Information Notice 2019-12, Recent Reported Medical Events Involving the Administration of Yttrium-90 Microspheres for Therapeutic Medical Procedure
ML19262G231 | |
Person / Time | |
---|---|
Issue date: | 12/31/2019 |
From: | Michael Layton, Chris Miller Office of Nuclear Material Safety and Safeguards, NRC/NRR/DRO |
To: | |
Benney B | |
References | |
IN-19-012 | |
Download: ML19262G231 (4) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, DC 20555-0001 December 31, 2019 NRC INFORMATION NOTICE 2019-12: RECENT REPORTED MEDICAL EVENTS
INVOLVING THE ADMINISTRATION OF
YTTRIUM-90 MICROSPHERES FOR
THERAPEUTIC MEDICAL PROCEDURES
ADDRESSEES
All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC master
materials licensees that are authorized for yttrium-90 (Y-90) microspheres in accordance with
Title 10 of the Code of Federal Regulations (10 CFR) 35.1000, Other Medical Uses of
Byproduct Material or Radiation from Byproduct Material. All Agreement State Radiation
Control Program Directors and State Liaison Officers.
PURPOSE
The NRC is issuing this information notice (IN) to inform licensees of recent reported medical
events that involved the administration of Y-90 microspheres. The NRC expects that recipients
will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar medical events. INs may not impose new requirements, and nothing in this IN
should be interpreted to require specific action. 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
From 2016-2018, the NRC received reports of 71 medical events involving NRC or Agreement
State licensees regarding the administration of Y-90 microspheres. Although 2019 data is not
yet available, these medical events continue and are monitored. These reported medical events
resulted from a variety of causes, such as errors with the written directive; clogging and kinking
in the catheters causing the administration of a reduced amount of microspheres to the patient;
and treatment of the wrong location, such as the wrong lobe of the liver. Events involving
treatment of the wrong location were identified when licensees used post-treatment imaging. It
is important to note that some of the events are associated with the inherent risks of the
treatment such as shunting to wrong treatment sites and may not be prevented by using the
current standard of care. The NRC requires reporting of events that meet medical events
criteria per 10 CFR 35.3045 and licensees approved conditions per 10 CFR 35.1000.
Of the reported medical events, seven events involved dose or activity going to the target organ
that exceeded the written directive by more than 20 percent as a result of human errors not
related to the physical delivery of the microspheres. The causes of these medical events
involved errors in measuring the activity before administration, improper control of vials
containing the microspheres, and failure to consult the written directive. One example occurred
on June 14, 2017, when the licensee delivered an activity of 8.55 gigabecquerels (GBq)
(231 millicurie (mCi)) to a patient instead of the prescribed activity of 1.71 GBq because the
ML19262G231 licensee did not verify the measured activity of the dosage with the written directive (Event
Notification [EN] 52807). Another example occurred on December 29, 2016, when a licensee
delivered an activity of 816.85 megabecquerels (MBq) (22.1 mCi) to a patient instead of the
prescribed activity of 90.76 MBq because the licensee used a vial intended for treatment of a
different area of the patients liver (EN 52473).
Of the Y-90 microspheres medical events that occurred from 2016 through 2018, 27 appear to
have involved blockages of the microspheres in the delivery system. Specifically, five events
involved kinks or dents in the catheter. In these events, the Y-90 microspheres built up and
caused a blockage around the kink or dent. The majority of the remaining 22 events occurred
because of suspected clumping of the Y-90 microspheres in the catheter. Clumping is a known
phenomenon which can occur for both of the Y-90 microsphere manufacturers (SIR-Spheres
and TheraSphere). Many events occurred during unique administrations, such as unusually
large or small doses or use of a slower flow rate. In one example, on October 27, 2017, a
licensee delivered an activity of 0.4255 GBq to a patient instead of the prescribed activity of
2.22 GBq because the microcatheter apparently clogged as a result of the large number of
microspheres being administered (EN 53040). Another example occurred on April 12, 2016, when the licensee delivered an activity of 0.04 GBq to a patient instead of the prescribed activity
of 1.29 GBq because of apparent clumping of the microspheres in the microcatheter (EN 51868).
In addition, there were eight other events that involved treatment to the wrong location, such as
the wrong lobe of the liver. Of these events, four involved an administrative error that caused
the microspheres to be delivered to a site other than prescribed location. In another event that
occurred on June 6, 2018, the interventional radiologist delivered the microspheres through the
wrong hepatic artery. A different interventional radiologist had previously performed
pretreatment mapping and identified the patient had atypical hepatic arterial anatomy, however, this was not reported to the radiologist preforming the treatment. This event resulted in a dose
of 11,086 centigray (rad) to the wrong liver lobe (EN 53448). The remaining three events
involved microspheres that traveled to the wrong liver lobe for unknown reasons. The four
events not associated with administrative errors were identified through post-treatment imaging.
Although the NRC regulations do not require post-treatment imaging, licensees must report
medical events identified by these images per 10 CFR 35.3045 and licensees approved
conditions per 10 CFR 35.1000.
DISCUSSION
Administrative errors involving the written directive for several of the above examples of medical
events, demonstrate the importance of licensees having a signed and dated written directive as
described in the Y-90 microsphere licensing guidance document, and licensees reviewing the
written directive before the administration of the Y-90 microspheres. The written directive shall
include the name of the patient or human research subject, the treatment site, the radionuclide
including the physical form (Y-90 microspheres), the model of spheres (i.e., TheraSphere or
SIR-spheres) or manufacturer (i.e., Nordion or Sirtex) and the prescribed dose or activity as
described in the Y-90 microsphere licensing guidance document. In addition, licensees should
determine and record the activity of the dosage before use, and only use it if it falls within 20
percent of the prescribed dosage. Finally, these medical events demonstrate the importance of
licensees developing, implementing, and maintaining written procedures to provide high
confidence that each administration is in accordance with the written directive. The NRC
recommends the use of timeouts in these procedures to ensure that planned administration
aligns with the written directive immediately before administration for Y-90 microspheres. In summary, this IN is intended to provide licensees with a heightened awareness of numerous
medical events involving incorrect administration of a prescribed dose or activity of Y-90
microspheres in the past several years. Licensees should be aware that small kinks in the
catheter can lead to an underdose, and the NRC recommends visual inspection of all tubing
before starting the procedure. Licensees should review manufacturer recommendations to
avoid clumping. Licensees are encouraged to communicate with their peers in the industry or
Y-90 microsphere vendors to identify best practices with respect to the administration of the
microspheres, especially in unique administrations such as when unusually large or small doses
or use of a slower flow rate is necessary for the patient.
CONTACT
S
This information notice requires no specific action or written response. Please direct any
questions about this matter to the technical contact listed below or to the appropriate regional
office.
/RA/ for /RA/
Christopher G. Miller, Director Michael C. Layton, Director
Division of Reactor Oversight Division of Materials Safety, Security, State, Office of Nuclear Reactor Regulation and Tribal Programs
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Katie Tapp, NMSS
301-415-0236 E-mail: Katherine.Tapp@nrc.gov
ML19262G231 EPIDS No.
OFFICE NMSS/MSST/MSEB QTE NMSS/MSST/MSEB NMSS/MSST/MSEB
NAME KTapp KAzariah-Kribbs LDimmick CEinberg
DATE 10 / 21 /19 9/23/19 10/22/19 11/6/19 OFFICE NMSS/MSST/MSEB NRR/DIRS/IRGB/PM NRR/DIRS/IRGB/LA NRR/DIRS/IRGB/BC
NAME MLayton BBenney IBetts LRegner
DATE 11/12/19 11/13/19 11/14/19 11/25/19 OFFICE NRR/DIRS/D
NAME CMiller for
DATE 12/31/19