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Medical Events Report FY 2014

Ronald D. Ennis, M.D.

Advisory Committee for the 

Medical Uses of Isotopes

October 09, 2015

Subcommittee members

• Ronald D. Ennis, M.D. (Chair)

• Susan Langhorst, Ph.D.

• Steve Mattmuller

• Michael O’Hara, Ph.D.

• Christopher Palestro, M.D.

• John Suh, M.D.

• Bruce Thomadsen, Ph.D.

• Pat Zanzonico, Ph.D.

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35.200 Use of unsealed byproduct 

material for imaging and 

localization

• Date Reported: >= 10/1/2013 and <= 9/30/2014

• 6 events

• In FY2014 were 2 events

• In 5 of the events the technologist 

o failed to calibrate the dose and/or, 

o failed to selected the correct dose, even though 

the radiopharmaceutical was properly labeled

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• NMED 140019: 18.5 MBq (500 mCi) In-111 

Leukocyte (WBC) dose injected to wrong patient

• Technologist failed to identify correct patient.

• Biggest concern is potential biologic effect, not the 

unintended radiation exposure

• In essence an unplanned blood transfusion

o from a ill patient vs. a healthy donor

o leukocytes (WBC) transfusion may have an incompatible 

blood type and/or pathogens or viruses 

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35.200 Use of unsealed byproduct 

material for imaging and 

localization
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• Date Reported: >= 10/1/2013 and <= 9/30/2014

• 4 events

• In FY2013 there were 2 events

• 1 event; the technologist selected the wrong I-131 

dose, selected an expired and now a nonradioactive dose (?) vs. the correct dose

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35.300 Use of unsealed byproduct 

material, Written Directive Required

• 1 event; 39 mCi of the Sm-153 dose was 

extravasated during administration, of the intended 

100 mCi dose

• 1 event; patient received 1 of 2 capsules for 150 

mCi dose of I-131

• Both events, not enough information to assess

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35.300 Use of unsealed byproduct 

material, Written Directive Required

• NMED 140069 1.11 MBq (30 mCi) I-131 dose to 

the wrong patient

• Patient did not speak English

• Registrar attached wrong wrist ID band

• Physician failed to correctly identify the patient

• Misadministration was noticed before patient left 

the hospital, administered a thyroid blocking agent.

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35.300 Use of unsealed byproduct 

material, Written Directive Required

• Event Type = Medical; Date Reported to NRC >= 

10/1/2013 and <= 9/30/2014; Medical Event: Procedure 

Given = BRACHY, MANUAL IMPLANT and BRACHY, 

MANUAL AFTERLOADER

• 30 events total

• But since 23 Y-90 microspheres and 2 breast 

localizations are§35.1000, only 5 §35.400 events: 4 

prostate, 1 gynecological

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Manual Implant Brachytherapy
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Medical Events 2013

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35.400 Medical 

events

2013: 16 MEs (18

patients)

2014: 5 ME’s

Gynecological 2 1

Prostate 14 (16 patients) 4

Gynecological Cs-137 1

• A) 15.09 Gy (rad) to skin of inner thigh – vaginal 

applicator was dislodged in patient who had partial 

paralysis below waist. Implant was in place at least 

49.5 hours (54.91 Gy) of planned 63.1 hour (70 Gy) 

implant. Treatment site received 78% of intended 

dose.

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35.400 Medical Events

Non-Prostate Manual 

Brachytherapy

• Patient had restless night and tossed and turned

• She did not recognize applicator was dislodged

• Daily skin checks in Dec 2013 showed no adverse 

effects 

• Corrective action: more frequent checks of applicator 

position and providing new training to personnel

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35.400 Medical Events

Non-Prostate Manual 

Brachytherapy

• 4 Medical Events (4 Patients) 

• Multiple Medical Events: 0

• 3 underdoses and 1 overdose

• 1 calculation plan error and 3 seed misplacement 

• I-125: 4 pts; Pd-103: 0 pts; Cs-131: 0

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35.400 Medical Events

Prostate Manual Brachytherapy
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Prostate: 4 

• Implant of scar tissue

– Corrective action: procedure modification and training ultrasound

• Seeds placed 3.5 cm inferior. Foley balloon was pierced 

and deflated

– Corrective action: training ultrasound

• Use of mCi rather than air kerma value (184 Gy rather 

than 145 Gy)

– Corrective action: Physician checks calibration sheet and values

• Physicians mistook penile bulb as prostate

– Corrective action: centralize seed program, follow policies, Q/A 

of ultrasound and training

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35.400 Medical Events

FY2013 FY2014

All §35.600 9 10

All HDR 8 9

LDR remote

afterloader 0 0

Gamma Knife

1 (+1 

Perfexion

)

1 (+1 

Perfexion

)

Teletherapy 0 0

35.600 Remote Afterloaders, 

Teletherapy, Gamma Knife

Event Site Number of Events

Breast 1

Gynecological (Vaginal 

cylinders – Although some 

not clear)

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Skin 2

Bronchus 1

HDR Brachytherapy Sites

• 4 Positioning problems: 

– 2 Wrong positioning, 

– 2 Wrong reference length entered, 

• 1 Wrong patient’s plan

• 2 Wrong dose entered or wrong source strength 

entered

• 2 Machine problems

35.600 HDR Brachytherapy 

Observations
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• Gamma Knife - 1 event (§ 35.600)

• Scheduling change lead to wrong patient’s plan used 

and wrong side treated

• Gamma Knife Perfexion – 1 event (§35.1000)

• Wrong site and wrong side due to poor 

communication with treatment planner 

35.600/35.1000 GammaKnife

Medical Events

FY2013 FY2014

All §35.1000 15* 26*

All Microsphere 13 23

SIR-Spheres 10 16

TheraSphere 3 7

Radioactive Seed 

Localization 1 2

§35.1000 Events

*Includes the Perfexion event already considered

§35.1000 Events

16 SIR-Spheres Events

•10 Catheter blocked/ material left in equipment

•2 Dose calculation error

•1 Error in drawing dose

•2 Unexpected shunts

•1 Unspecified

7 TheraSpheres Events

• 1 Unexpected shunt

• 6 Catheter blocked/ material left in equipment

§35.1000 Events
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2 Radioactive Seed Localization Events

• 1 seed fall during tumor removal, found and retrieved 

49 days later

• 1 Two seeds used when only one was ordered on the 

written directive

§35.1000 Events

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• NMED event involving medical license or associated 

license

• NMED event associated with medical license

• Does not include §35.3045 or 35.3047 events or other 

patient safety events

Other Medical Byproduct Material 

Events

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Categories

• Miscellaneous – 8 

• Leaking sealed sources – 4 

• Lost materials/sources (no Cat. 1 or 2) – 30 

• Shipping issues – 10 

• Landfill alarms – 113 

Other Medical Byproduct Material 

Events

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• Occupational overexposure – 2

• Suspected public overexposure – 1

• Airborne constraint exceeded – 1

• Equipment failures – 3

• Suspicious activity – 1 

Other Events - Miscellaneous
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• Cs-137 source (<300 μCi) – 2

• I-125 source (localization) – 1

• Co-57 line source – 1

Other Events – Leaking Sealed 

Sources

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• Lost after procedure (I-125) – 10

• Lost/found/lost and found – 2/2/4

• Lost during shipment – 6

• Package thrown away – 1

• Licensee out of business – 1 (2 sources)

• Theft – 3 

Other Events – Lost 

Materials/Sources

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• Delivered to wrong address/location – 5

• Stored in unsecured area – 1

• Accident/Highway Patrol delivery – 1

• Shipping package issues – 2

• No license approval for receipt – 1 

Other Events – Shipping Issues

Reports from Agreement States –

12% AL 85% CA 1% FL 1% NC 2% NC

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Isotope Hospital Residence Not identified

I-131 2 23 37

In-111 1 2

Tc-99m 18 14

Tl-201 3

Not identified 3 3 7

Other Events - Landfill
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• No obvious trends or patterns this year

• Each year there are ~15,000,000 diagnostic and 

150,000 therapeutic procedures performed utilizing 

radioactive materials

• The tiny fraction presented here today is reassuring and 

confirms the generally safe fashion these materials are 

administered to patients in the USA

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Conclusions Acronyms

• cm – centimeter

• Cs – Cesium

• FY – Fiscal Year

• Gy (rad) –Gray 

• GYN - gynecological

• HDR – High dose-rate

• I - Iodine

• LDR – Low dose-rate

• MBq - megabequerel

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Acronyms

• mCi – millicurie

• ME – Medical Event

• NMED - Nuclear Material Events Database

• Pd - Palladium

• Pt(s) – Patient(s)

• QA - Quality Assurance

• rem - roentgen equivalent in man

• Y- Yttrium

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