ML20206M705

Forwards AEOD/C601, Case Study Rept on Rupture of I-125 Brachytherapy Source at Univ of Cincinnati Medical Ctr, for Info

ML20206M705
Person / Time
Issue date:	08/14/1986
From:	Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Asselstine, Roberts, Zech NRC COMMISSION (OCM)
References
NUDOCS 8608210333
Download: ML20206M705 (1)

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' AUG 141986 ME.10RANDUM FOR: Chairman Zech Comissioner Roberts Comissioner Asselstine -

Comissioner Bernthal FROM: Victor Stello, Jr.

Executive Director for Operations

SUBJECT:

AE0D CASE STUDY REPORT ON THE RUPTURE OF AN I0 DINE-125 BRACHYTHERAPY SOURCE AT THE UNIVERSITY OF CINCINNATI MEDICAL CENTER Enclosed for your information is a copy of an AE0D case study report on the rupture of an iodine-125 brachytherapy seed at the University of Cincinnati Medical Center. This report documents AE0D's efforts, findings, and conclusions on the subject and reflects the results of the peer review process. Recomendations from AE0D concerning this study have been previously forwarded to other offices for appropriate action.

I would be pleased to provide any clarification or further information that you may desire.

(Signed) Jack 11. Boa Victor Stello, Jr.

Executive Director for Operations

Enclosure:

As Stated cc w/ enclosure:

SECY OGC ACRS Distribution w/o enclosure:

PDR AE0D RF ED0 RF AE0D SF V. Stello, ED0 C. J. Heltenes J. Roe, DED0 F. J. Hebdon I 9j 0 T. Rehm, A0/E00 K. Black [k ~ o f.b, J. Sniezek, DEDR0GR S. Pettijohn L/ jY J. Davis, NMSS. y}

J. Taylor, IE y i

0FC :NAS w  : C/NAS :DD/AE :D/AE0 :E  :  :

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'NAME :SPettijohn:eh:KBlac :FJHe q)/ :CJH emes :VSt 1 o, Jr.:  :

_____:____________:____________:____________:____________:__ y ______:____________:___________

DATE :8/7/86  : 8/\/86

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8/ll/86 _ :8/l /86 :8/ '//86  :  :

0FFICIAL RECORD CO)Y 8608210333 860814 PDR ORG NEXD

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AE0.D/C601 Case Study Report on the Rupture of an Iodine-125 Brachytherapy Source at the University of Cincinnati Medical Center by the Office for Analysis and Evaluation of Operational Data Nonreactor Assessment Staff August 1986 ,

Prepared by:

Samuel L. Pettijohn leted by the Office This for Analysis and Evaluation of Operational Data (AE0D) with regard report documents the results of a study comp to particular operating events. The findings and reconnendations do not necessarily represent the final position or requirements of " - - -

the responsible program office nor the Nuclear Regulatory Commission.

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TABLE OF CONTENTS

. 1 P&9*

EXECUTIVE

SUMMARY

................................................... 1 f

1. INTRODUCTION................................................... 5 1

2. DESCRIPTION OF THE EVENT....................................... 6 2.1 General................................................... 6 2.2 Chronology of Events...................................... 6

3. ANALYSIS OF THE EVENT.......................................... 8 3.1 Seed Rupture.............................................. 8 3.2 Contamination and Personnel Uptakes. . . . . . . . . . . . . . . . . . . . . . . 9

4. LICENSEE AND SOURCE MANUFACTURER ACTIONS....................... 11 4.1 Licensee Actions.......................................... 11 4.2 Source Manufacturer Actions............................... 11

5. FIN 0INGS....................................................... 12

6. CONCLUSIONS AND RECOMMENDATIONS................................ 13 a

7. REFERENCES..................................................... 14 APPENDIX A................................................ 15 APPENDIX B................................................ 16 APPENDIX C................................................ 18 APPENDIX D................................................ 21 i

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EXECUTIVE SUPMARY l

The University of Cincinnati Medical Center reported to'the Nuclear Regulatory Commission (NRC) Region III by telephone the rupture of an iodine-125 seed (nominal activity of 40 millicuries). The seed, which was one of eight seeds 1 being used by the University of Cincinnati Medical Center for brachytherapy treatment of brain tumors, was ruptured during removal of the seed from Heyer-Schulte coaxial catheters.. The seeds, containing iodine-125 adsorbed on anion exchange resin spheres within a .05 mm thick welded titanium capsule, are manufactured by the 3M Company. The 3M Company specification sheet for the seeds indicates that the seeds can be used as removable brachytherapy implants.

Because of the initial high activity of the seeds, the seeds can be used to 7 ~

, treat several patients. Furthermore, users of the seeds are motivated to reuse

.- the seeds because of the relatively high cost of the seeds. The use of the seeds as removable implants is in contrast with the use of lower activity (0.1 to 1 millicurie) iodine-125 seeds also manufactured by the 3M Company, which are used as permanent implants (e.g., prostate cancer treatment).

The seeds are loaded into catheters for use in temporary brachytherapy implants.* Therefore, each reuse of the seeds involves removing them from old catheters and loading them into new ones. It was during this process of removing the seeds from old catheters using scissors, a razor blade, and a

, needle that one of the seeds was ruptured. The cause of the rupture was

! detemined to be a cut by the scissors or one of the other sharp objects used i

to cut the catheters to free the seeds.

, Licensee personnel were not immediately aware that one of the seeds had been

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ruptured.** Consequently, the seeds were loaded into new catheters and

, implanted in the scheduled patient. As a result, the patient received a

thyroid burden and exposure of 557 microcuries and 2087 rads respectively.

4 The discovery by licensee personnel that a seed (s) had been ruptured followed the discovery of iodine-125 contamination on a source storage / transport bucket for iridium-192 that had been stored in the brachytherapy source room (BSR).

The iodine-125 contamination on the source storage / transport bucket and the ,

iodine-125 seed rupture were discovered on the day after the seeds were removed from an old catheter and loaded into the new catheter and implanted in the .

patient.

• Seeds used in permanent implants may also be loaded into catheters; however, there is no requirement to remove the seeds from the catheters since the implants are permanent.

• • During the period in which the seeds were possessed by the hospital,.th,e, ,

seeds had been removed from old catheters and loaded into new catheters <

on two separate occasions.

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The removal of the seeds from the old catheters and loading of the seeds into l the new catheters were done in the BSR, an area not ventilated by a fume hood.

As a result, the BSR, including the exhaust system, was contaminated (1000-11000 dpm/200 cma ). Also, although the BSR exhaust system was on at least for a period of time after the seed rupture, the pressure in the BSR was apparently higher than that in the area outside of the BSR. This higher pressure apparently resulted from a blockage in the BSR exhaust system. This resulted in some iodine-125 being released into an area where a number of hospital personnel received uptakes of iodine-125. In total, at least 60 hospital personnel, including personnel involved in the control and clean-up of the contamination, and a friend of the patient received thyroid uptake doses of l .04 to 209 nanocuries.

Following the seed removal operation, the work area (in the BSR) and the tools used in the removal and loading of the seeds were surveyed with a survey meter normally capable of detecting low levels of iodine-125. However, the BSR had high background radiation which apparently masked the positive indication of contamination. The licensee did not perfom wipe surveys normally done to detect low levels of contamination. After the contamination was discovered, licensee personnel took action to control and decontaminate the area.

Because of the seed rupture event, the University of Cincinnati decided to

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terminate the use of high activity iodine-125 seeds until the safety and i health physics aspects of the use of these seeds were studied.*

I AE00 undertook a review of this incident to determine if there is a generic problem associated with the reuse of high activity iodine-125 seeds in brachytherapy implant protocols, and to assess any associated health and safety problems.

The incident at the University of Cincinnati is the only incident of its

type known to us involving high activity (30-40 millicurie) iodine-125 seeds.

4 There have been several similar incidents involving the use of low activity (0.1-1 millicurie) iodine-125 seeds. (See NRC Infomation Notices 80-35 and

80-35, Supplement 1.)

Based on our evaluation of this incident we found that:

1. The risk of an iodine-125 seed rupture is relatively high when the seeds are reused for several patients. The risk of a seed rupture is associated with:

! -- The susceptibility of the seeds to damage from typical tools used for removing the seeds (razor blade, scissors, etc.); and The discolored or stained condition of the catheters after use in therapy, making viewing of the seeds difficult.

*As of the date of this report the University of Cincinnati has not resumed-the practice of reusing the seeds to treat multiple patients.

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2. The consequence of the seed rupture at the University of Cincinnati, .

involving patient and other personnel uptakes and facility contaruination, could have been mitigated by adequate radiation surveys of the work area and the tools used to remove.the seeds from the catheter, or by perfomin'g a leak test of the seeds. Additionally, personnel uptakes other than the patient and the facility contamination could have likely been prevented if the seed removal operation had been performed under i a fume hood.

3. It appears that the consequence (personnel uptakes, and personnel and facility contamination) of a similar event could also be mitigated by employing radiation safety procedures designed to detect promptly if a seed is ruptured and to prevent personnel uptakes and personnel and facility contamination. Such procedures would include: perfoming the removal / reloading operation in a fume hood; perfoming wipe surveys of tools and the area used for the removal and reloading of the seeds;

,. or leak testing the seeds following the removal / reloading operation.

In addition to the specific findings stated above, we believe that attention should be called to one other aspect of the incident:

-- The University of Cincinnati's licensed program represents a large isotope research and medical use program that typically employs a full-time health physics staff which is generally

familiar with the use (.f a wide variety of radioisotopes. In this event, however, it appears that licensee personnel failed to appreciate or understand the potential for a seed to be ruptured by the seed removal operation or the consequence of such a rupture, in that the protocol describing procedures to be followed for temporary implants did not require (1) that the seed removal operation be conducted in a fume hood; or (2) that a wipes survey leak test

• be performed to verify the integrity of the seeds before the sources were reused.

l Based on our findings, we recommend that:

1. The Office of Inspection and Enforcement (IE) send an Information Notice

- to the affected licensees describing the event at the University of

' Cincinnati and describino the action taken by the licensee and the source manufacturer (3M Company) to prevent the recurrence of similar events.

- 2. The Office of Nuclear Material Safety and Safeguards (NMSS) in conjunction with the appropriate regional office should insure that the 3M Company's license and the license (s) of any other NRC licensees who supply high intensity iodine seeds be amended to require that, in addition to instructions and safety precautions regarding use of the seeds that are normally communicated to purchasers or other users of the seeds, specific instructions and safety precautions for reusing the seeds be communicated.

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• NRC regulations do not require such a leak test.

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4-These procedures should include, as a minimum, the recommendation that the removal of the seeds from catheters be done under a fume hood and' recommended safety precautions for insuring the prompt detection of a leaking seed, for example, performing comprehensive wipe surveys of tools and the area used for the removal and reloading of- the seeds or leak testing the seeds following the removal / reloading operation.

3. The Office of Nuclear Material Safety and Safeguards (NMSS) should explore the option of. addressing the reuse of the high activity fodine-125 seeds during the license issue, renewal, or amendment process and consider requiring licensees who will be using the seeds to submit procedures for handling the seeds to NRC for review.

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1. INTRODUCTION .~

l The University of Cincinnati reported to NRC Region III by telephone that an iodine-125 brachytherapy source was found to be leaking. .The licensee later.

submitted a written report giving an account of the circumstances surrounding the source rupture (Ref. 1).

In the month following the event, inspection personnel from the NRC Region III office conducted a special inspection to review the facts surrounding the source rupture. The results of this inspection are documented in Region III ,

Inspection Report No. 30-02764/84-02 (Ref. 2).

The University of Cincinnati's medical isotope program is licensed under )

10 CFR Part 33 and Part 35, " Broad Scope Byproduct Material License." A " Broad

Scope Byproduct Material License," among other things, authorizes licensees to employ a radiation safety committee to conduct safety evaluations of proposed l uses (including human use) of byproduct material (e.g., review facilities and equipment, operating or handling procedures, training and experience of users, etc.) and approve such uses in lieu of requesting from NRC approval of proposed uses. The other type of byproduct material license for human use issued by NRC is a " Limited Scope Medical License" authorized under 10 CFR Part 35. This license, among other things, differs from the " Broad Scope Byproduct Material License" in that specific isotopes or groups of isotopes and their authorized uses are listed in the license and any changes in authorized use must be l approved by NRC before the changes are implemented.

t In regard to the use or reuse of high intensity iodine-125 seeds, the following observations are made relative to licensing:

Under the " Broad Scope Byproduct Material License," the use of

, the seeds is authorized through the mechanism of approval of l

uses of byproduct material by the radiation safety committee.

Under the " Limited Scope Medical License," the use of the seeds is authorized through 10 CFR Part 35.100(f)(8) which authorizes the use of " Iodine-125 as seeds for interstitial treatment of cancer."

The " Limited Scope Material License" requires the licensee to follow the radiation safety and handling instructions approved '

by the Nuclear Regulatory Commission or an Agreement State and furnished by the manufacturer in the leaflet or brochure that accompanies the source.

AE00's review and analysis of the incident was undertaken to determine whether there is a generic problem.with the reuse (treating several patients with the same set of seeds) of high activity iodine-125 seeds, and to assess any associ-ated health and safety problems. This review is primarily based on information obtained from the licensee's report, the NRC Region III inspection report and a telephone conversation with University of Cincinnati personnel involved with the radiation therapy program. The incident at the University of Cinciniiati" is the only incident of its type known to us involving high activity (30-40 millicurie) iodine-125 seeds. There have been several similar incidents involving the use of low activity (0.1-1 millicurie) iodine-125 seeds. (See NRC Information Notices 80-35 and 80-35, Supplement 1.)

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Section 2 is a description of the source rupture event; Section 3 is an l analysis of the event; Section 4 discusses the licensee's and the source manufacturer's actions following the event; Section 5 gives the fMings of the study; and Section 6 contains the conclusions and recommendations of the study. Appendix A is a copy of the licensee's protocol for the use of iodine-125 seeds in brachytherapy; Appendix B is the manufacturer's specifica-tion sheet for the iodine-125 seeds; Appendix C is the manufacturer's specification sheet for the Heyer-Schulte coaxial catheters; and Appendix D is the manufacturer's specification sheet for the MiniMonitor 125 radiation survey meter.

2. DESCRIPTION OF THE EVENT 2.1. General The source rupture event at the University of Cincinnati involved the rupture

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of a high activity (40 millicurie) iodine-125 seed. The seed was one of eight seeds being used as a temporary implant in the brachytherapy treatment of brain tumors. The seeds were manufactured by the 3M Company. Because the seeds could be used as temporary brachytherapy implants and because of the high 4

activity and relatively high cost of the seeds, the University of Cincinnati was using the same set of seeds to treat several patients. This reuse of the seeds involved removing the seeds from catheters and loading them into new catheters prior to each insertion. The use of high activity iodine-125 seeds as removable brachytherapy sources was a new procedure at the University of Cincinnati.* Previous uses of iodine-125 seeds involved the use of low activity fodine-125 seeds (0.1-1 millicurie) as permanent brachytherapy implants.

! 2.2 Chronology of Events The following excerpt from the NRC Region III inspection report gives a chronology of licensee actions leading to the rupture of the iodine-125 seed.

(For further details see Ref. 2.)

(1) On Friday (day 1), the Radiation Safety Office received 400 millicuries of iodine-125 brachytherapy seeds. A total of 10 seeds, 40 millicuries each, were inventoried.

(2) On Monday (day 4), eight of the ten seeds were prepared and implanted.

4 (3) On Friday (day 8), the seeds were removed from the first patient.

(4) On Monday (day 11), the eight seeds were removed from the original catheters. Five seeds were prepared for treatment of patient 2, however, this treatment was cancelled.

• A protocol describing procedures to be followed for temporary brain implants received radiation safety committee approval prior to use of the seeds (Appendix A).

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7-(5) On Monday (day 18), the five seeds were removed from the ^

catheter.and eight seeds were prepared and implanted into patient 3.

(6) On Tuesday (day 19), a wipe test of a shipping container revealed iodine-125 contamination. Source of contamination was traced to the brachytherapy source storage room [BSR].

(7) On Wednesday (day 20), a wipe test of the patient's head and bandage revealed no contamination.

(8) On Thursday (day 21), a thyroid count on the technician who prepared the seeds revealed a 209 nanocurie uptake.

(9) On Friday (day 22), air flow rates in the brachytherapy source storage room were determined. Urine bioassays of

, personnel working with the seeds revealed nanocurie amounts of iodine-125.

.(10) On Saturday (day 23), the seeds were removed from patient 3.

After explant, a survey of the patient's neck revealed a radiation level of 1.5 mR/hr at two inches from the thyroid.

The patient was discharged.

(11) On Tuesday (day 26), a urine bioassay from the patient revealed 57.6 microcuries of iodine-125. The NRC in Region III was notified.

(12) On Wednesday (day 27), a thyroid bioassay on patient 3 revealed a burden of 557 microcuries.

(13) On Thursday (day 28), determination of area contamination continued.

(14)OnFriday(day conditions and29)Ionstaken.the act NRC Region III was Decontamination informed of the storageof current room [BSR) continued.

(15) On Monday (day 32), the exhaust system in the storage room

[BSR] was modified to increase flow rates.

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(16) On Tuesday (day 33), evaluation of contaminated areas continued. '

(17) On Wednesday (day 34), the condition of the patient was determined. The walls in the storage room [BSR] were painted l

to "fix" the contamination.

l (18) On Thursday (day 35), air samples taken from the storage room [BSR] revealed no detectable activity. . . . . . ,

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3. ANALYSIS OF THE EVENT 3.1 Seed Rupture, A review of the manufacturer's specification sheet for the iodine-125 seeds shows that the seeds consist of a welded titanium capsule containing iodine-125 adsorbed on anion exchange resin spheres (Appendix B). The titanium capsule wall thickness is .05 mm. The capsule is a cylinder .8 mm in diameter and 4.5 mm long. The catheters used at the University of Cincinnati were Heyer-Schulte coaxial after-loading catheters made of a silicone elastomer.

They consist of an inner and an outer catheter,16.5 cm long and 15 cm long, respectively (Appendix C). The catheter manufacturer specifies that the catheters are recommended for " single use only"; therefore, reuse of the iodine-125 seeds contained in the catheters requires removing the seeds from the old catheter and loading them into a new catheter.

The technique used for removing the seeds from the catheters at the University of Cincinnati consisted of first cutting the ends off of the catheters using scissors and then using a razor blade to shear the plastic tubing longi-tudinally in such a manner as to expose the bare seed within the catheter enough so that forceps could grasp the seed. This same technique was reportedly used for removing the seeds on both day 11 and day 18. The protocol describing procedures to be followed for using the high activity iodine-125 seeds for temporary implants did not address how to remove the seeds from the catheters. The technologist involved in the seed removal feels that the seed was likely ruptured by the scissors when the ends of the catheters were cut off.

g Following the discovery of iodine-125 contamination in the BSR and after the sources were removed from the patient, all sources were returned to the 3M

Company for analysis. An excerpt from the 3M Company repurt of the analysis states

(Ref. 3)

In conclusion, of the ten high-activity I-125 seeds returned to 3M for inspection following discovery of radioactive contamination at your institution, only one seed (seed #2) released I-125. In our estimation this release was caused by structural damage to the ,

titanium shell of the seed in the form of a transverse cut near the weld end. The cut may have been caused by a scissors or wire cutter, etc., used to free seeds from the catheters prior to loading them into new catheters.

This result is consistent with the technologist's view of the cause of the

! seed rupture.

The technologist involved in the seed removal feels that this cut had likely 1 occurred during removal of the seeds on day 11. The seeds removed at that time were contained in catheters that were stained from having been implanted in a i

tumor, thus making it difficult to see the seeds in the catheter. In addition, the technologist indicated that the inner catheter and outer catheter were stuck together and could not be separated, further hindering visibility of the seeds. By contrast, the seeds that were removed from the catheters on' day 18 )

had not been used (i.e., the therapy use had been cancelled); therefore, the  !

catheters were clear and allowed greater visibility of the seeds.

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- g-l 3.2 Contamination and Personnel Uptakes --

The removal of the seeds on both day 11 and day 18 was done in the brachy-therapy source room in an open area that was not ventilated by a fume hood.

Also, the BSR apparently was under a slight positive pressure at the time ,

because of a blockage in the room's exhaust system (a damper was partially closed) that reduced the exhaust flow rate to less than the exhaust flow rate l for the area outside of the BSR.*

Licensee personnel stated that both times the seeds were removed, radiation surveys of the work area and the tools used in removing the seeds were made and i that these surveys revealed no contamination. The surveys were made with a Nuclear Associate MiniMonitor 125 which, according to the manufacturer's specification sheet, has a minimum range of 0-500 counts per minute (cpm)

(Appendix D). The Region III inspection report noted that the background radiation level in the BSR was normally high because of the proximity of other

- brachytherapy sources. This made it difficult to detect contamination using a survey meter. Wipe surveys, which involve wiping suspected contaminated areas with cotton swabs or similar material and later counting the wipes, were not done. Good health physics practices and NRC regulatory requirements indicate that, under the circumstances, wipe surveys should have been performed to look for contamination.** In addition, good health physics practices indicate that, since removal of the seeds from catheters involved non-routine handling of the seeds which increased the risk that seeds could be damaged, the seeds should have been leak-tested following removal of the seeds from the catheters. The protocol describing procedures to be followed for using the high activity iodine-125 seeds for temporary implants did not address wipe surveys or leak testing of the seeds.

) On day 19, the day after the sources were implanted in a patient, the licensee discovered iodine-125 contamination on a source storage / transport bucket for iridium-192 that had been stored in the BSR. The iodine-125 contamination which was discovered during routine wipe surveys of the bucket (being prepared for shipment) averaged approximately 625'dpe/200 cm2 The contamination was

! traced to the BSR. The BSR was sealed off and decontamination was begun. Wipe l testing of the brachytherapy source room revealed contamination levels of 1000-11000 dpm/200 cm2 The day following the discovery of iodine-125 contesination in the BSR, licensee personnel wipe tested the patient's lead hat and bandage to check for contamination. No contamination was found. Later, after it was determined

• Following the discovery of contamination in the BSR, it was closed off using plastic over the door. It was noted that the plastic was ballooned outward, indicating a positive differential pressure between the BSR and the area outside of the BSR.

• • The licensee was cited by NRC/ Region III for being in violation of ^

10 CFR 20.201(b), which requires licensees to make surveys as necessary and reasonable under the circumstances to evaluate the radiation hazards.

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that the source of the iodine-125 contamination was the implanted seeds, a ^

medical decision was made to leave the sources implanted for the prescribed period of the therapy (Ref. 4).*

The implanted seeds were removed from the patient on day 23. The catheters i containing the seeds were placed in a lead-shielded container and taken to the radiation safety laboratory and placed in a fume hood. The catheters containing

the seeds were later sent to the 3M Company for evaluation. A survey of the patient's room with a survey meter revealed no contamination. However, a survey of the patient revealed a radiation level of 1.5 millirem per hour 2 inches from the thyroid gland. The patient was released from the hospital on day 25. On day 27, the patient returned to the hospital for a bioassay and the results indicated a thyroid burden and exposure of 557 microcuries and 2087 rads, respectively.

The positive differential pressure between the BSR and the area outside it existed for several days following the discovery of iodine-125 contamination in the room. The positive differential pressure contributed to the airborne migration of the iodine-125 into adjacent areas. This resulted in numerous personnel who frequented these areas receiving uptakes of iodine-125. Other personnel involved in the control and cleanup of the contamination also received iodine-125 uptakes. Bioassay results for these personnel indicated that:

The technician who prepared the iodine-125 seeds had a thyroid uptake of 209 nanocuries; and At least sixty hospital personnel and a friend of the patient had thyroid uptakes that ranged from .04 to 209 nanocuries.

The maximum permissible thyroid burden (MPBB) for iodine-125 is 500 nanocuries.

Although the contamination of the BSR was extensive, wipe surveys and air samples revealed that the contamination was essentially limited to the BSR.

Wipe tests taken in the brachytherapy source room on day 29 showed contamina-tion levels that ranged from 160-3900 dpm/200 cm2 for the wall and floor to 1900 dpe/200 cm2 on the lowered-ceiling tiles. A maximum total of 25 micro-curies of iodine-125 was estimated to be in the paint on '.he walls. Air

samples taken in the BSR on day 32 showed air concentrations of 125 dpm/20 l fts (less than the maximum permissible concentraticns for restricted areas).

Air samples taken outside of the BSR showed negligible iodine-125 concentra-tions. However, some contamination (low level) was found on the surface area j of the BSR exhaust vent at the point of release.

The University of Cincinnati successfully decontaminated the BSR or fixed the i contamination by repainting the walls.

• Because a medical evaluation and decision was made to leave the implanted. .

sources in place, the iodine-125 uptake by the patient was not deemed by NRC to be a medical misadministration as defined in 10 CFR 35.41.

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4. LICENSEE AND SOURCE MANUFACTURER ACTIONS . , .

4.1 Licensee Actions .

As a result of the source rupture, the University of Cincinnati suspended the useofhighintensityiodine-125seedspendingtheinvestigationoftheevent 1

(Ref. 5). The University of Cincinnati, in their response to the NRC Notice -

of Violation,** expressed concern that there was a likelihood of other occur-rences of source ruptures involving the reuse of high intensity iodine-125 seeds.

An excerpt from the University of Cincinnati's response is as follows:

The sealed source was opened by a radiation safety technologist j under conditions of poor visibility. This accident could have i happened at any installation in the country where the seeds would

. have been placed in plastic tubing which becomes discolored from use and an attempt made to retrieve the seeds and reutilize them because of their cost.

i 4.2 Source Manufacturer Actions In a letter to NRC dated February 11, 1985, regarding the 3M Company's " peer review" of the AE00 preliminary case study report of the event, the Company stated that " subsequent to the Cincinnati incident, 3M upgraded its internal procedures aimed at providing additional control for institutions /uses involving high activity seeds."

The following description of the upgraded procedures was presented:

1. 3M Customer Service directs all phone inquires about the use of I-125 Seeds Model 6702 for brain implants to someone L in Technical Service.

l 2. This Technical Service person summarizes 3M's REQUIREMENTS of an institution prior to selling the seeds for such use, which include submission to 3M of 1) a Brain Implant Protocol, 2) an l Institutional Review Board (or equivalent) approval of that I

protocol, and 3) a copy of the Patient Informed Consent form. ,

in the same phone conversation, risks and hazards associated '

with the handling of the 30-40 sci seeds are summarized to include the consequences of cutting a seed while removing it

'from the afterloading catheters. (The Cincinnati incident is alluded to but the hospital is not identified.) ,

l *As of the date of this report the University of Cincinnati has not resumed the practice of reusing the seeds to treat multiple patients.

• • The University of Cincinnati was in noncompliance with the License ' " " '

Condition 15, which states that sealed sources shall not be opened, and 10 CFR 20.210, failure to make adequate radiation surveys.

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3. A follow-up Brain Implant Protocol letter is mailed to - -

the customer.

Prior to the Cincinnati incident, a phone call was not always; followed with a letter since it was believed that adequate verbal instructions were given to a knowledgeable customer.... Following the Cincinnati incident, a follow-up letter was always sent.... We believe that requiring a radiation safety section in the implant protocol provided adequate assurance that the seeds would not be mishandled if reused.

The letters also directed the customer to knowledgeable people

[in 3M] who could advise about the proper handling of seeds during reuse.

5. FINDINGS

. - 1. The risk of an iodine-125 seed rupture is relatively high when the seeds are reused for several patients. The risk of a seed rupture 4

is associated with:

i The susceptibility of the seeds to damage from typical tools

, used for removing the seeds (razor blade, scissors, etc.); and 1 --

The discolored or stained condition of the catheters after j use in therapy, making viewing of the seeds difficult.

2. The consequence of the seed rupture at the University of Cincinnati, involving patient and other personnel uptakes and the facility contamina-

tion, could have Deen mitigated by adequate radiation surveys of the work area and the tools used to remove the seeds from the catheter, or by

, performing a leak test of the seeds. Additionally, personnel uptakes other than the patient and the facility contamination could have likely been prevented if the seed removal operation had been performed under a fume hood.

j 3. It appears that the consequence (personnel uptakes, and personnel and facility contamination) of a similar event could also be mitigated by employing radiation safety procedures designed to detect promptly if a ,

seed is ruptured and to prevent personnel uptakes and personnel and facility contamination. Such procedures would include: performing the

,! removal / reloading operation in a fume hood; performing wipe surveys of tools and the area used for'the removal and reloading of the seeds; or leak testing the seeds following the removal / reloading operation.

I

' In addition to the specific findings stated above, we believe that attention should be called to one othar aspect of the incident:

The University of Cincinnati's licensed program represents a large isotope research and medical use program that typically i

employs a full-time health physics staff which is generally _ , ,

familiar with the use of a wide variety of radioisotopes. In this event, however, it appears that licensee personnel failed

. to appreciate or understand the potential for a seed to be

ruptured by the; seed removal operation or the consequence of k

+ 9

,__.-,-.._,,-.....,,_.m ,,_.,,.,...,_,.,,,__.__-.,m,,_,.,.,_,_.,

such a rupture, in tha.t the protocol describing procedures to - -

be- followed for temporary implants did .not require (1) that the seed removal operation be conducted in a fume hood; or i (2) that a wipes survey leak test be performed to verify the integrity of the seeds before the sources were reused.

6. CONCLUSIONS AND RECOMMENDATIONS l Based on our findings, we recommend that:

1. The Office of Inspection and Enforcement (IE) send an Information Notice to the affected licensees describing the event at the University of Cincinnati and describing the action taken by the licensee and the source manufacturer (3M Company) to prevent the recurrence of similar events.

2. The Office of Nuclear Material Safety and Safeguards (NMSS) in conjunction

~ _

with the appropriate regional office should insure that the 3M Company's license and the license (s) of any other NRC licensees who supply high intensity iodine seeds be amended to require that, in addition to instructions and safety precautions regarding use of the seeds that are normally communicated to purchasers or other users of the seeds, specific instructions and safety precautions for reusing the seeds be communicated.

These procedures should include, as a minimum, the recommendation that the removal of the seeds from catheters be done under a fume hood and recommended safety precautions for insuring the prompt detection of a leaking seed, for example, performing comprehensive wipe surveys of tools and the area used for the removal and reloading of the seeds or leak testing the seeds following the removal / reloading operation.

p 3. The Office of Nuclear Material Safety and Safeguards (NMSS) should explore the option of addressing the reuse of the high activity iodine-125 seeds during the license issue, renewal, or amendment process and consider requiring licensees who will be using the seeds

'to submit procedures for handling the seeds to NRC for review.

~

,  %. . , , _... , . -, -_ . _ -~ - - -

14 .

7. REFERENCES (1) Letter from Eugene L. Saenger, M.D., to NRC.

(2) Region III Inspection Report Number 30-02764/84-02 (DRSS).

(3) Letter from David Kubiatowicz, Medical Products Division, 3M Company to Peter Ho, M.D., Department of Radiation Therapy, University of Cincinnati Hospital General.

(4) Letter from Eugene L. Saenger, M.D., Chairman, Radiation Safety Committee, University of Cincinnati Medical Center, to William Axelson, NRC (Region III).

(5) Memorandum from Eugene L. Saenger, M.D., University of Cincinnati Medical Center to Bernard S. Arin, M.D. and Peter Y. C. Ho, M.D. ,

University of Cincinnati Medical Center.

(6) Letter from Robert G. Wissink, Manager, Health Physics Services, 3M Company te Darrell Wiedeman, Chief, Materials Radiation Protection Section, NRC (Region III).

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APPENDIX A P otocol for the use.of 125 1 sealed sources for Implant into patient 's tumor

-

1. Upon receiving 125 1 shipment o

A.

A wipe test is first made Inside the source container bottle by Radiation Safety to detect possible leakage of the sealed source.

~

B. Calibration of each shipment of sealed sources is done by Radiatice Oncology with a dose calibrator uslag an N85 standard source (avaF lable late 1983). .

- 2. Preparation for implants A. The 125 1 seeds are loaded into shielded cartridges or af terloading devices by Radiation Oncology technologist /staf f/ residents with'special tools designed for handling the seeds standing behind a lead shiel d or wearing a lead apron.

, B. Af terloading, the instrumnnts useu ior.. handling the 125 1 seeds will be bhecked with a thin window counter to check for leakege contamination due to possible mechanical damage to the seeds.

C. The shielded cartridges or af terloading devices are gas sterilized for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or steam sterilized for 10 minutes.

/

3. During implant in patients and immediately post implant A. The' Instruments used in the implant should be nonitored with a thin window counter af ter the implant to check for leakage contamination due to possible mechanical damage to the seeds. ,

B.

The suction apparatus, tubing and kaps, including the Foley bag ere checked for loose 125 1 seeds and removed appropriately for disposal by Radiation Oncology or Radiation Safety.

4.

Post implant monitoring - per Radiation Saf ety regarding exposure to personnel

5. If leakage is discovered l A. Upon receiving shipment - container is to be ' sealed and disposed appropriately by Radiation Safety.

} , . B. During handling of seeds - all personnel or patients involved are to have i

their urine checked and undergo thyroid counting to nonitor exposure.

6. All unused 125 1 seeds are to be returned to Radiation Safety for disposal except for reusable high activity 125 1 seeds (40 MCI), which are to be stored in Radiation Oncology's shielded safe. These will be returned when ,the activity is below 10 mci each.

7. All operators and technologists handling 125 1 seeds will wear finger badges.

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. APPENDIX B e *

~

ll-125 8eeds No.6702 Description Warnings . I 8.125 Seeds 6702 censist of a weidesi stanium capsule containing todine.125 sesormed on snion emenani,e resin spheres.

• The 8 125 Seed titanium capsule has excellent corrosion resistance, but at is attacesed by concensrated hydrochloric acid.

s.125 Seeds have been designed not so ane used en a concentrated t.Its .de.ete.d hcl environment. ,

4 o.... o os

m. se. a Precautions '

$ \ ,

/ Preparation for Use/ Sterilization l.125 Seeds are radioacasve and approgetate precautions must be taken when handling these sources. At steps of the implantation

' o.s .. I h **-

l procedure should be planned in advance to minimite radiation j exposure to personnet.consastent wiert published exposure limits.

Personnel morutoring is requered for insasveduals workmg witn t.12 e.s Seeds. A film badge or TLD dosameter worn on the body and. !or i

/ handling. a ring badge um provede adectuate detection.

Physical Characteristics

~', lodine 125 has a half-life of 60.2 days and decays by electron 8 125 Seeds are prowded in a glass viel which should be

,japture witn the emession cf cf.saraeteristic photons and Auger maintained in a lead vial contaener for saorage. When transporting i electrons. The electrons are absorbed Dy the tatanium wall of seeds within the hospital premsses, an appropriate carrier with adequate sheelding should be used.

the 1 125 Seed. The, principal photori emissions are 27.4 and ,

j 35.5 kev x-rays and a 35.5 key garr s a. ' All manip'usations iswoeveng 8 125 Seeds should be carried out To correct for the physical decay of to Jane.125. the decr, factors behind shielding of' s ucs aize and thsckmess as willadecuately at selected days af ter the assay dat t tre shown in the sable below. shield the operator. OtRECT CONTACT *.VITH THE SOURCES SHOULD BE AVOIDED.In additson.8125 Seeds should be o.ar cwt e.dm t; s. n.w La. ee.2 c.js handled only with forceps. with as muete distance as oractical

1. o.u o.ce between sources and the operator. l.125 SEEDS SHOULD NO) oars F.c2.re n.,. recs.r e..................u.o BE PICKED UP WITH THE HANDS.

=.....................=>

2........ i.i25 Sods are NOT r.e when shipp

• * .......o g 3, . . . . . . . . . . . . . gg ,,,,iii,,,, , ,,,, ,,,,,c,,,,, ,, ,,,,ed,,, and,,ia,s, s,u,ch o, m,,u,st ,,, be a l .."((((.'(([c.s33 42 22*.*[.'.'.'2.'[.C.' 44 ....................e.803 as17 Impf antation. Regardless of the methoca selected.l.125 Seeds toa....................e.s

. ... ... ............st2 .

4 . . . . . . . . . . . . . . . . . . . . u 8s should be placed in an adequately shselded container prser to placemeniin e me,.a mncham be,. anipu,ation onhe see, i2 . ... . . . . . . . . ... . . . . . a e r i

. prior to or i iiowin u '... 7.'....$.7.I.'7.2

. .. . ... ..0 813 . . ........ ....................g aeg so 3r. . .. ..* ... .nie,.ding . . .of.socn . ..,,,,,,;,,,,,,,,,,,,,,,,,,,n,,

...stori,eiratio,n

,g asrsH 2snound '27.'.'2222 i,e, carried ou,t as,2 be 18 . . . operstor.1n addition. l.125 Seeds shoued be handled onty with so . . . . . . . ... . ........ IL7 H ss .................... Es2s forceps, with as much cMtance as pracocal between sources ano 22 . . . . . . .. . .. .... .. .. e 77s se ... ................e.s13 24 . . . . . . . . . . . . . .. . . . . . a 7 5 s so . . . . . . . . . . . . . . . . . e so t the operator. Autoclaves should be equipped with traps or other means to prevent seed loss througft the drain hole.

l .'.*2.'2.~.272.S 2 [.'* 22.*.'.".".'.* 8125 Seeds have been designed to wittistand normalaatJefave 30 . . . . . . . . . . . . . . . .. . . . . e. 70s es . . ................O.ase 32 . . . . . . . . . . .. . . . . . . e e s 2 se . . . .. . .... . . . . . . .. . aas r temperature and pressure variations from 121' C at 15 oss to 34 . . .. . . ... . . . . . . .. . .. a s rs 7e . . . . . . . . . . . . . . . . . . . a 44 7 138* C at 35 psi.1.125 SEEDS ArlE NOT INTENDED TO BE l Radiation Protection STERlLIZED USING DRY HEAT AND SHOULD NOT BE SUBJECTED TO TEMPERATURES AND PRESSURES IN The half value thickness of lead for lodine.125 is 0.025 mm. Thus, a EXCESS OF THESE 1.IMITS(138' Cand 35 psi).

O.25 mm lead sheet will provide > 99% reduchon in exposure.

8 125 Seeds should be autoclaved in bulk or individualir in l Action 5 appropriate containers of autoctave. compatible materials. Thes.

! materials include stainsess steef. giass. nyton. and tefion. l.125 I.125 Seeds emit 27.4 and 35.5 kev a. rays and a 35.5 kev Seeds anay also be autoctaved in selected accessories to ga vima. Tne cimical efficacy of the sources derives solely from commencany.avaHablinmosannoos s. Among mese accessones tne interaction of these sonizmg radsations with the tissue being are the stainless steel cartridge of the Mick applicator and gun, treated ~ and nylon and teflon tubing used as seed holders with Henschke and Scots applicators. When in doubt about the chemicat nature Dose distribution around each individual seed is not isotropic. This of these te'ed hoeders. either sterilize the materials witn etnylene enesotropy should be included in dose distribution calcutabons. oxide or autoctave a sample of the materials containing dummy Titanium encapsulation' assures good tissue compatibihty and seeds before attempting to load wien rad.oactive seeds. DO NOT results in a total self-aesorpteon of approumately 16%. AUTOCLAVE 8125 SEEDS IN PLASTIC TUSING OR OTHER PLASTIC CONTAINERS.

Indicalions , ,. Armougn s.125 Seeds have a high structuralintegrity. it is nossid 8 125 Seeds are indicated for interstitial treatment ot tumors which througn mugh handamg. high temperasuretorwheng. mat a have tne tossowing en3racteristecs: unresectadie, localized. and seed could leak or be ruptured. if sucs a rare occurrence does moderate radsosensetsvity. -

happen. the area should be closed ott. the seeds packaged into s.

8 125 Seeds may be used for selected radiation applications as .

sealed contamer and the area decontaminated. Decontaminatsorn r3movaose emplants. can be confirmed by taking wipe samples of theimmed ate area Personnel movement should be controIIed to avo.d scread of an, 8 125 Seeds are indecated to treat reseduas tumors fossowing ressoactive contamanatic,n. Whenever a soerce es damaged.

Complebon of a course of external radiation therany. In addition, personnel working in the area should esadergo a tevyro.c. scan to recurreat tumors may be emplanted wem 1 125 Seeds. assure that they have not been contaas.inated by centtet, angestir or ennatsuon et sodme. 25. -

Contraindications '

As wim other brachymerspy sources treatment of tumors in ,

generassy coor cono, tion tea u'ceratedt es not recommended with e

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. Mdical Product 3 Divisiont3M TCAAP 4 Now Brighton, Minnesota 55112

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Certification 'KM54963 . 70 4.9 lodine 125 Sealed Sources For Medical Uses' 1 Sep.1983 Consignee:

UNIV CINCINNATI MED. CTR RADI0 ISOTOPE I A83 Address: 234 GOODMAN ST CINCINNATI. OH 45267 Y

The following radioactive sources are certified by Minnesota Mining and Manufacturing Company (3M) te .'. ave been subjected to the tests described below and to have been given the results listed.

Modet Number g7gg

• Lot Number , 7g,g g l

Oyantity 10

• l Activity Range (mci)*

38 0 40- 3 Total Activity (mca-390.0 I Assay Date g

All seeds have passed a leak test showing <0.005uC1 of removable us lodine activity. No other certification

~

, , , is to be implied.

3

• By " mci" we mean " apparent activity in millicuries", which is descriptive of output activity only and not the total quantity of I 125 contained within the titanium capsule of the Seed.

For accounting purposes, the cuantity of I-125 contained in Model 6702or Model 6711 Seeds is about 1.2 or l 1.6 respectively multiplied by the stated apparent activity in millicuries.

Read the reverse side of this form for information about Seed construction, method of calibration and definition of " apparent activity in millicuries". l

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Obty Control h Date . , ,

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.he ,ollow,ng procedur. Is speci., .eder .e.lces .r. '

furnished by Phillip H. Cutin, M.D.,a for Informational supplied either sterlie or purposes; nonsterile as Indicated on the product label. Nonsterile SPEClflCAtl0NS (All Dimensions are Nominal) products, if intended for Suture The Coealel Af terloading implantation or en aseptle Catalog Catheter een be used for application, m9st be cleaned Number Description Tis Coller- Catheter Lengthi '

implantion of radioactive and o'trillaed prior to uses Oleawter laner Outer '

sources into brein tumors. ?Y $-se predwet is nonsterile, G4000)$-SI Cosalal Afterloading The outer catheter Is t** cleantne sad steellisetton 03 Catheter Clear medlopaeve i cm 84.5 cm 15 ce generally eleced to e tumor 03  ! cm 16.$ cm Il em target through a Duer hole or procedures glwen below have Redlopeoue I cm

-04 23.3 cm it em tutst drift hole using a been found effective and are Redlocaoue i cm stylet gulded by computed. provided es a gulde. 23.5 cm 27 cm '.

tomegraphy directed Special Order Devices are Manufactured 8 Distributed by:

etereotesy. The gatheter $7tRitt!Atl0M passes through the ellicone AMttlCAN HtTER-$CHVtif l this product is recommended Division of i base before entering the for single use only. American Hospital Supply Corporation y

brain. It is recommended that each 600 Pine Avenue 1, lastitution establish the Colete CA 9518?

when the catheter is et the efficacy of its sterillsation Telephone (80$) 967 34$1 .

target, the sillcone base la pushed down to the skin or to procedure by a method which the stull. It can then be includes the sterilltetton of autured in position, or, in en Intentionally contaminated g product.

the case of the skull, it can >d be glued to the bone with 00 biological othesive. Then, Do not steellite in the the outer catheter is glued to packenino system supplsed. g the base with biological The following cleaning and adhesive. The stylet is (

removed and restaced with the steellination technloues have ,__, ,

Inner catheter contelning the been found effective and are e provided as a guidel e redloactive sources. The inner catheter is secured to

• Remove the Meyer-Schulte the outer catheter with a drop Coontal Aftertoeding Catheter of biological adhesive.

from its package in a clean M0W SUPPtite environment using gloved hands. Lipt, fingerprints, j

toch catheter la provided tele and other surface Individually wrapeed in a conteminants con cause forelen body reactions. Utmost won 17 trit [ condition, and consists of en esternal cautlon should be teken to catheter with auturing flenge evold contaminente.

end two tele 9Coging Internal Use en alcohol (ethyl er catheters. All catheters must Isoerepyl) sweb to remove olly Manufactured and Oletributed byl be cleaned and steellised per surface contaminents.

the instructions below. AmtAICAN HEYER*lCHULTE 8 sp.

. DIvlston of s

e,hiili. M. .utio, M. . Hand devices wash,o,olled sillcone e m.elmum of is American Mosettel Supply Corporet ten . ]'

uaive, sit, of Con fo,nte pine O' Hospitals = minutes in a solution of miid .00eie C.A,ve,nue, ag SOS Pernessus surgical soop or e one percent ii entonic detergent. If it is telephone (803) 967-3431 m, .

Department of N4urosurgety >i l DeeMet) necessary to use a brush, only San Francisco, 941%) f pg

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• e ,

I Functional failure of the Pe0DVC y INf0enATION OlSCt01Unt catheter system due to separation of its component laternettonal Customers - Caughlin, Christoe%er 7., Even Amerleen Meyer-Schulte has cat oleo product s parts can result in serious B. Douple, John W. Strohbehn, comellections. Catheters may esercised reasonable care in For product leformation or to Welter L. taten Jr., S. Stuart migrate into other eroes the chalce of materfels and trembly, and T.t. Wong, causine serious harm to the manuf actiere of this product. order directly, contact your "Interstitlet Hyperthermie in '

patient, ame r le en Meyer-Schult* local American Meyer-Schulte Com61 net ton with escludes all warrantles e d stributor or the American V. erschytheresy,"

ce I l;ogg, 148 Infection la e common and =hether empressed or lepiled Mueller International Customer (July 1983), 705 ls by operation of law or Service Department et 1500 .

serious comellcotten of a otheralse, including, but not usuhegen Road, McCow Park IL catheter system and is most 60085 USA.

Cheryulu, K.R.N. ! "A new I frequently caused by skin limited t o, any Imolled Telephone (112) af terleading technleve for 4f3-3$00, Telen (fux) 989 coataminants. Septiceale, marrantles of merchantabilit?

or fitness. Amorecen Hey,r- 210-195. Interstitiet irredletlee using which occwes most frequently redloactive microstheres." Am j

In debilitated Infants, can Schulte shall not be liebte for any incidental er in Canada, contact AHS/ Medical J. soenteenal Radium ther Nuct result from infections tonseqveatlel loss, demaae or Specieltles, Division of McGa*

nada 103: (1964), l93.

j anywhere in the body and may esponse, directly or Supply Ltd., 2390 Arnentle develop with few or no nood, Mississauge, Onterlo, Cohen, J.S. and 0.M. Skleroff, symptoms, it may occur es e Indirectly erlsing from the . "A New Approach to the 4

result of a wound Infection. use of this product. Amerleen Canede L$N 301.

(486) $21-949),

Tel*Dhone Surgical-Redlologic Menegement in the event of en infection, Meyer-Schulte neither assumes of Breast Concer with removal of the catheter system nor authertses any other Internettonal Customers = Interstitial Irldlum, Jevenel is Indicated in addition to person to assume for it, any of the Albert flesteln nedical I 5

the appropriate chemotherapy. other or pod itlonal liability Special creducta Center, Vol. ), No. 8, gr_fesponstb tity in p, For information on special (December 1956). yo RETURNED C0005 90LICT connection with this device. order devices, please contact Fletcher, 4.H., and M. 8 U.S. Customere PRODUCT ORotR INFORMAtl0N the Customer Service Stoveill "A study of Department at American esplicit distribution of U.S. Customers - Cetatoe Meyer-Schulte, 690 Pine Autherlastion must be received Proevctg Avenue, Colete CA 93117 USA. redletion in interstittel Implantation." Redloloav, 788 from Amorecen Meyer*SChulte, telephone (885) 967-1451, I

Olvision of Amerleen Hospital (1762), 766-787.

Supply Corporation, prior to to order directly in the Telen (Twx) 980 334-1865.

U.S.A., please contact Gray, S.R., 1. Sheldon, M.O.

the return of merchandise. Amerleen V. Mueller, esclusive tevgtont regeret few Merchandise retr nede must have Freedmen, and A.R. Redent all manufacturer's seats United States distributor for restelcts this device to salg "Fibrosercome! A compilcetlen Ontact and be received within all Amerleen Meyer-Schulte by or on the order of e of interstlttel redletlon 60 dets of date of levoice to products wlth distribution phy s ic i an ,

therapy for a beten be eliginie for eredit or centers In Irvine end Nerverd alsL10cRAPMt heemenglema occuring efter 18 replacement. seturned CAI Orlando FL years." Br. J. of sedfelegg, Mccow Perm SL,ssedford Noteress cas products may be subject to MA, Aw. sed, H t., J.M.v. sursers, IFl (1974), 60.t l .

restocking chargss. Romulus Mis Minneapolls MN8 Maryland Heights MOs Edison and H.R. Marcusel "The Sutin, Phillip M. and Rey M.

Internat ional Cutigmarg NJs Columbus ohs Richardson influence of tumor dose Dormendy Jr., "A Coestal and woodland Ts. speciffection on the early Catheter System for '

elinical resul,ts of Afterleeding Redioective Autherlaat ton for return of U.S. Customers - Speelet snterstlttel radium longue merchandise should be obtained sour::es for Interstettel from youe respective dealer. Products Imolante" 3.A hl list (1934), Ipp. irredletJon of seeln tumors,"

Other conditions noted above For information on special J. Neurosure, $6 (May 898I),

also apply. Carfulv, R.E.N.I "An 714-735. .

Order devices, please Contact the Customer Service afterloading Method for Department of American Interstillel Implantatten of Cutin, Phillip H. et al, Heyer-Schulte, 600 Pine radloactive seed." " Permanent and Removable Penminerve Med. 138 (1978),

implants for the prachytherapy Avenue, Colete CA 93117,

) foll-free telephone (400) 3Sg.36). of Brein tumors,",Redletion.

Oncoloer, Bioloey Phystra, 335-5758. 7:10 (October 1981),

1313-1388.

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o - T fPPENDI-X D MiniMonitor 125 l Contamination Monitor ...

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Measures low-level "'I surface N'

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contamination quickly and accurately 1ti g g".

4% , .w e High sensitivity (Iower detection limit-0.002 Ci). gr @ . y e Three ranges (0 500, SK and 50K cpm).

f. 9  ;- ,'g,.

• Large-area, screened detector permits contact -

surface measurements. -

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For the first time, a compact, sensitive rnonitor is avail-

• O $9 y.' ', s-

~ . able for the detection of 151 surface contamination levels as low as 0.002 aCi.

A large-area, thin-window GM detector, recessed in a -

conical housing on the back of the instrument, permits Detector: Halogen-quenched CM pancake tube,1.2* diam.

direct-contact measurements of surfaces.The maximum Readout: 2 % ~ analor meter, marked 0 to S00.

amount of removable contamination allowed' (0.005 Ranges: 0-500,0-5,000,0-50,000 cpm.

,Cil is well within the detector limits of the unit. All Accuracy:210% of full scale.

surfaces as well as hands. clothing, shoes, etc., may be Controls: Off, Battery Test. x100, x10, x1 ranges-all en routinely monitored by using this hand. held instrument. one switch.

Lightweight (22 ounces) and portable, the monitor op. Time Constants: 10 sees (x1): 2 secs (x10); 02 secs (x100).

erstes on 4 alkaline "AA" cells. All controls are con. Batteries : Fou r "A A" elksline cells (500-hour tife).

veniently located on the instrument's face. An LED in- Operating Tem pe rature :-20'C to + 55'C (-4 *F to + 130'F).

dicator flashes with each . incident radiation pulse. The Temperature Dependence: 215% over noted temperature LED also indicates that the unit is "on." range.

., MiniMonitor 125 may be used as a convenient, general. Constraction: All solid state electronics. Righ-impact plastir response survey meter for radiation detection in t e laboratory. The 3. range selector switch permits rap {id Acy,7,ories Supplied: Flastic conta aination shield License.

changing of survey ranges. Radiation levels are read free check source.

on a large 2% meter. The monitor includes a plastic SkW6 m wi& d M. Mme contamination shield for protecting the detector hous- 05 572 MiniMonitor 125 Contamination Monitor 3325.00 ing and a license-free radioactive source for checking the instrument's overall operation.

• Per NRC or Agreement State regulations. -

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