1 Lessons Learned from International Radiological Incidents Clinical Assistant Professor (Radiology)...

1

Lessons Learned from International Lessons Learned from International Radiological IncidentsRadiological Incidents

Lessons Learned from International Lessons Learned from International Radiological IncidentsRadiological Incidents

Clinical Assistant Professor (Radiology)Clinical Assistant Professor (Radiology)School of Medicine and Health SciencesSchool of Medicine and Health Sciences

The George Washington University, Washington DC, USAThe George Washington University, Washington DC, USA

Clinical Assistant Professor (Radiology)Clinical Assistant Professor (Radiology)School of Medicine and Health SciencesSchool of Medicine and Health Sciences

The George Washington University, Washington DC, USAThe George Washington University, Washington DC, USA

Chair, Science CommitteeChair, Science CommitteeInternational Organization for Medical PhysicsInternational Organization for Medical Physics

Chair, Science CommitteeChair, Science CommitteeInternational Organization for Medical PhysicsInternational Organization for Medical Physics

Cari Borrás, D.Sc., FACR, FAAPMCari Borrás, D.Sc., FACR, FAAPM

NSSI Sources and Services (LANL/OSRP) ConsultantNSSI Sources and Services (LANL/OSRP) Consultant

2

Acknowledgment / Acknowledgment / DisclaimerDisclaimerAcknowledgment / Acknowledgment / DisclaimerDisclaimer

I am grateful to the Pan American Health Organization (PAHO), which I served as a staff member from 1988-2003 and as a consultant since.

Although some of the data shown here were obtained while working at PAHO, the opinions expressed in this presentation are solely mine and do not represent any organization.

I am grateful to the Pan American Health Organization (PAHO), which I served as a staff member from 1988-2003 and as a consultant since.

Although some of the data shown here were obtained while working at PAHO, the opinions expressed in this presentation are solely mine and do not represent any organization.

7

Industrial Irradiator AccidentIndustrial Irradiator AccidentSan Salvador, El Salvador, 1989San Salvador, El Salvador, 1989Industrial Irradiator AccidentIndustrial Irradiator Accident

San Salvador, El Salvador, 1989San Salvador, El Salvador, 1989

8

Pool-Type IrradiatorPool-Type Irradiator

Source Source RackSource Source RackSource Pencil

Co-60

13

Pulley System on the Pulley System on the Roof of the IrradiatorRoof of the Irradiator

18Source: REAC/TSSource: REAC/TS

BB

CC

32 d32 d

32 d32 d 32 d32 d 121 d121 d

32 d32 d 121 d121 d

121 d121 d

AA

23

DisposalDisposal of Radioactive of Radioactive BrachytherapyBrachytherapy SourcesSources

ExperiencesExperiences

DisposalDisposal of Radioactive of Radioactive BrachytherapyBrachytherapy SourcesSources

ExperiencesExperiences

In the early 1990’s several incidents involving the

improper disposal of brachytherapy sources were

reported to the Pan American Health Organization

by countries which requested assistance.

24

Leaking/ damaged sourcesLeaking/ damaged sources (( 137137Cs Cs andand 226226RaRa)) causing causing contaminationcontamination

Inappropriately buriedInappropriately buried 226226RaRa sourcessources

226226RaRa sources in nasopharynx applicator no longer in sources in nasopharynx applicator no longer in useuse

226226RaRa sources stuck in rotating drum storage vaultsources stuck in rotating drum storage vault

Leaking/ damaged sourcesLeaking/ damaged sources (( 137137Cs Cs andand 226226RaRa)) causing causing contaminationcontamination

Inappropriately buriedInappropriately buried 226226RaRa sourcessources

226226RaRa sources in nasopharynx applicator no longer in sources in nasopharynx applicator no longer in useuse

226226RaRa sources stuck in rotating drum storage vaultsources stuck in rotating drum storage vault

Incidents EncounteredIncidents EncounteredIncidents EncounteredIncidents Encountered

In each case the sources were In each case the sources were removedremoved and, where and, where

applicable, applicable, decontaminationdecontamination procedures followed. procedures followed.

In each case the sources were In each case the sources were removedremoved and, where and, where

applicable, applicable, decontaminationdecontamination procedures followed. procedures followed.

25

Brachytherapy Sources Removed by Brachytherapy Sources Removed by PAHO, 1991 - 1996PAHO, 1991 - 1996

Brachytherapy Sources Removed by Brachytherapy Sources Removed by PAHO, 1991 - 1996PAHO, 1991 - 1996

CountrySource* leaking

Activity (MBq/mCi)

Puerto Rico, USA, 1991 Ra-226* 3700 / 100

Port of Spain, Trinidad, 1991Cs-137*

Ra-226

6956 / 188

5661 / 153

Santiago de los Caballeros, Dominican Republic, 1991

Ra-226* 4292 / 116

Port au Prince, Haiti, 1991 Ra-226 7585 / 205

Georgetown, Guyana, 1996 Ra-226 6290 / 170

26

A physician cut a Ra-226 needle to fit it in an applicator

designed for Cs-137 tubes, contaminating the safe, and

some rooms. A physicist from Puerto Rico had

decontaminated some items and buried the rest in the

hospital garden, leaving the Ra-226 sources in the safe.

Santiago de los Caballeros Dominican Republic, 1991Santiago de los Caballeros Dominican Republic, 1991

27

Ra-226 sources removal from Ra-226 sources removal from Santiago de los Caballeros, Santiago de los Caballeros,

Dominican RepublicDominican Republic

Ra-226 sources removal from Ra-226 sources removal from Santiago de los Caballeros, Santiago de los Caballeros,

Dominican RepublicDominican Republic

Radiation AlarmRadiation Alarm Radiation AlarmRadiation Alarm

28

RemovalRemoval Radioactive Sources Radioactive Sources HaitiHaitiRemovalRemoval Radioactive Sources Radioactive Sources HaitiHaiti

29

In Haiti, the Ra-226 In Haiti, the Ra-226 sources and the sources and the

radioactive waste in radioactive waste in the garden the garden

“repository” were “repository” were removed and brought removed and brought to the US, but the Co-to the US, but the Co-

60 brachytherapy 60 brachytherapy sources in the wall of sources in the wall of

the radiotherapy the radiotherapy department stayed.department stayed.

In Haiti, the Ra-226 In Haiti, the Ra-226 sources and the sources and the

radioactive waste in radioactive waste in the garden the garden

“repository” were “repository” were removed and brought removed and brought to the US, but the Co-to the US, but the Co-

60 brachytherapy 60 brachytherapy sources in the wall of sources in the wall of

the radiotherapy the radiotherapy department stayed.department stayed.

30

DisposalDisposal Radioactive Radioactive Sources Sources GuyanaGuyana

DisposalDisposal Radioactive Radioactive Sources Sources GuyanaGuyana

Radium sources were Radium sources were also removed from also removed from

Guyana. An old Guyana. An old storage vault storage vault

consisting of a rotating consisting of a rotating drum with pie-shaped drum with pie-shaped

drawers inside an drawers inside an outer cylindrical shield outer cylindrical shield

had jammed. The had jammed. The mechanism was mechanism was

successfully dislodged successfully dislodged and the sources and the sources

transported to the transported to the United States for final United States for final disposal under PAHO disposal under PAHO

ownership. ownership.

32

Radiotherapy OverexposuresRadiotherapy OverexposuresRadiotherapy OverexposuresRadiotherapy Overexposures

CITY,CITY,COUNTRY, COUNTRY,

DATEDATEPROBLEMPROBLEM

OVER-OVER-EXPOSURE EXPOSURE

FACTORFACTOR

FATALITIES FATALITIES WITHIN 1 WITHIN 1

YEARYEAR

San Jose, Costa Rica,

26 August - 27 September

1996

Miscalibration of Cobalt-60

Unit1.72 42 / 115

Panama City,Panama,

August 2000 - March 2001

Treatment Planning Error

1.5 to 2.5 17 / 28

33

The IAEA / WHO Network of SSDLs

SSDL network memberSSDL member and affiliated PSDLPSDL affiliated member

34

IAEA / WHOIAEA / WHOTLD Postal Dose Quality AuditTLD Postal Dose Quality Audit


Latin America

38%

West Pacific 23%

SE. Asia15%

East Mediter.

10%

Europe 12%

Africa 2%

Years 1969-2000104 countries1012 hospitals3673 audits

Years 1969-2000Years 1969-2000104 countries1012 hospitals3673 audits

35



cum

ula

tive n

um

ber

of

measu

rem

en

tsin

hosp

itals

(th

era

py b

eam

s ch

eck

ed

)

36

Nu

mb

er o

f U

ni t

sN

um

be r

of

Un

i ts

Nu

mb

er o

f U

ni t

sN

um

be r

of

Un

i ts

Dose Deviation (%)Dose Deviation (%)Dose Deviation (%)Dose Deviation (%)



1992: 69 Total1992: 69 Total1992: 69 Total1992: 69 TotalPAHO TLD RESULTSPAHO TLD RESULTS

““TYPICAL” YEARTYPICAL” YEAR

PAHO TLD RESULTSPAHO TLD RESULTS

““TYPICAL” YEARTYPICAL” YEAR

Points to the left of the Points to the left of the histogram represent histogram represent

overexposuresoverexposures

Points to the left of the Points to the left of the histogram represent histogram represent

overexposuresoverexposures

Acceptable: ± 5%Acceptable: ± 5%

(47 Units)(47 Units)

Acceptable: ± 5%Acceptable: ± 5%

(47 Units)(47 Units)

% Dose Deviation = % Dose Deviation = % Dose Deviation = % Dose Deviation =

Dose determined by User - Average IAEA DoseDose determined by User - Average IAEA DoseDose determined by User - Average IAEA DoseDose determined by User - Average IAEA Dose

Average IAEA Average IAEA DoseDoseAverage IAEA Average IAEA DoseDose

x 100x 100x 100x 100

Points to the right of the Points to the right of the histogram represent histogram represent

underexposuresunderexposures

Points to the right of the Points to the right of the histogram represent histogram represent

underexposuresunderexposures

37

Costa RicaCosta RicaDeviation (%) ChronologyDeviation (%) Chronology

Costa RicaCosta RicaDeviation (%) ChronologyDeviation (%) Chronology

198919891990199019911991199219921993199319941994199519951995199519961996

198919891990199019911991199219921993199319941994199519951995199519961996

-4.3-4.321.321.3 8.08.0

25.925.9NR*NR*69.869.825.525.5-7.2-7.2

-4.3-4.321.321.3 8.08.0

25.925.9NR*NR*69.869.825.525.5-7.2-7.2

------

26.326.3NR*NR*68.968.938.338.3-5.9-5.9

-45.1-45.1

------

26.326.3NR*NR*68.968.938.338.3-5.9-5.9

-45.1-45.1

* Dosimeters not returned* Dosimeters not returned

** Unit Calibration had been performed by IAEA Expert** Unit Calibration had been performed by IAEA Expert

* Dosimeters not returned* Dosimeters not returned

** Unit Calibration had been performed by IAEA Expert** Unit Calibration had been performed by IAEA Expert

YearYearYearYear Alcyon IIAlcyon IIAlcyon IIAlcyon IITheratron - 80Theratron - 80Theratron - 80Theratron - 80

-2.3, -3.3**-2.3, -3.3**-2.3, -3.3**-2.3, -3.3**

38

Costa Rica Calibration Error (1996)Costa Rica Calibration Error (1996)Costa Rica Calibration Error (1996)Costa Rica Calibration Error (1996)

UnitUnitUnitUnit Timer SettingTimer SettingTimer SettingTimer Setting

Theratron-80Theratron-80Alcyon IIAlcyon II

Theratron-80Theratron-80Alcyon IIAlcyon II

Minutes and SecondsMinutes and SecondsMinutes and Decimals ofMinutes and Decimals of

MinutesMinutes

Minutes and SecondsMinutes and SecondsMinutes and Decimals ofMinutes and Decimals of

MinutesMinutes

Dose RateDose RateDose RateDose RateMeasurementsMeasurementsMeasurementsMeasurements CalculationsCalculationsCalculationsCalculations

0.3 min (18s)0.3 min (18s)0.3 min (18s)0.3 min (18s) 30 sec30 sec30 sec30 sec

3030181830301818

= 1.67= 1.67= 1.67= 1.67

39

Patient DosimetryPatient DosimetryPatient DosimetryPatient Dosimetry

Pelvis Pelvis

Head & NeckHead & NeckSpine Spine

Mediastinum Mediastinum

Arm Arm

Thorax Thorax

Shoulder Shoulder

AbdomenAbdomenLymphaticsLymphaticsEsophagus Esophagus

OthersOthers

Pelvis Pelvis

Head & NeckHead & NeckSpine Spine

Mediastinum Mediastinum

Arm Arm

Thorax Thorax

Shoulder Shoulder

AbdomenAbdomenLymphaticsLymphaticsEsophagus Esophagus

OthersOthers

SiteSiteSiteSite Nr. of TreatmentsNr. of TreatmentsNr. of TreatmentsNr. of Treatments Nr. of FieldsNr. of FieldsNr. of FieldsNr. of Fields

393932328844333333222222

RestRest

393932328844333333222222

RestRest

2-282-284-304-303-153-155-205-205-125-127-207-203-103-10

16-2216-2211-2811-2816-2016-20

--

2-282-284-304-303-153-155-205-205-125-127-207-203-103-10

16-2216-2211-2811-2816-2016-20

--

40

Patient DosimetryPatient DosimetryPatient DosimetryPatient Dosimetry

PelvisPelvisHead & NeckHead & NeckSpineSpineMediastinumMediastinumArmArmThoraxThoraxShoulderShoulderAbdomenAbdomenLymphaticsLymphaticsEsophagusEsophagus


Field Size (cm x cm)Field Size (cm x cm)Field Size (cm x cm)Field Size (cm x cm)

8x88x8 5x55x516x516x510x610x615x815x819x419x415x815x8

31x2231x2216x1616x16 4x84x8

8x88x8 5x55x516x516x510x610x615x815x819x419x415x815x8

31x2231x2216x1616x16 4x84x8

15x1515x1512x1012x1020x720x7

15x1215x1220x1320x1317x1217x1229x2429x24

------

15x1515x1512x1012x1020x720x7

15x1215x1220x1320x1317x1217x1229x2429x24

------

SiteSiteSiteSiteRangeRangeRangeRange AverageAverageAverageAverage

24x2924x2914x2114x2131x1631x1619x1819x1822x1622x1626x1526x1522x1622x1628x2828x2832x3532x3512x612x6

24x2924x2914x2114x2131x1631x1619x1819x1822x1622x1626x1526x1522x1622x1628x2828x2832x3532x3512x612x6

41

Patient DataPatient DataMedical Evaluation: October 1996Medical Evaluation: October 1996


AABBCC

AABBCC

Range AverageRange AverageRange AverageRange Average MM FFMM FF (%)(%)(%)(%)

HospitalHospitalHospitalHospital Age (Years)Age (Years)Age (Years)Age (Years) GenderGenderGenderGender ChemotherapyChemotherapyChemotherapyChemotherapy

23-80 5423-80 5419-88 5919-88 59 2-10 52-10 5

23-80 5423-80 5419-88 5919-88 59 2-10 52-10 5

21 3721 3711 2511 25 5 25 2

21 3721 3711 2511 25 5 25 2

2828 2626

100100

2828 2626

100100

42



CureCurePalliationPalliationCureCurePalliationPalliation

6565595965655959

5959181859591818

Treatment GoalTreatment GoalTreatment GoalTreatment Goal P, Percentage ofP, Percentage ofTotal (%)Total (%)

P, Percentage ofP, Percentage ofTotal (%)Total (%)

Adverse EffectsAdverse Effects(% of P)(% of P)

Adverse EffectsAdverse Effects(% of P)(% of P)

Deceased by 21 October 1996: Deceased by 21 October 1996: 88

43

Dose RangesDose Ranges(Gy)(Gy)

Dose RangesDose Ranges(Gy)(Gy)



3.53.513.213.215.215.213.213.222.222.248.048.014.614.646.946.937.037.022.822.8

3.53.513.213.215.215.213.213.222.222.248.048.014.614.646.946.937.037.022.822.8

93.293.2128.5128.5

67.567.568.068.044.944.968.268.279.679.657.257.251.051.066.266.2

93.293.2128.5128.5

67.567.568.068.044.944.968.268.279.679.657.257.251.051.066.266.2

107.0107.0107.0107.0

81.981.995.595.554.654.649.049.0

111.5111.534.034.041.041.046.246.2

107.0107.0107.0107.0

81.981.995.595.554.654.649.049.0

111.5111.534.034.041.041.046.246.2

Range of Overdoses (Ratio: Given Dose/Prescribed Dose) 1.19 2.60Range of Overdoses (Ratio: Given Dose/Prescribed Dose) 1.19 2.60Range of Overdoses (Ratio: Given Dose/Prescribed Dose) 1.19 2.60Range of Overdoses (Ratio: Given Dose/Prescribed Dose) 1.19 2.60

SiteSiteSiteSite TumorTumorTumorTumor MaximumMaximumMaximumMaximum

44



AABBCC

AABBCC

46/5846/5824/3624/36

6/76/7

46/5846/5824/3624/36

6/76/7

SitesSitesSitesSitesHospitalHospitalHospitalHospital Observable Lesions/Observable Lesions/Number of PatientsNumber of PatientsObservable Lesions/Observable Lesions/Number of PatientsNumber of Patients

PharynxPharynxEsophagusEsophagus

Kidney (Hematuria) Kidney (Hematuria) Skin Skin

PharynxPharynxEsophagusEsophagus

Kidney (Hematuria) Kidney (Hematuria) Skin Skin

45

Patient DataPatient DataMedical Evaluation: June 1997Medical Evaluation: June 1997


Patient Dosimetry Inaccuracies: 25%Patient Dosimetry Inaccuracies: 25%Patient Dosimetry Inaccuracies: 25%Patient Dosimetry Inaccuracies: 25%

PatientsPatientsEvaluatedEvaluatedWith Effects definitely due to RadiationWith Effects definitely due to RadiationWith Effects probably due to RadiationWith Effects probably due to RadiationWith no Effects attributable to RadiationWith no Effects attributable to Radiation

PatientsPatientsEvaluatedEvaluatedWith Effects definitely due to RadiationWith Effects definitely due to RadiationWith Effects probably due to RadiationWith Effects probably due to RadiationWith no Effects attributable to RadiationWith no Effects attributable to Radiation

NumberNumber7171272722222121

NumberNumber7171272722222121

46



Radiation EffectsRadiation EffectsTetraplegiaTetraplegiaNeurosisNeurosisLhermitte SyndromeLhermitte SyndromeNeurological DisordersNeurological DisordersProgressive ParesthesiaProgressive ParesthesiaEsophageal StenosisEsophageal StenosisSkin NecrosisSkin NecrosisFibrosis and EdemaFibrosis and EdemaLymphedemaLymphedemaRectitis-EnteritisRectitis-EnteritisCystitisCystitisImpotenceImpotence

Radiation EffectsRadiation EffectsTetraplegiaTetraplegiaNeurosisNeurosisLhermitte SyndromeLhermitte SyndromeNeurological DisordersNeurological DisordersProgressive ParesthesiaProgressive ParesthesiaEsophageal StenosisEsophageal StenosisSkin NecrosisSkin NecrosisFibrosis and EdemaFibrosis and EdemaLymphedemaLymphedemaRectitis-EnteritisRectitis-EnteritisCystitisCystitisImpotenceImpotence

NumberNumber 11 11 22 55 33 11 331010 33 99 22 11

NumberNumber 11 11 22 55 33 11 331010 33 99 22 11

47

Co-60 Overexposure; Costa Rica 1996Co-60 Overexposure; Costa Rica 1996

Source: IAEASource: IAEASource: IAEASource: IAEA

48

Co-60 Co-60 OverexposureOverexposure

Costa Rica Costa Rica 19961996

Co-60 Co-60 OverexposureOverexposure

Costa Rica Costa Rica 19961996

Source: IAEASource: IAEA

49

Health Care Institution - ActionsHealth Care Institution - Actions• Project of Modernization of Radiation Therapy Services in Project of Modernization of Radiation Therapy Services in

the Country (National Policy Change)the Country (National Policy Change)

• Equipment Specifications Outlines and Bidding Process for:Equipment Specifications Outlines and Bidding Process for:

Teletherapy UnitsTeletherapy Units

SimulatorSimulator

Treatment Planning SystemTreatment Planning System

Dosimetry EquipmentDosimetry Equipment

Treatment AccessoriesTreatment Accessories

• Training of Current Staff, including Maintenance PersonnelTraining of Current Staff, including Maintenance Personnel

• New Personnel ContractsNew Personnel Contracts

One Radiotherapy PhysicistOne Radiotherapy Physicist

Two Radiation OncologistsTwo Radiation Oncologists

Two Radiotherapy TechnologistsTwo Radiotherapy Technologists

• Comprehensive Quality Assurance ProgramComprehensive Quality Assurance Program

• Project of Modernization of Radiation Therapy Services in Project of Modernization of Radiation Therapy Services in the Country (National Policy Change)the Country (National Policy Change)

• Equipment Specifications Outlines and Bidding Process for:Equipment Specifications Outlines and Bidding Process for:

Teletherapy UnitsTeletherapy Units

SimulatorSimulator

Treatment Planning SystemTreatment Planning System

Dosimetry EquipmentDosimetry Equipment

Treatment AccessoriesTreatment Accessories

• Training of Current Staff, including Maintenance PersonnelTraining of Current Staff, including Maintenance Personnel

• New Personnel ContractsNew Personnel Contracts

One Radiotherapy PhysicistOne Radiotherapy Physicist

Two Radiation OncologistsTwo Radiation Oncologists

Two Radiotherapy TechnologistsTwo Radiotherapy Technologists

• Comprehensive Quality Assurance ProgramComprehensive Quality Assurance Program

50

Ministry of HealthMinistry of HealthRegulatory Authority - Radiation SafetyRegulatory Authority - Radiation Safety

ActionsActions

Ministry of HealthMinistry of HealthRegulatory Authority - Radiation SafetyRegulatory Authority - Radiation Safety

ActionsActions

• More frequent Inspections to all Radiotherapy More frequent Inspections to all Radiotherapy Services in the Country Services in the Country

• Quality Assurance Standard strictly enforcedQuality Assurance Standard strictly enforced

• Obligatory 40 hr Refresher Course on Radiation Obligatory 40 hr Refresher Course on Radiation Protection for Radiation Oncologists and Protection for Radiation Oncologists and Radiotherapy TechniciansRadiotherapy Technicians

• Ministry of Health’s Equipment Loan ScheduleMinistry of Health’s Equipment Loan Schedule

• Participation in External AuditsParticipation in External Audits

• More frequent Inspections to all Radiotherapy More frequent Inspections to all Radiotherapy Services in the Country Services in the Country

• Quality Assurance Standard strictly enforcedQuality Assurance Standard strictly enforced

• Obligatory 40 hr Refresher Course on Radiation Obligatory 40 hr Refresher Course on Radiation Protection for Radiation Oncologists and Protection for Radiation Oncologists and Radiotherapy TechniciansRadiotherapy Technicians

• Ministry of Health’s Equipment Loan ScheduleMinistry of Health’s Equipment Loan Schedule

• Participation in External AuditsParticipation in External Audits

51

Legal Consequences: San Jose, Costa RicaLegal Consequences: San Jose, Costa RicaLegal Consequences: San Jose, Costa RicaLegal Consequences: San Jose, Costa Rica

26 Feb 2000: Local Physicist Accused of 28 Homicides

14 Cases of Radiation InjuryFalsifying Documents

Using False Documents

30 July 2001: Found Guilty of14 Homicides

50 Radiation InjuriesCondemned to 6 Years in Jail and

5 of not being able to practice Profession

12 August 2003: Supreme Court Upheld Decision

26 Feb 2000: Local Physicist Accused of 28 Homicides

14 Cases of Radiation InjuryFalsifying Documents

Using False Documents

30 July 2001: Found Guilty of14 Homicides

50 Radiation InjuriesCondemned to 6 Years in Jail and

5 of not being able to practice Profession

12 August 2003: Supreme Court Upheld Decision

52

MiscalibrationsMiscalibrationsCo-60 UnitsCo-60 Units

MiscalibrationsMiscalibrationsCo-60 UnitsCo-60 Units

Country Year PatientsOverdosed

USA 1974-1976 426Germany 1986-1987 86

UK 1988 207Costa Rica 1996 114


USA 1974-1976 426Germany 1986-1987 86

UK 1988 207Costa Rica 1996 114

54

Hardware / Software Linear Hardware / Software Linear AcceleratorsAccelerators

Hardware / Software Linear Hardware / Software Linear AcceleratorsAccelerators


Canada &USA

1985-1987 3

Spain 1990 27Poland 2001 5


Canada &USA

1985-1987 3

Spain 1990 27Poland 2001 5

55

Brachytherapy ProblemsBrachytherapy ProblemsBrachytherapy ProblemsBrachytherapy Problems

Country Year PatientsOverdosed /Underdosed

UK 1988-1989 22(-10% - +10%)

USA 1992 1 (Overdosed)

Country Year PatientsOverdosed /Underdosed

UK 1988-1989 22(-10% - +10%)

USA 1992 1 (Overdosed)

56

Treatment Planning ErrorsTreatment Planning ErrorsTreatment Planning ErrorsTreatment Planning Errors

Country Year Patients Under/ Overdosed

UK

USA

1982-1990

1987-1988

1,045 (Under)

33 (Over)

Panama 2000-2001 28 (Over)

Country Year Patients Under/ Overdosed

UK

USA

1982-1990

1987-1988

1,045 (Under)

33 (Over)

Panama 2000-2001 28 (Over)

57

1

2

3

4

5 6

7

9

10

8

1112

Each block individually digitizedEach block individually digitizedEach block individually digitized

1

2

9

1011

12

3

45

6

7

8

All blocks digitized at once

Internal and External Perimeter

in the Same Direction

All blocks digitized at onceAll blocks digitized at once

Internal and External PerimeterInternal and External Perimeter

in the in the SameSame Direction Direction

2

1

12

910

11

8

76

5

4

3

All blocks digitized at onceAll blocks digitized at once

Internal and External PerimeterInternal and External Perimeter

in in OppositeOpposite Direction Direction

Error with TPSError with TPS

Multidata Multidata Version 2.1.1Version 2.1.1

““External Beam”External Beam”

Error with TPSError with TPS

Multidata Multidata Version 2.1.1Version 2.1.1

““External Beam”External Beam”

Treatment Time: Treatment Time: TT

Treatment Time: Treatment Time: TT

~ 2 T~ 2 T~ 2 T~ 2 T T T 10% 10%T T 10% 10%

58

Prescribed Dose: Prescribed Dose: 50 Gy50 Gy

Number of Number of Fractions: 28Fractions: 28

Prescribed Dose: Prescribed Dose: 50 Gy50 Gy

Number of Number of Fractions: 28Fractions: 28

Treatment Time :Treatment Time :

1.01 min1.01 min

Treatment Time :Treatment Time :

1.01 min1.01 min

Treatment Time:Treatment Time:

0.50 min0.50 min

Treatment Time:Treatment Time:

0.50 min0.50 min

#10 Rectum

59

Teletherapy Absorbed Dose ErrorsTeletherapy Absorbed Dose Errors

Delivered Dose - Prescribed Dose

Prescribed DoseERROR (%) =

ION-Identified PatientsAdditional Patients

60

Mortality vs. DoseMortality vs. DoseMortality vs. DoseMortality vs. Dose

0

10

20

30

40

50

60

70

80

90

100

70 90 110 130 150 170 190

Rectal biological effective dose (Gy)

Dead

pati

en

ts (

%)

0

10

20

30

40

50

60

70

80

90

100

70 90 110 130 150 170 190


Dead

pati

en

ts (

%)

(/= 10)

61

No colostomy With colostomy

Survival vs. DoseSurvival vs. Dose

62

LENT/SOMA vs. DoseLENT/SOMA vs. Dose

0

1

2

3

4

70 90 110 130 150 170 190


Av

era

ge L

EN

T/S

OM

A s

co

re

Data Points

Mean Values

Trend

(/= 10)

63

Rectal ComplicationsRectal ComplicationsOverexposed PatientsOverexposed PatientsRectal ComplicationsRectal ComplicationsOverexposed PatientsOverexposed Patients

0

5

10

15

20

25

0

5

10

15

20

25

? 0 1 2 3 4 5

RTOG Scale

64

Cobalt-60 Overexposure; Panama 2000 - 2001Cobalt-60 Overexposure; Panama 2000 - 2001Hemorrhagic Rectal MucosaHemorrhagic Rectal Mucosa

65

RTOG - Rectal ComplicationsRTOG - Rectal ComplicationsControl PatientsControl Patients

RTOG - Rectal ComplicationsRTOG - Rectal ComplicationsControl PatientsControl Patients

66

Patients with RTOG = 0 withPatients with RTOG = 0 withTumor Activity at last Follow UpTumor Activity at last Follow Up

Patients with RTOG = 0 withPatients with RTOG = 0 withTumor Activity at last Follow UpTumor Activity at last Follow Up

StageStage Nr. of PatientsNr. of Patients

11 7 / 16 7 / 16

22 2 / 192 / 19

33 4 / 84 / 8

NCNC 1 / 51 / 5

No RTOG scoreNo RTOG score 22

67

CONCLUSIONSCONCLUSIONSCONCLUSIONSCONCLUSIONS

Cause of the OverexposureCause of the Overexposure▲ The overexposure was caused due to a violation of the TPS The overexposure was caused due to a violation of the TPS

instructions; instructions; however, however, a good software program should have a good software program should have alerted the user that the procedure was not authorized (as alerted the user that the procedure was not authorized (as Multidata’s Multidata’s External BeamExternal Beam does now). does now).

▲ Treatment times generated by a TPS require Treatment times generated by a TPS require manualmanual verificationverification. (No TPS . (No TPS quality controlquality control existed at the ION) existed at the ION)

Contributing FactorsContributing Factors▲ The large The large patient workloadpatient workload (> 70 patients / 1 machine) (> 70 patients / 1 machine)▲ The fact that teletherapy treatments were done in one The fact that teletherapy treatments were done in one

hospital, where physics charts were kept and brachytherapy hospital, where physics charts were kept and brachytherapy treatments, patient follow up and clinical charts in anothertreatments, patient follow up and clinical charts in another

Cause of the OverexposureCause of the Overexposure▲ The overexposure was caused due to a violation of the TPS The overexposure was caused due to a violation of the TPS

instructions; instructions; however, however, a good software program should have a good software program should have alerted the user that the procedure was not authorized (as alerted the user that the procedure was not authorized (as Multidata’s Multidata’s External BeamExternal Beam does now). does now).

▲ Treatment times generated by a TPS require Treatment times generated by a TPS require manualmanual verificationverification. (No TPS . (No TPS quality controlquality control existed at the ION) existed at the ION)

Contributing FactorsContributing Factors▲ The large The large patient workloadpatient workload (> 70 patients / 1 machine) (> 70 patients / 1 machine)▲ The fact that teletherapy treatments were done in one The fact that teletherapy treatments were done in one

hospital, where physics charts were kept and brachytherapy hospital, where physics charts were kept and brachytherapy treatments, patient follow up and clinical charts in anothertreatments, patient follow up and clinical charts in another

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ION ACTIONSION ACTIONSION ACTIONSION ACTIONS

Establishment of a QAEstablishment of a QA/Radiation Protection /Radiation Protection Committee to oversee potential problemsCommittee to oversee potential problems

Purchase of new equipment: Linacs, TPS, etc.Purchase of new equipment: Linacs, TPS, etc.

More radiation oncologists, medical physicists More radiation oncologists, medical physicists and radiotherapistsand radiotherapists

Consolidation of all radiotherapy services in Consolidation of all radiotherapy services in one hospital (IONone hospital (ION))

Establishment of a QAEstablishment of a QA/Radiation Protection /Radiation Protection Committee to oversee potential problemsCommittee to oversee potential problems

Purchase of new equipment: Linacs, TPS, etc.Purchase of new equipment: Linacs, TPS, etc.

More radiation oncologists, medical physicists More radiation oncologists, medical physicists and radiotherapistsand radiotherapists

Consolidation of all radiotherapy services in Consolidation of all radiotherapy services in one hospital (IONone hospital (ION))

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Legal Consequences: Panama City, PanamaLegal Consequences: Panama City, PanamaLegal Consequences: Panama City, PanamaLegal Consequences: Panama City, Panama

▲ Panama plaintiffs sued Multidata and then Theratronics in the US and in Panama

▲ Two US courts (Missouri and Texas) have dismissed the case because the event did not happen in the US

▲ The Panamanian court dismissed the charges saying that the case had been filed in two courts simultaneously

▲ Once the cases has been dismissed in the US, the plaintiffs are free to sue again in Panama

▲ Panama plaintiffs sued Multidata and then Theratronics in the US and in Panama

▲ Two US courts (Missouri and Texas) have dismissed the case because the event did not happen in the US

▲ The Panamanian court dismissed the charges saying that the case had been filed in two courts simultaneously

▲ Once the cases has been dismissed in the US, the plaintiffs are free to sue again in Panama

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Legal Consequences: Panama City, Panama (Cont.)Legal Consequences: Panama City, Panama (Cont.)Legal Consequences: Panama City, Panama (Cont.)Legal Consequences: Panama City, Panama (Cont.)

18 May 2004: Three Local Physicists 18 May 2004: Three Local Physicists AccusedAccused of ofSecond-Degree MurderSecond-Degree Murder

18 November 2004: One of the physicists acquitted,18 November 2004: One of the physicists acquitted,the other two found guilty, sentenced to four years in the other two found guilty, sentenced to four years in

prison, and barred from practicing their profession prison, and barred from practicing their profession for seven years.for seven years.

They have appealed, but they are very anxious, given They have appealed, but they are very anxious, given the precedent established by the Costa Rica case.the precedent established by the Costa Rica case.

Appeal is still pendingAppeal is still pending

18 May 2004: Three Local Physicists 18 May 2004: Three Local Physicists AccusedAccused of ofSecond-Degree MurderSecond-Degree Murder

18 November 2004: One of the physicists acquitted,18 November 2004: One of the physicists acquitted,the other two found guilty, sentenced to four years in the other two found guilty, sentenced to four years in

prison, and barred from practicing their profession prison, and barred from practicing their profession for seven years.for seven years.

They have appealed, but they are very anxious, given They have appealed, but they are very anxious, given the precedent established by the Costa Rica case.the precedent established by the Costa Rica case.

Appeal is still pendingAppeal is still pending

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Common Issues – Accidental Medical ExposuresCommon Issues – Accidental Medical ExposuresCommon Issues – Accidental Medical ExposuresCommon Issues – Accidental Medical Exposures

▲ There was a dosimetry error: the calculated / computed There was a dosimetry error: the calculated / computed treatment times differed significantly from the intended values.treatment times differed significantly from the intended values.

▲ The physicists made the error and failed to detect it.The physicists made the error and failed to detect it.▲ The technologists treating the patients did not notice anything The technologists treating the patients did not notice anything

unusual about the treatment times given by the physicists.unusual about the treatment times given by the physicists.▲ QC programs did not include manual dose calculations.QC programs did not include manual dose calculations.▲ The physicians failed to notice clinical outcomes significantly The physicians failed to notice clinical outcomes significantly

different from those expected.different from those expected.▲ The patient workload was very big.The patient workload was very big.▲ The human resources were scarce.The human resources were scarce.▲ The physicists worked in more than one facility.The physicists worked in more than one facility.▲ The physicists were found legally responsible.The physicists were found legally responsible.▲ The radiation oncologists responsible for the patient treatment The radiation oncologists responsible for the patient treatment

were not indicted.were not indicted.

▲ There was a dosimetry error: the calculated / computed There was a dosimetry error: the calculated / computed treatment times differed significantly from the intended values.treatment times differed significantly from the intended values.

▲ The physicists made the error and failed to detect it.The physicists made the error and failed to detect it.▲ The technologists treating the patients did not notice anything The technologists treating the patients did not notice anything

unusual about the treatment times given by the physicists.unusual about the treatment times given by the physicists.▲ QC programs did not include manual dose calculations.QC programs did not include manual dose calculations.▲ The physicians failed to notice clinical outcomes significantly The physicians failed to notice clinical outcomes significantly

different from those expected.different from those expected.▲ The patient workload was very big.The patient workload was very big.▲ The human resources were scarce.The human resources were scarce.▲ The physicists worked in more than one facility.The physicists worked in more than one facility.▲ The physicists were found legally responsible.The physicists were found legally responsible.▲ The radiation oncologists responsible for the patient treatment The radiation oncologists responsible for the patient treatment

were not indicted.were not indicted.

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ConclusionsConclusionsConclusionsConclusions▲ Developing countries should not be denied the

possibility of high-tech equipment deployment, provided there is adequate infrastructure and sufficiently trained personnel.

▲ Sustainability depends on the Government’s political will and the ability of the facility to implement QC/QA and maintenance programs and to provide continuing education to the staff.

▲ National policies regarding radioactive waste from medical, industrial, research and educational activities as well as radiological emergency preparedness and response plans need to be developed and implemented.

▲ Developing countries should not be denied the possibility of high-tech equipment deployment, provided there is adequate infrastructure and sufficiently trained personnel.

▲ Sustainability depends on the Government’s political will and the ability of the facility to implement QC/QA and maintenance programs and to provide continuing education to the staff.

▲ National policies regarding radioactive waste from medical, industrial, research and educational activities as well as radiological emergency preparedness and response plans need to be developed and implemented.

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Main Problems in Implementing a Main Problems in Implementing a Radiation Safety Culture in Latin Radiation Safety Culture in Latin

America and the CaribbeanAmerica and the Caribbean

Main Problems in Implementing a Main Problems in Implementing a Radiation Safety Culture in Latin Radiation Safety Culture in Latin

America and the CaribbeanAmerica and the Caribbean▲ It is not a priority for Governments▲ Regulatory Authorities, where they exist, lack

adequate infrastructure and trained personnel▲ Salaries are meager and jobs scarce▲ Mistakes are punished severely, hence

professionals do not take responsibilities nor they assume risks

▲ In many instances, continuing education must be sought outside the country

▲ It is not a priority for Governments▲ Regulatory Authorities, where they exist, lack

adequate infrastructure and trained personnel▲ Salaries are meager and jobs scarce▲ Mistakes are punished severely, hence

professionals do not take responsibilities nor they assume risks

▲ In many instances, continuing education must be sought outside the country

QUALITYASSURANCEPROGRAM

QUALITYASSURANCEPROGRAM

MAINTENANCEPROGRAM

MAINTENANCEPROGRAM

RADIATION SAFETYSTANDARDS

RADIATION SAFETYSTANDARDS

PROGRAM OF CONTINUINGEDUCATION

PROGRAM OF CONTINUINGEDUCATION

EQUIPMENTPURCHASE

EQUIPMENTPURCHASE

FACILITY PLANNINGAND

RENOVATION

FACILITY PLANNINGAND

RENOVATION

COMPREHENSIVE PLAN FOR FACILITY ORGANIZATION AND DEVELOPMENTCOMPREHENSIVE PLAN FOR FACILITY ORGANIZATION AND DEVELOPMENT

TECHNOLOGYASSESSMENT PROGRAMS

TECHNOLOGYASSESSMENT PROGRAMS

INADEQUATEFACILITIES

INADEQUATEFACILITIES

OBSOLETE AND/ORNON-FUNCTIONING

EQUIPMENT

OBSOLETE AND/ORNON-FUNCTIONING

EQUIPMENT

MINIMALLY TRAINEDPERSONNEL

MINIMALLY TRAINEDPERSONNEL

INEFFECTIVEOPERATIONALPROCEDURES

INEFFECTIVEOPERATIONALPROCEDURES

UNSAFE RADIATIONCONDITIONS

UNSAFE RADIATIONCONDITIONS

RUN-DOWN BUILDINGSRUN-DOWN BUILDINGS NO PROCUREMENTSPECIFICATIONS

NO PROCUREMENTSPECIFICATIONS

INADEQUATESALARIES

INADEQUATESALARIES

ATTITUDINAL BEHAVIOR

ATTITUDINAL BEHAVIOR

LACK OF FINANCIAL RESOURCES AND INEFFICIENT RESOURCE ALLOCATIONLACK OF FINANCIAL RESOURCES AND INEFFICIENT RESOURCE ALLOCATION

POOR SCHOOLINGPOOR SCHOOLING

PROFESSIONALLICENSING BOARDS

PROFESSIONALLICENSING BOARDS

RADIATION SAFETYLEGISLATION / REGULATIONS

RADIATION SAFETYLEGISLATION / REGULATIONS

NEEDS ATGOVERNMENT

LEVEL

NEEDS ATGOVERNMENT

LEVEL

NEEDS ATINSTITUTIONAL

LEVEL

NEEDS ATINSTITUTIONAL

LEVEL

INFRASTRUCTUREPROBLEMS

INFRASTRUCTUREPROBLEMS

ROOTCAUSESROOT

CAUSES

BOTTOMLINE

BOTTOMLINE

DEVELOPING COUNTRIES RADIOLOGICAL HEALTH PROBLEM TREEDEVELOPING COUNTRIES RADIOLOGICAL HEALTH PROBLEM TREE

POLICIES AND STRATEGIESPOLICIES AND STRATEGIES

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