Information Notice 1990-59, Errors in Use of Radioactive Iodine-131: Difference between revisions

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{{#Wiki_filter:UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555September 17, 1990NRC INFORMATION NOTICE NO. 90-59:ERRORS IN THE USE OF RADIOACTIVE IODINE-131
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY
 
COMMISSION
 
OFFICE OF NUCLEAR MATERIALS
 
===SAFETY AND SAFEGUARDS===
WASHINGTON, D.C. 20555 September
 
17, 1990 NRC INFORMATION
 
NOTICE NO. 90-59: ERRORS IN THE USE OF RADIOACTIVE
 
IODINE-131


==Addressees==
==Addressees==
:All medical licensees.
:
All medical licensees.


==Purpose==
==Purpose==
:This information notice is intended to emphasize to medical use licensees thepotential radiation dose levels resulting from errors in the administrationof iodine-131 to humans. This issue was previously addressed in IE InformationNotice No. 85-61, Suppliment 1: Misadministrations To Patients UndergoingThyroid Scans (attached). Due to the significance and frequency of recurrenceof these errors, NRC believes this issue should be readdressed. It is expectedthat licensees will review this information for application to their own proceduresfor the administration of iodine-131, distribute the notice to those responsiblefor radiation safety and quality assurance, and consider actions, if appropriate,to establish procedures to preclude the misadministration of iodine-131 at theirfacilities. However, suggestions contained in this notice do not constitute anynew U.S. Nuclear Regulatory Commission (NRC) requirements, and no writtenresponse is required.
: This information


==Description of Circumstances==
notice is intended to emphasize
:The following cases are recent events reported to NRC that have resulted inunintended radiation doses to humans, as a result of the administration ofradioactive iodine:Case 1: A patient with a history of thyroid cancer was scheduled for heryearly whole-body scan. Before the scan, the patient underwent a pregnancytest, with negative results. After the pregnancy test results were received,the technologist began to complete a departmental questionnaire to obtaininformation from the patient relative to the requested procedure. Thequestionnaire addressed the possibilities of pregnancy and lactation. However,before completing the questionnaire, the technologist was called away and didnot return to complete the form before administration of the iodine-131. Asa result, the patient was given the intended dosage of 4.89 millicuries ofiodine-131. Approximately 48 hours later when the patient was scanned, therewas considerable iodine-131 uptake in her breasts. When questioned by thephysician, the patient indicated that she had given birth to a female infanttwo weeks earlier and had been nursing this infant for approximately the last36 hours. The total body dose to the infant was estimated to be 17 rads,and the radiation dose to the infant's thyroid was estimated to be 30,000rads. A synthetic thyroid hormone replacement has been prescribed for thechild, with scheduled periodic follow-ups. The unintended dose to the mother'sbreasts was estimated to be 8.9 rads.> 920156 Z J 49_0we


IN 90-59September 17, 1990 Case 2: A patient to be scheduled for a thyroid scan was administered 3millicuries of iodine-131 instead of the intended dosage of 300 microcuries ofiodine-123. The patient's physician called in the request for a thyroid scanto the secretary of the nuclear medicine department, who inadvertentlyscheduled a whole-body scan. No written request from the physician wasrequired. The dosage at this facility for a whole-body scan is 3 millicuriesof iodine-131, whereas the dosage for a thyroid scan is 300 microcuries ofiodine-123. The estimated dose to the patient's thyroid gland due to thiserror was 4700 rads.Case 3: A patient was scheduled for an ectopic thyroid evaluation, with anintended dosage of 100 microcuries of iodine-131. In completing the NuclearMedicine department referral sheet, the referring physician incorrectlyrequested a post-thyroidectomy neck scan. As a result, the patient wasadministered 1 millicurie of iodine-131, with an estimated dose to thethyroid of 1300 rads.Case 4: A patient was scheduled for an ectopic thyroid evaluation, with anIntended dosage of 50 to 100 microcuries of iodine-131. The technologistconsulted the department procedure manual that listed prescribed dosages forspecific scans, and the dosage was incorrectly listed as 4.5 millicuries. As a'result, the patient was administered 4.3 millicuries. The estimated dose'tothis patient's thyroid gland was 4300 rads.Case 5: A patient was administered a dosage of 15 microcuries of iodine-131.Almost immediately following the administration, the patient indicated to thetechnologist that she was approximately 4 to 5 weeks pregnant.. The technologistfailed to ask the patient if she was pregnant before the administration. Thepatient had arrived at the department with a baby in her arms, and thetechnologist assumed that the patient was not pregnant. The total body dose tothe fetus was estimated to be 2 to 4 millirem. Since the fetal thyroid isincapable of concentrating iodine-131 until approximately 12 weeks of gestation,it was estimated that there was no additional dose to the fetal thyroid.
to medical use licensees
 
the potential
 
radiation
 
dose levels resulting
 
from errors in the administration
 
of iodine-131 to humans. This issue was previously
 
addressed
 
in IE Information
 
Notice No. 85-61, Suppliment
 
1: Misadministrations
 
===To Patients Undergoing===
Thyroid Scans (attached).
 
Due to the significance
 
and frequency
 
of recurrence
 
of these errors, NRC believes this issue should be readdressed.
 
It is expected that licensees
 
will review this information
 
for application
 
to their own procedures
 
for the administration
 
of iodine-131, distribute
 
the notice to those responsible
 
for radiation
 
safety and quality assurance, and consider actions, if appropriate, to establish
 
procedures
 
to preclude the misadministration
 
of iodine-131 at their facilities.
 
However, suggestions
 
contained
 
in this notice do not constitute
 
any new U.S. Nuclear Regulatory
 
Commission (NRC) requirements, and no written response is required.Description
 
of Circumstances:
The following
 
cases are recent events reported to NRC that have resulted in unintended
 
radiation
 
doses to humans, as a result of the administration
 
of radioactive
 
iodine: Case 1: A patient with a history of thyroid cancer was scheduled
 
for her yearly whole-body
 
scan. Before the scan, the patient underwent
 
a pregnancy test, with negative results. After the pregnancy
 
test results were received, the technologist
 
began to complete a departmental
 
questionnaire
 
to obtain information
 
from the patient relative to the requested
 
procedure.
 
The questionnaire
 
addressed
 
the possibilities
 
of pregnancy
 
and lactation.
 
However, before completing
 
the questionnaire, the technologist
 
was called away and did not return to complete the form before administration
 
of the iodine-131.
 
As a result, the patient was given the intended dosage of 4.89 millicuries
 
of iodine-131.
 
Approximately
 
48 hours later when the patient was scanned, there was considerable
 
iodine-131 uptake in her breasts. When questioned
 
by the physician, the patient indicated
 
that she had given birth to a female infant two weeks earlier and had been nursing this infant for approximately
 
the last 36 hours. The total body dose to the infant was estimated
 
to be 17 rads, and the radiation
 
dose to the infant's thyroid was estimated
 
to be 30,000 rads. A synthetic
 
thyroid hormone replacement
 
has been prescribed
 
for the child, with scheduled
 
periodic follow-ups.
 
The unintended
 
dose to the mother's breasts was estimated
 
to be 8.9 rads.> 920156 Z J 4 9_0we
 
IN 90-59 September
 
17, 1990 Case 2: A patient to be scheduled
 
for a thyroid scan was administered
 
3 millicuries
 
of iodine-131 instead of the intended dosage of 300 microcuries
 
of iodine-123.
 
The patient's
 
physician
 
called in the request for a thyroid scan to the secretary
 
of the nuclear medicine department, who inadvertently
 
scheduled
 
a whole-body
 
scan. No written request from the physician
 
was required.
 
The dosage at this facility for a whole-body
 
scan is 3 millicuries
 
of iodine-131, whereas the dosage for a thyroid scan is 300 microcuries
 
of iodine-123.
 
The estimated
 
dose to the patient's
 
thyroid gland due to this error was 4700 rads.Case 3: A patient was scheduled
 
for an ectopic thyroid evaluation, with an intended dosage of 100 microcuries
 
of iodine-131.
 
In completing
 
the Nuclear Medicine department
 
referral sheet, the referring
 
physician
 
incorrectly
 
requested
 
a post-thyroidectomy
 
neck scan. As a result, the patient was administered
 
1 millicurie
 
of iodine-131, with an estimated
 
dose to the thyroid of 1300 rads.Case 4: A patient was scheduled
 
for an ectopic thyroid evaluation, with an Intended dosage of 50 to 100 microcuries
 
of iodine-131.
 
===The technologist===
consulted
 
the department
 
procedure
 
manual that listed prescribed
 
dosages for specific scans, and the dosage was incorrectly
 
listed as 4.5 millicuries.
 
As a'result, the patient was administered
 
4.3 millicuries.
 
The estimated
 
dose'to this patient's
 
thyroid gland was 4300 rads.Case 5: A patient was administered
 
a dosage of 15 microcuries
 
of iodine-131.
 
Almost immediately
 
following
 
the administration, the patient indicated
 
to the technologist
 
that she was approximately
 
4 to 5 weeks pregnant..
 
===The technologist===
failed to ask the patient if she was pregnant before the administration.
 
The patient had arrived at the department
 
with a baby in her arms, and the technologist
 
assumed that the patient was not pregnant.
 
The total body dose to the fetus was estimated
 
to be 2 to 4 millirem.
 
Since the fetal thyroid is incapable
 
of concentrating
 
iodine-131 until approximately
 
12 weeks of gestation, it was estimated
 
that there was no additional
 
dose to the fetal thyroid.


==DISCUSSION==
==DISCUSSION==
:All licensees are reminded of the importance of ensuring the safe performanceof licensed activities, in accordance with NRC regulations, requirements oftheir licenses, and accepted medical practice. The forementioned casesillustrate: the lack of familiarity with appropriate thyroid studies anddosages; the necessity of consistently following quality control procedures;and a need to understand the significance of radiation doses that result -from the administration of millicuries versus microcuries of radiopharmaceuticalscontaining radioiodine. Specifically, the radiation dose to the thyroid,resulting from a dosage of one millicurie rather than one microcurie ofj .
:
All licensees
 
are reminded of the importance
 
of ensuring the safe performance
 
of licensed activities, in accordance
 
with NRC regulations, requirements
 
of their licenses, and accepted medical practice.
 
The forementioned
 
cases illustrate:  
the lack of familiarity
 
with appropriate
 
thyroid studies and dosages; the necessity
 
of consistently
 
following
 
quality control procedures;
and a need to understand
 
the significance
 
of radiation
 
doses that result -from the administration
 
of millicuries
 
versus microcuries
 
of radiopharmaceuticals
 
containing
 
radioiodine.
 
Specifically, the radiation
 
dose to the thyroid, resulting
 
from a dosage of one millicurie
 
rather than one microcurie
 
of j .
 
IN 90-59 September
 
17, 1990 iodine-131, is a one thousand-fold
 
increase.
 
In addition, the radiation
 
dose received from an activity of iodine-131 is approximately-100
fold greater than the dose from the same activity of iodine-123.
 
The following
 
table illustrates
 
the relationship
 
between microcurie
 
versus millicurie
 
quantities
 
of iodine-131, as well as the radiation
 
dose differential
 
between iodine-123 and iodine-131, for three different
 
age groups, with a thyroid uptake of 15 percent.TABLE: 1 year 5 years Adult A Comparison
 
of IsQtopes and'Radiation
 
Doses for Various Age Groups Assuming 15% Uptake by the Thyroid*Rads per uqi Rads per mCi I-123 1-131 I-123 1-131 old 0.07 7.40 70.3 7400 old 0.04 4.07 40.0 4070 0.007 0.78 7.0 777...* Based on information
 
from ICRP-Publication
 
No. 53 All workers should have a clear understanding
 
of the significance
 
of errors.in scale when calculating
 
and preparing
 
diagnostic
 
dosages versus therapeutic
 
dosages of radiopharmaceuticals
 
containing
 
radioiodine.
 
The threshold
 
at which a diagnostic
 
dosage becomes a therapeutic
 
dosage is low, and depends on the age of the patient and the percent uptake by the patient's
 
thyroid gland.Consequently, the potential
 
for causing a significant, undesired
 
radiation dose to a patient's
 
thyroid gland must always be kept in mind when administering
 
iodine radiopharmaceuticals.
 
Licensees
 
are reminded that the package inserts provided by the manufacturers
 
contain information
 
pertinent
 
to both proper dosages and radiation
 
doses, and may be valuable resources
 
when reviewing
 
imaging policies and procedures
 
for errors and inconsistencies.
 
Nuclear medicine department
 
procedures
 
should include provisions
 
for questioning
 
female patients about the possibility
 
of pregnancy
 
or lactation.
 
By attention
 
to detail, and adherence
 
to departmental
 
policy and procedures, many incidents
 
involving
 
radioactive
 
iodine-131 may be avoided.
 
r-IN 90-59 September
 
17, 1990 No specific written response is required by this information
 
notice. If you have any questions
 
regarding
 
this matter, please contact the appropriate
 
regional office or this office.M r Cunnnhm, ro Division of Industrial
 
and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
 
Technical
 
Contact: Sally Merchant, NMSS (301) 492-0637-Attachments:
1. List of Recently Issued NMSS Information
 
Notices.2. List of Recently Issued NRC Information
 
Notices.
 
Attachment
 
1 IN 90-59 September
 
17, 1990 LIST OF RECENTLY ISSUED HMSS INFORMATION
 
NOTICES Information
 
Date of Notice No. Subject Issuance Issued to: 90-50 Minimization
 
of Methane Gas in Plant Systems and Radwaste Shipping Containers
 
08/08/90 All holders licenses or permits for reactors of operating construction
 
nuclear power 90-44 Dose-Rate
 
Instruments
 
06/29/90 90-38 Requirements
 
for Processing
 
05/29/90 Financial
 
Assurance
 
Submittals
 
for Decommissioning
 
90-35 Transportation
 
of Type A-Quantities
 
of Non-Fissile
 
Radioactive
 
Materials 90-31 Update on Waste Form and High Integrity
 
Container Topical Report Review Status, Identification
 
of Problems with Cement Solidication, and Reporting
 
of Waste Mishaps 90-27 Clarification
 
of the Recent Revisions
 
to the Regulatory
 
===Requirements===
for Packaging
 
of Uranium Hexafluoride (UF 6 ) for Transportation
 
90-24 Transportation
 
of Model SPEC 2-T Radiographic
 
Exposure Device 90-20 Personnel
 
Injuries Resulting
 
from Improper Operation
 
of Radwaste Incinerators
 
05/24/90 05/04/90 04/30/90 04/10/90 03/22/90 All NRC licensees All fuel facility and materials All U.S. Nuclear Regulatory
 
Commission (NRC) Licensees All holders of operating licenses or construction
 
permits for nuclear power reactors, fuel cycle licenses, and certain byproduct
 
materials licenses All Uranium Fuel Fabrication
 
and Conversion
 
Facilities
 
All NRC licensees authorized
 
to use, transport, or operate radiographic
 
exposure devices and source changers All NRC licensees who process or incinerate
 
radioactive
 
waste
 
--Attachment
 
2 -IN-90-59 !September
 
17, 1990. LIST OF RECENTLY ISSUED NRC INFORMATION
 
NOTICES Information
 
Date of Notice No. Subject Issuance Issued to 90-58 90-57 90-56 90-55 83-44 Supp. 1 Improper Handling of Ophthalmic
 
Strontium-90
Beta Radiation
 
Applicators
 
===Substandard, Refurbished===
Potter & Brumfield
 
Relays Misrepresented
 
As New Inadvertent
 
Shipment of A Radioactive
 
Source In A Container
 
Thought To Be Empty Recent Operating
 
Experi-ence on Loss of Reactor Coolant Inventory
 
While In A Shutdown Condition Potential
 
Damage to Redundant
 
Safety Equip-ment As A Result of Backflow Through the Equipment
 
and Floor Drain System Summary of Requalification
 
===Program Deficiencies===
Criminal Prosecution
 
of Wrongdoing
 
Committed
 
by Suppliers
 
of Nuclear Products or Services Potential
 
Failures of Auxiliary
 
Steam Piping and the Possible Effects on the Operability
 
of Vital Equip-ment 9/11/90 9/5/90 9/4/90 8/31/90 8/30/90 8/28/90 8/24/90 8/16/90 All NRC medical licensees.
 
All holders of OLs or CPs for nuclear power reactors.All U.S. Nuclear Regulatory
 
Com-mission (NRC)licensees.
 
All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of GLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.90-54 89-18 Supp.1 90-53 OL = Operating
 
License CP = Construction
 
Permit
 
IN 90-September
 
,1990 No specific written response is required by this information
 
notice. If you have any questions
 
regarding
 
this matter, please contact the appropriate


IN 90-59September 17, 1990 iodine-131, is a one thousand-fold increase. In addition, the radiation dosereceived from an activity of iodine-131 is approximately-100 fold greater thanthe dose from the same activity of iodine-123. The following table illustratesthe relationship between microcurie versus millicurie quantities of iodine-131,as well as the radiation dose differential between iodine-123 and iodine-131,for three different age groups, with a thyroid uptake of 15 percent.TABLE:1 year5 yearsAdultA Comparison of IsQtopes and'Radiation Doses forVarious Age Groups Assuming 15% Uptake by the Thyroid*Rads per uqi Rads per mCiI-123 1-131 I-123 1-131old 0.07 7.40 70.3 7400old 0.04 4.07 40.0 40700.007 0.78 7.0 777...* Based on information from ICRP-Publication No. 53All workers should have a clear understanding of the significance of errors.inscale when calculating and preparing diagnostic dosages versus therapeuticdosages of radiopharmaceuticals containing radioiodine. The threshold at whicha diagnostic dosage becomes a therapeutic dosage is low, and depends on the ageof the patient and the percent uptake by the patient's thyroid gland.Consequently, the potential for causing a significant, undesired radiationdose to a patient's thyroid gland must always be kept in mind when administeringiodine radiopharmaceuticals.Licensees are reminded that the package inserts provided by the manufacturerscontain information pertinent to both proper dosages and radiation doses,and may be valuable resources when reviewing imaging policies and proceduresfor errors and inconsistencies. Nuclear medicine department procedures shouldinclude provisions for questioning female patients about the possibility ofpregnancy or lactation. By attention to detail, and adherence to departmentalpolicy and procedures, many incidents involving radioactive iodine-131 may beavoided.
regional office or this office.~4M zlgned #1 Richard Cunningham, Director Division of Industrial


r-IN 90-59September 17, 1990 No specific written response is required by this information notice. If youhave any questions regarding this matter, please contact the appropriate regionaloffice or this office.M r Cunnnhm, roDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards
and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards


===Technical Contact:===
Technical
Sally Merchant, NMSS(301) 492-0637-Attachments:1. List of Recently Issued NMSSInformation Notices.2. List of Recently Issued NRCInformation Notices.


Attachment 1IN 90-59September 17, 1990 LIST OF RECENTLY ISSUEDHMSS INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to:90-50Minimization of Methane Gasin Plant Systems and RadwasteShipping Containers08/08/90All holderslicenses orpermits forreactorsof operatingconstructionnuclear power90-44Dose-Rate Instruments06/29/9090-38 Requirements for Processing 05/29/90Financial Assurance Submittalsfor Decommissioning90-35 Transportation of Type A-Quantities of Non-FissileRadioactive Materials90-31 Update on Waste Form andHigh Integrity ContainerTopical Report Review Status,Identification of Problemswith Cement Solidication, andReporting of Waste Mishaps90-27 Clarification of theRecent Revisions to theRegulatory Requirementsfor Packaging of UraniumHexafluoride (UF6 ) forTransportation90-24 Transportation of ModelSPEC 2-T RadiographicExposure Device90-20 Personnel InjuriesResulting from ImproperOperation of RadwasteIncinerators05/24/9005/04/9004/30/9004/10/9003/22/90All NRC licenseesAll fuel facilityand materialsAll U.S. NuclearRegulatory Commission(NRC) LicenseesAll holders of operatinglicenses or constructionpermits for nuclear powerreactors, fuel cyclelicenses, and certainbyproduct materialslicensesAll Uranium FuelFabrication and ConversionFacilitiesAll NRC licenseesauthorized to use,transport, or operateradiographic exposuredevices and sourcechangersAll NRC licenseeswho process or incinerateradioactive waste
Contact: Sally Merchant, NMSS (301) 492-0637 Attachments:
1. List of Recently Issued NMSS Information


--Attachment 2 -IN-90-59 !September 17, 1990. LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to90-5890-5790-5690-5583-44Supp. 1Improper Handling ofOphthalmic Strontium-90Beta Radiation ApplicatorsSubstandard, RefurbishedPotter & Brumfield RelaysMisrepresented As NewInadvertent Shipment of ARadioactive Source In AContainer Thought To BeEmptyRecent Operating Experi-ence on Loss of ReactorCoolant Inventory WhileIn A Shutdown ConditionPotential Damage toRedundant Safety Equip-ment As A Result ofBackflow Through theEquipment and Floor DrainSystemSummary of RequalificationProgram DeficienciesCriminal Prosecution ofWrongdoing Committed bySuppliers of NuclearProducts or ServicesPotential Failures ofAuxiliary Steam Piping andthe Possible Effects on theOperability of Vital Equip-ment9/11/909/5/909/4/908/31/908/30/908/28/908/24/908/16/90All NRC medicallicensees.All holders of OLsor CPs for nuclearpower reactors.All U.S. NuclearRegulatory Com-mission (NRC)licensees.All holders of OLsor CPs for nuclearpower reactors.All holders of OLsor CPs for nuclearpower reactors.All holders of GLsor CPs for nuclearpower reactors.All holders of OLsor CPs for nuclearpower reactors.All holders of OLsor CPs for nuclearpower reactors.90-5489-18Supp.190-53OL = Operating LicenseCP = Construction Permit
Notices.2. List of Recently Issued NRC Information


IN 90-September ,1990 No specific written response is required by this information notice. If youhave any questions regarding this matter, please contact the appropriateregional office or this office.~4M zlgned #1Richard Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards
Notices.E. Kraus/Tech.


===Technical Contact:===
Ed.8/21/90 1311}}
Sally Merchant, NMSS(301) 492-0637Attachments:1. List of Recently Issued NMSSInformation Notices.2. List of Recently Issued NRCInformation Notices.E. Kraus/Tech. Ed.8/21/901311
}}


{{Information notice-Nav}}
{{Information notice-Nav}}

Revision as of 13:46, 31 August 2018

Errors in Use of Radioactive Iodine-131
ML031130270
Person / Time
Site: Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant  Entergy icon.png
Issue date: 09/17/1990
From: Cunningham R E
NRC/NMSS/IMNS
To:
References
IN-90-059, NUDOCS 9009120156
Download: ML031130270 (8)


UNITED STATES NUCLEAR REGULATORY

COMMISSION

OFFICE OF NUCLEAR MATERIALS

SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 September

17, 1990 NRC INFORMATION

NOTICE NO. 90-59: ERRORS IN THE USE OF RADIOACTIVE

IODINE-131

Addressees

All medical licensees.

Purpose

This information

notice is intended to emphasize

to medical use licensees

the potential

radiation

dose levels resulting

from errors in the administration

of iodine-131 to humans. This issue was previously

addressed

in IE Information

Notice No. 85-61, Suppliment

1: Misadministrations

To Patients Undergoing

Thyroid Scans (attached).

Due to the significance

and frequency

of recurrence

of these errors, NRC believes this issue should be readdressed.

It is expected that licensees

will review this information

for application

to their own procedures

for the administration

of iodine-131, distribute

the notice to those responsible

for radiation

safety and quality assurance, and consider actions, if appropriate, to establish

procedures

to preclude the misadministration

of iodine-131 at their facilities.

However, suggestions

contained

in this notice do not constitute

any new U.S. Nuclear Regulatory

Commission (NRC) requirements, and no written response is required.Description

of Circumstances:

The following

cases are recent events reported to NRC that have resulted in unintended

radiation

doses to humans, as a result of the administration

of radioactive

iodine: Case 1: A patient with a history of thyroid cancer was scheduled

for her yearly whole-body

scan. Before the scan, the patient underwent

a pregnancy test, with negative results. After the pregnancy

test results were received, the technologist

began to complete a departmental

questionnaire

to obtain information

from the patient relative to the requested

procedure.

The questionnaire

addressed

the possibilities

of pregnancy

and lactation.

However, before completing

the questionnaire, the technologist

was called away and did not return to complete the form before administration

of the iodine-131.

As a result, the patient was given the intended dosage of 4.89 millicuries

of iodine-131.

Approximately

48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> later when the patient was scanned, there was considerable

iodine-131 uptake in her breasts. When questioned

by the physician, the patient indicated

that she had given birth to a female infant two weeks earlier and had been nursing this infant for approximately

the last 36 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br />. The total body dose to the infant was estimated

to be 17 rads, and the radiation

dose to the infant's thyroid was estimated

to be 30,000 rads. A synthetic

thyroid hormone replacement

has been prescribed

for the child, with scheduled

periodic follow-ups.

The unintended

dose to the mother's breasts was estimated

to be 8.9 rads.> 920156 Z J 4 9_0we

IN 90-59 September

17, 1990 Case 2: A patient to be scheduled

for a thyroid scan was administered

3 millicuries

of iodine-131 instead of the intended dosage of 300 microcuries

of iodine-123.

The patient's

physician

called in the request for a thyroid scan to the secretary

of the nuclear medicine department, who inadvertently

scheduled

a whole-body

scan. No written request from the physician

was required.

The dosage at this facility for a whole-body

scan is 3 millicuries

of iodine-131, whereas the dosage for a thyroid scan is 300 microcuries

of iodine-123.

The estimated

dose to the patient's

thyroid gland due to this error was 4700 rads.Case 3: A patient was scheduled

for an ectopic thyroid evaluation, with an intended dosage of 100 microcuries

of iodine-131.

In completing

the Nuclear Medicine department

referral sheet, the referring

physician

incorrectly

requested

a post-thyroidectomy

neck scan. As a result, the patient was administered

1 millicurie

of iodine-131, with an estimated

dose to the thyroid of 1300 rads.Case 4: A patient was scheduled

for an ectopic thyroid evaluation, with an Intended dosage of 50 to 100 microcuries

of iodine-131.

The technologist

consulted

the department

procedure

manual that listed prescribed

dosages for specific scans, and the dosage was incorrectly

listed as 4.5 millicuries.

As a'result, the patient was administered

4.3 millicuries.

The estimated

dose'to this patient's

thyroid gland was 4300 rads.Case 5: A patient was administered

a dosage of 15 microcuries

of iodine-131.

Almost immediately

following

the administration, the patient indicated

to the technologist

that she was approximately

4 to 5 weeks pregnant..

The technologist

failed to ask the patient if she was pregnant before the administration.

The patient had arrived at the department

with a baby in her arms, and the technologist

assumed that the patient was not pregnant.

The total body dose to the fetus was estimated

to be 2 to 4 millirem.

Since the fetal thyroid is incapable

of concentrating

iodine-131 until approximately

12 weeks of gestation, it was estimated

that there was no additional

dose to the fetal thyroid.

DISCUSSION

All licensees

are reminded of the importance

of ensuring the safe performance

of licensed activities, in accordance

with NRC regulations, requirements

of their licenses, and accepted medical practice.

The forementioned

cases illustrate:

the lack of familiarity

with appropriate

thyroid studies and dosages; the necessity

of consistently

following

quality control procedures;

and a need to understand

the significance

of radiation

doses that result -from the administration

of millicuries

versus microcuries

of radiopharmaceuticals

containing

radioiodine.

Specifically, the radiation

dose to the thyroid, resulting

from a dosage of one millicurie

rather than one microcurie

of j .

IN 90-59 September

17, 1990 iodine-131, is a one thousand-fold

increase.

In addition, the radiation

dose received from an activity of iodine-131 is approximately-100

fold greater than the dose from the same activity of iodine-123.

The following

table illustrates

the relationship

between microcurie

versus millicurie

quantities

of iodine-131, as well as the radiation

dose differential

between iodine-123 and iodine-131, for three different

age groups, with a thyroid uptake of 15 percent.TABLE: 1 year 5 years Adult A Comparison

of IsQtopes and'Radiation

Doses for Various Age Groups Assuming 15% Uptake by the Thyroid*Rads per uqi Rads per mCi I-123 1-131 I-123 1-131 old 0.07 7.40 70.3 7400 old 0.04 4.07 40.0 4070 0.007 0.78 7.0 777...* Based on information

from ICRP-Publication

No. 53 All workers should have a clear understanding

of the significance

of errors.in scale when calculating

and preparing

diagnostic

dosages versus therapeutic

dosages of radiopharmaceuticals

containing

radioiodine.

The threshold

at which a diagnostic

dosage becomes a therapeutic

dosage is low, and depends on the age of the patient and the percent uptake by the patient's

thyroid gland.Consequently, the potential

for causing a significant, undesired

radiation dose to a patient's

thyroid gland must always be kept in mind when administering

iodine radiopharmaceuticals.

Licensees

are reminded that the package inserts provided by the manufacturers

contain information

pertinent

to both proper dosages and radiation

doses, and may be valuable resources

when reviewing

imaging policies and procedures

for errors and inconsistencies.

Nuclear medicine department

procedures

should include provisions

for questioning

female patients about the possibility

of pregnancy

or lactation.

By attention

to detail, and adherence

to departmental

policy and procedures, many incidents

involving

radioactive

iodine-131 may be avoided.

r-IN 90-59 September

17, 1990 No specific written response is required by this information

notice. If you have any questions

regarding

this matter, please contact the appropriate

regional office or this office.M r Cunnnhm, ro Division of Industrial

and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Technical

Contact: Sally Merchant, NMSS (301) 492-0637-Attachments:

1. List of Recently Issued NMSS Information

Notices.2. List of Recently Issued NRC Information

Notices.

Attachment

1 IN 90-59 September

17, 1990 LIST OF RECENTLY ISSUED HMSS INFORMATION

NOTICES Information

Date of Notice No. Subject Issuance Issued to: 90-50 Minimization

of Methane Gas in Plant Systems and Radwaste Shipping Containers

08/08/90 All holders licenses or permits for reactors of operating construction

nuclear power 90-44 Dose-Rate

Instruments

06/29/90 90-38 Requirements

for Processing

05/29/90 Financial

Assurance

Submittals

for Decommissioning

90-35 Transportation

of Type A-Quantities

of Non-Fissile

Radioactive

Materials 90-31 Update on Waste Form and High Integrity

Container Topical Report Review Status, Identification

of Problems with Cement Solidication, and Reporting

of Waste Mishaps 90-27 Clarification

of the Recent Revisions

to the Regulatory

Requirements

for Packaging

of Uranium Hexafluoride (UF 6 ) for Transportation

90-24 Transportation

of Model SPEC 2-T Radiographic

Exposure Device 90-20 Personnel

Injuries Resulting

from Improper Operation

of Radwaste Incinerators

05/24/90 05/04/90 04/30/90 04/10/90 03/22/90 All NRC licensees All fuel facility and materials All U.S. Nuclear Regulatory

Commission (NRC) Licensees All holders of operating licenses or construction

permits for nuclear power reactors, fuel cycle licenses, and certain byproduct

materials licenses All Uranium Fuel Fabrication

and Conversion

Facilities

All NRC licensees authorized

to use, transport, or operate radiographic

exposure devices and source changers All NRC licensees who process or incinerate

radioactive

waste

--Attachment

2 -IN-90-59 !September

17, 1990. LIST OF RECENTLY ISSUED NRC INFORMATION

NOTICES Information

Date of Notice No. Subject Issuance Issued to 90-58 90-57 90-56 90-55 83-44 Supp. 1 Improper Handling of Ophthalmic

Strontium-90

Beta Radiation

Applicators

Substandard, Refurbished

Potter & Brumfield

Relays Misrepresented

As New Inadvertent

Shipment of A Radioactive

Source In A Container

Thought To Be Empty Recent Operating

Experi-ence on Loss of Reactor Coolant Inventory

While In A Shutdown Condition Potential

Damage to Redundant

Safety Equip-ment As A Result of Backflow Through the Equipment

and Floor Drain System Summary of Requalification

Program Deficiencies

Criminal Prosecution

of Wrongdoing

Committed

by Suppliers

of Nuclear Products or Services Potential

Failures of Auxiliary

Steam Piping and the Possible Effects on the Operability

of Vital Equip-ment 9/11/90 9/5/90 9/4/90 8/31/90 8/30/90 8/28/90 8/24/90 8/16/90 All NRC medical licensees.

All holders of OLs or CPs for nuclear power reactors.All U.S. Nuclear Regulatory

Com-mission (NRC)licensees.

All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of GLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.90-54 89-18 Supp.1 90-53 OL = Operating

License CP = Construction

Permit

IN 90-September

,1990 No specific written response is required by this information

notice. If you have any questions

regarding

this matter, please contact the appropriate

regional office or this office.~4M zlgned #1 Richard Cunningham, Director Division of Industrial

and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Technical

Contact: Sally Merchant, NMSS (301) 492-0637 Attachments:

1. List of Recently Issued NMSS Information

Notices.2. List of Recently Issued NRC Information

Notices.E. Kraus/Tech.

Ed.8/21/90 1311