Information Notice 2005-17, Manual Brachytherapy Source Jamming
| ML051780232 | |
| Person / Time | |
|---|---|
| Issue date: | 06/23/2005 |
| From: | Chris Miller NRC/NMSS/IMNS |
| To: | |
| References | |
| IN-05-017 | |
| Download: ML051780232 (7) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 June 23, 2005 NRC INFORMATION NOTICE 2005-17: MANUAL BRACHYTHERAPY SOURCE JAMMING
ADDRESSEES
All medical licensees authorized to possess a Mick applicator.
PURPOSE
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to alert
addressees to recently reported medical events with ruptured seeds that have occurred at
different facilities during manual brachytherapy as a result of seed jamming. It is expected that
recipients will review the information for applicability to their facilities and consider actions, as
appropriate, to avoid similar problems. However, suggestions contained in this IN are not new
NRC requirements; therefore, no specific action or written response is required.
DESCRIPTION OF CIRCUMSTANCES
NRC has received ten medical event reports in the last five years, two of them recently, involving the rupture of a jammed brachytherapy seed source while used in a
Mick Radio-Nuclear Instruments, Inc. Model Mick Applicator. However, there may be more
events with seeds containing accelerator-produced radioactive material that are not required to
be reported to the NRC. In one of the ten incidents reported, during the prostate brachytherapy
procedure, the cartridge containing seeds jammed in a Mick Applicator. When the licensee
attempted to dislodge the seed from the applicator, the seed ruptured. This caused radioactive
contamination to spread onto the applicator and surrounding surfaces. The applicator was
placed in a plastic bag and stored behind lead shielding in the hot laboratory. This description
is representative of all ten incidents.
Licensees corrective actions included procedure modifications, such as changes in handling of
the applicator and cartridge after the occurrence of a cartridge jam, and personnel training.
DISCUSSION
In the ten events over the past five years, the cause of the seed rupture was excessive force
applied by the operator to the seed cartridge when trying to dislodge the jammed seed. The
force of pulling the cartridge out with the seed jammed is large enough to shear the seed and
cause contamination. The manufacturer, Mick Radio-Nuclear Instruments, Inc., is aware that
seed jamming may occur and provides instructions in the User Manual to follow when
attempting to dislodge the jammed seed. It is not apparent if the licensees involved in these
events followed the recommended procedure for dislodging jammed seeds. Attempting to force
the seed cartridge out of the applicator is contrary to the manufacturers instructions. Mick
Radio-Nuclear Instruments, Inc. recommends the following techniques to dislodge jammed
seeds:
- Partially unscrew the head of the magazine (no more than one turn), thereby relieving
the downward pressure on the seeds. Please note that the magazine head and the
cartridge are NOT designed or intended to be taken apart. This is only done to relieve
the spring pressure on the seeds. Carefully attempt to remove the magazine from the
applicator.
- Flush the jammed seed out of the applicator using a light pressure water flush. This
must be done over a collection pan situated such that all seeds are collected and
accounted for.
If the seeds cannot be removed safely, place the applicator in quarantine. The
applicator must be surveyed (for radiation) to determine if the broken seed has
contaminated the applicator.
If contaminated, the applicator must remain in quarantine for a minimum of 10
half-lives.
If clean, it is recommended that the applicator be returned to the manufacturer
for evaluation and repair/adjustment.
(Source: Mick 200-TPV Applicator Instruction Manual, Pg.15A, Form #:405-06; Rev. E;
4/15/05)
The State of Wisconsin has also identified the recent seed ruptures and has issued an IN on
the issue dated June 9, 2005. The Wisconsin IN is attached for your reference.
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below.
/RA/
Charles L. Miller, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contacts: Nima Ashkeboussi, NMSS John P. Jankovich, NMSS
(301) 415-7637 301-415-7904 E-mail: naa@nrc.gov E-mail: jpj2@nrc.gov
Attachments: 1. State of Wisconsin Information Notice
2. List of Recently Issued NMSS Generic Communications
Note: NRC generic communications may be found on the NRC public Website, http://www.nrc.gov, under Electronic Reading Room/Document Collections. * Partially unscrew the head of the magazine (no more than one turn), thereby relieving
the downward pressure on the seeds. Please note that the magazine head and the
cartridge are NOT designed or intended to be taken apart. This is only done to relieve
the spring pressure on the seeds. Carefully attempt to remove the magazine from the
applicator.
- Flush the jammed seed out of the applicator using a light pressure water flush. This
must be done over a collection pan situated such that all seeds are collected and
accounted for.
If the seeds cannot be removed safely, place the applicator in quarantine. The
applicator must be surveyed (for radiation) to determine if the broken seed has
contaminated the applicator.
If contaminated, the applicator must remain in quarantine for a minimum of 10
half-lives.
If clean, it is recommended that the applicator be returned to the manufacturer
for evaluation and repair/adjustment.
(Source: Mick 200-TPV Applicator Instruction Manual, Pg.15A, Form #:405-06; Rev. E;
4/15/05)
The State of Wisconsin has also identified the recent seed ruptures and has issued an IN on
the issue dated June 9, 2005. The Wisconsin IN is attached for your reference.
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below.
/RA/
Charles L. Miller, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contacts: Nima Ashkeboussi, NMSS John P. Jankovich, NMSS
(301) 415-7637 301-415-7904 E-mail: naa@nrc.gov E-mail: jpj2@nrc.gov
Attachments: 1. State of Wisconsin Information Notice
2. List of Recently Issued NMSS Generic Communications
Note: NRC generic communications may be found on the NRC public Website, http://www.nrc.gov, under Electronic Reading Room/Document Collections.
ML051780232 *See previous concurrence
NAME NAshkeboussi* EKraus* THarris RCorreia CMiller
DATE 6/14/05 6/14/05 6/17/05 6/21/05 6/23/05 DIVISION OF PUBLIC
HEALTH
1 WEST WILSON STREET
P O BOX 2659 Jim Doyle MADISON WI 53701-
2659 Governor
State of Wisconsin 608-267-4797 Helene Nelson FAX: 608-267-
3695 Secretary Department of Health and Family Services dhfs.wisconsin.gov
INFORMATION NOTICE
TO: Department of Health and Family Services
Radioactive Material Medical Use Licensees
FROM: Department of Health and Family Services
Radioactive Materials Program
DATE: June 9, 2005 SUBJECT: Information Notice concerning MICK Applicators
PURPOSE
The Wisconsin Department of Health and Family Services is issuing this information notice to
inform medical use licensees of recent incidents involving jamming of the MICK Applicator. It
is expected that recipients will review this information for applicability to their licensed activities
and consider actions, as appropriate, to avoid similar problems. Suggestions contained in this
Information Notice are not new DHFS requirements; therefore, no specific action or written
response is required.
DESCRIPTION OF CIRCUMSTANCES
During the period of April 1, 2005 to June 1, 2005, the Department of Health and Family
Services became aware of two incidents in which a MICK Applicator jammed resulting in a Pd-
103 seed being ruptured.
In the first incident, the Radiation Oncologist after changing cartridges encountered resistance
when implanting the first seed. The Radiation Oncologist was then unable to insert the stylete
(i..e., plunger) more then a few millimeters when trying to implant the second seed. Upon trying
to remove the cartridge to investigate the problem, a Pd-103 brachytherapy prostate seed broke.
In the second incident, the Radiation Oncologist after changing cartridges encountered a similar
problem. The implantation needle became detached from the MICK Applicator during the
Attachment 1 process of trying to install a new cartridge. After reattaching the implantation needle, the
Radiation Oncologist attempted to implant the first seed. However, the stylete would not insert
more then a few millimeters. The Radiation Oncologist then attempted to remove the cartridge
to investigate why the applicator had jammed. In the process of removing the cartridge, a Pd-103 brachytherapy prostate seed broke, resulting in the spread of contamination.
In discussions with other licensees, the Nuclear Regulatory Commission and other Agreement
States, it was discovered that there have been other reported cases involving the MICK
Applicator becoming jammed. In some cases, the licensees were able to get the applicators
working again and in other cases the prostate seeds have broken.
DISCUSSION
Failure to perform preventative maintenance on the MICK Applicator may be the cause for
jamming incidents. Licensees are reminded that they should perform the manufacturer's
recommended preventative maintenance on the MICK Applicator.
Licensees are also reminded not to screw cartridges into or out of the MICK Applicator. Both
the reusable and disposable cartridges are designed to seat in the MICK Applicator by simply
pushing them into the magazine receptor with a noticeable click.
Licensees should also be aware that the 'Disposable MICK Cartridge' maximum seed capacity is
15 seeds. The maximum seed capacity for the 'Reusable MICK Cartridge' is 10 seeds. If
loading more then the maximum seed capacity, the applicator could jam. In addition, the
'Shielded / Disposable MICK Magazines' are designed for one time use ONLY.
The MICK web site at http://www.micknuclear.com contains information on dislodging
jammed seeds. An excerpt from the web site is included for your information.
This Information Notice requires no specific action or written response. If you have any question
about the information in this notice, please contact Cheryl K. Rogers at (608) 266-8135 or email
at rogerck@dhfs.state.wi.us or Jason Hunt at (608) 266-9443 or email at
huntjh@dhfs.state.wi.us.
Implant Sequence - (Continued)
Recommended
Useful Tips During the Implant Process:
When Loading the Magazine into the Applicator, ensure the Magazine sets into the Applicator properly, loading with a
noticeable Click.
Ensure the needle is properly connected to the Applicator. The needle should CLICK into the Needle Receptor and
should not disconnect unless the Needle Release Button is depressed.
During implantation, ensure the seed is completely advanced through the needle. Do not advance the seed partially out
of the cartridge and retract the Push-Wire Rod. This may cause the seeds to drop unevenly and seeds may become
jammed in the cartridge.
When loading Mick Magazines, visually check that the seeds are loaded straight and even in the cartridge. If the seeds
are placed askew in the cartridge, it may cause jamming during the implant procedure.
After an implant procedure, it is strongly recommended a physical seed inventory be performed to account for all
seeds.
Dislodging Jammed Seeds:
If and when a seed is jammed between the Applicator Needle Chuck and the Seed Cartridge, DO NOT force the seed
Magazine out of the Magazine receptor area of the Applicator. Undue pressure on the seeds may cause the seeds to
break or fracture.
The following techniques can be attempted:
' Partially unscrew the head of the magazine (no more than one turn), thereby relieving the downward
pressure on the seeds. Please note that the Magazine Head and the cartridge are NOT designed or intended
to be taken apart. This is only done to relieve the spring pressure on the seeds. Carefully attempt to remove
the Magazine from the Applicator.
' Flush the jammed seed out of the Applicator using a light pressure water flush. This must be done over a
collection pan situated such that all seeds are collected and accounted for. If the seeds cannot be removed
safely, place the Applicator in quarantine. The Applicator must be surveyed (for radiation) todetermine if the
broken seed has contaminated the Applicator.
If contaminated, the Applicator must remain in quarantine for a minimum of 10 half-lives.
If clean, it is recommended that the Applicator be returned to the manufacturer for evaluation and repair/adjustment.
Returning an Applicator for Service or Repair:
1. Call MRNI, Inc., Customer Service Tel. 914-667-3999 to obtain a Return Authorization number.
2. Mick Applicators (Instrument only) must be sterilized before sending to MRNI, Inc.
3. MRNI, Inc. will fax you form #414-10 to be completed by you (without the proof of a decontamination form, your Mick Applicator will be returned unserviced).
Upon MRNIs Receipt of Mick Applicator:
The Mick Applicator will be analyzed to determine the extent of the repair. We will then call the Contact Person to get
authorization for repair and cost before we commence with any work. The Mick Applicator will be returned prior to
your next case date.
-15A Recently Issued NMSS Generic Communications
Date GC No. Subject
Addressees
06/10/05 RIS-05-10 Performance-Based All industrial radiography
Approach for Associated licensees and manufacturers and
Equipment in 10 CFR 34.20 distributors of industrial
radiography equipment.
04/18/05 RIS-05-06 Reporting Requirements for All material licensees possessing
Gauges Damaged at portable gauges, regulated under
Temporary Job Sites 10 CFR Part 30.
04/14/05 RIS-05-04 Guidance on the Protection All holders of operating licenses
of Unattended Openings or construction permits for nuclear
that Intersect a Security power reactors, research and test
Boundary or Area reactors, decommissioning
reactors with fuel on site, Category 1 fuel cycle facilities, critical mass facilities, uranium
conversion facility, independent
spent fuel storage installations, gaseous diffusion plants, and
certain other material licensees.
05/17/05 IN-05-013 Potential Non-conservative All licensees using the Keno-V.a
Error in Modeling criticality code module in
Geometric Regions in the Standardized Computer Analyses
Keno-v.a Criticality Code for Licensing Evaluation (SCALE)
software developed by Oak Ridge
National Laboratory (ORNL)
05/17/05 IN-05-012 Excessively Large Criticality All licensees authorized to
Safety Limits Fail to possess a critical mass of special
Provide Double nuclear material.
Contingency at Fuel Cycle
Facility
04/07/05 IN-05-010 Changes to 10 CFR Part 71 All 10 CFR Part 71 licensees and
Packages certificate holders.
Note: NRC generic communications may be found on the NRC public website, http://www.nrc.gov, under Electronic Reading Room/Document Collections.
Attachment 2