ML20216F661
| ML20216F661 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1998 |
| From: | Camper L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Combs F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20216F665 | List: |
| References | |
| NUDOCS 9804170158 | |
| Download: ML20216F661 (5) | |
Text
k MEMORANDUM TO:
Frcderick C. Combs, Chrirmin April 15, 1998 Generic Assessm:nt Panel Division of industri!! and 9
Medical Nuclear Safety, NMSS FROM:
Larry W. Camper, Chief j
Materials Safety Branch
/
Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
MICHAEL REESE HOSPITAL BRACHYTHERAPY q
MISADMINISTRATION The attached January 14,1998, letter from the licensee to the Division of Radioactive Materials, State of Illinois,' December 17,1997, e-mail from the Division of Radioactive Materials, State of j
lilinois, to the NRC Office of State Programs, and March 5,1998, Note to file were reviewed.
j The root cause of the event appears to be the licensee's use of an ultrasound device that did not have the resolution required to visualize the ends of the needles. The problem was resolved when the licensee purchased the proper equipment. The licensee implied that there was a problem with the needles and the manufacturer would modify the needles, but in fact the manufacturer only increased scrutiny of the needle tips for acceptance.
Sinco the lesson leamed is the need to utilize imaging devices with appropriate resolution capabilities, this does not warrant an information notice on scanners or a letter to medical societies. If GAP believes it important to publicize the event, root cause, and resolution, the best vehicle may be a paragraph in the NMSS news letter. If this approach is taken, the following paragraph may be used:
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Michael Reese Hospital Brachytherapy Misadministration J
The licensee reported a misadministration during a prostrate cancer treatment procedure in which 33 of 81 seeds were implanted in the bladder. The resolution capabilities of the ultrasound device used to position the seeds was inadequate for that use. The licensee purchased an ultrasound device with the proper resolution and has not reported further problems.
I CONTACT:
Donna-Beth Howe, NMSS/IMNS j
(301)415-7848 b
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'41 DISTRIBUTION: IMNS 6083 IMNS NMSS r/f GNRC FJIe Center,
PDR Yes No DOCUMENT NAME: K:\\DBH\\ TAR \\ULTRASND. GAP To receive a copy of this document, indicate in the box: "C" = Copy withou ttachment/ enclosure "E" = Copy with attachment /enct
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NAME DHowe W SBag66tt LCampq(\\ /I~
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FOLLOW-UP ASSIGNMENT SHEET SORT > Assignment Date / Event Date QUERY > Assigned Date >= 01/03/98 & Assigned Date <= 01/09/98 & Event Date <= D1/08/98 & Event Type = "NMS" ASSIGNED / REFERRED TO: IMOB ASSIGNMENT DATE: 01/05/98 LICENSEE / VENDOR:
MICHAEL REESE HOSPITAL, IL EN NO:
33492 EVENT DATE:
12/17/97 NR WO EVENT TYPE:
NMS yhb SPECIALTY CODE:
0
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PN NO:
ACCESSION NO:
O CTHER REPORT:
EVENT / CONDITION DESCRIPTION MEDICAL MISADMINISTRAfl0N: LICENSEE ATTEMPTED TO IMPLANT 88 l-125 SEED!, BUT ONLY 49 SEEDS REMAINED IN THE TREATMENT SITE. THE REMA!NING 39 SEEDS " MIGRATED" TO THE BLADDER. BELIEVED ULTnASOUND WAS USED TO GUIDE SEEDS.
SPECIFIC FOLLOW-UP ASSIGNMENT stoce w u,_
Pc4(avLens CLOSEOUT TEXT SAFETT SIGNIFICANCE: SIG g,y a,,
CANDIDATE FOR OP EVENTS BRIEFING 7 YES, 98 01 GENERIC FOLLOW-UP REC 0004 ENDED: NO GENERIC SAFETY ISSUE: NO STATUS DUE DATE' "'" ~
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OTHER INFORMAfl0N:
"$ KILL OF CRAFT" ISSUE..AT 1/13/98 OP EVENTS BRIEFING, OSP REPORTED THAT THEY ARE WAITlWG FOR THE STATE'S REPORT.
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2929 south Ellis 1
Chicego, Illinois 60616-3390 l
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Mr. Bmce Sanza Head ofInspection and Enforcement Division of Radioactive Materials State ofIllinois Department of Nuclear Safety 1035 Outer Park Drive Springfield, Illinois 62704 January 14,1998 Re: Reportable incident for Radioactive Materials License # IL-01097-01
Dear Mr. Sanza:
l We are providing the attached report pursuant to the Illinois Radiation Protection Act.
This written report follows the oral report, which was made to you on January 5,1998.
Briefly, this patient received less radiation to his prostate than was prescribed. The patient has been informed orally and in writing of this event and the additional treatment that we recommend so that he receives an appropriately higher cumulative dose of treatment. We do not believe that the patient will suffer any ill consequences from this event. We have reviewed this. natter through our safety and quality assurance processes and with the manufacturer of the equipment involved and believe that adequate steps have been taken to reduce the risk of this type ofincident occuning again.
If additional information is needed, please contact either of us at (312) 791-2510.
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Leon Myrianthopoulos, Ph.D.
Jaishanker Nautiyal, M.D.
Medical Physicist Attending Physician
2929 South EHis l,
Chicago niinois 60616-3390
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Telephone 312M91-2000 0
Michael Reese Hospital and Medical Center 1
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Reportable Bracytherapy Event for Radioactive Materials License # IL-01097-01 1
Type of Treatment: Permanent Implant ofprostate with Iodine-125 seeds Licensee's Name: Michael Reese Hospital and Medical Center Prescribing Physician: Jaishanker Nautiyal, M.D.
This gentleman has a Stage II prostate cancer. There are several acceptable methods of treating his condition. The methods of treatment with radiotherapy include external beam radiotherray alone, brachytherapy using irtpl mts, or a combination of external beam radiotherapy and brachytherapy. After discussion of the treatment options with this patient, we planned to use brachytherapy using the permanent implantation ofiodine -
125 (I-125) seeds for a planned dose of 160 Gy.
The implants are placed in the prostate in the operating room under general anesthesia.
18 gauge needles preloaded with I-125 seeds are inserted through the perineum into the prostate. The location of the needles is determined using a template that is rigidly attached to a stabilizer which is attached to the operating table. An ultrasound probe is also attached to the stabilizer and inserted into the rectum to visualize the prostate and the tip of the needles. This is generally a reliable method of verifying the depth of needle penetration during the procedure. Prior to the procedure, the ultrasound display grid is calibrated to the implant template grid. To assist in locating the end of the needle and, therefore the seed placement, we use needles which have had the tips modified by the manufacturer.
J j
1 Due to the proximity of the bladder to the prostate, it is expected that some I-125 seeds will be deposited in the bladder instead of the prostate. At the end of the procedure and I
while the patient is still in the operating room and under anesthesia, an x-ray is mutinely taken to locate any seeds in the bladder. Those seeds are then removed from the bladder, j
In this instance, the post implant x-ray showed that there were more seeds in the bladder j
than anticipated. Of the 82 seeds implanted,33 were in the bladder. The seeds in the bladder were removed. Removal was done quickly by cystoscopy without any incisions or injury to the patient. The patient was informed on the day of surgery that an excess j
number of seeds had been placed in the bladder and that these seeds were removed. He j
was also told that after CT scans were done, the dosimetry would be calculated and he would likely need additional extemal beam irradiation to achieve an optimal cumulative dose.
I 1
V 2929 south Dlis Chiergo. Illinois 60616-3390 T
. Telephone 312/791-2000 Michael Reese Hospital and Medical Center Thereafter, we calculated the dose from the I-125 seeds in his prostate. The patient received 60 Gy to approximately the posterior 2/3 of the prostate and 40Gy was delivered to the anterior 1/3 of the prostate. These calculations were confirmed on January 5,1998.
We consulted with our colleagues and determined that providing additional external beam therapy would be the most effective way to conclude his treatment. We have advised the patient of our recommendations and he will undergo additional extemr.: beam irradiation treatments over a period of 5 weeks.
Quality Assurance Review This incident occurred because more than the anticipated number of the I-125 seeds was placed too " deep" past the base of the prostate and into the bladder. We believe that there were two likely causes. First, in retrospect the tips of the needles were difficult to visualize. Dr. Nautiyal and the others present thought that they were clearly seeing the tip of the needle on ultrasound and, therefore, that the seeds were being placed in the prostate. It appears that the tip of the needles were " farther" than what could be seen on ultrasound. Although we were using the newest version of the technology, it appears that
( there may be manufacturing methods that can improve the modification of t t
enhance consistent visualization of the needle tip. We have reviewed this with the manufacturer and they have agreed to additional quality control steps, which they will i
dertake prior to shipping any more needles to us. We also believe that, although we used our best calibration efforts, the ultrasound grid and the template grid may not have been perfectly matched. We will replace the ultrasound unit and will, in the future, use equipment which we believe will correlate the grids more rehably. We also plan to undertake verification tests prior to the use of the new equipment. While nothing can produce perfect localization in an ultrasound guided procedure, we believe that these efforts will reduce the risk to the anticipated level.
This report and the accompanying cover letter have been reviewed by the undersigned Radiation Safety fficer of this hospital.
Y7s Allan P. Jackunek Radiation Safety Officer l
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