Information Notice 2019-05, 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.
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
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
NAME MLintz* PMcKenna* CMiller*
DATE 08/07/19 08/14/19 08/14/19