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

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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY
{{#Wiki_filter:UNITED STATES


COMMISSION
NUCLEAR REGULATORY COMMISSION


OFFICE OF NUCLEAR MATERIALS
OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS


===SAFETY AND SAFEGUARDS===
WASHINGTON, D.C. 20555 September 17, 1990
WASHINGTON, D.C. 20555 September
NRC INFORMATION NOTICE NO. 90-59:   ERRORS IN THE USE OF RADIOACTIVE IODINE-131
 
17, 1990 NRC INFORMATION
 
NOTICE NO. 90-59: ERRORS IN THE USE OF RADIOACTIVE
 
IODINE-131


==Addressees==
==Addressees==
Line 34: Line 28:


==Purpose==
==Purpose==
: This information
:
This information notice is intended to emphasize to medical use licensees the


notice is intended to emphasize
potential radiation dose levels resulting from errors in the administration


to medical use licensees
of iodine-131 to humans. This issue was previously addressed in IE Information


the potential
Notice No. 85-61, Suppliment 1: Misadministrations To Patients Undergoing


radiation
Thyroid Scans (attached). Due to the significance and frequency of recurrence


dose levels resulting
of these errors, NRC believes this issue should be readdressed. It is expected


from errors in the administration
that licensees will review this information for application to their own procedures


of iodine-131 to humans. This issue was previously
for the administration of iodine-131, distribute the notice to those responsible


addressed
for radiation safety and quality assurance, and consider actions, if appropriate, to establish procedures to preclude the misadministration of iodine-131 at their


in IE Information
facilities. However, suggestions contained in this notice do not constitute any


Notice No. 85-61, Suppliment
new U.S. Nuclear Regulatory Commission (NRC) requirements, and no written


1: Misadministrations
response is required.


===To Patients Undergoing===
==Description of Circumstances==
Thyroid Scans (attached).
:
 
The following cases are recent events reported to NRC that have resulted in
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.
unintended radiation doses to humans, as a result of the administration of


However, before completing
radioactive iodine:
Case 1: A patient with a history of thyroid cancer was scheduled for her


the questionnaire, the technologist
yearly whole-body scan. Before the scan, the patient underwent a pregnancy


was called away and did not return to complete the form before administration
test, with negative results. After the pregnancy test results were received, the technologist began to complete a departmental questionnaire to obtain


of the iodine-131.
information from the patient relative to the requested procedure. The


As a result, the patient was given the intended dosage of 4.89 millicuries
questionnaire addressed the possibilities of pregnancy and lactation. However, before completing the questionnaire, the technologist was called away and did


of iodine-131.
not return to complete the form before administration of the iodine-131. As


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


48 hours later when the patient was scanned, there was considerable
iodine-131. Approximately 48 hours later when the patient was scanned, there


iodine-131 uptake in her breasts. When questioned
was considerable iodine-131 uptake in her breasts. When questioned by the


by the physician, the patient indicated
physician, the patient indicated that she had given birth to a female the infant


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


the last 36 hours. The total body dose to the infant was estimated
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


to be 17 rads, and the radiation
child, with scheduled periodic follow-ups. The unintended dose to the mother's


dose to the infant's thyroid was estimated
breasts was estimated to be 8.9 rads.


to be 30,000 rads. A synthetic
920156
>9_0we        Z 4J


thyroid hormone replacement
IN 90-59 September 17, 1990 Case 2: A patient to be scheduled for a thyroid scan was


has been prescribed
millicuries of iodine-131 instead of the intended dosage ofadministered      3
                                                              300 microcuries of


for the child, with scheduled
iodine-123. The patient's physician called in the request for


periodic follow-ups.
a thyroid scan


The unintended
to the secretary of the nuclear medicine department, who inadvertently


dose to the mother's breasts was estimated
scheduled a whole-body scan. No written request from the physician


to be 8.9 rads.> 920156 Z J 4 9_0we
required. The dosage at this facility for a whole-body scan is            was


IN 90-59 September
3 of iodine-131, whereas the dosage for a thyroid scan is 300 microcuriesmillicuries


17, 1990 Case 2: A patient to be scheduled
iodine-123. The estimated dose to the patient's thyroid gland                  of


for a thyroid scan was administered
error was 4700 rads.                                              due  to  this


3 millicuries
Case 3: A patient was scheduled for an ectopic thyroid evaluation, intended dosage of 100 microcuries of iodine-131. In completing        with an


of iodine-131 instead of the intended dosage of 300 microcuries
Medicine department referral sheet, the referring physician         the  Nuclear
 
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
incorrectly


requested
requested a post-thyroidectomy neck scan. As a result, the patient
 
a post-thyroidectomy
 
neck scan. As a result, the patient was administered


1 millicurie
administered 1 millicurie of iodine-131, with an estimated dose          was


of iodine-131, with an estimated
thyroid of 1300 rads.                                              to  the


dose to the thyroid of 1300 rads.Case 4: A patient was scheduled
Case 4: A patient was scheduled for an ectopic thyroid evaluation, Intended dosage of 50 to 100 microcuries of iodine-131. The technologistwith an


for an ectopic thyroid evaluation, with an Intended dosage of 50 to 100 microcuries
consulted the department procedure manual that listed prescribed


of iodine-131.
dosages for


===The technologist===
specific scans, and the dosage was incorrectly listed as 4.5 millicuries.
consulted


the department
'result, the patient was administered 4.3 millicuries. The estimated                As a


procedure
this patient's thyroid gland was 4300 rads.                              dose'to


manual that listed prescribed
Case 5: A patient was administered a dosage of 15 microcuries


dosages for specific scans, and the dosage was incorrectly
Almost immediately following the administration, the patient      of iodine-131.


listed as 4.5 millicuries.
technologist that she was approximately 4 to 5 weeks pregnant..indicated      to the


As a'result, the patient was administered
The


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


The estimated
patient had arrived at the department with a baby in her arms,                  The


dose'to this patient's
technologist assumed that the patient was not pregnant. The      and    the


thyroid gland was 4300 rads.Case 5: A patient was administered
the fetus was estimated to be 2 to 4 millirem. Since the fetal total body dose to


a dosage of 15 microcuries
incapable of concentrating iodine-131 until approximately 12        thyroid is


of iodine-131.
weeks


Almost immediately
it was estimated that there was no additional dose to the fetal         of gestation, thyroid.
 
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
All licensees are reminded of the importance of ensuring the
 
are reminded of the importance


of ensuring the safe performance
safe performance


of licensed activities, in accordance
of licensed activities, in accordance with NRC regulations, requirements


with NRC regulations, requirements
their licenses, and accepted medical practice. The forementioned                of


of their licenses, and accepted medical practice.
illustrate: the lack of familiarity with appropriate thyroid          cases


The forementioned
dosages; the necessity of consistently following quality control studies and


cases illustrate:
and a need to understand the significance of radiation doses          procedures;
the lack of familiarity
from the administration of millicuries versus microcuries of  that    result -
containing radioiodine. Specifically, the radiation dose      radiopharmaceuticals


with appropriate
resulting from a dosage of one millicurie rather than one to the thyroid, microcurie of


thyroid studies and dosages; the necessity
j  .


of consistently
IN 90-59 September 17, 1990 radiation dose


following
iodine-131, is a one thousand-fold increase. In addition, the            greater than


quality control procedures;
received from an activity of iodine-131 is approximately-100 fold            illustrates
and a need to understand


the significance
the dose from the same activity of iodine-123. The following table      of  iodine-131, the relationship between microcurie versus millicurie quantities    and  iodine-131, as well as the radiation dose differential between iodine-123 for three different age groups, with a thyroid uptake of 15 percent.


of radiation
TABLE:  A Comparison of IsQtopes and'Radiation Doses for


doses that result -from the administration
Various Age Groups Assuming 15% Uptake by the Thyroid*
                          Rads per uqi                  Rads per mCi


of millicuries
I-123          1-131          I-123      1-131
      1 year  old      0.07          7.40          70.3        7400
      5 years old      0.04          4.07          40.0        4070
      Adult            0.007          0.78            7.0          777
                                                                                .    .  .


versus microcuries
*  Based on information from ICRP-Publication No. 53 of errors.in


of radiopharmaceuticals
All workers should have a clear understanding of the significance    therapeutic


containing
scale when calculating and preparing diagnostic dosages versusthreshold at which


radioiodine.
dosages of radiopharmaceuticals containing radioiodine. The                  on the age


Specifically, the radiation
a diagnostic dosage becomes a therapeutic dosage is low, and depends


dose to the thyroid, resulting
thyroid   gland.


from a dosage of one millicurie
of the patient and the percent uptake by the patient's                  radiation


rather than one microcurie
Consequently, the potential for causing a significant, undesired  when    administering


of j .
dose to a patient's thyroid gland must always     be kept in mind
 
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.
iodine radiopharmaceuticals.


Licensees
manufacturers


are reminded that the package inserts provided by the manufacturers
Licensees are reminded that the package inserts provided by the           doses, contain information pertinent  to both  proper dosages  and radiation


contain information
when  reviewing  imaging  policies  and  procedures


pertinent
and may be valuable resources                                                    should


to both proper dosages and radiation
for errors and inconsistencies. Nuclear medicine department procedures of


doses, and may be valuable resources
include provisions for questioning female patients about the    possibility


when reviewing
pregnancy or lactation. By attention to detail, and adherence to departmental    may be


imaging policies and procedures
policy and procedures, many incidents involving radioactive iodine-131 avoided.


for errors and inconsistencies.
r- IN 90-59 September 17, 1990 No specific written response is required by this information


Nuclear medicine department
have any questions regarding this matter, please contact        notice. If you


procedures
office or this office.                                      the appropriate regional


should include provisions
M    rCunnnhm, ro


for questioning
Division of Industrial and


female patients about the possibility
Medical Nuclear Safety


of pregnancy
Office of Nuclear Material Safety


or lactation.
and Safeguards


By attention
===Technical Contact:===


to detail, and adherence
===Sally Merchant, NMSS===
                    (301) 492-0637- Attachments:
1. List of Recently Issued NMSS


to departmental
Information Notices.


policy and procedures, many incidents
2. List of Recently Issued NRC


involving
Information Notices.


radioactive
Attachment 1 IN 90-59 September 17, 1990 LIST OF RECENTLY ISSUED


iodine-131 may be avoided.
HMSS INFORMATION NOTICES


r-IN 90-59 September
===Information                              Date of===
Notice No.            Subject            Issuance    Issued to:
90-50      Minimization of Methane Gas    08/08/90   All holders of operating


17, 1990 No specific written response is required by this information
in Plant Systems and Radwaste              licenses or construction


notice. If you have any questions
Shipping Containers                        permits for nuclear power


regarding
reactors


this matter, please contact the appropriate
90-44      Dose-Rate Instruments          06/29/90    All NRC licensees


regional office or this office.M r Cunnnhm, ro Division of Industrial
90-38      Requirements for Processing    05/29/90    All fuel facility


and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Financial Assurance Submittals            and materials


Technical
for Decommissioning


Contact: Sally Merchant, NMSS (301) 492-0637-Attachments:
90-35      Transportation of Type A        05/24/90  All U.S. Nuclear
1. List of Recently Issued NMSS Information


Notices.2. List of Recently Issued NRC Information
-    Quantities of Non-Fissile                  Regulatory Commission


Notices.
Radioactive Materials                      (NRC) Licensees
 
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
90-31      Update on Waste Form and      05/04/90  All holders of operating


of Type A-Quantities
High Integrity Container                  licenses or construction


of Non-Fissile
Topical Report Review Status,              permits for nuclear power


Radioactive
Identification of Problems                reactors, fuel cycle


Materials 90-31 Update on Waste Form and High Integrity
with Cement Solidication, and             licenses, and certain


Container Topical Report Review Status, Identification
Reporting of Waste Mishaps                byproduct materials


of Problems with Cement Solidication, and Reporting
licenses


of Waste Mishaps 90-27 Clarification
90-27     Clarification of the          04/30/90    All Uranium Fuel


of the Recent Revisions
Recent Revisions to the                    Fabrication and Conversion


to the Regulatory
Regulatory Requirements                    Facilities


===Requirements===
for Packaging of Uranium
for Packaging


of Uranium Hexafluoride (UF 6 ) for Transportation
Hexafluoride (UF6 ) for


90-24 Transportation
Transportation


of Model SPEC 2-T Radiographic
90-24      Transportation of Model       04/10/90    All NRC licensees


Exposure Device 90-20 Personnel
SPEC 2-T Radiographic                      authorized to use, Exposure Device                           transport, or operate


Injuries Resulting
radiographic exposure


from Improper Operation
devices and source


of Radwaste Incinerators
changers


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
90-20      Personnel Injuries            03/22/90   All NRC licensees


Commission (NRC) Licensees All holders of operating licenses or construction
Resulting from Improper                  who process or incinerate


permits for nuclear power reactors, fuel cycle licenses, and certain byproduct
Operation of Radwaste                    radioactive waste


materials licenses All Uranium Fuel Fabrication
Incinerators


and Conversion
- -  Attachment 2      -
                                                            IN-90-59 !
                                                            September 17, 1990
                                                            . LIST OF RECENTLY ISSUED


Facilities
NRC INFORMATION NOTICES


All NRC licensees authorized
Information                                    Date of


to use, transport, or operate radiographic
Notice No.              Subject              Issuance    Issued to


exposure devices and source changers All NRC licensees who process or incinerate
90-58          Improper Handling of            9/11/90    All NRC medical


radioactive
Ophthalmic Strontium-90                      licensees.


waste
Beta Radiation Applicators


--Attachment
90-57          Substandard, Refurbished        9/5/90      All holders of OLs


2 -IN-90-59 !September
Potter & Brumfield Relays                    or CPs for nuclear


17, 1990. LIST OF RECENTLY ISSUED NRC INFORMATION
Misrepresented As New                        power reactors.


NOTICES Information
90-56          Inadvertent Shipment of A        9/4/90      All U.S. Nuclear


Date of Notice No. Subject Issuance Issued to 90-58 90-57 90-56 90-55 83-44 Supp. 1 Improper Handling of Ophthalmic
Radioactive Source In A                      Regulatory Com- Container Thought To Be                      mission (NRC)
              Empty                                        licensees.


Strontium-90
90-55          Recent Operating Experi-         8/31/90     All holders of OLs
Beta Radiation


Applicators
ence on Loss of Reactor                      or CPs for nuclear


===Substandard, Refurbished===
Coolant Inventory While                      power reactors.
Potter & Brumfield


Relays Misrepresented
In A Shutdown Condition


As New Inadvertent
83-44          Potential Damage to              8/30/90    All holders of OLs


Shipment of A Radioactive
Supp. 1        Redundant Safety Equip-                      or CPs for nuclear


Source In A Container
ment As A Result of                          power reactors.


Thought To Be Empty Recent Operating
Backflow Through the


Experi-ence on Loss of Reactor Coolant Inventory
Equipment and Floor Drain


While In A Shutdown Condition Potential
System


Damage to Redundant
90-54          Summary of Requalification      8/28/90    All holders of GLs


Safety Equip-ment As A Result of Backflow Through the Equipment
Program Deficiencies                        or CPs for nuclear


and Floor Drain System Summary of Requalification
power reactors.


===Program Deficiencies===
89-18          Criminal Prosecution of          8/24/90    All holders of OLs
Criminal Prosecution


of Wrongdoing
Supp. 1        Wrongdoing Committed by                      or CPs for nuclear


Committed
Suppliers of Nuclear                        power reactors.


by Suppliers
Products or Services


of Nuclear Products or Services Potential
90-53          Potential Failures of           8/16/90    All holders of OLs


Failures of Auxiliary
Auxiliary Steam Piping and                  or CPs for nuclear


Steam Piping and the Possible Effects on the Operability
the Possible Effects on the                 power reactors.


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.
Operability of Vital Equip- ment


All holders of OLs or CPs for nuclear power reactors.All U.S. Nuclear Regulatory
OL = Operating License


Com-mission (NRC)licensees.
CP = Construction Permit


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
IN 90-
                                                                September ,1990 No specific written response is required by this information notice. If you


License CP = Construction
have any questions regarding this matter, please contact the appropriate


Permit
regional office or this office.


IN 90-September
~4M zlgned #1 Richard Cunningham, Director


,1990 No specific written response is required by this information
Division of Industrial and


notice. If you have any questions
Medical Nuclear Safety


regarding
Office of Nuclear Material Safety


this matter, please contact the appropriate
and Safeguards


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


and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
===Sally Merchant, NMSS===
                    (301) 492-0637 Attachments:
1. List of Recently Issued NMSS


Technical
Information Notices.


Contact: Sally Merchant, NMSS (301) 492-0637 Attachments:
2. List of Recently Issued NRC
1. List of Recently Issued NMSS Information


Notices.2. List of Recently Issued NRC Information
Information Notices.


Notices.E. Kraus/Tech.
E. Kraus/Tech. Ed.


Ed.8/21/90 1311}}
8/21/90
                                    1311}}


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

Latest revision as of 04:03, 24 November 2019

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
NRC/NMSS/IMNS
To:
References
IN-90-059, NUDOCS 9009120156
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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 the infant

two weeks earlier and had been nursing this infant for approximately 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

>9_0we Z 4J

IN 90-59 September 17, 1990 Case 2: A patient to be scheduled for a thyroid scan was

millicuries of iodine-131 instead of the intended dosage ofadministered 3

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

required. The dosage at this facility for a whole-body scan is was

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

iodine-123. The estimated dose to the patient's thyroid gland of

error was 4700 rads. due to this

Case 3: A patient was scheduled for an ectopic thyroid evaluation, intended dosage of 100 microcuries of iodine-131. In completing with an

Medicine department referral sheet, the referring physician the Nuclear

incorrectly

requested a post-thyroidectomy neck scan. As a result, the patient

administered 1 millicurie of iodine-131, with an estimated dose was

thyroid of 1300 rads. to the

Case 4: A patient was scheduled for an ectopic thyroid evaluation, Intended dosage of 50 to 100 microcuries of iodine-131. The technologistwith an

consulted the department procedure manual that listed prescribed

dosages for

specific scans, and the dosage was incorrectly listed as 4.5 millicuries.

'result, the patient was administered 4.3 millicuries. The estimated As a

this patient's thyroid gland was 4300 rads. dose'to

Case 5: A patient was administered a dosage of 15 microcuries

Almost immediately following the administration, the patient of iodine-131.

technologist that she was approximately 4 to 5 weeks pregnant..indicated to the

The

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

patient had arrived at the department with a baby in her arms, The

technologist assumed that the patient was not pregnant. The and the

the fetus was estimated to be 2 to 4 millirem. Since the fetal total body dose to

incapable of concentrating iodine-131 until approximately 12 thyroid is

weeks

it was estimated that there was no additional dose to the fetal of gestation, thyroid.

DISCUSSION

All licensees are reminded of the importance of ensuring the

safe performance

of licensed activities, in accordance with NRC regulations, requirements

their licenses, and accepted medical practice. The forementioned of

illustrate: the lack of familiarity with appropriate thyroid cases

dosages; the necessity of consistently following quality control studies and

and a need to understand the significance of radiation doses procedures;

from the administration of millicuries versus microcuries of that result -

containing radioiodine. Specifically, the radiation dose radiopharmaceuticals

resulting from a dosage of one millicurie rather than one to the thyroid, microcurie of

j .

IN 90-59 September 17, 1990 radiation dose

iodine-131, is a one thousand-fold increase. In addition, the greater than

received from an activity of iodine-131 is approximately-100 fold illustrates

the dose from the same activity of iodine-123. The following table of iodine-131, the relationship between microcurie versus millicurie quantities and iodine-131, as well as the radiation dose differential between iodine-123 for three different age groups, with a thyroid uptake of 15 percent.

TABLE: 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

1 year old 0.07 7.40 70.3 7400

5 years old 0.04 4.07 40.0 4070

Adult 0.007 0.78 7.0 777

. . .

  • Based on information from ICRP-Publication No. 53 of errors.in

All workers should have a clear understanding of the significance therapeutic

scale when calculating and preparing diagnostic dosages versusthreshold at which

dosages of radiopharmaceuticals containing radioiodine. The on the age

a diagnostic dosage becomes a therapeutic dosage is low, and depends

thyroid gland.

of the patient and the percent uptake by the patient's radiation

Consequently, the potential for causing a significant, undesired when administering

dose to a patient's thyroid gland must always be kept in mind

iodine radiopharmaceuticals.

manufacturers

Licensees are reminded that the package inserts provided by the doses, contain information pertinent to both proper dosages and radiation

when reviewing imaging policies and procedures

and may be valuable resources should

for errors and inconsistencies. Nuclear medicine department procedures of

include provisions for questioning female patients about the possibility

pregnancy or lactation. By attention to detail, and adherence to departmental may be

policy and procedures, many incidents involving radioactive iodine-131 avoided.

r- IN 90-59 September 17, 1990 No specific written response is required by this information

have any questions regarding this matter, please contact notice. If you

office or this office. the appropriate regional

M rCunnnhm, 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 08/08/90 All holders of operating

in Plant Systems and Radwaste licenses or construction

Shipping Containers permits for nuclear power

reactors

90-44 Dose-Rate Instruments 06/29/90 All NRC licensees

90-38 Requirements for Processing 05/29/90 All fuel facility

Financial Assurance Submittals and materials

for Decommissioning

90-35 Transportation of Type A 05/24/90 All U.S. Nuclear

- Quantities of Non-Fissile Regulatory Commission

Radioactive Materials (NRC) Licensees

90-31 Update on Waste Form and 05/04/90 All holders of operating

High Integrity Container licenses or construction

Topical Report Review Status, permits for nuclear power

Identification of Problems reactors, fuel cycle

with Cement Solidication, and licenses, and certain

Reporting of Waste Mishaps byproduct materials

licenses

90-27 Clarification of the 04/30/90 All Uranium Fuel

Recent Revisions to the Fabrication and Conversion

Regulatory Requirements Facilities

for Packaging of Uranium

Hexafluoride (UF6 ) for

Transportation

90-24 Transportation of Model 04/10/90 All NRC licensees

SPEC 2-T Radiographic authorized to use, Exposure Device transport, or operate

radiographic exposure

devices and source

changers

90-20 Personnel Injuries 03/22/90 All NRC licensees

Resulting from Improper who process or incinerate

Operation of Radwaste radioactive waste

Incinerators

- - 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 Improper Handling of 9/11/90 All NRC medical

Ophthalmic Strontium-90 licensees.

Beta Radiation Applicators

90-57 Substandard, Refurbished 9/5/90 All holders of OLs

Potter & Brumfield Relays or CPs for nuclear

Misrepresented As New power reactors.

90-56 Inadvertent Shipment of A 9/4/90 All U.S. Nuclear

Radioactive Source In A Regulatory Com- Container Thought To Be mission (NRC)

Empty licensees.

90-55 Recent Operating Experi- 8/31/90 All holders of OLs

ence on Loss of Reactor or CPs for nuclear

Coolant Inventory While power reactors.

In A Shutdown Condition

83-44 Potential Damage to 8/30/90 All holders of OLs

Supp. 1 Redundant Safety Equip- or CPs for nuclear

ment As A Result of power reactors.

Backflow Through the

Equipment and Floor Drain

System

90-54 Summary of Requalification 8/28/90 All holders of GLs

Program Deficiencies or CPs for nuclear

power reactors.

89-18 Criminal Prosecution of 8/24/90 All holders of OLs

Supp. 1 Wrongdoing Committed by or CPs for nuclear

Suppliers of Nuclear power reactors.

Products or Services

90-53 Potential Failures of 8/16/90 All holders of OLs

Auxiliary Steam Piping and or CPs for nuclear

the Possible Effects on the power reactors.

Operability of Vital Equip- ment

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


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