Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor...

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1 Medical Devices Radiation Safety Medical Devices Medical Devices Radiation Safety Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil Visiting Professor Visiting Professor DOIN DOIN - - DEN / UFPE DEN / UFPE Recife, Pernambuco, Brazil Recife, Pernambuco, Brazil Cari Borr Cari Borr á á s, D.Sc., FACR, FAAPM s, D.Sc., FACR, FAAPM Co Co - - Chair, IUPESM Chair, IUPESM Health Technology Health Technology Task Group Task Group

Transcript of Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor...

Page 1: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Medical Devices

Radiation Safety

Medical Devices Medical Devices

Radiation SafetyRadiation Safety

Visiting Professor

DOIN-DEN / UFPE

Recife, Pernambuco, Brazil

Visiting ProfessorVisiting Professor

DOINDOIN--DEN / UFPEDEN / UFPE

Recife, Pernambuco, BrazilRecife, Pernambuco, Brazil

Cari BorrCari Borráás, D.Sc., FACR, FAAPMs, D.Sc., FACR, FAAPM

CoCo--Chair, IUPESMChair, IUPESM

Health Technology Health Technology

Task GroupTask Group

Page 2: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

2

Radiological

equipment has

changed a bit since

the early days...

Radiological

equipment has

changed a bit since

the early days...

Page 3: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

3PET/CTPET/CT

DRDR

CTCTCT

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4

First

Co-60

Unit

(1951)

First First

CoCo--60 60

Unit Unit

(1951)(1951)

CsCs--137 137

TeletherapyTeletherapy

(1960(1960’’s)s)

Orthovoltage XOrthovoltage X--Ray (1990Ray (1990’’s)s)

Linac Linac

with with

IGRT IGRT

(200s)(200s)

External Beam Therapy

Page 5: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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BrachytherapyBrachytherapy

Ra

Needles

1929

Ra

Needles

1929

Manchester

Applicator

Manchester

Applicator

LDR

1970 -

1980

LDR

1970 -

1980

HDR

1990

HDR

1990

1950

-

1960

1950

-

1960

Electronic

Brachytherapy

2000

Electronic

Brachytherapy

2000

Cs-137 Ir-192

Miniature

X-Ray

Tube

Page 6: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

R. Mackie 2009

Page 7: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Global Annual Number of Radiological Exams

and Treatments per 1,000 People

Global Annual Number of Radiological Exams Global Annual Number of Radiological Exams

and Treatments per 1,000 Peopleand Treatments per 1,000 People

PracticePractice 19971997-- 2007 2007 1991 1991 -- 19961996

420420

(1,230)(1,230)

5.65.6

(19)(19)

1.01.0

(1.9)(1.9)

X RaysX Rays

Nuclear MedicineNuclear Medicine

RadiotherapyRadiotherapy

562562

(1,607)(1,607)

5.15.1

(19)(19)

0.80.8

(2.4)(2.4)

( Data for HCL I )( Data for HCL I )UNSCEAR 2008UNSCEAR 2008

Page 8: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

Annual per Caput Effective Dose (mSv)

for theUnited States Population

Annual per Caput Effective Dose (mSv) Annual per Caput Effective Dose (mSv)

for theUnited States Populationfor theUnited States Population

8

19801980 20062006

Medical: 3.0

UNSCEAR2008

Page 9: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

Radiation RisksRadiation RisksRadiation Risks

▲ External

▲ Internal

▲▲ ExternalExternal

▲▲ InternalInternal

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ll AbsorptionAbsorption

ll InhalationInhalation

ll IngestionIngestion

Contamination PathwaysContamination Pathways

Page 10: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Deterministic Effects

Radiation effects for which generally a threshold

level of dose exists above which the severity of

the effect is greater for a higher dose.

Deterministic EffectsDeterministic Effects

Radiation effects for which generally a threshold Radiation effects for which generally a threshold

level of dose exists above which the severity of level of dose exists above which the severity of

the effect is greater for a higher dose. the effect is greater for a higher dose.

Stochastic Effects

Radiation effects, generally occurring without a

threshold level of dose, whose probability is proportional

to the dose and whose severity is independent of the dose.

Stochastic EffectsStochastic Effects

Radiation effects, generally occurring without a Radiation effects, generally occurring without a

threshold level of dose, whose probability is proportional threshold level of dose, whose probability is proportional

to the dose and whose severity is independent of the dose.to the dose and whose severity is independent of the dose.

Page 11: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

1111

Effects of Cell DeathEffects of Cell Death

DDoseose

((mGy)mGy)

Probability of DeathProbability of Death

DD

100%100%

CoCo--60 Radiotherapy 60 Radiotherapy

OverexposureOverexposure

Panama 2000Panama 2000--20012001

Page 12: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

Whole body response : adultWhole body response : adultWhole body response : adult

Acute irradiation syndromeAcute irradiation syndromeAcute irradiation syndrome

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Chronic irradiation syndrome

Surv

ival tim

e

Dose

Lethal dose 50 / 30BMS(bone

marrow)

GIS(gastro

intestinal) CNS(central nervous

system)

1-10 Gy

10-50 Gy

> 50 Gy

•Whole body clinic

of a partial-body

irradiation

•Mechanism:

Neurovegetative

disorder

•Similar to a sick

feeling

•Quite frequent in

fractionated

radiotherapy

Page 13: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

Skin InjuriesSkin InjuriesSkin Injuries

13

Interventional Radiology

Over-Exposure, USA 1991

Interventional Radiology Interventional Radiology

OverOver--Exposure, USA 1991Exposure, USA 1991

Page 14: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

Effects in the EyeEffects in the EyeEffects in the Eye

▲ Eye lens is highly radiosensitive.

▲ Coagulation of proteins occur with doses greater than 2 Gy.

▲ There are 2 basic effects:

▲▲ Eye lens is highly radiosensitive.Eye lens is highly radiosensitive.

▲▲ Coagulation of proteins occur with doses greater than 2 Gy.Coagulation of proteins occur with doses greater than 2 Gy.

▲▲ There are 2 basic effects:There are 2 basic effects:

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> 0.15> 0.155.05.0

Visual Visual

impairment impairment

(cataract)(cataract)

> 0.1> 0.10.50.5--2.02.0Detectable Detectable

opacitiesopacities

Sv/year for Sv/year for

many yearsmany years

Sv single brief Sv single brief

exposureexposure

EffectEffect

Page 15: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Deterministic Effects

Radiation effects for which generally a threshold

level of dose exists above which the severity of

the effect is greater for a higher dose.

Deterministic EffectsDeterministic Effects

Radiation effects for which generally a threshold Radiation effects for which generally a threshold

level of dose exists above which the severity of level of dose exists above which the severity of

the effect is greater for a higher dose. the effect is greater for a higher dose.

Stochastic Effects

Radiation effects, generally occurring without a

threshold level of dose, whose probability is proportional

to the dose and whose severity is independent of the dose.

Stochastic EffectsStochastic Effects

Radiation effects, generally occurring without a Radiation effects, generally occurring without a

threshold level of dose, whose probability is proportional threshold level of dose, whose probability is proportional

to the dose and whose severity is independent of the dose.to the dose and whose severity is independent of the dose.

Cancer Heritable Effects

Page 16: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Frequency (%)

10 20 30 40Absorbed dose (Gy)

Genetic (Heritable) Effects

(Mutations)

Genetic (Heritable) Effects

(Mutations)

10

5

0

Fruit Fly Experiments

Fruit Fly Fruit Fly

ExperimentsExperiments

Page 18: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Genetic EffectsGenetic EffectsGenetic Effects

▲ Ionizing radiation is known to cause hereditary

mutations in many plants and animals

BUT

▲ Intensive studies of 70,000 offspring of the atomic

bomb survivors have failed to identify an increase

in congenital anomalies, cancer, chromosome

aberrations in circulating lymphocytes or

mutational blood protein changes.

▲▲ Ionizing radiation is known to cause hereditary Ionizing radiation is known to cause hereditary

mutations in many plants and animalsmutations in many plants and animals

BUTBUT

▲▲ Intensive studies of 70,000 offspring of the atomic Intensive studies of 70,000 offspring of the atomic

bomb survivors have failed to identify an increase bomb survivors have failed to identify an increase

in congenital anomalies, cancer, chromosome in congenital anomalies, cancer, chromosome

aberrations in circulating lymphocytes or aberrations in circulating lymphocytes or

mutational blood protein changes.mutational blood protein changes.

Page 19: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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ICRP Detriment-Adjusted Nominal Risk

Coefficient for Cancer and Heritable Effects

(ICRP 103, 2007)

(10-2 Sv-1 – Percent per Sievert)

ICRP DetrimentICRP Detriment--Adjusted Nominal Risk Adjusted Nominal Risk

Coefficient for Cancer and Heritable Effects Coefficient for Cancer and Heritable Effects

(ICRP 103, 2007)(ICRP 103, 2007)

(10(10--22 SvSv--11 –– Percent per Sievert)Percent per Sievert)

Exposed Exposed

PopulationPopulation

Cancer Cancer

InductionInduction

Heritable Heritable

EffectsEffects

Whole 5.5 0.2

Adult 4.1 0.1

Page 20: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Radiation Radiation

Therapy Therapy

PublicationsPublications

Unintended Unintended

ExposureExposure

ss

ICRP 112,

2010

20082008

20002000

ICRP 112, 2010

Page 21: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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ProblemProblem CountryCountry YearYearPatients Patients

OverdosedOverdosed

CoCo--60Mis60Mis--

calibrationscalibrations

USA 1974-1976 426

Germany 1986-1987 86

UK 1988 207

Costa Rica 1996 114

Hardware / Hardware /

Software Software

Linear Linear

AcceleratorsAccelerators

Canada &

USA1985-1987 3

Spain 1990 27

Poland 2001 5

TreatmentPlTreatmentPl

anninganning

USA 1987-1988 33

Panama 2000 28

Page 22: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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ICRP 2010ICRP 2010

Page 23: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

621 Radiotherapy Mistakes (NYT)*

New York State, 2001 - 2008

621 Radiotherapy Mistakes (NYT)*621 Radiotherapy Mistakes (NYT)*

New York State, 2001 New York State, 2001 -- 20082008

* The information presented is that reported in the New York * The information presented is that reported in the New York

Times (NYT) by Walt Bogdanich in January 2010. No Times (NYT) by Walt Bogdanich in January 2010. No

independent verification for accuracy has been performed.independent verification for accuracy has been performed.

Nr. PatientsNr. Patients Cause of overexposureCause of overexposure

133 Beam-shaping devices error

284 Wrong target

50 Wrong patient

1 Faulty calculation

2 Lack of tests after machine repair

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Page 24: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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2 Radiotherapy Mistakes (NYT)*

New York City, 2005

(Patients died in 2007)

2 Radiotherapy Mistakes (NYT)*2 Radiotherapy Mistakes (NYT)*

New York City, 2005New York City, 2005

(Patients died in 2007)(Patients died in 2007)

Cancer Cancer

SiteSite Cause of overexposureCause of overexposureComments / Comments /

ConsequencesConsequences

Tongue

Multileaf collimator for

IMRT did not work.

Open field instead.

(Varian)

3 of 5 fractions given. Severe

morbidity. Physicist checks RX

Dose given : 7 times prescribed

Hospital and Varian sued

Varian modifies software

Breast Wedge not in the beam.

27 of 28 fractions given.

Morbidity appears at the end.

Dose given: 3.5 times prescribed

Page 25: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Radiotherapy Mistakes (NYT)*

Other USA States

Radiotherapy Mistakes (NYT)*Radiotherapy Mistakes (NYT)*

Other USA StatesOther USA StatesState

Year

Nr.

Patients

Cancer

Site

Cause of

overexposure

Overdose

(%)

Florida

200577 Brain Linac miscalibration 50

Louisiana

20051 Prostate

Wrong CT scan for

TPS

100 (38

fractions)

Texas

20041 Prostate

EBT + Brachy : No

dose prescription, no

post-implant calcs

?

Ohio

20061 Breast

Incorrect

magnification factor100

Page 26: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

Radiotherapy Mistakes

Veterans Affairs Hospitals

Radiotherapy MistakesRadiotherapy Mistakes

Veterans Affairs HospitalsVeterans Affairs Hospitals

LocationLocation

YearYearNr. PatientsNr. Patients Cancer SiteCancer Site

Cause of Cause of

overexposureoverexposure

Philadelphia Philadelphia

PennsylvaniaPennsylvania

2002 2002 -- 20082008

9797 ProstateProstate

Incorrect Incorrect

placement ofplacement of

II--125 seeds125 seeds

No dosimetryNo dosimetry

East OrangeEast Orange

New Jersey New Jersey

20062006

5656

36 overirradiated36 overirradiated

20 had 20 had ““errorserrors””

ProstateProstate

Head & NeckHead & Neck

LungLung

BreastBreast

2 Others2 Others

No staff No staff

training in training in

IMRTIMRT

No experienceNo experience

No QC, QANo QC, QA

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Page 27: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Page 28: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

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Page 29: Medical Devices Radiation Safety - WHO · Medical Devices Radiation Safety Visiting Professor DOIN-DEN / UFPE Recife, Pernambuco, Brazil ... Practice 1997 - 2007 1991 - 1996 420 (1,230)

29C. Borrás V ALFIM 2010