Information Notice 2019-05, Patient Skin Contamination Events Associated with I-131 During Neuroblastoma Treatments: Difference between revisions

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{{#Wiki_filter:UNITED STATES
{{#Wiki_filter:ML19094B733
 
UNITED STATES


NUCLEAR REGULATORY COMMISSION
NUCLEAR REGULATORY COMMISSION
Line 24: Line 26:
SAFETY AND SAFEGUARDS
SAFETY AND SAFEGUARDS


WASHINGTON, D.C. 20555 August 14, 2019 NRC INFORMATION NOTICE 2019-05: PATIENT SKIN CONTAMINATION EVENTS
WASHINGTON, D.C. 20555  
 
August 14, 2019  
 
NRC INFORMATION NOTICE 2019-05: PATIENT SKIN CONTAMINATION EVENTS


ASSOCIATED WITH I-131 METAIODOBENZYLGUANIDINE DURING
ASSOCIATED WITH I-131 METAIODOBENZYLGUANIDINE DURING
Line 33: Line 39:
All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC master materials
All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC master materials


licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers.
licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers.


==PURPOSE==
==PURPOSE==
The NRC is issuing this information notice (IN) to alert addressees of potential patient
The NRC is issuing this information notice (IN) to alert addressees of potential patient


contamination risks associated with therapeutic treatments with iodine-131 (I-131) meta- iodobenzylguanidine (MIBG). The NRC expects that recipients will review the information for
contamination risks associated with therapeutic treatments with iodine-131 (I-131) meta- iodobenzylguanidine (MIBG).   The NRC expects that recipients will review the information for


applicability to their facilities and consider actions, as appropriate, to avoid similar problems.
applicability to their facilities and consider actions, as appropriate, to avoid similar problems.
Line 44: Line 50:
Information contained in this IN does not constitute new NRC requirements; therefore, no specific
Information contained in this IN does not constitute new NRC requirements; therefore, no specific


action or written response is required. The NRC is providing this IN to the Agreement States for
action or written response is required. The NRC is providing this IN to the Agreement States for


their information and for distribution to their medical licensees, as appropriate.
their information and for distribution to their medical licensees, as appropriate.
Line 53: Line 59:
toxicities caused by I-131 skin contamination from leaks associated with a therapeutic treatment
toxicities caused by I-131 skin contamination from leaks associated with a therapeutic treatment


using I-131 MIBG. In 2018, an infusion line leaked, and approximately 221 millicuries (mCi) of the
using I-131 MIBG. In 2018, an infusion line leaked, and approximately 221 millicuries (mCi) of the


834 mCi, the intended dosage, contaminated the patients bed linens. The leak was identified at
834 mCi, the intended dosage, contaminated the patients bed linens. The leak was identified at


completion of the procedure and likely occurred at the connector. During the treatment, the patient
completion of the procedure and likely occurred at the connector. During the treatment, the patient


was disconnected from the infusion pump and allowed to go to the lavatory. The port line was
was disconnected from the infusion pump and allowed to go to the lavatory. The port line was


disconnected at the connector and may not have been properly reconnected. After the leak was
disconnected at the connector and may not have been properly reconnected. After the leak was


discovered, at the completion of the treatment, the patients clothes were immediately changed, and
discovered, at the completion of the treatment, the patients clothes were immediately changed, and


the bed linens were removed; however, the patients skin was not decontaminated. Two days later, the patient reported discomfort and was found to have an erythematous lesion that degenerated
the bed linens were removed; however, the patients skin was not decontaminated. Two days later, the patient reported discomfort and was found to have an erythematous lesion that degenerated


into a moist desquamation the following day. The dose to the patients skin was estimated to be
into a moist desquamation the following day. The dose to the patients skin was estimated to be


55,000 centigray (cGy) (rads) to a 15cm2 area of skin.
55,000 centigray (cGy) (rads) to a 15cm2 area of skin.
Line 73: Line 79:
In 2013, the NRC was notified that a patient being treated with one Curie of I-131 MIBG for
In 2013, the NRC was notified that a patient being treated with one Curie of I-131 MIBG for


neuroblastoma had his catheter start to leak a day following treatment. Urine contaminated the
neuroblastoma had his catheter start to leak a day following treatment. Urine contaminated the


patient and bedding. Upon discovery, the patient's skin was immediately cleaned, the catheter
patient and bedding. Upon discovery, the patient's skin was immediately cleaned, the catheter


removed, and the patient's clothing and sheets changed. Six weeks later, a physician examining
removed, and the patient's clothing and sheets changed. Six weeks later, a physician examining


the patient noted skin irritation on the patient's inner thighs and buttocks consistent with radiation
the patient noted skin irritation on the patient's inner thighs and buttocks consistent with radiation


injury. The estimated dose to the patient's skin was approximately 1,000 cGy.
injury. The estimated dose to the patient's skin was approximately 1,000 cGy.
ML19094B733


==DISCUSSION==
==DISCUSSION==
Line 90: Line 94:
practices and procedures to prevent leaks and spills from causing significant patient skin
practices and procedures to prevent leaks and spills from causing significant patient skin


contamination. Identification of significant contamination on the skin is challenging with this therapy
contamination. Identification of significant contamination on the skin is challenging with this therapy


because the patient becomes a significant source of gamma radiation that interferes with standard
because the patient becomes a significant source of gamma radiation that interferes with standard


contamination surveys and monitoring techniques. In addition, low level I-131 contamination of
contamination surveys and monitoring techniques. In addition, low level I-131 contamination of


patient, clothing, and bed linens is expected from the patients perspiration, saliva, or other bodily
patient, clothing, and bed linens is expected from the patients perspiration, saliva, or other bodily


fluids. Therefore, licensees should have procedures for the identification and decontamination of
fluids.   Therefore, licensees should have procedures for the identification and decontamination of


skin contamination from leaks or spills to minimize exposure to the patients skin in order to prevent
skin contamination from leaks or spills to minimize exposure to the patients skin in order to prevent
Line 110: Line 114:
Use absorbent pads with a membrane under the port line, tube, and infusion pump line, if they pass
Use absorbent pads with a membrane under the port line, tube, and infusion pump line, if they pass


over the patient or the patients bed. In the event of a leak in the delivery system, the absorbent
over the patient or the patients bed. In the event of a leak in the delivery system, the absorbent


pads will absorb and reduce the quantity of material that may contaminate the patient and facilitate
pads will absorb and reduce the quantity of material that may contaminate the patient and facilitate
Line 122: Line 126:
mCi of I-131. Monitoring the patients clothing and bed linens is likely the most effective way to
mCi of I-131. Monitoring the patients clothing and bed linens is likely the most effective way to


determine when a patient is potentially contaminated from a leak or spill. Therefore, after the
determine when a patient is potentially contaminated from a leak or spill. Therefore, after the


treatment is completed, remove the patients clothing and bedding to a low background area and
treatment is completed, remove the patients clothing and bedding to a low background area and


survey them to assure that they are not contaminated above expected values. Significantly
survey them to assure that they are not contaminated above expected values. Significantly


contaminated clothing and bedding indicates that the patient may have been contaminated from a
contaminated clothing and bedding indicates that the patient may have been contaminated from a
Line 138: Line 142:
Consider development of a procedure to address patient fluid management prior to and during
Consider development of a procedure to address patient fluid management prior to and during


infusion. A catheter may be employed, and the use of absorbent pads with the catheter line would
infusion. A catheter may be employed, and the use of absorbent pads with the catheter line would


be prudent, as a precaution for line leakage.
be prudent, as a precaution for line leakage.
Line 144: Line 148:
Patient-specific decontamination procedures and radiation safety incident response procedures
Patient-specific decontamination procedures and radiation safety incident response procedures


should be developed. I-131 MIBG exhibits an affinity for bonding to the skin; thus, a shower with
should be developed. I-131 MIBG exhibits an affinity for bonding to the skin; thus, a shower with


mild soap may not prove overly effective for decontamination. Any decontamination practices and
mild soap may not prove overly effective for decontamination. Any decontamination practices and


procedures developed should consider the overall health and age of the patient.
procedures developed should consider the overall health and age of the patient.


==CONTACT==
==CONTACT==
This information notice requires no specific action or written response. Please direct any questions
This information notice requires no specific action or written response. Please direct any questions


about this matter to a technical contact listed below or the appropriate regional office.
about this matter to a technical contact listed below or the appropriate regional office.


/RA/                                                   /RA/
/RA/  
Christopher G. Miller, Director               Andrea L. Kock, Director
 
/RA/  
Christopher G. Miller, Director
 
Andrea L. Kock, Director
 
Division of Inspection and Regional
 
Division of Materials Safety, Security, Support
 
State, and Tribal Programs


Division of Inspection and Regional            Division of Materials Safety, Security, Support                                        State, and Tribal Programs
Office of Nuclear Reactor Regulation


Office of Nuclear Reactor Regulation          Office of Nuclear Material Safety
Office of Nuclear Material Safety


and Safeguards
and Safeguards


Technical Contacts: Katherine Tapp
Technical Contacts: Katherine Tapp


(301) 415-0236 Katherine.Tapp@nrc.gov
(301) 415-0236 Katherine.Tapp@nrc.gov


Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under NRC Library/Document Collections.
Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under NRC Library/Document Collections.


ML19094B733                                           *concurred via email
ML19094B733  
*concurred via email


OFFICE TECH EDITOR     NMSS/MSST/MSEB   NMSS/MSST/MSEB/MR   NMSS/MSST/MSEB/BC        RI/DNMS/DD
OFFICE TECH EDITOR
 
NMSS/MSST/MSEB
 
NMSS/MSST/MSEB/MR


ST
ST


NAME    JDougherty*    KTapp*          LDimmick*            CEinberg*                JTrapp*
NMSS/MSST/MSEB/BC
DATE    06/12/19      06/12/19        06/13/19            06/13/19                06/17/19 OFFICE RIII/DNMS/DD  RIII/DNMS/D      RIV/DNMS/D          NMSS/MSST/D              NRR/DIRS/IRGB/LA


NAME  CLipa*        DPelton*          VGaddy* for LHowell KWilliams* for AKock*    IBetts*
RI/DNMS/DD
DATE    06/26/19      07/09/19        08/13/19            08/08/19                  06/17/19 OFFICE NRR/DIRS/IRGB/ NRR/DIRS/IRGB/BC  NRR/DIRS/D


NAME
JDougherty*
KTapp*
LDimmick*
CEinberg*
JTrapp*
DATE
06/12/19
06/12/19
06/13/19
06/13/19
06/17/19 OFFICE  RIII/DNMS/DD
RIII/DNMS/D
RIV/DNMS/D
NMSS/MSST/D
NRR/DIRS/IRGB/LA
NAME  CLipa*
DPelton*
VGaddy* for LHowell
KWilliams* for AKock*
IBetts*
DATE
06/26/19
07/09/19
08/13/19
08/08/19
06/17/19 OFFICE  NRR/DIRS/IRGB/
PM
PM


NAME   MLintz*       PMcKenna*         CMiller*
NRR/DIRS/IRGB/BC
DATE   08/07/19       08/14/19         08/14/19}}
 
NRR/DIRS/D
 
NAME
 
MLintz*  
PMcKenna*  
CMiller*  
 
DATE
 
08/07/19  
08/14/19  
08/14/19}}


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

Latest revision as of 03:48, 5 January 2025

Patient Skin Contamination Events Associated with I-131 During Neuroblastoma Treatments
ML19094B733
Person / Time
Issue date: 08/14/2019
From: Andrea Kock, Chris Miller
NRC/NMSS/DMSST, NRC/NRR/DIRS/IRGB
To:
Lintz M, 415-4051, NRR/DIRS
References
IN-19-005
Download: ML19094B733 (4)
v • d • e


ML19094B733

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR REACTOR REGULATION

OFFICE OF NUCLEAR MATERIAL

SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555

August 14, 2019

NRC INFORMATION NOTICE 2019-05: PATIENT SKIN CONTAMINATION EVENTS

ASSOCIATED WITH I-131 METAIODOBENZYLGUANIDINE DURING

NEUROBLASTOMA TREATMENTS

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC master materials

licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers.

PURPOSE

The NRC is issuing this information notice (IN) to alert addressees of potential patient

contamination risks associated with therapeutic treatments with iodine-131 (I-131) meta- iodobenzylguanidine (MIBG). The NRC expects that recipients will review the information for

applicability to their facilities and consider actions, as appropriate, to avoid similar problems.

Information contained in this IN does not constitute new NRC requirements; therefore, no specific

action or written response is required. The NRC is providing this IN to the Agreement States for

their information and for distribution to their medical licensees, as appropriate.

DESCRIPTION OF CIRCUMSTANCES

In the past five years, the NRC has been notified of two events in which patients have had skin

toxicities caused by I-131 skin contamination from leaks associated with a therapeutic treatment

using I-131 MIBG. In 2018, an infusion line leaked, and approximately 221 millicuries (mCi) of the

834 mCi, the intended dosage, contaminated the patients bed linens. The leak was identified at

completion of the procedure and likely occurred at the connector. During the treatment, the patient

was disconnected from the infusion pump and allowed to go to the lavatory. The port line was

disconnected at the connector and may not have been properly reconnected. After the leak was

discovered, at the completion of the treatment, the patients clothes were immediately changed, and

the bed linens were removed; however, the patients skin was not decontaminated. Two days later, the patient reported discomfort and was found to have an erythematous lesion that degenerated

into a moist desquamation the following day. The dose to the patients skin was estimated to be

55,000 centigray (cGy) (rads) to a 15cm2 area of skin.

In 2013, the NRC was notified that a patient being treated with one Curie of I-131 MIBG for

neuroblastoma had his catheter start to leak a day following treatment. Urine contaminated the

patient and bedding. Upon discovery, the patient's skin was immediately cleaned, the catheter

removed, and the patient's clothing and sheets changed. Six weeks later, a physician examining

the patient noted skin irritation on the patient's inner thighs and buttocks consistent with radiation

injury. The estimated dose to the patient's skin was approximately 1,000 cGy.

DISCUSSION

These medical events show the importance of the development and implementation of effective

practices and procedures to prevent leaks and spills from causing significant patient skin

contamination. Identification of significant contamination on the skin is challenging with this therapy

because the patient becomes a significant source of gamma radiation that interferes with standard

contamination surveys and monitoring techniques. In addition, low level I-131 contamination of

patient, clothing, and bed linens is expected from the patients perspiration, saliva, or other bodily

fluids. Therefore, licensees should have procedures for the identification and decontamination of

skin contamination from leaks or spills to minimize exposure to the patients skin in order to prevent

risk of adverse effects should a leak or spill event occur.

Potential actions licensees may take to minimize the risk of skin contamination and unintended skin

dose to the patient include the following.

Use absorbent pads with a membrane under the port line, tube, and infusion pump line, if they pass

over the patient or the patients bed. In the event of a leak in the delivery system, the absorbent

pads will absorb and reduce the quantity of material that may contaminate the patient and facilitate

clean-up.

Detecting significant contamination from leaks or spills on the skin of a patient is challenging, as

there will be significant gamma emissions from a patient who has been administered hundreds of

mCi of I-131. Monitoring the patients clothing and bed linens is likely the most effective way to

determine when a patient is potentially contaminated from a leak or spill. Therefore, after the

treatment is completed, remove the patients clothing and bedding to a low background area and

survey them to assure that they are not contaminated above expected values. Significantly

contaminated clothing and bedding indicates that the patient may have been contaminated from a

leak or spill, and that decontamination procedures should be implemented.

Develop processes and procedures to minimize interruptions during the infusion process to reduce

the probability that the treatment is interrupted and that the port line will need to be disconnected.

Consider development of a procedure to address patient fluid management prior to and during

infusion. A catheter may be employed, and the use of absorbent pads with the catheter line would

be prudent, as a precaution for line leakage.

Patient-specific decontamination procedures and radiation safety incident response procedures

should be developed. I-131 MIBG exhibits an affinity for bonding to the skin; thus, a shower with

mild soap may not prove overly effective for decontamination. Any decontamination practices and

procedures developed should consider the overall health and age of the patient.

CONTACT

This information notice requires no specific action or written response. Please direct any questions

about this matter to a technical contact listed below or the appropriate regional office.

/RA/

/RA/

Christopher G. Miller, Director

Andrea L. Kock, Director

Division of Inspection and Regional

Division of Materials Safety, Security, Support

State, and Tribal Programs

Office of Nuclear Reactor Regulation

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Katherine Tapp

(301) 415-0236 Katherine.Tapp@nrc.gov

Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under NRC Library/Document Collections.

ML19094B733

  • concurred via email

OFFICE TECH EDITOR

NMSS/MSST/MSEB

NMSS/MSST/MSEB/MR

ST

NMSS/MSST/MSEB/BC

RI/DNMS/DD

NAME

JDougherty*

KTapp*

LDimmick*

CEinberg*

JTrapp*

DATE

06/12/19

06/12/19

06/13/19

06/13/19

06/17/19 OFFICE RIII/DNMS/DD

RIII/DNMS/D

RIV/DNMS/D

NMSS/MSST/D

NRR/DIRS/IRGB/LA

NAME CLipa*

DPelton*

VGaddy* for LHowell

KWilliams* for AKock*

IBetts*

DATE

06/26/19

07/09/19

08/13/19

08/08/19

06/17/19 OFFICE NRR/DIRS/IRGB/

PM

NRR/DIRS/IRGB/BC

NRR/DIRS/D

NAME

MLintz*

PMcKenna*

CMiller*

DATE

08/07/19

08/14/19

08/14/19


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