but the TPS
already had the data in the computer plan. This error resulted
in underexposure of over 1000 patients by as much as 30%.
• Other accidents were related to entering incorrect data into the
TPS computer.
Contributing factors
• Insufficient understanding of the TPS (no staff training on the
new equipment for treatment planning);
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 Examples – Treatment planning (cont)

Contributing factors (cont)

• Lack of an independent check of the dose planning

(either by manual calculations to selected points or by
measurement on a phantom, or by “in vivo” dosimetry);

• Lack of formal commissioning of the TPS (no test

before using the TPS for treating patients).

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 Examples – Treatment Simulation

Anatomical error with identification of the patient’s left and

right sides interchanged.

Contributing factors

• the treatment was simulated in an unusual position;

• there was no check of the anatomical site relative to the
check film.

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 Examples – Treatment set up and delivery

Treatment of the wrong patient, wrong site, giving the

wrong treatment, applying the wrong treatment schedule.

Contributing factors

• Lack of procedures for proper identification of the patient,

the anatomical site or the treatment schedule;

• procedures not followed rigorously.

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 Causes of accidents

Brachytherapy accidents may be

related to:
• Equipment design;
• Source order and delivery;
• Source calibration and acceptance;
• Source preparation for the treatment;
• Treatment planning and dose
calculation;
• Source removal.
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 Examples – Equipment Design and testing

Sources were dislodged from the drive mechanism of a high

dose rate (HDR) remote after loading device and remained
in the patient. The patient died from the radiation dose.

Contributing factors

• The HDR device apparently was not adequately tested

for conditions such as a source train jammed in the
catheter or a kinked catheter.

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Examples – Equipment Design and testing (cont)

Contributing factors (cont)

• Conflicting signals - the HDR device indicator was showing
“source shielded” while an area monitor indicated the
presence of radiation. The wrong signal was accepted.
• The external radiation monitor had a history of malfunctions
and was not trusted.
• A portable survey instrument was not used to confirm the
return of the sources to the HDR device after the treatment.

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 Examples – Source orders, delivery, etc

Different units of activity were used by the hospital (mCi) and the
manufacturer (mg-Ra-equivalent). This led to a patient receiving a
radiation dose 74% greater than prescribed.
In three cases, patients received less than the prescribed dose
due to the use of sources without a check on the source activity.

Contributing factors

• Different activity units were used by the hospital and manufacturer;

• Insufficient check of documents (order and delivery);
• A source calibration check was not undertaken before use (source
strength determination).

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 Examples – Treatment planning

Errors in treatment time calculations ranged from - 59% to + 49%.

Contributing factors

• Copies of an obsolete form were still available for clinical use;

• Records did not include the treatment distance relevant to the
treatment time calculations;
• Miscommunication between the radiation oncologist, physicist
and others (a treatment plan was modified but an unmodified
plan was used);
• Lack of independent verification of treatment time calculations.

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 Examples – Source preparation

• Wrong sources were used resulting, in one instance, of

treatment with less than 50% of the prescribed dose;

• In one case the manufacturer delivered a source with

essentially no activity;
• Two 192Ir sources were lost;
• A leaking 125I source was re-used;
• Sources withdrawn from clinical use were used with
incompatible applicators.

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 Examples – Source preparation (cont)

Contributing factors

• Personnel handling sources and applicators lacked proper

training;
• Source activity was not verified;
• Failure to properly audit the inventory of radiation sources;
• Source leakage was not detected during preparation. A similar
incident in another hospital had not triggered a check action;
• Sources withdrawn from clinical use were re-used by mistake.

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 Examples – Delivery of treatment

• a resident physician did not implant all prescribed sources;

• a wrong patient was treated;
• a source ribbon was dislodged from the catheter and was
taped by a nurse on the face of the patient;
• sources became displaced;
• sources were removed by the patient;
• a source that did not match the applicator was loose and fell
out of the applicator.

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 Examples – Delivery of treatment (cont)

Contributing factors

• untrained physician working without supervision;

• nurses without appropriate training were caring for
brachytherapy patients;
• no written safety procedures;
• poor communication of instructions that were not
understood.

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 Examples – Source removal

• Sources lost due to lack of appropriate checks after

removal.

Contributing factors

• Sources were not accounted for after removal;

• The patient, their clothes, the room and waste from the
treatment room were not monitored.

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 Lessons learned

Studies have shown that most accidents could have been

prevented by consistent application of the Requirements 34
– 42 (3.144 – 3.184) of the GSR Part 3.

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 Accidents in radiotherapy

Human error resulting in a

therapeutic treatment delivered:

• to the wrong patient

• to the wrong treatment site

• with a substantially different dose,
or dose fraction, to that prescribed
by the medical practitioner

Equipment malfunction

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 The Panama accident

This accident, investigated by the IAEA, occurred at a

facility that provided radiotherapy for cancer patients.

• In keeping with common practice, the facility used

blocks of shielding material to modify the shape of the
radiation beams to protect normal tissue, including
critical structures, during treatment.

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 The Panama accident (cont)

• A computerized treatment planning system (TPS) was

used to calculate the dose distribution and determine
treatment times.
• The TPS allows a maximum of four shielding blocks per
field to be taken into account when calculating treatment
times and dose distributions.
• The data for each shielding block should have been
entered into the TPS separately.

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 The Panama accident (cont)

• In August 2000, to satisfy the request of a radiation

oncologist to include five blocks in the field, the method
for digitizing the shielding blocks was changed.

• It was found that it was possible to enter data into the

TPS for multiple shielding blocks together, as if they
were a single block, thereby apparently overcoming the
limitation of four blocks per field.

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 The Panama accident (cont)

• Although the TPS accepted entry of the data for

multiple shielding blocks as if they were a single block,
the computer output indicated a treatment time
substantially longer than it should have been.

• The result was that patients received a proportionately

higher dose than that prescribed.
• The modified treatment protocol was used for 28 patients,
treated between August 2000 and March 2001 for prostate
cancer and cancer of the cervix.

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 The Panama accident (cont)

• In November 2000, a radiation oncologist started to

observe unusually prolonged diarrhoea in some patients.
In December 2000, the effect was observed in other
patients.

• The Department’s physicists reviewed the treatment plans

but did not find any anomaly.
• The computer outputs (dose distribution and treatment
time) calculations were not checked.

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 The Panama accident (cont)

The outcome at 30 May 2000

• 8 of the 28 patients dead.

 5 deaths - radiation related.

 2 deaths - unknown if radiation related.
 1 death due to metastatic cancer.
• 20 patients surviving.

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 The Panama accident (cont)

• “Additional radiation effects will become apparent in

the affected patients over the next months and years
and, given the radiation doses received, the morbidity
and mortality can be expected to increase.”

• “Most of the surviving patients already have serious

medical problems related mainly to bowel and bladder
overexposure. Most of the untoward bowel and bladder
effects cannot be remedied.”

Investigation of an Accidental Exposure of Radiotherapy Patients in Panama

IAEA Vienna 2001
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The Panama accident (cont)

Compliance with legislation

The radiotherapy department of the facility applied for
authorization in 1997 but this had not been granted by the
time of the accidental exposure, pending the resolution of
several outstanding issues.
Records showed that the Regulatory Body had issued a
number of reminders to the department since 1997:

• requesting information, principally the manuals of

procedures for radiation protection and quality assurance.

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 The Panama accident (cont)

Compliance with legislation (cont)

• A number of brachytherapy sources from the facility were found to

be in use in a different hospital without authorization;

• An incident had occurred in which a cobalt therapy source had

not returned to the ‘OFF’ (shielded) position, risking excessive
radiation exposure of staff and patients. No radiation oncologist
was present at the hospital at the time.
The Regulatory Body sent a letter to the facility reminding it of its
obligation to have at least one radiation oncologist always
present when patients are being treated.

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 The Panama accident (cont)

The event was triggered by:

• the search for a way to overcome the limitation to four shielding
blocks.
Contributory factors
• Several different ways of digitizing the shielding blocks were
accepted by the computer;
• There was no warning on the computer screen when the blocks
were digitized in an unacceptable way i.e. in a way different to
that prescribed in the manual;

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 The Panama accident (cont)

• When blocks were digitized incorrectly, the TPS produced a

diagram which was the same as that produced when data were
entered correctly, thereby giving the impression that the
calculated results were correct.

• The modified protocol was used without a verification test i.e.

without a manual calculation of the treatment time for comparison
with the computer calculated treatment time, or a simulation of
treatment by irradiating a water phantom and measuring the dose
delivered.
• Although the treatment times were about twice those required for
correct treatment, the error went unnoticed.

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 Not an isolated event

• More than 90 cases of

accidental exposures in
radiotherapy have been
documented.

• Accidents have occurred in

both brachytherapy and
external beam radiotherapy.
• Accidents occur in both
developed and developing
countries

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 Consequences in practice

If the dose:

• is too low - reduction of tumor control probability. There is

no second chance!

• is too high – risk of acute complications and late

complications.

There is less likelihood that an accident will occur where a

country has a functioning regulatory system. However, these
countries may be over-represented in accident summaries
possibly because all (?) accidents are actually reported.

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 Lessons learned

“Registrants and licensees shall promptly investigate any of

the following unintended or accidental medical exposures:

(a) any therapeutic treatment delivered to either the wrong

patient or the wrong tissue, or using the wrong
pharmaceutical, or with a dose or dose fractionation
differing substantially from the values prescribed by the
medical practitioner or which may lead to undue acute
secondary effects;”

[GSR Part 3 Requirement 41. 3.179]

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Lessons learned from the Panama accident

• Treatment planning is a critical aspect of treatments.

• Written procedures are required.
• New procedures must be tested - including documentation.
• Computer calculations should be verified manually.
• Treatment planning software should include:
 an instruction manual;
 on-screen warnings;
 fool-proof tests.

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Lessons learned from the Panama accident (cont)

• Ongoing communication with the treatment device

manufacturer is important for both service and staff training.

• Radiotherapy facilities must be appropriately resourced

(staffing, equipment etc) in keeping with the patient
workload.
• The licensee, responsible medical practitioner, RPO and
senior staff must encourage a strong safety culture in all
personnel through appropriate supervision and interaction.
• Directions from the Regulatory Body must be complied with
promptly.

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 Investigation of accidents

• Minor accidents should be investigated by the licensee and

the results, along with the corrective actions, reported to the
Regulatory Body.

• The Regulatory Body should prescribe the types of accidents

and incidents that must be reported.
• For more serious, or potentially serious accidents and
emergencies, an independent investigation by the Regulatory
Body (and sometimes also by other government authorities)
should be conducted in addition to the investigation conducted
by the user.

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 Investigation of accidents (cont)

• Determine the root causes and contributing factors.

• Assess the consequences in terms of exposure and the

likelihood of exposure of:
 exposure of patient, staff (or public)

• Identify corrective actions.

• Derive the lessons to be learned and the significance of the

findings for other radiotherapy facilities.

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 What action should the Regulatory Body take
in response to a lost radioactive source?

If a therapy radioactive source is no longer on-site and no

longer under the licensee’s control (through poor inventory
control, improper transfer or disposal, theft etc) and that
loss is confirmed, the Regulatory Body should immediately
inform government and initiate the appropriate emergency
response plan.

Consider the need for wider national

and international notification

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 What action should the Regulatory Body take
in response to a reported accident or incident?

Determine if an inspection is necessary

to obtain first-hand information of the
cause of the accident or incident.

The licensee’s report should be reviewed (in

collaboration with other authorities and government
agencies, if appropriate to the circumstances)

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 What action should the Regulatory Body take
in response to a reported accident or incident?

Determine how similar accidents or

incidents can be best avoided in future
and recommend corrective measures.

Determine what
enforcement action, if any,
may be appropriate
Accidents
and
Incidents

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 What action should the Regulatory Body take
in response to a reported accident or incident?

Particularly in cases where injury (or

the perceived risk of injury) may lead to
litigation, determine the potential health
outcomes, responsibility and liability
(under the radiation safety legislation)
for the accident or incident.

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 What action should the Regulatory Body take
in response to a reported accident or incident?

Disseminate the findings of the

investigation to all relevant
clients, organizations and
professional associations.

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 References

• IAEA Human Health Series No. 14 Planning National

Radiotherapy Services. IAEA, Vienna 2010

• Setting Up a Radiotherapy Programme: Clinical, Medical

Physics, Radiation Protection and Safety Aspects. IAEA,
Vienna 2008

• IAEA-TECDOC-1040 Design and implementation of a

radiotherapy programme: Clinical, medical physics,
radiation protection and safety aspects

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 References (cont)

• Medical Handling of Accidentally Exposed Individuals. IAEA

Safety Series No. 88
• Event No. 8: “Calibration error after a source change in a
60Co unit.”

• Event No. 20: “Design error in accelerator control software.”

• Event No. 70: “Inadequate implantation and loss of
sources.”

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 References (cont)

• Radiation Protection and Safety of Radiation Sources:

International Basic Safety Standards. Generic Safety
Requirements. GSR Part 3 (Interim) Vienna (2011)
• IAEA Safety Guide: Radiological Protection for Medical
Exposure to Ionizing Radiation (Safety Standards
Series No. RS-G-1.5, 2002)

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