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

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)

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.

ML19094B733

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 NMSS/MSST/MSEB/BC RI/DNMS/DD

ST

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/ NRR/DIRS/IRGB/BC NRR/DIRS/D

PM

NAME MLintz* PMcKenna* CMiller*

DATE 08/07/19 08/14/19 08/14/19