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PRM-035-008 - 54FR19378 - Amersham Corporation: Receipt of Petition for Rulemaking
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Issue date:	05/05/1989
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ADAMS Template: SECY-067 DOCUMENT DATE: 05/05/1989 TITLE: PRM-035-008 - 54FR19378 -AMERSHAM CORPORATION:

RECEIPT OF PETITION FOR RULMAKING CASE

REFERENCE:

PRM-035-008 54FR19378 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PRM-035-008 RULE NAME: AMERSHAM CORPORATION: RECEIPT OF PETITION FOR RULEMAKING PROPOSED RULE FED REG CITE: 54FR19378 PROPOSED RULE PUBLICATION DATE: 05/05/89 NUMBER OF COMMENTS: 1 ORIGINAL DATE FOR COMMENTS: 06/05/89 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: FINAL RULE PUBLICATION DATE: I I NOTES ON PETITION CONCERNED WITH USAGE OF IRIDIUM-192 WIRE FOR TREATMENT OF TATU&* CANCER. PER 1991 REG. AGENDA. PETITION FOR RULEMAKING WITHDRAWN OF RULE BY LTR OF 3/23/93. FILE LOCATED ON P-1.

TO FIND THE STAFF CONTACT OR VIEW THE RULEMAKING HISTORY PRESS PAGE DOWN KEY HISTORY OF THE RULE PART AFFECTED: PRM-035-008 RULE TITLE: AMERSHAM CORPORATION: RECEIPT OF PETITION FOR RULEMAKING PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: 04/28/89 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: I I STAFF CONTACTS ON THE RULE CONTACT!: MICHAEL LESAR MAIL STOP: P 209 PHONE: 492-7758 CONTACT2: MAIL STOP:

DOCKET NO. PRM-035-008 (54FR19378}

In the Matter of AMERSHAM CORPORATION: RECEIPT OF PETITION FOR RULM AKING DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 02/23/89 11/14/88 PETITION OF AMERSHAM CORPORATION: CONCERNS IRIDIUM

-192 WIRE FOR INTERSTITIAL TREATMENT OF CANCER 05/01/89 04/28/89 FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING 06/08/89 05/30/89 COMMENT OF MICHAEL T. GILLIN, PH.D. ( l}

04/19/93 03/23/93 LETTER TO DR. ANTHONY TSE, NRC FROM BRYAN BAKER, AMERSHAM, ENCLOSING A LETTER WITHDRAWING THE PETITION FOR RULEMAKING.

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 MEMORANDUM FOR: Emile Julian, Chief Docketing and Services Branch, SECY FROM: Sher Bahadur, Chief Regulation Development Branch, DRA, RES

SUBJECT:

FORWARDING A LETTER WITHDRAWING A PETITION As discussed between you and Dr . Anthony Tse of my staff, enclosed is a letter (with an attachment) from Dr. Bryan W. Baker of the Amersham Corporation requesting that his petition for rulemaking (PRM- 35-8) be withdrawn.

Please docket this letter. We will prepare the necessary documents for withdrawal after receiving the docketed request.

Sher Bahadur, Chief Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research

Enclosure:

Letter from Bryan W. Baker w/att.

DOCKET NUMBER r PETITION RULE PRM 3S-f-

[ 5-Lf FR l'fJ' t-) ;, CKU UJ USNHC

93 APR 19 P12 :Q 7 March 23, 1993 Amersham Holdings, Inc.

2636 S. Clearbrook Drive Arlington Heights, IL 60005 Dr. Anthony N. Tse tel (708) 593-6300 Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ~mersham

Dear Dr. Tse:

I enclose a copy of a letter I am sending to Illinois Department of Nuclear Safety, withdrawing my requests for the addition of "Iridium-192 wire for interstitial treatment of cancer" to the former Group VI "Use of Sources and Devices containing radioactive material for certain medical uses" and for our Model Number ICW.100 to be approved for distribution to medical licensees.

Do not hesitate to call me should you have any questions concerning this subject. I shall be pleased to discuss them with you and may be reached by phone at (708) 593-6300, extension 379.

z;;;

Bryan W. Baker, Ph.D.

Corporate Manager Nuclear Licensing and Industrial Liaison BWB/jc Enclosure

\I.S. Nuv. *. *.,.;CRY COMMiSSIOt-.

D<:,;: *:: i ,,,,, . ~. ;:;r::WICE SECTION O,T:C:: (1;* f:-lc SE:CR:: fARY Of fHt: COMMISSION

March 23, 1993 *93 APR 19 Pi2 :07 Amcrsham Holdings,lnc.

2636 S. Clearhrook Drive

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,Jci-: : ta; , 'f Arlington Heights, IL 60005 Joseph G. Klinger, Head :,k,\ ,

Licensing Section tel (708 ) 593-6300 Division of Radioactive Materials Illinois Department of Nuclear Safety 1035 Outer Park Drive ~Amersham Springfield, Illinois 62704 Re: License IL-01044-02, Formerly 12-12836-0SMD

Dear Mr. Klinger:

I had written your colleague, Mr. Steven C. Collins, on November 14, 1988, requesting an amendment to License 12-12836-05MD to add Iridium-192 wire products, Model Number ICW.100, for distribution to Group VI licensees. I also requested that Iridium-192 wire for interstitial treatment of cancer be added to Group VI "Use of sources and devices containing radioactive material for certain medical uses".

IDNS forwarded this latter request to NRC, and it was published in the Federal Register as a petition.

Since making that submission, market needs have changed and our emphasis on products has changed. Consequently, I now withdraw the amendment requests I made in my letter of November 14, 1988. I am sending a copy of this letter to Dr. Anthony Tse at the NRC.

I do request that Model Number ICW.100 (NR-136-S-259-S) is retained in the NRC Registry of Sealed Sources and Devices.

Please call me should you have any questions concerning this request. I shall be pleased to discuss them with you and may be reached by phone at (708) 593-6300, extension 379.

SZ!ely, (t-4__

B ~ ,--Ph:O:- ___ _

Corporate

.* ---Manager Nuclear Licensing and Industrial Liaison BWB/jc cc: Dr. Anthony Tse

(!)

J. Frank Wilson, M.D., FACR Chairman May 30, 1989 Departtnent of Radiation Oncology Roger W Byhard~ M.D.

Maurice Greenberg, M.D., FACR Nora A. Janjan, M.D. Secretary Colleen A. Lawton, M.D.

Kevin J. Murray, M.D. us Nuclear Regulatory Commission Laird E. Olson, M.D. Washington, D.C. 20555 Medical Radiation Physics Michael T Gillin, Ph.D.

Daniel F. Grimm, M.S.

Attention: Docketing & Service Branch Darwin L. Zellmer, Ph.D.

Radiation Biology

Dear Sir,

AY E. Hopwood, Ph.D.

, E. Moulder, Ph.D.

The purpose of this letter is to comment on docket No. PRN 35-8, which is a petition for rule making from the Amersham Corporation to include Ir-192 wire for the interstitial treatment of patients with cancer. This letter is being written in support of that petition. As a radiological physicist who works at several institutions, one of which possesses a broad license and thus is permitted to have Ir-192 wire, and one of which does not, it is certainly my opinion that patients who are treated at the Community Hospital were there do not have access to Ir-192 wire for interstitial brachytherapy treatments receive treatments whose dose distributions are less desirable than those patients who can be treated with wire. Ir-192 seeds, especially when spaced 1. 10 cm-to-cm spacing, produce substantially inhomogeneous type of dose distributions at distances as far away as 1 cm from the source.

Enclosed find a copy of an article of which I am co-author which describes the lack of contamination associated with the routine handling of such Ir-192 wire sources. Contamination was only obtained when the source was deliberately physically abused. It is my opinion that such contamination would be a problem no matter what brachytherapy source was physically abused .

In conclusion, it is my opinion that the use of Ir-192 wire has dosimetric advantages to patients over the use of seeds and there is no known information which established this as a radioactive hazard in its routine handling. Thank you very much for your consideration in this matter.

\\_~ ~

Michael T. Gillin, Ph.D.

Associate Professor Radiation Oncology Medical College of Wisconsin MTG/va Enc .

Milwaukee County Medical Complex 8700 West Wisconsin Avenue Milwaukee, Wisconsin 53226 (414) 257-5636

. S. U LE,' f'! 1:n; Y co~ MISStON DO G '"ECTION or- J:TARY

-l ION

Quantitation of the Amount of Contamination Obtained From Iridium-192 Sources DANIEL F. GRIMM, MS, MICHAEL T. GILLIN, PhD Department of Radiation Oncology, The Medical College of Wisconsin, Milwaukee, Wisconsin Iridium-192 in the form of either a wire or pins does not meet standard definitions of a "sealed source." This study was designed to measure the amount of removable activity from wire and pin sources of 1112Ir under both normal and "destructive" handling procedures. During normal handling, only small amounts of contamination were removed from the sources. The activity was always below the 185-Bq limit set by the Nuclear Regulatory Commission for sealed sources. Up to eight times this level was found for destructive handling. We conclude that the risk of con-tamination is extremely low for either user or patient under routine use of 192lr wires.

Key Words: Iridium-192 Pins, Wires, Contamination, Destruction Endocurietberapy/Hyperthermia Oncology 1988;4:17-21 ridium-192 is an important isotope in contem- Radiation Protection and Measurements has I porary radiation oncology. The advantages of 192lr over other traditional high energy emitting published the following definition of sealed source:

isotopes include a lower average photon energy, a A radioactive source sealed in a container or hav-small outer diameter, and the absence of gaseous ing a bonded cover, in which the container or decay products. Another practical advantage is the cover bas sufficient mechanical strength to pre-ability to adjust the source length to the dimension vent contact with and dispersion of the radioac-defined by the clinical situation. Iridium-192 is tive material under conditions of use and wear for available in the form of seeds, wire, straight pins, which it was designed. i and hairpins. While it may be argued that with Iridium-192 does not meet either definition of a proper center-to-center spacing the seed source sealed source for several reasons. The iridium and the wire source are equivalent, there is no seed wire is encased in a 90% platinum-IO% iridium substitute for either the straight pin or the hairpin tube. No attempt is made to seal t.'J.e ends. The cas-sources. ing itself becomes radioactive during the neutron There are at least two definitions of sealed irradiation. A wipe test performed either on the sources being promulgated. The US Nuclear ends of the sources or with sufficient vigor on the Regulatory Commission defines sealed source as central region of the source should result in some "any byproduct material that is encased in a cap- detectable activity. The purpose of this work was sule designed to prevent leakage or escape of the to quantitate the amount of activity removed from byproduct material." 1 The National Council on different types of 192lr sources under conditions of both normal and destructive handling.

Address for Reprints: Daniel F. Grimm, MS, Department of Materials and Methods Radiation Oncology , Medical College of Wiscon- Continuous sources of 192lr are available in both sin/Milwaukee County Medical Complex, 8700 West Wiscon-sin Avenue, Milwaukee, WI 53226.

wire and pin forms from at least two different sup-Received for Publication: May 20, 1987 pliers.* Pins can be obtained as either straight pins Accepted for Publication: December 2, 1987 or hairpins. The physical characteristics of these January 1988 ISSN 8756-1687 Copyright © 1988 17

Grimm & Gillin Table 1. Physical Characteristics of lridium-192 Sources Source Type Diameter, Inner (Core) Sheath mm Diameter, mm Thickness, mm Thin wire 0.3 0.1 0.1 Thick wire 0.5 0.3 0.1 Thick wire 0.6 0.4 0.1 Hairpin 0.5 0.3 0.1 Straight pin 0.5 0.3 0.1 sources are shown in Table I . In all cases the working surface was scanned for deposits of ac-iridium core is encased in a o: I-mm platinum- tivity. As might be expected, there was visible iridium sheath. damage to the sources after this procedure was Ordinary handling of the sources was ac- completed.

complished with standard 12-inch tweezers, short locking forceps, and a small scissors. Wipe tests Counting Procedure and Statistics were performed by vigorously scrubbing the wires Each wipe sample was loaded in a test tube and and tools with either cotton-tipped applicators or counted in an automatic scintillation well gauze strips soaked in ethyl alcohol. Particular at- counter. t Window level settings of the counter tention was paid to the serrations on the tips of the were adjusted to include all energies from 100 to tweezers or forceps. 500 keV . This range includes all the major gamma rays from 1921r. Calibration of the well counter Handling Procedures was performed using a segment of a calibrated The various sources were subjected to a series of 192Ir source. A calibration certificate _for the tests. The initial tests involved numerous routine source was obtained from the Laboratorie de handling procedures.- Tests progressed to routine Metrologit des Rayonnements Ionisants. The total cutting activities. The final part of the test in- activity of the calibrated source had an uncertainty volved destructive handling of the sources by of +/-6.5% .

vigorous scraping with the serrated edge of the To obtain a very low activity sample for inter-tweezers while the sources were held in a locked comparison, the mass of the calibrated source was forceps. first measured on an analytical balance to obtain Wipe tests were performed for each sample after the specific activity. Then a small piece approx-removal from its shipping container. Each source imately I mm in length was cut off and weighed.

was next picked up 20 times using the tweezers The relative mass was used to determine the activi-and then a wipe test of the tweezers was taken. ty of this small sample. The activity of this source Each wire source was then inserted and pulled at the start of our wipe tests was approximately through a small plastic tube a total of five times 1000 Bq. The uncertainty of the mass was on the and a wipe test of the tweezers was performed. In order of +/-7 %* The overall uncertainty in the addition, the plastic tube was also analyzed for source calibration was +/-9.7%, assuming relative-contamination. The plastic tubes were the same ly constant linear activity.

ones that are used for implant procedures. The The uncertainty of the activity from the various next set of tests involved cutting the sources with wipe samples was taken to be a function of the a scissors. Five separate cuts were performed, wipe sample counts and the background counts. 3 wiping the cut ends of the wires and the scissors The uncertainty, in percent, was taken to be the blades individually after each cut. The final test in- quotient of the square root of the sum of the sam-volved grasping the sources with locking forceps ple and background counts by the net counts.

and sliding the tweezers along the source while ap- Because of the very low activities anticipated, plying pressure. Wipe tests were performed on the counting was limited to a long preset time rather tweezers after every five scrapes until the source than a preset number of counts. By choosing a broke or until 50 scrapes were performed. Finally, time long enough to allow the background to reach the source and the forceps were test wiped. The approximately 1000 counts, we were still able to 18 Endocurie, Hypertherm, Oncol. Vol. 4

Iridium Contamination Table 2. Wipe Test Results After Normal Handling Type of Source Removable Activity, Bq Source Source Tweezers After Container Itself Grasping 20 Times Wire (0.3 mm) 0 4 0 Wire (0.5 mm) 0 3 0 Hairpin 0 4 0 Straight pin 0 0 0 measure removable activities as low as 3 Bq to an mm for the 0.3-mm diameter wire and 1.0 mm for uncertainty of less than 25 %* For this report, all 0.5-mm wire. For the purposes of this report, activities with an uncertainty of greater than 25 % 14-cm lengths of both 0.3-mm and 0.5-mm wire have been reported as O Bq. were loaded into and pulled through a plastic tube five separate times using tweezers and/or forceps.

After this procedure, the tubes and wipe tests of Results and Discussion the tweezers, forceps, and wires were analyzed for The goal of this work was to determine the contamination. Table 3 shows the results of these possibility of removing activity during handling of tests. The highest amount of removal activity was these nonsealed sources. The secondary goal was 28 Bq, which is well below the 185-Bq standard to determine the amount of activity present with (0.005 µCi) set by the NRC for sealed sources. 4 deliberate destruction of the source. Thus, the first One advantage of the use of iridium wire or pins action was to wipe test the sources and their pigs is the ability to cut the wire or pin so that it when the shipping packages were first opened. matches the clinically desired length. A 192lr wire These results, which are shown in Table 2, in- or pin can be cut using a regular scissors. For the dicate extremely low activity amounts in the next test, all four different sources were cut a total sources and no removable activity from the pigs. of five times with a scissors while holding the Our normal procedure is to remove the sources source with a tweezers. After each cut, both from the pig, place them in a calibrated well freshly cut ends of the wire and the scissor blades ionization chamber, and then into a storage pig. were wipe tested. These results are shown in Table For the purposes of this report, we picked up each 4. The values show that normally a little con-source a total of 20 times with a pair of tweezers tamination can be removed from either the cut and then returned it to its pig. The tweezers and wire or the scissor blades. However, two of the 20 the source were then wipe tested. There was no cuts resulted in considerably larger amounts of detectable contamination removed from the contamination on the scissor blades. These values, tweezers or any source after this routine handling. 113 and 143 Bq, are still below the level set by the Wire sources are generally placed into small NRC for sealed sources.

plastic tubes before being implanted into the pa- The final test performed on the sources was tient. The internal diameter of the plastic tube deliberately destructive. One end of the source depends on the diameter of the wire, being 0.35 was firmly grasped ;

with a locking forceps. The Table 3. Wipe Tests After Tube Loading Source Removable Activity, Bq Forceps Tweezers Wire Tube Wire (0.3 mm) 10 28 6 13 Wire (0.5 mm) NIA 9 0 0 JanU/1. 1988 19

Grimm & Gillin Table 4. Wipe Test Results After Cutting Five Times Source Activity Removable Activity, Bq Wire Scissors Tweezers Range of Average Range of Average At End of Activity Activity Activity Activity Cutting Wire (0.3 mm) 0-12 2 0-18 4 12 Wire (0.5 mm) 0-14 5 4-143 34 4 Hairpin 0-36 5 6-133 42 0 Straight pin 0-61 20 0 0 0 source was then grasped tightly with tweezers near cesium-137 and radium-226, and does not emit the forceps and pulled through the serrated teeth of any gaseous decay products.

the tweezers. After five such pulls, the tweezers The largest amount of contamination found from were wipe tested. Ten groups of five pulls each all the t~sts was approximately 1500 Bq. Assum-were performed, unless the source fractured first, ing that this amount would be permanently which happened with the 0.5-mm wire. In addi- deposited in a patient during an implant, the resul-tion, the forceps and wire were wipe tested at the tant dose would be approximately .05 Gy. This end of the procedure. Results of these tests are dose is just a fraction of a percent of the dose shown in Table 5. Under these deliberately delivered during a normal therapeutic interstitial destructive circumstances, it was possible to application. Thus, it has no clinical significance.

remove more activity than is allowed for a sealed Iridium-192 in the form of wires and pins offers source. many clinical advantages. We have identified Samples of the work surface cover sheet were special tools for use of these sources, such as counted after the completion of testing for each tweezers, forceps, and wire cutters. We have at-source. The samples were simply cut and placed in tempted to follow the routine safety measures of test tubes for counting. The maximum activity time, distance, and shielding when using these found on the work surface was 66 Bq. sources. We routinely manipulate and cut sources Despite the fact that 192lr does not meet any to meet the clinical situation at hand. Given nor-definition of a sealed source, our results indicate mal handling of such sources, this work indicates that for routine handling and cutting the removable that both the worker and the patient are free from contamination is less than that which is allowed for unnecessary exposure owing to contamination of sealed sources, namely, 185 Bq. With destructive cutting and loading of the sources. Cleaning the handling of the sources, larger amounts of activity cutting device is a reasonable procedure to follow can be removed. This is not unique to 1921r after 192lr sources have been cut. It is also prudent sources, for all sources can be destroyed if given to routinely change the paper on the working sur-inappropriate handling. In fact, 192Ir has the ob- face where this cutting is performed. However, vious advantage of being short-lived, relative to this is just good standard practice. This work Table 5. Wipe Tests After Destructive Handling by Scraping SO Times Source Removable Activity, Bq Tweezers Forceps Wire Range of Average At completion of scraping Activity Activity Wire (0.3 mm) 61 -1521 495 3 17 Wire (0.5 mm)36-547 265 8 264 Hairpin 6-90 56 0 135 Straight pin 13-179 68 0 0 20 Endocurie, Hypertherm, Oncol. Vol. 4

Iridium Contamination indicates that it is not necessary to take elaborate References or expensive precautions in handling and manipulating this material.

1. Title 10, chapter I, Code of Federal Regulations-Energy, part 30.4(4).

Acknowledgments 2. Protection Against Radiation From Brachythcrapy Sources.

Commissariat a l 'Energie Atomique (available NCRP report No. 40, 1972.

3. A Handbook of Radioactivity Measurements Proccdura, from CIS-US in the United States) and Amersham. ed 2. NCRP report No. SB, 1985.

t Packard Auto-Gamma Scintillation Spec- 4. Title 10, chapter I, Code of Federal Regulations-Encrgy, trometer model 5220. part 35.14(b)(5).

\

January 1988 21

DOCKET NUMBER 3~-8 PETITION RULE_P_RM_

(tlJ r R /037t)

NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 Docket No. PRM-35-8 Amersham Corporation; Receipt of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rule making; notice cf receipt.

SUMMARY

The Commission is publishing for public comment a notice of receipt of a petition for rulemaking dated November 14, 1988, which was filed with the Commission by Amersham Corporation. The petition was docketed by the Commission on February 15, 1989, and has been assigned Docket No. PRM-35-8. The petitioner requests that the Commission amend its regulations concerning the medical use of byproduct material to include Iridium-192 wire for interstitial treatment of cancer in the provisions of 10 CFR 35.400 that govern the use of sources for brachytherapy.

DATE: Submit comments by June 5, 1989. Comments received after this date will be considered ff it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

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ADDRESSES: All persons who desire to submit written comments concerning the petition for rulemaking should send their comments to the Secretary of the Commission, U. S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

Deliver comments to the One White Flint North Building, 11555 Rockville Pike, Rockville, Maryland between 7:30 a.m. and 4:15 p.m.,

Federal Workdays.

For a copy of the petition, write the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

- The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street, NW., Lower Level, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Acting Chief, Rules Review Section, Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: 301-492-7758 or Toll Free: 800-368-5642.

SUPPLEMENTARY INFORMATION: The Nuclear Regulatory Commission (NRC) has established provisions that regulate the medical use of byproduct material in 10 CFR Part 35. Under these provisions, medical licensees are permitted to use small, radioactive sources to treat cancer. These sources are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is known as brachytherapy. The list of sources approved for use in brachytherapy is set out in 10 CFR 35.400.

The petitioner requests that the NRC amend 10 CFR 35.400 to add Iridium-192 wire for the interstitial treatment of cancer to the list of sources approved for use in brachytherapy. The petitioner manufactures and markets a range of Iridium-192 wire products and accessories designed to facilitate product use.

The source wire consists of an alloy of iridium and platinum which is encased in a pure platinum sheath. The composite is drawn into a wire of various diameters ranging from 0.3 to 0.6 mm. The inactive platinum sheath is 0.1 mm. The wire is irradiated to activate the Iridium-192 nuclide. The wire may then be cut and mounted in holders to specified lengths by the user. In some cases, the petitioner may arrange to supply the wire ready mounted in narrow bore plastic tubing.

The petitioner does not regard these products as sealed sources because of the unavoidable contam;nation generated in the source casing during neutron irradiation. However, the petitioner states that the contamination does not represent a serious problem because of the short half life and low energy of the contaminants.

According to the petitioner, about half of the removable contamination showed a half life of 2.5 days and the remaining

- portion showed a half life of 15 days. No gamma radiation was

~mitted by the contaminants.

The petitioner has submitted a proposed amendment to the Illinois Department of Nuclear Safety (IONS) requesting the addition of Iridium-192 wire products, Model Number ICW.100, to Amersham's Medical Source Distribution License. The products covered by Model Number ICW.100 were marketed by Amersham in the United States prior

- to May 28, 1976, and were included in the Amersham/Searle Clinical Radiation Sources and Accessories Catalog of April 1973. The products covered by this model number were listed with the FDA as medical devices in August 1979.

As noted, the Amersham product consists of a platinum covered platinum-iridium alloy. The difference in hardness between the comparatively soft platinum outer sheath and the harder alloy core causes the platinum to smear over the end of the wire as it is cut.

This minimizes contamination and improves the integrity of cut wire.

As a result, Amersham states that it has not encountered any problem of 11 flaking 11 or delamination of the Iridium-192 wire.

Amersham also supplies two accessories that aid in the safe handling, cutting, and loading of the Iridium-192 wire. The first accessory, wire loader, code N.4100, is used to cut the 0.3 mm diameter wire by way of a special guillotine and to enclose and fix

- it in a small diameter nylon tube. The wire is, almost without exception, implanted in patients after enclosure in nylon tubing.

The second accessory is pin cutter, code ASN.200. The pin cutter and its associated handling device are used on the 0.6 mm diameter wire fabricatd into the shape of single-pins or 11 hair pins". These are, almost without exception, directly implanted in patients without the use of a nylon tubing.

- The petitioner requests this amendment so that each medical licensee that intends to use Iridium-192 wire source for the interstitial treatment of cancer may do so without having to request and obtain a specific amendment to the license authorizing the medical use of

byproduct material. As a result, the products manufactured and marketed by the petitioner would be more easily available to a greater number of potential users.

Dated at Rockville, Maryland, this Lit - day o f ~ 1989.

Fr the Nuclear Regulatory Commission.

Samuel J. Chi k, Secretary of the Commissio".

.DOCKET NUMB R Amersham Corporation iETITION RUL PRM 3s 2636 South Clearbrook Drive Arlington Heights. llinois 60005-4692

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a9 rrn 1s P2 :04 F Amersham November 14, 1988 Michael A. Lamastra Section Chief, NMSS Branch U.S. Nuclear Regulatory Conmiss1on 11555 Rockville Pike

- Rockville, MD 20852

Dear Mr. Lamastra,

I enclose a copy of an amendment we have submitted to the Illinois Department of Nuclear Safety (IONS) requesting the addition of Iridium-192 wire products, Model number ICW.100 to our Medical Source Distribution License.

In anticipation of IONS approval of this amendment request, I am writing to request that NRC amend 10CFR35.400, *use of sources for brachytherapy* to include Iridium-192 wire for interstitial treatment of cancer.

I shall be pleased to discuss any questions you may have concerning this request and may be reached by phone at (312) 593-6300.

Sincerely yours,

/{J lJ (0J..*~-

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Bryan~

Manager, Environmental & Safety Regulatory Affairs Enclosure BWB:j il 2360[

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Ji.mersham Corporation 2636 South Clearbrook Drive Arlington Heights, Illinois 60005-4692 (312) 593-6300 Amersham November 14, 1988 Steven C. Collins Chief, Division of Radioactive Materials Illinois Dept. of Nuclear Safety 1035 Outer Park Drive Springfield, IL 62704

Dear Hr. Collins:

Re: License Number 12-12836-0SHD I am requesting an amendment to the above Medical Source Distribution License If. to add Iridium-192 wire products, Hodel Number ICW.100 for distribution to Group VI licensees. The NRC Registry number for ICW.100 is NR-136-S-259-S.

The products covered by this Hodel Number were marketed by Amersham in the United States prior to Hay 28, 1976 and were included in our Amersham/Searle Clinical Radiation Sources and Accessories Catalog of April 1973. I enclose copies of the relevant pages of that catalog.

The products covered by Model number ICW.100 were listed with the FDA as medical devices in August 1979. I enclose copies of the device listings, document numbers A239375 (wire) and A239376 (pins).

I am also enclosing copies of the draft package insert, unpacking instructions and a draft copy of the label we propose to use. We are waiting for illustrations for the package insert, and will submit a copy of the completed package insert when it becomes available. I also enclose copies of the instructions for the Iridium wire loader and the pin cutter that we supply.

There are some minor corrections to be made to these instructions, and they are indicated in the text. I will send you copies of the final printed package insert and instructions when they become available.

We do not regard these products as sealed sources since in the as neutron-irradiated condition it is essentially impossible to produce a contamination-free product. However, wipe tests reveal that the degree of contamination is minimal. This is achieved by rigorous cleaning and handling protocols prior to reactor irradiation. A recent publication reviewing the degree of removable contamination and its acceptability within the medical conmunity is attached - Quantitation of the Amount of Contamination obtained from Iridium-192 sources - Grinm and Gillin; Endocurie. Hyperthenn. Oncol.

Vol. 4, Jan. 1988, pp 17-21.

We understand that there have been reported cases of *flakingu or delamination of Ir-192 wire. This problem has not been encountered with the Amersham product which consists of a platinum covered platinum-iridium alloy. The difference in hardness between the comparatively soft platinum outer sheath and the harder alloy core causes the platinum to smear over the end of the wire as it is cut, further minimizing contamination and improving the integrity of cut wire.

The amendment we are submitting is to add Iridium-192 wire products to our Medical Source Distribution license. Amersham also supplies 2 accessories that aid in the safe handling, cutting and loading of the Ir 192 wire.

The wire loader Code .N.4100 is used not only to cut the 0.3 nm diameter wire via a special guillotine, but also to enclose and fix it in a small diameter nylon tube. In the light of its small size, the 0.3 11111 diameter wire is, almost without exception, only implanted in patients after enclosure in nylon tubing.

The pin cutter Code ASN-200 and associated handling device is used on the more robust 0.6 nm diameter wire fabricated into the shape of single-pins or

hair-pinsu; these are almost without exception, always directly implanted in patients without the use of a nylon tube.

32 Ill. Admin. Code, Section 330 Appendix C Group VI, hand 10 CFR 35.400 (d) refer to *Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer*. As stated above, our request is to add Iridium-192 wire to our Medical Source Distribution License. I understood from a meeting with Hr. Michael lamastra, NRC*on June 24, 1988 that when a product is added to a Medical Distribution license, its use is added to the list of approved uses in the regulations. I am sending Mr. Lamastra a copy of this letter, and asking NRC for, *Iridium-192 wire for interstitial treatment of cancer" to be added to 10CFR 35.400 "Use of Sources for Brachytherapy*.

I hope that the information I have provided will enable you to add Model number ICW.100 Iridium-192 to our Medical Source Distribution License and for

Iridium-192 wire for interstitial treatment of cancer* to be added to 32 Ill Admin. Code, Section 330 Appendix C Group VI *use of sources and devices containing radioactive material for certain medical uses*.

,,,.

11' .,

->-,.:*:

Page 3 I enclose a check for $144.00 the license fee for an amendment to this license.

Do not hesitate to call me should you have any questions concerning this amendment request. I may be reached by phone at (312) 593-6300, extension 379.

Sincerely yours,

/'> /)

/...J --,,,,.~. ,. . r .J,,, -'--~--

~

bryan W. Baker, Ph.D.

Manager, Environmental and Safety Regulatory

Enclosures:

l) Catalog pages

2) Device listings (2)

3) Package insert

4) Unpacking instructions

5) Draft label

6) Wire loader instructions

7) Pin cutter

8) Reprint

9) Check BWB:jil 2254E

... REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE NO: NR-136-S-259-S DATE: ATTACHMENT NO. 1, Amersham Amersham Corporation 2636 S. Clearbrook Drive Arlington Heights, IL 60005 IRIDIUM-192 WIRE APPLICATOR NRC Model ICW.100 Amersham Code 10-1.l Nominal Act i v.i ty 75 mCi Measurement Date August 10, 1985 For precise doserate from source, see Radioactive Source Test Report, Read data sheet before opening this container. Handle this radioactive material with GREAT CARE.

"Prototype label"

- I

REGISTRY OF RADIOACTIVE SEALED SOURCES AND.DEVICES SAFETY EVALUATION OF SEALED SOURCE .

NO: NR-136-S-259-S DATE: .tillf~l-.1984 PAGE l OF 5 SOURCE TYPE: Brachytherapy Source Wire MODEL: ICW 100 MANUFACTURER/DISTRIBUTOR: Amersham Corporation 2636 South Clearbrook Drive Arlington Heights, IL 60005 MANUFACTURER/DISTRIBUTOR:

ISOTOPE: Iridium-192 MAXIMUM ACTIVITY: 200- millicuries (4 mCi/cm lengt LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use NO CUSTOM DEVICE: - - YES X

REGISTRY OF RADIOACTIVE SEALED SOURCES ANO DEVICES SAFETY* EVALUATION 01 SEALED SOURCE DATE:

. - PAGE *2 OF 5 JUN 2 3 1984 SOURCE TY*PE-: gracfiytfierapy So\l'1"ce Wtre DESCR! PTION,,

The sourc~ wire consists of an alloy of iridium and platinum which is encased in a pure platinum sfieatfi. Tnts compostte is tfi.en mecfiantcally drawn tnto a wire of vartoas diameters ranging from 0.3 mm to 0.6 mm. In all cases~ the "inactive" platinum sheatfi is 0.1 mm thi:ck.

The wire is tnen irradtated in a reactor resulting tn activation of the iridium to Irtdum~-192 nacltde. Tfie matertal may then be dtspatched in a va*riety of fonnats. Most frequently, tfie user requtres to cot and rno.unt tlie wire in holders to specified 1engtlis, 6bt in some cases AmeJ'sham can arrange to snpply the wire ready mounted in narrow 6ore plasttc tafitng.

The two basic versions of use are the "Pierquin/Patne Technique" which has a djameter of 0.3 mm wire and uses a plastic guide tu6e, and a technique which uses a 0.6 mm dtameter wire wntch is sufficiently rigid to be inserted directly into-the ttssue wttfi tfie atd of steel gutde ptns.

Contamtnants are generated tn the source castng during neutron irradiation~ These isotope conta~tnants a-re s*fiort half.,.ltfe. A6.out nalf of the removable contam.fnation exht6ited a half life of 2.5 days and tfie other half showed a nalf life of around 15 days. No gamma radiation was emttted 6y tfiese contaminants~ Altfwngh the presence of this contamtnatton ts undenta6le and unavoida6le, tt is considered that the very snort fialf life and low energy of the contaminant isotopes does not rep~e~ent a sertoas pro6lem.

LABELING~

Individual wtres a-re not marked tn any way since there ts insufficient space to do tfiis. Tne inner contatner wfiich the sources are deli"vered in is labeled as shown in ATTACHMENT No. l. "Prototype label".

The outer container which carries the shipment is labeled i*n accordance with the requirements of the U.S. DOT for Type A containers and witn Section 32.74, 10 CFR 32.

DIAGRAM:

dimens.

in mm

J REGISTRY OF RADIOACTiVE SEALED SOURCES AND DEVICES SAFETY.EVAL1ATION OF SEALED SOURCE J\ilN 2 3 1924 NO~ NR-136-S-259~-S

. .. .. - -PAGE 3 -OF 5 SOURCE TYPE: Brachytnerapy Source Wire CONDITIONS OF NORMAL USE:

The source.- is intended speci fi cal ly for medical use and exclusively for use in a medical environment. It should 6e stored, locked, in a restricted area. This source should be used only 6y competent persons trained in the technqiues for which it is requtred.

- PROTOTYPE TE-STING!

This material is not regarded by Amersham as sealed, in that it cannot be guaranteed to meet the requtrements of less than 5 nCi renovable contamination.

In consequence, prototype testing to ANSI standards is inappropriate.

However, both the iridium wire and the iridium pins have achieved ANSI N542 per-formance ratings of 77C53312 where the criterion for passing was defined as being no significant deterioration in the removable contamination test compared with untested sources. Similarly, all types o*f wire have passed bend tests in which they were bent around a 2 mm diameter pin and then straightened again.

The wires have been in used for over -10 years in hospitals throughout the world and by broad licensees *in the United States.

EXTERNAL RADIATION LEVELS:

The maximum amount of material which a hospital physicist might normally have exposed at one time is 200 mCi. This amount of material would generate a dose rate field of the order of that indicated below:

Distance Dose Rate 5 ems 35 R/hr 30 ems l R/hr l 00 ems 90 mR/hr However, these figures should not be used for planning patient dosimetry. The dosimetry of iridium wire is complex and is dealt with in a number of theoretical papers. The customer is provided with a simple test report detailing radiation measurements on the material.

.. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES NO: NR-136-S-259-S DATE:* PAGE 4 OF 5 SOURCE TYPE: Brachytherapy Source Wire QUALITY ASSURANCE AND CONTROL:

All materia1s used in the fabrication of this product are checked against suppliers*

specifications prior to manufacture. Finished sources are checked to ensure that removable contamination .is not excessive,.; .e., greater than 50 nCi. Above the 50 nCi level, Arnersham holds wire for decay or decontaminates appropriately prior to shiµ:ient.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

o The sources shall be distributed only to persons specifically licensed by the NRC pursuant to Sections 35.13 of T1tle 10~ Code of Federal Regulations, Part 35 or equivalent provisions of Agreement State Regulations.

o The source and storage containers shall be tested at six month intervals to detect excessive removable contamination. Typically, a SO cm length of wire will yield a removable contamination level of 50 nanocuries. Any removable levels in excess of this should prompt decontamination action by the user.

o Handling, storage, use, transfer, and disposal: To be detennined by the licensing authority. Inview that these wires exhibit high surface dose rates when unshielded, they should be handled only by experienced licensed personnel and using adequate handling and shielding equi:pment and procedures.

o Reviewers Note: The use of these wires require that they be cut into smaller lengths. This will result in contained cutting edges and equipment. You should determine if the applicant has sufficient procedures to handle this contamination problem.

o This registration sheet and ttie information contained within the references shall not be changed or transferred without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data contained in the references cited below, we conclude that the Model ICW 100 brachytherapy source wire design is acceptable for licensing purposes. Furthermore, we conclude that the Model ICW 100 source would be expected to maintain its containment integrity for normal conditions of use and-accidental conditions which might occur during uses specified in this certificate.

I

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES NO: NR-136-S-259-S DATE: JUN 2 3 !QSt PAGE 5 OF 5 SOURCE TYPE: Brachytherapy Source Wire

REFERENCES:

The following supporting documents for the Model !CW _IOO brachytherapy source wire design is hereby incorporated by reference and is made a part of this registry document:

0 Amersham Corporation's letters dated October 28, 1983, April 17, 1984, May 23, 1984, June 14, 1984, and enclosures thereto.

ISSUING AGENCY:

U. S. Nuclear Regulatory Commission JUN 2 3 10°-~

Date: _ _ _ _ _ _ _ _ _ _ __

Concurrence: ~ 11. -~'-(1 *Yf.

~ ~

Clinical radiation sources and Accessories This catalog describes the beta and gamma emitting appliances available for clinical purposes and includes a wide range of accessories.

We offer a comprehensive range of radioactive products besides those listed here. and the fol-lowing catalogs are also available on request:

Radiochemicals Radiation Sources for industry and research Radioactive Supplies and Accessories Radiopharmaceuticals Contents Page General information How to order 2 Supply details 2 Licensing and Registration 3 Clinical radiation sources Product index 4 Technical information Construction, specifications 5 Measurement, nominal activity 5 Testing 6 Medical reference sources 8 Bone densitometry sources 9 Surface applicators r

10 lrradiators 14 Ophthalmic and nasopharyngeal applicators 16 Interstitial and intracavitary appliances 20 Wires for implantation/afterloading 28 Accessories Product index 29 Applicators 30 Forceps 38 Safe and viewing equipment 39 Price list 40 Printed in the United States April 1973 S731001

General lnfonnation:

How to Order Orders may be placed by mail, telex or telephone. Each order should include the following information:

1. Purchase order number and/or contract number and quotation number if applicable.

2. Ship to address.

3. Bill to address (if different from 2).

4. Catalog number and name of product.

5. Quantity required.

6. Special product requirements, if any.

7. Delivery date required.

8. Special instructions, if any.

9. USAEC or agreement state license number, if required.

To avoid duplicate shipments written confirmation of orders placed by telephone or telex must be marked "Confirming Order-Do Not Ship ..,

Shipping Containers Containers are designed for maximum safety and economy in transportation and conform to the appro-priate transportation regulations. Whenever possible, lightweight non-returnable containers are used.

Delivery Every effort is made to ensure prompt filling and delivery of orders. but no responsibility is assumed for delay or non-delivery by carrier.

Prices All prices listed in this catalog are in U.S. dollars, F.O.B. Arlington Heights. Illinois (unless stated otherwise I. In Canada, F .O.B. Toronto International Airport. Transportation and insurance are charged to

-~ the customer at cost. Every effort will be made to give reasonable notice of price changes. but we reserve the right to change prices without notice. Minimum order $75.

Payment Terms are net 30 days from date of invoice unless other terms have been negotiated.

Returns/Credits Because of the nature of the products listed in this catalog. all sales are considered final. Products can-not be returned to stock for resale. once they have left the direct control of Amersham/Searle.

Orders which are incorrectly filled due to errors by Amersham/Searle or which are damaged in transit may be returned to Amersham/Searle for full credit. Notice of claim must be made in writing to Amersham/Searle within 15 days after receipt of the order.

If the customer demonstrates that the product does not meet the specifications or quality described in the catalog or technical literature. the product may be returned for full credit providing that Amersham/

Searle is notified in writing within 15 days after receipt of the order. The customer must have exercised reasonable care in the storage and protection of the product.

Before a return shipment is made. it is necessary to obtain permission and shipping instructions from Amersham/Searle. Unidentified returns will be stored for 10 days and then discarded.

2

Licensing and Registration In most countries persons processing, using, selling or transporting radioactive materials must be licensed by a national authority. Users of radioisotopes should familiarize themselves with all applica-ble regulations.

In the United States, a person who wishes to employ radioactive sources must possess an appropriate USAEC or agreement state license.

Full information of Federal and State Licensing is available from:

U. S. Atomic Energy Commission Division of Materials Licensing Washington, D. C. 20545 A copy of a customer's license, together with all amendments. is required before shipment can be made.

Canada:

In Canada purchasers of radioactive material should possess a radioisotope license which can be obtained from:

The Atomic Energy Control Board Post Office Box 1046 Ottawa. Canada A copy of a customer's license. together with all amendments, is required before shipment can be made.

Warranty Amersham/Searle Corporation warrants its products to be of the quality described in its catalog and technical literature at the time of shipment. Any complaint or breach of warranty must be notified to the company within 15 days of the receipt ot"the order. The maximum liability for breach of warranty shall be the invoice price of the product.

ADDRESSES FOR ORDERING AND TECHNICAL INFORMATION in the United States: in Canada:

Amersham/Searle Corporation 400 Iroquois Road 2636 S. Clearbrook Drive Oakville, Ontario Arlington Heights, Illinois 60005 Telephone: (416) 364-2183 Telephone: (3121 593-6300 Telex: 069-82216 Telex: 28-2452 3

Clinical radiation sources This section describes our extensive range of Product index Page radiation sources for clinical use. The types listed

are those which are most widely use, but no catalog of this kind can include a source for every applica- Bone densitometry sources tion. Often the most suitable design of source or americium-241 9 assembly is best decided by discussion between iodine-125 9 radiotherapists or medical physicists and our tech-nical staff. Opportunities to examine new problems Extracorporea I blood irra diators are welcomed.

strontium-90 14 We have developed a very wide range of source manufacturing techniques, so that we can select the Interstitial and intracavitary appliances 20 most appropriate combination of these to ensure cesium-137 needles and tubes 21 the maximum efficiency combined with safety in use. " sources for afterloading 23 cobalt-60 sources for afterloading 24

- Other radiation sources are listed in our catalog gold-198 grains

25 of "Radiation Sources for industry and research." iridium-192 wires and pins 28 This catalog is available on request. tantalum-182 wires and pins 28 yttrium-90 rods for pituitary implantations 26 The products in this section are grouped according to the type of application for which they are intended. Each entry includes a brief description of Medical reference sources the method of construction and a note of the testing Gamma camera checking sources 8 procedures applied to the source. A summary of Isotope assay calibrator check sources 8 the relevant nuclear data is provided for each group. In most cases reference is made to original papers describing clinical use. Surface and ophthalmic applicators 10 cobalt-60 ophthalmic applicators 18 strontium-90 beta-teletherapy sources 14

" nasopharyngeal applicators 16 ophthalmic applicators 16 plaques and plates 12

- -** -----****-** **. ~-*-. **-*-*-- ------ --- -------*----*-"-*-**-*--***-*----- - .. *-**--* *.... -~

Clinical radiation sources:

Technical information Construction Nominal activity A well-designed radiation source emits the required For most of the radiation sources described in this radiation a$ efficiently as possible whilst providing catalog a set of nominal activities is listed. showing a high degree of safety and integrity, both in normal the strengths at which the sources are manufactured use and in extreme conditions. The active components for stock. In some cases, sources are available with are in most cases in the form of insoluble compounds, strengths up to a stated maximum value.

ceramics or metal foils or wires, thus enabling sources to be constructed with the required uniformity of Because of activity losses in manufacture and by distribution whilst achieving flexibility in design and radioactive decay. it is not always possible to supply maintaining safety standards. a source of exactly the value requested.

Specification and measurement If a source is of a type which is offered at specific nominal activities, it is the practice (unless otherwise The strength of a radiation source may be defined stated) to,supply a source having a strength within by specifying its radiation output or by stating the the range -0% to.- 25% of nominal.

radioactivity of its contents. Sources offered in a continuous range of activities are supplied with a value within ::: 10% of that In this catalogue the strengths of beta sources are ordered.

expressed either in curies or in some cases by giving the surface dose-rate in a specified material. In either case, if no source is available within the specified limits, the customer is consulted before a Gamma sources are specified in terms of the activity source of different activity is despatched.

of the contents. the equivalent activity of the source.

or as milligrams radium equivalent.

Equivalent activity is defined as that activity which is equal to the activity of a point source of the same radionuclide which would give the same exposure rate at the same distance from the centre of the source (I.C.R.U. Report 10c, N.B.S. Handbook No. 86, page 25). The relationship between equivalent activity and exposure rate, under conditions of minimum scatter, at a distance which is large compared with the source (in the radial direction if the source is cylindrical, or along its axis if it is disc

shaped) is given in the following table:

nuclide exposure rate at 1 metre for 1mCi Cesium-137 0*33mR/h Cobalt-60 1*30mR/h Gold-198 0*235mR/h lridium-192 0*48mR/h Radium-226 0*825mR/h (1 mg with 0*5mm Pt screenage)

Tantalum-182 0*68mR/h Milligrams radium equivalent is the weight in milligrams of radium-226 as a point source screened by 0*5mm platinum which gives the same exposure rate at 25cm in air.

\

Clinical radiation sources:

Technical information Testing for leakage and contamination L. Immersion test Ill The source is immersed in water at 50 "C for Stringent tests for leakage are* an essential feature of 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months and the activity in the water measured.

radioactive source production. The methods adopted Limit: 0*005µCi.

depend on the design and intended application of the source. and also on statutory requirements.

Where necessary, tests can be specially modified to meet particular requirements.

The standard methods used for testing radiation sources are listed below. The particular tests used for each type of source are given under the Special testing appropriate catalogue entry.

Some of our clinical sources have been tested A. Wipe test I according to the following:

The source is wiped with a swab or tissue, moistened with ethanol or water; the activity removed is * "Special Form** category of-the IAEA transport measured. Limit 0*005µCi. reyulations (IAEA Safety Series No. 6. 1967).

The certificate numbers given against approved B. Wipe test II -items in the sources listing are those issued by the The source is wiped with a swab or tissue. moistened UK Dept. of the Environment.

with ethanol or water; the activity removed is measured. Limit: 0*05µCi. (This test is described in American National Standards Institute (ANSI)

Appendix A of 8.S. 3513 :1962.) Classification (USASI Report N5.10, 1968).

D. Bubble test The source is immersed in a suitable liquid The testing programme is being continued and will (ethanediol) and the pressure in the vessel reduced include testing to the recently formulated to 100mm of mercury. No bubbles must be observed. requirements of the ANSI for brachytherapy sources (This test is described in Appendix B of (ANSI Sub-Committee N44/2.3. 1972).

8.S. 3513 :1962.) and to those due to be adopted by the ISO (Draft Standard for the Safety Classification of E. Emanation test Sealed Radioactive Sources. December 1971 ).

The source is placed in a glass specimen tube with a length of polyethylene tubing (40

3mm); the

, tube is closed by a rubber bung and left for 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months . The information on source testing given in this The beta activity of the polyethylene is measured catalog includes results available up to December 1* immediately with an end window counter. 1972.

Limit: 5 c:p.m. above background, corresponding to about 1 O* 9 Ci radon in 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months . Details of the rurrent status of particular sources are available on request.

F. Immersion test I The source is immersed in water at 50 C for 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months and the activity in the water measured. Certification Limit: 0*05µCi. The results of testing radiation sources are reported in either a TEST REPORT or a CERTIFICATE OF G. Immersion test II MEASUREMENT.

The source is immersed in water which is raised to 100 C and held at that temperature for 5 min. The A Test Report is issued when the source has been water is then removed. the source cooled. and the the subject of a routine measurement by comparison procedure repeated twice. Sources are passed if the with a laboratory standard. No limits of accuracy are

activity extracted in the final procedure does not stated.

exceed 0*01 µCi.

A Certificate of Measurement is issued when the H. Helium mass spectograph test source has been individually calibrated. Limits of Limit: leak rate of 1 O* 8 standard cm 3 /sec. accuracy are stated.

K. Emanation test (scintillation counting test for radon)

The appliance is immersed in a solution of a phosphor in an organic liquid under vacuum: the leakage of radon is measured by liquid scintillation counting.'

(DWIGHT, q. J., Radiochemical Centre Report R.176.)

The limit Cdrresponds to ~ 5 *, 10- 11 Ci per 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months .

6

. Radioactive wires Jmmd;*.

r*~ml 1

,.Jr-1_r 3mm d1o1. -----~

l

t r*

50mm 4!,mm 50mm I

I

(/ 1mml_

T- .1 I

I I

7mml_

J Iridium -192 Iridium -192 Tantalum - 182 single-pin (IC\'Y.22) hairpin (ICW.12) hairpin (TAW.12 and 13)

Figure 18

!,mm r

40mm f

r 2mm~.

L L 40mm

_,/

1e

- Slotted guide needle. straight Figure 19 Slotted guide needle, curved Slotted hairpin guide, plain Slotted hairpin guide, with lip Iridium -192 wire lead disc

I Inner nylon tube

-_--,,..,- J Nylon ball

-l I

\__-----~\

Tissue Outer nylon tube Typical assembly Figure 20 27

Radioactive wires ruclide l~v~rall dia. lcode Platinum covered iridium and tc1ntalum wires are

'form supplied in 50cm lengths, loosely coiled. The iridium-192 0*3 ICW.1 50cm coil thickness of the platinum coating is sufficient to filter 0*6 ICW.12 Hairpin out the beta emission.

0*6 ICW.22 Single-pin The thin iridium wire, ICW.1, is intended for use in afterloading.

tantalum-182 0*4 TAW.10 50cm coil 0*6 TAW.11 50cm coil Iridium and tantalum wires are also available in the 0*6 TAW.12 Hairpin form of standard 'hairpin'. or single-pin shapes, 0*4 TAW.13 Hairpin see fig. 18.

Availability Measurement ICW.1 : a bank of wire coils with activities up to 2mg Wire activities are expressed in milligrams radium radium equivalent per cm is maintained; despatch equivalent per centimetre; for definition, see page 5 normally within 7 days of receipt of order. Activities not available from 'bank' are despatched within 3 weeks.

Other wires and pins, despatched within 3 weeks of receipt of order.

Accessories-see fig. 19 For Pierquin/Paine afterloading technique For use with 'hairpins' and 'single-pins' (see first reference below) rescription Theatre pack 1 (gamma sterilized) Slotted guide needles 2 x 80cm outer nylon tubing constructed in stainless steel according 160cm marker wire to the designs used by Pierquin and Paine 80cm nylon thread straight, length 40mm N.454 Theatre pack 2 (gamma sterilized) N.202 curved, length 40mm N.464 4 packs each of 6 nylon balls Slotted hairpin guides 4 packs each of 6 lead discs constructed in stainless steel according Theatre pack 3 (not sterilized) N.203 to the designs used by Pierquin and"Paine 5 metres inner nylon tubing plain, length 40mm N.474 5 metres marker thread with lip, length 40mm N.484 Plain guide needles for implanting the Tool for implanting tantalum 'hairpins*,

outer nylon tubing available from the Endoscopic Instrument Co. Ltd.

length 100mm N.210 62 Shirland Road, London W9 length 1 50mm N.215 Availability of Accessories length 200mm N.220 Dispatch is normally within 7 days of receipt of Mandrel for use with above order.

length 250mm N.325 Crimping tool, for crimping lead discs N.400 Combination Pack N .900 Comprising 4 each N .201 4 each N.203 1 each N.202, N.210, N.215 N.220, N.325 References PIEROU IN, B.

'Precis de Curietherapie'. Masson and Cie, Paris, 1964.

PAINE, C.H.

'Modern afterloading methods for interstitial HALL, R.J., OLIVER, R. and SHEPSTONE, B.J.

radiotherapy'. Clin. Radio/. 23, 263-272, 1972. 'Routine dosimetry with tantalum 182 and iridium-192 wires'. Acta Radiologica, 4, 155-160, 1966.

PIEROUIN, B., CHASSAGNE, D. and COX, J.D.

'Toward consistent local control of certain malignant BRASFIELD, R.D. and HENSCHKE, U.K.

tumours--endoradiotherapy with iridium-192'. 'lntravascular irradiation of the internal mammary Radiology, 99 (3), 661-667, 1971. lymph nodes in breast cancer'.

DARBY, J., LASBURY, B. and PAINE, C.H.

Amer. J. Roentgenol, 85, 849-859, 1961.

'A protected loading device for thin 192 1r wires'. MEREDITH, W.J., GREEN, D. and KAWASHIMA, K.

Brit. J. Radio/, 45, 778-781, 1972. 'The attenuation and scattering in a photon of gamma-rays from some radionuclides used in mould and SIMON, N.

interstitial gamma-ray therapy'.

'lridium-192 as a radium substitute'.

Brit. J. Radiol, 39, 280-286, 1966.

Amer. J. Roentgenol. 93, 170-178, 1965.

Specifications:

Only typical sources are listed.

Enquiries invited for sources to other specifications.

-,o

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PUBLIC HEAL TH SERVICE Food ond Drug Administration FOOD AND DRUG ADMINISTRATION Bureau of Medical Devices (HFK-124)

MEDICAL DEVICE LISTING ~Ti!~rGs::t:. ton20910 I ..

Note: This form is authorized by Section 510of the Federal Food, Drug, ond Cosmetic.Act (21 U.S.C. 360). 'Failure to report.*

~his information is a violation of Section 30l(p) of the Act (21 U.S.C. 331(p)). Persons who violate this provisi~n moy;.if c*i>n*~ *

victed, b~ subject loo fine or imprisonment or both. The submission of any report that is false or misleading in on*y mo-te-~iol:**;

respect is o violation of Section 30l(q)(2), (21 U.S.C. 331(g)(2l)ond may be o violation of 18 U.S.C. 1001. *: * :..._.**;> :*.".::

I .. 7 B 14 I5 1(1 21 22 * '* .. ' 27

1. DOCUMENT NUMBER 2. INITIAL DOCUMENT NUMBER 3. REASON FOR SUBMISSION 4. ACTIVITY DATE S. REPORT DATE MO. DAY YR. MO. DAY YR.

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12. IS THE ABOVE LISTED DEVICE THE SUBJECT OF ANY PERFORMANCE STANDARD ESTABLISHED PURSUANT _ _ _*. _._s_2*_ _ _ _ _ ,.*..

. TO SECTION 514 OF THE FEDERAL FOOD, DRUG, AHO COSMETIC ACT OR SECTION 358 OF THE RADIATION YE~.*.*. _:*. **.**.***.'rt:"""1.N.o_*~.:

CONTROL FOR HEAL TH AND SAFETY ACT? .. 1.1..J 1--~-------------------------------------------+-,-,--,-,.,.,..,.-,-,-..,.....,,.,~----.

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13. IS THE ABOVE LISTED DEVICE THE SUBJECT OF A PREMARKET APPROVAL PURSUANT TO SECTION(S) 505, 3.311 .. * **

507 OR 515 OF THE FEDERAL FOOD, DRUG AND COSMETIC ACTT

. ~. .

130. IDENTIFY ANY APPROVED PREMARKET APPLICATION BY ITS ASSIGNED FDA NUMBER: i-;:,;.;;s_8__._._ _ _._.__:s_*--is ** * *

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Complete and relum lo:

. . PUBLIC HEAL TH SERVICE , Food ond Drug Administrat.loJ1 .

FOOD AND DRUG ADMINISTRATION Bureau of Medicol Devices"(HFK-124) '.

MEDICAL DEVICE LISTING :-,* 8757 Georgia Avenue : : .,:**"*-

Silver Spring, MD 20910 * \'

Note: *This.form is auth~rized by Section S10of the Federal Food, Drug, ond Cosmetic Act (21 U.S.C. 360). F~ili:,"re t~ r~port *-

"this information is a violation of Section 301(p) of the Act (21 U.S.C. 33l(p)). Persons who violate this provision may, if con**

. victed, be subject to a fine or imprisonment or both. The submission of any report that is False or misleading in any '!1aterial

I, DOCUMENT NUMBER 7 8

2. INITIAL DOCUMENT NUMBER

respect is a violation of Section 30l(q)(2), (21 U.S.C, 331(g){2lland may be a violation of 18 U.S.C. 1001.

15

3. REASON FOR SUBMISSION 111 21

.ACTIVITYDATE S. REPORTDATE 22 27 MO. DAY YR. MO. DAY YR.

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211. 211. ': ; : . -. - .. .!B

6. OWNER/OPERATOR NAME 7. OWNER/OPERATOR ID NO.

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.12. IS THE ABOVE LISTED DEVICE THE SUBJECT OF ANY PERFORMANCE STANDARD ESTABLISHED PURSUANT Uol

, , *. TO SECTION 514 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT OR SECTION 358 OF THE RADIATION *

.'~:_": .. CONTROL FOR HEAL TH AND SAFETY ACTT. * . ., 0:'?' E.s*~,{** g'.:) NO __":

120. ENTER THE APPROPRIATE NAME AND SECTION NUMBER FROM CHAPTER 21 OF THIS CODE OF FEDERAL llU 32 813 211 3U

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. J-'KY amersham 9020-1 disk 995 kk leletype I Inch Proced*ures for unpacking, transfer and storage of lrldium-192 medical brachytherapy sources For iridium-192 wire (coils. single pins and hairpins)

The transport containers are designed to make it easy for the user to remow the source using the appropriate safety precautions. However, such source mowments Should only be carried out by a person who understands the precautions to be taken when working with radiation and is fully informed about the operations he is I . about to pertOfTT\.

This insert concems these operations.

It refers to the containers used to transport medical radiation sources and explains:

What to do on receipt " the package page 2 Ameraham Corporation Amersham Canada Linited 16315 South Clearbrook Drive 505 Iroquois S110,e Road Arlinglon Heighll. llhnois 60005 Oakville. On1a110 L6H 2R3 A mersham 1-(800) 323-0668/(312) 364-7~23 1-(800) 266-5061/(.16) 842-2720 1

I On receipt of package

1) Check that all documentation, including label description, agrees with acknowledgement of order. tt there are any anomalies please notify Amersham Corporation as soon as possible.

2) Notify the local Health Physicist or oCher 'Competent Person' that the ptq!gage has IWTived. (See Specific precautions to be taken, Genera1J1~

3) tt the package is not to be opened immediately, a suita~ and secure store must be provided. This store should be reserwd for radioactive materials only and must be adequately shielded and labeled.

Unpacking procedures The source should only be unpacked in a specially designated area by authorized trained personnel.

The NCtlona on precautions and general guidance should be carefully read before unpacking the source.

Preparation for using the source or transferring it to a storage facility should be made before unpacking the source. Radiation levels should be checked using a dose rate meter at each stage of the unpacking. The exposure rate on the surface d the package may be as high as 200 mR/h and !Ms encountered at each stage of the unpacking will get progressively higher.

various packing combinations are used depending on the type of source enclosed.

A) Outer containment I) Open the cardboard carton or expanded polystyrene drum by cutting the adhesive plastic tape (figures 1(8) and (b)). (!OJ\

I) Lift out the inner sealed metal can and open it using a COl'lY8ntionaj)fropener (figure 2).

II) RemCNe 1he inner lead container and open it by removing the strip of self-adhesive plastic tape and lifting the lid. The sources will noN be unshielded and appropriate precautions should be taken.

B Inner contaln~~~~~ndent on source type) m-192 coils ttoc:Jes ICW.1030 to ICW.1300) four coils are supplied in each package. The coils are contained in a plastic tub inside a lead container and are separated by foam pads (figure 3). Remove the cols and pads by rifting them out one at a time using long forceps, taking care to separate the coil from the pad if the end of the wire has caught in the i:

i: .r;...m-192 hairpins and single pins (product codes ICW.3040 to ICW.3300

! : ~CW.4040 to ICW.4300)

!: Up to lixteen pins may be supplied in each package. The pins are contained in an all.lninum can with a threaded lid, inside a lead container (figure 4). Each pin Is wrapped in an aluminum foil enYelope to protect it. A loop of wire is left prctrudng from each ~ope so that the pin may easily be separated from the envelope using forceps immediately prior to implant. The pins should be stored in the erMlope until ready for use.

C) Inspection 1: The ec,urces should be inspected immediately following rem<MI from the inner containment, taking care to restrict personnel dose levels by the use of suitable lhielding and viewing using magnification. Ar'{ damage or OCher causes for c:onc:em should be reported to Arnersham Corporation without delay.

amenihaln~1*

cllk 1185 Ilk

=- . .*.

Specfflc precautions to be taken General

1) lJS8fS must comply with the proyisions d the Nuclear Regulatory Commission and/or the licereng conditions d Agreement Slates.

I) Do~ bJCh the &OUrce with the hand. Nlsfs use beeps.

I) These sources are ~ classified as sealed sources.

4) The SOUfC8S should be handed, whenewr possible, behind appropriate shields.

I) b minimize the radiation dose to operalOrs hands. lhe 90Urces llhoufd be hancled using forceps d at least 30 cm length.

I) Frequent checks for surface contamination should be carried out in the areas where 1hese sources are handled, and on arrt equipment or apparatus with which they come ir1o contact. ..

7) These sources lhouSd, wheneYer possible. be handled behind lead shields and WlWBd rtvougt, a lead glass window or minor system. A magrifi9f lhould be uaed tor detsied visual inspection.

lrtdlum-192 .....

1) The wires are ~ classified as sealed 80Urtes because their platirun cladding ccnains low laYels d radioadMty and also 1hey are ~ sealed at the end& Smal quantities d contamination may be deposited on areas which come in contact wilh ihe l0Uf'08S and appropriate precautions should lhererore be taken.

I) The wires are easily bent and great care should be taken ID awid kinking the wire as this will create dfficulties when loacing into the inner nylon 1ubing used tar applicaliori.

i.

Notes for general guidance Allholql these eources have al been designed 10 minimize surface conlamination

,_ n leakage d activity, they are ~ classified as sealed 80Ul08S as defirwd in 1he l NRC ~ Appropriale precautions must therefore be . _ . when

'

tral dening or using these aources.

1hese l0ur'CBS rnuat ort, be unpacked or 1ral l&ferTed from their lran8port conlainer tJ/ a Uy lrained and aulhoriad pnon. (See: Specffic precaulions 10 be IBk8n.

I

Geraa, 1 Qn pag8 5).

0 for al 101.108 mcMmen1s outside lhe lhieking d 1he 1rai mport canainer, 1h11 IDlcMing poi'D lhould be ncled:

1) A doae nll8 mn,,11tns-;'1PVIIJ1t1 1W18Y1 be readily Milable and UNd 1D check

......ll"f"t~iJIDOO!t It el9o esser1ial ID hlM one available in Cll88 d mishap&

lI I) 1he l0Ul'09S nut be handled clrdy.

l I) Nwtl/1 Ul8 rernalB handing l0cll.

1 F

I l 4) Reduce ecpoan to personnel tJ/ 1he uae d lhieking, d8lanoe and time *

' ; ~ .

I t i

~ i WhenM9r poaible peraons moving ndation eources lhould _,,..,. work behind t: raclation ..... In general lhe best radiation lhielda tar gamma radiation .,.

made tram der-. ~ ll0fnic nLl1'.lbef' malerias, IUCh 88 lead. 1he affectiwmess

'i d lead lhielding tor lrklum-192 ii lhown, In '8rml d thickness d material requred f0r * ""91'1 lral llfflillion laclor. In llble 1(8).

~

f

~*

- *111~--~ p *

(*) (b)

J

'RanamlNlon fac1or ~ ltanamlulon factor 05 0.1 0.01 ~ 05 0.1 001 Thlckneu of INd mm 4 13 31 53 125 245 390 In cases where it is not possible or corwenient ID work behind radiation shields.

then maxmum cistance and minimum time must be used to keep personnel

e,q>osure ID a mirimum, but remember that all materials provide some sort cl radiation shielding providing they are between )Q.I and the source. Even concrel8 walls can provide useful additional screening as shown in the table 1b and advarCage cl this should be taken whenewr possible.

Sources should not be permanendy stored in their transport container without the use cl additional shielding. Permanent storage is normally best achiewd by the use cl a purpose buit storage cell or containet b) Distance Reduction cl exposure using distance can be very effective and therefore shwd be used ID adva,uge whenewr possible.

Distance protection is based on the inwrse equare law. Quite simply, If the dslance is halved the dose wifl go up by a factor cl 4 and if the cistance is doubled the dose wl be reduced to 0.25 cl its original wlue.

1mle 2 gives a,camples d variations cl exposure rate with dstance from poirt 80Uf0eS tor typical aclivilies. .

'llble2 lctivity Expo9ure rate at distance of:

1mm 1cm 10cm 30cm 1m 3m J

R/min R/min mRlmin mR/min pR/min pR/rnin 3~ Ge,, 100mCi 800 B 80 8.9 800 89 e _ The vak.J8S ~ in lllble 2 ind"lca!s quite clearty why 80Urces should newr be bJched by hand and wtrt beeps cl at least 30 cm in length should be used when harding them.

c) Time The lhitd fadDr which can help ID reduce e,cposure ID ndation is time. The - -

i : dc:m received ~ ~ ~ o n irM>lving raciation IOUGoodrces is direclty __...

popa,tiona ID the time _., ID carry out that operation. plaMng ,_,,

--,s helps ID reduce acpoeure time ID a l'l'linnun.

.: Amerslwn Co,poratlon I * ~ ~ a.b1ook DrM, Minglcf\ - - - llnoil 80005

. 1{800)32Mll5 Alrierahlm Canida Llmlt8d 505 - - Sharl Roaf, 0lkvle. Ontario UIH 2R3 142-2720 / ~ 387-<<>60 (C)rt,'Quebec) 8-5081 l9llld lfflll tt-

SW *1tii\Mf'.'-f 11PM tPW I --

I lridium-192 Wire Afterloading System Intended Use: The lr-192 wire sources and afterloading system are intended for use in interstitial and intracavitary brachytherapy ~ures for the treatment of malignant diseases.

WARNING: These products are Intended apecfflcally for medical use and acluslvely for use In a medical radiological environment. It 18 strongly rac:ommended that this aource type not be employed without extensive prtor cllnlcal experience In Its UH. It ahould be stored and locked In

INtricted area when not In use and handled only by trained, competent personnel.

Introduction si,c::,,s.

tr-192 wire brachytherapy sources for the treatment of~ant diseases are manufactured in 3 basic forms: coh, hairpins and Precautions Before initiating any patient treatment the parties responsible for the use of the referenced radiation source(s) should ascertainl ~ 1ollowing:

1) That there is suitable radiatior, tten,ctJor, instrumentation available to quantify the exposure levels present in the vicinity al 1he source.

2) That .all *applicable U.S. Nuclear Regulatory Commission and/or Agreement State requirements for possession and use d lladioactive materials have been (or can be) met.

3) That the patient and/or the patient's farmy have been thoroughly informed of the hazards attendant to the use of radioa::Siw materials in the treatment of cancer:

Amerlham Corporation 2636 Scuh Clearbrook Driw Mngl0n Heights. linois 60005 (800)32U695

=~~mHed Amersham (416) 842-2720 I (800) 387-4060 (OrilOuebec)

(800) 268-5061 (rest d Canada) amensham 9020-2 disk 995 kk

lllillil------.... ------~

Regulatory Responslbllltles All institutions licensed for the possession and use of these materials are required to meet certain minimum requirements of the U.S. Nuclear Regulatory Commission or the appropriate Agreement State. Persons in possession of these sources are required by law to meet all such regulatory concerns. These include (but are not limited to) the necessity for conducting proper surveys for protection of personnel, for proper room monitoring and posting and for proper 1

accountability and disposition of the radioactive sources.

~ Handllng lnstn1ctlo~s o... lI.

, Each unit of the Amersham iridium wire loader is accompanied by a set of ~ D--~ t-. I

'-1 '( instructions entitled "Procedures for Unpacking, Transfer, and Storage of ~ (-.J f

~ ~ lridium-192 Medical Brachytherapy Sources," and iridium Wire Loader (code {){}- l:JQ,,

t' N.4100 Directio for " A warning label on the transport package warns \ \{\

t, to rea oata eats carefully before using the ~ /

~ that the information provided in the Amersham ~ only intended for use in preparing material for surgery; actual surgical techniques are left to the user's discretion, but we recommend that users should seek additional information from other sources on surgical techniques, dosimetry calculations and other relevant treatment methodologies before any attempt is made to carry out treatments.

Amersham lr-192 wire should only be handled by authorized experienced medical personnel.

Dosage and Administration Extensive training in the application of radioactive sources to given tumor volumes is a strict prerequisite to their use. various methods exist for establishing the amount of radiation at a given point. These calculations should only be performed by a physician, physicist or dosimetrist competent in such procedures.

Doses may vary according to the type and position of the tumor and on the specific clinical circumstances associated with the treatment. It has been shown that treatment times as short as three days or as long as eleYen days give no difference in recurrence or necrosis. 12 Parameters such as the tolerance to radiation of normal tissue close to the treatment zone. 12 and whether or not the

tumor has been previously treated must be taken into account.

The optimum dose rates. treatment times and treatment volume to be irradiated are determined by evaluating all the available clinical information which may be associated with a treatment. Complex calculations must then be performed by a trained physician, physicist or dosimetrist, usually with the aid of a computer to determine the exact geometry and radioactive strength of an array ct lr-192 wires or pins and optimum treatment time. which will result in the prescribed dose being administered to the treatment volume.

The Amersham iridium wire system is designed for use with the "Pierquin/Paine" afterfoading technique. 2 and the i>aris System" at dosimetry,12 for which dosimetry tables are available. 13 Considerable skill is needed at the implantation stage to ensure that the geometry of the array ct wires confonns as closely as possible to the geometry determined by the computer calculations. Details of the necessary surgical and implantation procedures to achieve this are described in the literature. ,.._11 *

2 I . . .... '

Directions for Use I Federal law prohibits the use of these sources on human subjects without the specific orders of a licensed physician. lr-192 sources for brachytherapy are inlended for use in appropriately designed and manufactured after1oading eocessories. These devices are not sterile.

Indications Amersham iridium wire is indicated for use primarily in the treatment of neoplasms in selected body sites by interstitial brachytherapy. Other parts of the body may also be treated using intracavitary methods.

The range of possible treatments and methodologies is very broad due to the large variety in the type and location of tumors in the body and on the various

cinical circumstances which may be associated with a given condition .

Many treatment methodologies have been reported in medical literature where successful results in the treatment of the tongue, 1s-1s floor of mouth, 17 hard paate, 19 lip, 7.20.21 breast, 22*24 bladder, 2s-27 prostate, 28.29 penis,30-33 neoplasms of 1he digestive tract, 33.34 and central nervous system35-39 have been accomplished with lr-192 wire. lechniques such as interstitial hyperthermia using lr-192,44-45 reports of instrumentation and technology, 9,40-43 dosimetry method4.5.11-13 and vaious reviews about interstitial brachytherapy11 *46.47 are also available.

Adverse Reactions Recurrence of cancer after treatment depends on the type of tumor and the specific clinical circumstances which surround a treatment. When iridium wire is used in conjunction with external beam treatments, the survival rate after five years can be high (of the order of 80-90%) in some cases. 14 Interstitial treatments using lr-192 wire are often carried out as a last resort aftel' other therapeutic techniques such as external beam treatments have failed; under 1hese circumstances the success rates are much lower. In less common treatments such as neoplasms of the brain and digestive tract, the prognosis for patients is generally poor. 14.33.39 As a general guide, the survival rates depend on lhe stage of graNth of the tumors as follows: T1 > 12 > 13 > > T4.

Contraindications lnadiation is contraindicated in healthy tissue, especially tissue close to the unor (treatment) volume. In some cases (e.g., bladder, rectum, carotid arteries) 1hese tissues may be particular1y sensitive to large doses of radiation.

Packaging lr-192 sources are supplied in containers designed to provide radiological shielding during shipping and storage.

The sources are shipped with measurement certificates giving Amersham values tor air-kerma rate and equivalent activity. Artf discrepancies between the source l8rial oombers, the serial numbers on the accompanying shipping papers and the serial numbers on the measurement certificates should be reported IMMEDIATELY to Amersham.

3 amersham 9020-28 disk 995 kk teletype

- W : ~ *,; Hltttfh&Wlflfriri¥&1XTl7Mi &&4¥ *":f.~ ilj'.;: .,~ - ~ *".".. ¥~~:~ ~ . .:.~** :1,"" j~ .,.... *~~ ... :: : ..4.... T: -:.*. ,._*~

O

'j i

t Lost Sources *f I

Normally, misplaced lr-192 sources can be found easily with an operational Geiger-Mueller detector (with audible ratemeter). Should attempts fail to find a f misplaced source within the first few hours after disc011ery of the loss, t I

IMMEDIATELY notify the appropriate State and/or Federal authorities.

Storage and Reuse of Wire t

~ t.a'.9~ I V\<ie.C-'T, The,.jleail8&."'Procedures for Unpacking, liansfer and Storage of lridium-192 Mecfical Brachytherapy Sources" provides additional information on the storage d Amersham lr-192 wire and hairpins. 't

~

When the products are not in use. it is necessary to store them in a shielded I

storage facility, to ensure that exposure to personnel is kept below the regulatory lellels. Only authorized medical and health physics staff should have access to the storage facility.

An accurate inventory system should be maintained to check that all radioactivity is accounted for, especially if lr-192 wire is being stored for recutting and reuse.

i which may result in numbers of small lengths being generated. A radiation smety officer or health physicist should be satisfied that a workable inventory control system has been established and that the locations of all lengths of radioactive wire can be accounted for before attempts are made to cut and recut lr-192 wira The 74-da:y half-life of lr-192 is long enough to enable the wire t> be reused in a number d treatments before the activity decays to too low a level to be c:A any surgical value. Before a length c:A wire is reused, howewr, it fflJSt be checked carefully in case any damage has been caused by previous handling and we recommend that each length is cleaned, tested for cxnamination and sterilized before reuse.

Wire already loaded inside nylon tubing must never be stored for long periods; the intense radiation close to a wire can cause radiation damage and embrittlement of nylon, which could cause breakage and severe problems during surgery. Wire should be loaded into fresh nylon tubing before each

- treatment..

It is possible to use more than one piece of wire inside a single nylon thread (lhere is enough room to put up to three wires side by side). This enables older decayed wire to be used in conjunction with newer wire to increase the activity, I needed, for a particular treatment, but it is important to take into account Ile decay factor for each piece of wire when computing the dose to the ll8aJ, ient volume.

If wire is to be used in this 'IIBJ/, the original measurement date of each length of wire should be recorded so that there can be no errors made in the decay corrections and exposure rate computations. In addition, the user should have aYaiable a detection system which can drectly measure the exposure rates from lenglhs of wire as a check on the accuracy of the exposure rate calculations.

Melhods of calibrating lr-192 wire have been reported in the literature.41 -42 Amersham recommends that wher8Y81' possible, a length ~ new wire should be used in a treatment, and reuse of decayed wire should be kept to a minimum or aoded altogether in order to simplify the storage, inventory and preparatory procedures which are needed to carry out a successful treatment. Note that it has been reported in the literature that when lr-192 wire is used more than twice, there is a noticeable worsening of cosmetic appearance c:A treated areas,

. possibly due to the use c:A wire which was damaged in previous treatmenls.<<>

4

7JFHZ5Pi:J'ii'S"'-:liC'i'"l'il'ffter . *rY1V'2fN:1[% *12nr~";";$R'#;-4itwenzer:ewrv.MliFe-M re: ;;;;;.a,.;; ;~~ . ~~* ;+ 5 CTlf-Construction The sources consist of an alloy of iridium and platinum which is encased in a pure platinum sheath. This composite is then mechanically drawn into a wire of various diameters ranging from 0.3 mm to 0.6 mm. In all cases, the inactiveR platinum sheath is 0.1 mm thick.

The wire is then irradiated in a reactor resulting in activation of natural iridium to lr-192. The material may then be dispatched in a variety of formats. Most frequently, the user will cut and mount the wire in holders to specified lengths.

but in some cases Amersham can arrange to supply the wire ready mounted in narrow bore plastic tubing. A sketch of typical wire formats is shown below.

WIRE COIL Nominal Content Nominal Output Product Code I '

Activity ;,

Air-Karma Exposure i Rate at Rate at 1 Meter 1 Meter nGy/hour * µA/hour '*

MBq/mm 1.11

µCi/mm 30 per mm 126 permm 14.4 ICW.1030 t 1.30 1.48 35 40 147 168 16.8 19.2 ICW.1035 ICW.1040 l

~

1.67 45 189 21.6 ICW.1045 1.85 50 210 24.0 ICW.1050 l 2.22 60 251 28.8 ICW.1060 2.59 70 293 33.6 ICW.1070 2.96 80 335 38.4 ICW.1080 3.33 90 377 43.2 ICW.1090 f

3.89 105 440 50.4 ICW.1105 4.44 120 503 57.6 ICW.1120

- 5.18 5.92 6.66 7.59 8.70 9.99 140 160 180 205 235 270 587 671 754 859 987 1,135 67.2 76.8 86.4 98.4 113.0 130.0 ICW.1140 ICW.1160 ICW.1180 ICW.1205 ICW.1235 icw.1210

~-

l*

/.

t:

11.10 300 1,257 144.0 ICW.1300 t ft*.

r 5

t f

amersham 902(Vi,:

disk 995 kk t

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i HAIRPIN ..

Nominal Content Nominal Output Product Code i:

Activity G Air-Kenna Exposure j Rite t Rate t f 1 Meter 1 Meter nGy/hour pR/hour MBq/mm pCi/mm per mm per mm 1.48 40 168 19.2 ICW.3040 1.67 45 189 21.6 ICW.3045 1.85 50 210 24.0 ICW.3050 2.22 60 251 28.8 ICW.3060 2.59 70 293 33.6 ICW.3070 2.96 80 335 38.4 ICW.3080 3.33 90 3TT 43.2 ICW.3090 3.89 105 440 50.4 ICW.3105 4.44 120 503 57.6 ICW.3120 5.18 140 587 67.2 ICW.3140 5.92 160 671 76.8 ICW.3160 6.66 180 754 86.4 ICW.3180 7.59 205 859 98.4 ICW.3205 8.70 235 987 113.0 ICW.3235 9.99 270 1,135 130.0 ICW.3270 11.10 300 1,257 144.0 ICW.3300 SINGLE PIN Nominal Content Nominal Output Product Code Activity Air-Kenna Exposure Rite at Rate at

- MBq/rrvn 1.48 1.67 1.85 "Ci/mm 40 45 50 1 Meter nGy/hour per mm 168 189 210 1 Meter pR/hour per mm 19.2 21.6 24.0 ICW.4040 ICW.4045 ICW.4050 2.22 60 251 28.8 ICW.4060 2.59 70 293 33.6 ICW.4070 2.96 80 335 38.4 ICW.4080 3.33 90. 377 43.2 ICW.4090 3.89 105 440 50.4 ICW.4105 .

I I

4.44 120 503 57.6 ICW.4120 5.18 140 587 67.2 ICW.4140 5.92 160 671 . 76.8 ICW.4160 6.66 180 754 86.4 ICW.4180 7.59 205 859 98.4 ICW.4205 8.70 235 987 113.0 ICW.4235 9.99 270 1,135 130.0 ICW.4270 11.10 300 1,257 144.0 ICW.4300 6

Description of Use Iridium wire is supplied in two basic formats for different purposes. In each case, the construction of the wire is the same; the difference lies in the dimensions of the wire, and in particular, in its diameter.

One version has a diameter of 0.3 mm and is consequently highly flexible. It is coiled up in lengths of approximately 50 cm. This product is intended for use in a particular technique called the "Pierquin/Paine Technique." 2 This is essentially an afterloading technique for the introduction of active wire into soft tissue. The wire is first cut into appropriate lengths and sealed into a narrow bore plastic tube. This whole process can be accommodated in one of several loading devices designed specifically for the purpose, particularly the Amersham lr-192 wire loader Model N.4100. In the case of larger hospitals with appropriate equipment, the hospital physicist may devise and build a custom loading arrangement.

A second plastic tube called a "guide tube" is then introduced into the patient using a steel needle. Once this is in place, the loaded inner tube can be fed into it and secured in place by the use of nylon beads and crimped lead discs.

This whole process is explained more thoroughly elsewhere. 1-U11 ,12 The second type of wire has a larger diameter, being around 0.6 mm. This material is sufficiently rigid to be inserted directly into the tissue with the aid of steel guide pins. A whole range of accessories is available to facilitate insertion of the active pins.

In these latter types of application, the wire is not encased in plastic tubing and it is not necessary to cut the wire since it is supplied in shapes which are designed to fit directly into the guides.

lr-192 wire contains inactive pure platinum cladding which absorbs all the emitted beta particles. The source emit photons of various fixed energies and a small amount of Bremsstrahlung, which is formed by the absorption of the beta particles within the platinum cladding.

Measurement The radiation output from wire and pins is stated in terms of the exposure rate at one meter per mm length of wire. This can be related to the equivalent radioa:tive content using the following table:

Nucllde Equlvalent Exposure Rate Absorbed Dose Rate

.Activity at 1 Meter In Air at 1 Meter (Approxlmately) lr-192 ~GBq, 1 Ci 0.48 R/hr 4mGy/hr The exposure rate at one meter in mR/hr may be converted to milligrams radium equivalent by multiplying by 1.212.

Purity /

The total gamma impurity will normally contribute <0.1% to the measured exposure rate.

7 amersham 9020-2c disk 995 kk

Quality Control All materials used in the fabrication of this product are checked against suppliers' specifications prior to manufacture. Finished sources are checked to ensure that removable contamination is not excessive.

This product is not regarded by Amersham as being a sealed source in that it cannot be guaranteed to pass the sealed source wipe test requirements at the time of use. The reason for that is that the product is manufactured by neutron irradiation and the casing of the wire becomes activated to a slight extent. The material used for this casing is pure platinum and this material has been chosen because the activation effect is minimized.

Wipe testing has been performed on both diameters of lr-192 wire at the time when the product would normally be released to the customer. In the case of the thicker (0.6 mm diameter) wire, wipe tests revealed removable contamination at around the 74 Bq, 2 nCi level. For a typical 50 cm length of wire which might be used for flexible implantations, the amount of removable contamination was betNeen 1.48 kBq, 40 nCi and 1.85 kBq, 50 nCi.

In both cases, the isotopic contaminants had a short half-life. About half of the removable contamination exhibited a half-life of 2.5 days and the other half-life of around 15 days. No gamma radiation was emitted by these contaminants. It is considered that the very short half-life and 1cm energy of the contaminant isotopes does not represent a serious problem.

Although these sources cannot be subjected to prototype testing in the normal

¥Sf, they have been through some ANSI simulation tests.

Both the iridium wire and the iridium pins have achieved ANSI performance ratings of C53312 where tbe criterion for passing was defined as being no significant deterioration in the removable contamination test compared with untested sources. Similarly, all types of wire have passed bend tests in which they were bent around a 2 mm diameter pin and lhen straightened again.

This product has been iri common usage for OYer 15 years in many hospitals throughout the world including broadly licensed hospitals in the United States.

Identification Individual wires are not marked in any ~ since there is insufficient space to do this. The inner container, in which the sources are delivered is labeled with the following: product code, nuclide, model number ICW.100, nominal activity,

measurement date, and 'caution radioactive material" plus the radiation trefoil.

The outer container which carries the shipment is marked in accordance with the requirements of the U.S. DOT for lype A containers.

Documentation A lest report is supplied with each unit. This gives details of quality control testing and states the measured exposure rate in air and the time of measurement referred to GMT.

Packaging Various packaging combinations are used depending on the type of source wire enclosed. The packaging is not intended for long term storage, nor is it intended tor reuse.

8 amersham 9020-2d disk 995 kk

tif fi95:ftltDlfW':~ . -'-* *. Y.::+/-mil6!1....

The wire is enclosed in the container in one of sewral Wf1:,JS. The stiff 0.6 mm diameter wire is wrapped individually in aluminum envelopes and packaged in screw-top aluminum containers. Each container fits into a lead pig which is mounted in a sealed can. The can is mounted in a polystyrene drum and the whole package cootorms to the U.S. DOT requirements for type A packages.

The 03 mm diameter wire is coiled and loaded into a plastic pot which fits inside a lead container. The rest of the packaging is as for the 0.6 mm diameter materials.

Avallablllty Coils and pins are normally available from stock with a wide range of exposure rates. Dispatch is normally within 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months from the receipt of an order at the Amersham International laboratories in the United Kingdom.

References

1. Paine. C.H.JModem Afterloading Methods tor lmntilial Radiolherap,t. Cliricsl Radiology, 23.

263-272. (1972).

2. Pierquin. B.. Chassagne. 0. and Cct. J.D.J "lcMards Consister1 Local Control of Certain Malignant bnonl-Endoradictherapy with lridium-192. Radiology. 99. 661-667. (1971).

3. Smon. N~ lridium-192 as a Radun Subslni'e, Am6rican Joum/11 d Floengef lQ/ogy. 93, 170-178, (1965). .

4. Pierquin, a, Prec:is de Curietherapie, Pllris. "'asst?" snd Ce. 344, (1964).

S Hal. E.J., Oln.er. R. and Shepstone. ~:J~ne Do8imelry wilh lllnlakm-182 and lroum-192 W1l9s. Acta Radiologica . ... 155-160, (11166).

6. Meredith, W.J., Green, 0. and Kawashima. K'JBritish Joumd d Radiology. 39, 280-286. (1966).

l Durrant. K.R. and EUis, F.JClinit::IM Radiology. 24, 502*505. (1973).

& Malalcer, K, Ellis. F. and Paine. C.H:1Ksloid Scars. A New Method of 'iaalment Comtining Surgery wilh lrterstitial Radiclherapy. Clinical Radiology. 27. 179-183. (1976).

8. Dalby, J., Lasbury, B. and Paine. C.H1A Prctacted Loading DeYice tor thin lr-192 Wll9S. British JocmsJ d Radiology. 45. 77&-781, (1972).

1Q Colins. L.> Tilo lnsrn.men!s IDr lhe Hancling of lridium-192 Hairpins. 8msh JoumBJ d Radiology.

48. &50. (1975).

11. Pierquin, a. Olahbazian, c. and Willen, F _ . ~ . St. Louis. USA. Warren Green, (1978).

12. Piarquin, a, Olbeix. A., Paine. C.H .. Ctasagne. 0., Mlwinalo. G. Wld Astl, ~ The Paris Sy&lllm in

~ Radiation lherap,-, Aais Rmologic;a 01cdogy. 17. 33-.ca. (1978).

13. Calebow. M.R1Do&imetry Tables tor Slandard lridium-192 Wll'II Planar lmplanls, Brilm Journal al Rmaogy, 57. 515-518. (1984).

14. Glasgow. G.P:,Malinckrod! ll'llllitule of Rlciclogy

W8st'inglon lJnMlrsily, St. Louis, Miacuri, Prilae Comrriuricalion.

1S Inoue. t, Hori, S., Miyata. Y., Ikeda. H., Shigematsu, Y., Fuchihala. H. and Tanaka. Y..,Dose and Dc9e Raia in Ir lnl8l'Slitial Irradiation lor Can:inoma of lhe bngue. Acta Radio/ (Oncd} {Sloddl), 17.

Z7-32, (1978).

16. Tlleda. M., Houriuchi, J. and ~ H,)lr-192 Hairpin. lnllnlitilll RadialhenJpr of bngue c.nc:.

Gin No Rinnl 27. 7-10. (1981).

1l llllda. H., Inoue. t, Miyata. Y., Oleki. S., Hl,Jami, A., 1snaka. Y., Wida. t, Fuc:flihala. H., Masaki, N. and Shigemalsu. Y..,Results of lhe 'halnlerC of Intra-oral Cat:inoma biJ lridium-192 Wire lraslitial Brachylherapy Compared wilh Results bi/ Radil.m Needes. Nippon Acta Radio/, 3a 23-27. (1978).

9

---~"""'*--------------------l!il!klli:#11111. ----11ilii!:ll?flll-:11111Wir:l'llliailll9WS---i[lj+/-_ _ _IIMIIWNmlliiiiill.'ll=ifi~S:ll!:l,iE::!'1l4Zi!1':#ll:A:illiC:.::a:::mwem*m:4r;:;*-*i.

18. Shigamalsu. Y., Masaki, N., Inoue, T., Miyata, Y., I"8da, H., Tanaka. Y., Hayami, A. and Ozeki, S.>

Results of hatment of lntraoral Carcinoma by lr-192 Hairpin technique Compared with 'halment by Radium Needles. Cancer ~ . 6: 132. (1981).

19. Pastsole. G.. lrwernizzi, A. and Pisani. P. 1Radiotherapy with 192-lridium on a Shaped Apparatus in lhe "halment of the Hard Palate U110f, Minerva MedlC81, 72, 1889-1894. (1981).

20. Pigneux, J., Richard, P.M. and Lagarde, C. 1The place of lnterstrtial Therapy Using 192-lridun in the Management of Carcinoma of lhe Lip. Cancer. 43, 1073-1on, (1979).

21. Gerbautet A.. Chassagne, D.. Hll)'BITl, M. and Vandenbrouck, C;) Carcinoma of the Lip. a Series ol 335 Cases. J Radio/ Electral Med Nucl, 59, ~10, (1978).

22. Brady, L.W.. Damsker. J.I .. Schatanoll, D. and Micaily, a 1Primary Radiation Therapy for Carcinoma of Iha Breast, Philadelphia Med, 7l, 53-55. (1981).

23. Bluming, A:Z.., Ozohan, M.L.. Mar1Qi. R.. Leibowita. R.L., Thompson, R.W.. Drickman. M .. Fingerhut, A.G. and Schlesinger. M.,L.umpectomy (L), Radical Axillary Node Dissection (DJ, External Beam Radiotherapy (RTE), and Iridium Implant (I) as lieatment ol Primary Breast Cancer-a Community Based Study (Meeting Abstract), Proc Am Assoc Cancer Res. 21, 405. (1980).

2~. Pluygers. E., Beauduin, M., Hermans. J. and Majois, F, Breasl Conserving 'i'ealmenl of Breasl Cancer by the Radiosurgic:al liichnique of the Jolimonl Hospital, Gynaeko/ Rundsdl, 21, 173-186.

{1981).

25. ll-lennile. J.. Cloche. P., Pemot, M., Delay. P., Wagner J. and Guillemin, P.,balment of Bladder bnors with lndium-192, °fMl!1y Nine Cases. Am Urol, (Paris), 16, 280-283. (1982).

26. Bofto. H .. Perrin, J.L., AIMlrt, J., Salle. M. and Pierquin, a) 1realmert of Malignant Bladder bnors by lrkium-192 Wiring, Urology. 16: 467-469, (1980).

Z1. Pizzi, G.a. Calzavara, F., Cauz20. C. ~ Zorat, P.y Endocurielherapy Cancer of the Bladder. A New lilchnique by Implant of 192-lricun with Cyponil lJbes, J Radie/, 60, 715-718. (1979).

28. Coult a, Chassagne. D. and ~ . 1, ll"llelsliliaJ Irradiation of Prosla!e Cancer with lridium-192 Wires. Praliminary Note, J Urol Nephrol {Paris), &l 113-116, (1977).

29. Court, a and Chassagne. D,lnterslitial Radiation Therapy of Cancer of the Prostate .Using lridium-192 Wires, Cancer 7teat Rep, 61, 329-330, (1977).

30. Daly, N.J.. Douchez. J. and Ccmbes. P.F.1/nt J Radist Oncol Biol Phys. S. 1239-1243. (1982).

31. Fortier. P., Mayliln, C., Gerbaulet. A., Z.eler, J. and li:Juraine. R.llridium-192 Interstitial Radiolherapy of Carcinoma of the Penis. Carcinologic Results, Dermatologic EYSlualion (repott of 87 cases), Ann DtJrrnatol lerereol. 106. -465-468. (1979).

32. Rayne!, M.. Chassagne. D., Baillet, F. n Pielquin, a, 1.lmors of the Male Genilal System.

Grurmiann. E. and Vahlensieck. W., Ed, New 'lbrk. Spriger.1Jerlag, (1977).

n Jaclcs0n, aR.,Iridium 1mp1ara in 'iearner1 of Anorec1a1 Carcinoma. Dis Cc1on Rectun, n MS-150, (1980).

34. "'8da. H., Kuroda, C., Uchida, H., Miyata. Y., Masaki, N., Shigematsu, Y., Monden, M. and Olramura, J. Jntrafuminal Irradiation wilh lridun-192 Wires for Extrahepalic Bile Dud Carcinoma-A Prelininary Report, Nippon lgaku Ho6ha9en Gttkksi Zasshi, 39, 1356-1358, (1979).

35. Muncinger, F.,Rationale and Melhods of lrulslitial fridun.192 Brachy,<:urie 1herap/ and lridun-192 or lodine-125 ProlraCled Long Term lrradialion, INSERM Symposium, 12, 340, (1979).

36. Mundinger, F., Busam, a, Birg, W. and Schildge. ~ Results of lrurstitial lridium-192 Brachy,curie Therapy and lridium-192 Prctraded Long Term lnadialion, INSERM Symposiim, 12, 340, (1979).

rl. Schlesiuger; M.. Bouhnik, H., M~ Q, Constans. J.P. and Szikla. G.1Associalion of Temparary

~ lr-192 Implantation and Eldllmal Radiolhenlpy in the Managemenl af SuprsenloriaJ 1mara: 1-:mque and Ooeinelry, INSERM Sympotlium, 12, 340, (1979).

38. Kely, P.J., Olson, M. H. and Wright. A.E..,ste,eotactic lmplartation of lridil.m-192 Into CNS Neoplasms, 5urg Neurol. 1a 349-354, (1978).

39. Bemslein, M. and Gutin, P.H, lm!l1titial Irradiation of Brain l.mots: A Review, Nwrosu,r,ery. 9, 7~*750, (1981).

<10. Bello. J.E., Oyarzun, C., Abrath, F.G. and Sole, .l.jStudy af the Characlenslics af lridun-192 Wire Ulllld in lnlerslllllll Implants, Radiology. 145, 224-225, {1982).

10 I I ....,

~

f-

. H 1'

41. Williamson, J.F.. Khan. F.M., Shanna. S.C. and Fulerton. G.°tMelhods for Routine Calibration ol Brachytherapy Sources. Radiology. 142, 511-515, (1982). *

42. Cobb, PD.. Chen. T.S. and Kase. K.A_,ca,ibralion o1 B r ~ lridlum-192 Sources. lrt J Radial Oncol Biol Phys, 7. 2$262, (1981).

43. Pame. C.H.,An lmPf0118d Aftlllloadlng lilchnique for Perineal Implants. Clin Radio/, 31, ~

(1980). .

44. Iba. N .. Forell, B.. Joseph, C., Lipsett, J. and Archambeau. J.Q>trnr111itial lmpianl wilh lnlerlltilial Hyperlhemua. Cancer. 50, 2518-2523. (1982).

45. Jo9eph, C.O., Aslrahan. M.. Lipsett, J., Archambeau. J., Forell. B. and George, F.W.11nterslitial Hyperthermia and Interstitial lridium-192 lmplanla!ion: A Technique and Preliminary Results. lrt J lwdial Oncol Biol Phys, 7. 827-833, (1981).

46. George, F.W. Modern ln181stitiat and lntracavilary Radiation Management, Cancer ~ .

~ 132, (1981{

~ Oelclos. l.tSelecled Abslracls on lnlffltitiaf and Surface Brachylherapy, Oncology CMlr\liew. U.S.

[)eparymenl ol Health and Hlmlll1 Services, P883-922809. 1-67, (1983).

48. Payne, J.H_,_Fur!her Simptilic:ation ol lhe lridun--192 WIie Alterloaang Method Using Nylon iJbe, Br J Radial. .50. 362-363, (1977).

Amersham Corporation 2636 South Clearbrook DriYe Ming!on Heig,ts. Illinois 60005

~~~mhed Amersham (800)~ (416) 842-2720 I (800) 387-4060 (Orclauebec)

(800) 268-5061 (rest ol Canada)

~1111.JSA Noll. 11188 1777118 MWllllm ii

lracllmlrk of MWllllm ... ,lalio,111 pie I J'

DRAFT COPY OF LABEL ,

IRIDIUM-192 WIRE Read the package insert before opening this container. Handle this radioactive source with GREAT CARE.

IONS Model: ICW.100 Code:

Nuclide: Ir192 Ref. Date:

Nominal Activity:

Source Serial No.:

This source is licensed by the Illinois Department of Nuclear Safety for distribution to persons licensed pursuant to Section 330.260{c) and/or Appendix C, Group VI, Section 330.280, or under equivalent licenses of the U.S.N.R.C. or Agreement State.

AMERSHAM (LABEL CODE)

AMERSHAM CORPORATION CAUTION ARLINGTON HTS., IL 60005 RADIOACTIVE (TREFOIL)

OAKVILLE, ONTARIO L6H 2R3 MATERIAL 2170E

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r Safety Instructions use of iridium-192 wire xY loader and shield ~

\j codes Shield: ASN.50 Loader: N.4100 contents

1. Shield-description

2. Shield-unpacking and preparation for use

3. Loader-preparation for use with shield

4. Assembly of loader and shield

5. Shielding data

6. Radiation protection

7. Operating procedure for loading wires a Pccessories Amarsham Corporation 21836 S0IAh Clearbrook Drive Amemham Canada Umited 505 IIOQUOIS Shore Road Amersham MnglDtt Heig1IS. llinoill 60005 Oakville, Ontario lBH 2R3 (800) 323-e695 (416) 842-2720 I (800) 387~ (Or1i'Cueoec)

(800) 268-5061 (rest cl Canada) amersham 9020-3 disk 995

~

i iGJR ~ niit . *iiAiMi&i ilNfi WW-$. Ntii -t&RII

1. Shield-description The shield (Product code ASN.50) is designed for use with the Amersham iridium-192 wire loader (Product code N.4100). It consists of the following component parts (see illustration below).

a) A 30 mm thick lead front shieldl1l with inset 60 mm thick lead glass window<2l mounted on a 30 mm thick steel base plate'3J.

b) A storage pot alignment disc<4l with knurled bolt<5l for attachment to shield base plate.

c) An iridium wire loader thumbwheel arm extension<SJ with allenkey7l for rema.iing the iridium wire loader thumbwheel and attaching the thumbwheel arm extension.

Note: The thumbwheel is part of the Amersham iridium wire loader (Product code N.4100).

cl) Koorted bolts(8l for the attachment of the iridium wire loader to the shield base plate.

Figure1 (B) Knurled (7) Allenke; bolts l8> Iridium wire loader llumb wheel arm CDd8nSlion (3) Slll8I base ptate, (4) SICnge pa 30 nm lhick lligrmen1 dilc 2

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2. Shield-unpacking and preparation for use

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) Check that all the components Hsted are included in the packaga b) Remove the packing from around the loader shield.

c) RemOYe the screws and the wooden retaining slats attaching the loader shield to the base of the container.

cl) Lift the shield, which weighs "'48 kg, out of the container taking care not to damage it.

The shield should be lifted by two people holding the front lead shielding. Do not attempt to lift the shield by the lead glass window.

> It is recommended that the shield be used on a bench ""900 mm high.

Ensure that the bench is suitably robust.

3

J I ~}\-

/:6

~a. Loader-preparation for use with shleld

~

~b)

Cliling IDOi Guide funnel The loader is bolted to the shield through the holes indicated The fellowing procedures should be carried out before the iridium wire loader (see diagram) is fixed in ~on on the iridium wire loader shield.

) Blade loadlng procedure The wire loader is supplied with a blade already fitted. Blades can be replaced as follows:

RemoY8 the blade holder from the cutting tool by unscrewing the two holder ralaining screws. Remove the screws from the blade holder. Frt the neN blade in position and replace the blade retaining screws. Replace the blade holder in the cutting tool and replace the two holder retaining screws.

b) Indenting tool check Check the position of the indenting tool as follows:

The position of the indenting tool with respect ID the guide slot can be altered by adjusting the indenting tool adjustment screw. This is positioned, as australed, at the front of the indenting tool.

The indenting tool should be adjusted ID give a permanent indent in a piece of 1BTiple inner tubing when depressed for at least 5 seconds. This can normally be achieved by positioning the indenting head close ID the bottom of the guide slot.

When the indenting head is in the correct position tighten the clamping nut on 1he indenting tool adjustment screw to fix it in position.

The loader is naN ready for use and can naN be fixed in position on the loader lhield.

4 LI

i I

i l

4. Assembly of loader and shleld a) The shield should be mounted on a suitable robust bench preferably in a purpose designed radiation area and in a position to give minimum radiation scatter.

b) Remove the knurled thumbscrew from the iridium wire loader using the 81181'ltcev-provided (see Figure 4).

c) Attach the arm extension to the thumbwheel arm and secure using the allenke-f provided (see Figure 5).

5

l l,,

d) The iridium-192 wire loader is noN positioned on the shield base plate, so that the iridium wire loader thumbwheel arm extension passes through the slot provided in the lead front of the shield. The loader is then positioned so that the holes in the loader base coincide with the threaded holes in the base plate.

> Use the two knurled bolts provided to attach the loader to the shield. i t) Attach the thumbwheel to the arm extension where it emerges ~rom the front j of the shield and secure using the allenkey provided (see Figure 6) ..

g) The iridium wire loader is now ready for use in position on the iridium wire loader shield. Ensure that the Installation 18 approved by Safety Officers at f.

the hospital.

(-.

Figure& t t

r

~

6

5. Shleldlng data Dose equivalent rate measurements have been made et a number of points around the loader shield, positioned in the center of a room to reduce scatter from surrounding walls, with 100 mm of 3.63 MBq/mm, 98 µCi/mm iridium-192 wire loaded into the wire loader.

The following dose equivalent rates were recorded:

Dose point Dose equivalent rate on the aurface of the shleld

µSv/h mrem/h A "'5 --..0.5 B "'5 --..0.5 C ....a --..0.8 The dose equivalent rate 200 mm under the center of the active length, underneath the shield's steel base plate at point D, was "'20 µSv/h, "'2 mrem/h.

A typical dose equivalent rate to the head of the operator was found to be

'\.20 µ.Sv/h, "'2 mrem/h.

A typcaJ dose equivalent rate to the body of the operator was found to be

"'15 µ.Sv/h, "'1.5 mrem/h.

Good planning will reduce exposure time to a minimum.

Should additional local shielding be required, please refer to Sectio,(s,R'adiation protection for guidance. L1/

Figure7 r

PoITTIC

........... 'Js. ....

7

6. Radiation protection a) Shielding Wherever possible. persons moving radiation sources should always work behind radiation shields. In general, the best radiation shields for gamma radiation are made from dense. high atomic number materials. such as lead.

The effectiveness of lead shielding for iridium-192, is shown, in terms of thickness of material requ!red for a given transmission factor, in Table 1a.

~le 1 a) Lead b) Concrete Radionuclide ll'ansmlsslon factor ll'anamlaalon factor 0.5 0.1 0.01 0.001 0.5 0.1 0.01 Thickness of lead Thickness of concrete mm mm lridium-192 3.5 12 28 47 130 245 390 In cases where it is not possible or convenient to work behind radiation shields, then maximum distance and minimum time must be used to keep personnel exposure to a minimum, but remember that all materials provide some sort of radiation shielding providing they are between you and the source. Even concrete walls can provide useful additional screening as shown in Table 1b and advantage should be taken of this whenever possible.

Sources should not be permanently stored in their transport container without the use of additional shielding. Permanent storage is normally best achieved by the use of a purpose built storage cell or container.

b) Distance Reduction of exposure using distance can be very effective and therefore should be used to advantage whenever possible.

Distance protection is based on the inwrse square law. Quite simply, if the distance is halved. the dose will go up by a factor of 4 and if the distance is doubled, the dose will be reduced to 0.25 of its original value.

labia 2 gives examples of variations of air-kerma rate and exposure rate with distance from point sources for typical activities.

1llble2 Radio- Nominal Nominal output nucllde content Alr-lcerma rate at £xpo1U'9 rate at activity

dlatance of dlatance of 1mm 100mm 1 m 1mm 100mm 1 m Gy/min µGy/min µGy/min A/min mR/min pR/min lridium-192 3.7 GBq, 100 mCi 7. 700 7 700 70 700 The values given in Table 2 indicate quite clearly why sources should neY8f' be touched by hand and why forceps of at least 300 mm in length should be used when handling them.

8

c) Time The third factor which can help to reduce exposure to radiation is time. The total dose received during any operation involving radiation sources is directly proportional to the time taken to carry out that operation. Good planning always helps to reduce exposure time to a minimum.

For 1111 aource movements outside the ahleldlng of the transport

,"- container, the tollowlng points should be noted:

~~

1) A dose rate monitor should always be readily available and used to check exposure calculations. It is also essential to have one available in case of mishaps. *

2) The sources must never be handled directly.

3) AJWf¥, use remote handling tools.

4) Reduce exposure to personnel by the use of shielding, distance and time.

iJ

~o 7, Operating procedure for loadlng wires

\e tr The iridium wire loader (Product code N.4100) and shield should nr:JN be assembled as shown.

) TaM the theater pack 3 (Product code N.203) and remove a length of inner

, nylon tubing (or take a length of inner nylon tubing from your bulk supplies).

The operator should take precautions to ensure tha1 no dirt or Olher foreign matter comes into contact with the nylon tubing. If contamination of the surface is suspected, then the tubing should be rejected. We recommend tha1 surgical glows are used throughout the operation of loading the wire.

9

filMIIYffitCWCYZitlfMjiiKi?PiYE-ii ;;;wx*::aer::tsfrzwnrmmzftr.,, : ~ ***-- ' ' f ~ ' . " : ~ - - ft@MffM! CT 7517? ES r*mzm

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I f

I b) Preparation of Inner nylon tubing Take the 1 meter length of inner nylon tubing and ensure the end is square by placing it into the guide slot to approximately 20 mm and fixing in a position parallel to the scale board using the clamping device. Lower cutting tool and press with gentle pressure to cut through tubing. Raise cutting tool and remow I tubing.

Note: if tubing is not cut cleanly, then replace blade (see section 3a) to ensure .

a clean cut.

Remow excess tubing from wire loader.

c) Loading tubing and Indenting to correct length lo ensure minimum radiation exposure, the tubing is indented to the correct length prior to loading the active wire. The aim is to load a length (x) c:A brown nylon thread, a length (y) c:A radioactive iridium wire and a length (z) c:A brown nylon thread (see Figure 8), a small amount of additional tubing should also be left on either end, say 20 mm, as shown, in Figure 8.

Load the inner nylon tube into the guide slot and indent tubing at the required length x + y + z + the additional unloading length (say 20 mm).

e.g., if you require x

60mm y

60mm z

60mm

additional unloaded length

20 mm i Total length from end of inner tubing to indent should be:

\ x+y+z+20 x:p J 60+60+60+20-200mm

.Jt)~ ~

~ t\\"1/ ~=- r =:::::::;:::*mm==~=ladioecliW=' -=*=r=======zmm====-c::~

=='°

~ry'-~*

J

~OMH~ Ovaad r ymm

.-1 tmm ~ head -- .. l nslftlorltube The indenting head indents at position 273 mm on the scale. So the nylon tube should be loaded into the guide slot until the end of the tube coincides with position 273 - 200

73 mm on the scale.

When you have established what lengths x, y and z you require and inserted the nylon tubing to the required length in the guide slot, the indenting tool should be depressed for at least 5 seconds to ensure a permanent seal, then lift the indenting tool .

.. I i

10

1-cl) Move the tubing along until it locates in the cutting head and clamp in position (see Figure 9).

J A ~ length of brown nylon marker thread from theater pack 3 (Product code N.203) and insert into guide funnel with your right hand (using forceps, if preferred) until resistance is met. Establish contact with rollers by turning the thumbwheel in a clockwise direction with your left hand. The thread will be seen to mo11e along the nylon tubing as the thumbwheel is turned.

f) Rotate the thumbwheel until position of thread is at x cm in the scale Qn the case of the example, 60 mm) (see Figure 10) and cut the thread by pushing the thumbMleel doNn with your left hand. Remow the unused market thread.

Figur99 Figure10

II 11 11 Leadlhield II 11 II 11 11 I

11

- *~-:.-. -- . --*

g) Loading of the active wire The 500 mm coils of radioactive iridium wire will be received in a standard lead transport pot. Up to four coils are supplied in each package. The coils are contained in a plastic tub inside the lead container and are separated by foam pads {see Figure 11). Remove the coils and pads by lifting them out one at a time using long forceps, taking care to separate the coil from the pad if the end of the wire has caught in the foam.

Flgln11 Inner c:ontairment for r:::,

ICW.1030 to ICW.1300

~ - - - Foam pads

- * - - Plastic tub Handling instructions are included in each package for your general guidance.

'1JlJ should, however, ensure that the SOUIC8S are unpacked and transferred from their transport container only by a fully trained and authorized person {See section 6 Radiation protection)..

h) The radioactive wire should be transferred, taking the precautions listed above, to a storage pot {Product code N.411) for use with the wire.

The pot is designed to feed directly no $lEt wire loader, providing protection from the active iridium wire coil. The ooil of active wire provided is loaded onto the central spigot and fed through a slot in the side cl the pot, as illustrated (see Figure 12). i' I

Figure12 12

I l.oldlng the storage pot with radioactive wire The 0.3 mm diameter radioactive wire is normally in 500 mm lengths wound as a loose coil.

b load the storage pot:

1) remow the lid of the pot.

2) working behind the shielding, remove the lid from the container in which the coil was supplied and take out the coil with forceps.

3) gripping one end. of the coil with forceps, lower the coil over the spigot in the center of the pot, as shown in *Figure 12, feeding the lower end of the coil through the slot so that it protrudes from the slot by about 25 mm.

4) replace the lid of the pot.

5) label the pot to identify the contents.

I) Place the storage pot containing the radioactive wire on the storage pot support disc on the base plate of the loader shield (see Figures 13 and 14). The disc is located so that the output feed slot of the storage pot is directly opposite the input feed funnel of the wire loader cutting head. Using forceps in your right hand to grip the radioactive wire, introduce into the guide* funnel and establish contact with the rollers (see Figure 15).

Figure13 Figure14 Input feed funnel al the wire l0IJder cutting head 0laput lled slot 13 I

Rotate the thumbwheel in a clockwise direction until position of end of wire is at y mm on the scale {in the case of the example, 60 mm) and cut the wire by pushing the thumbwheel down.

Push the cut wire "'5 mm along the scale then retrieve the wire from the loader by rotating the thumbwheel in an anticlockwise direction.

Until further wire is required, the storage pot containing the unused radioactive wire can either be removed to a position behind some local lead shielding or rotated iNiay through ""90 ° {the lead storage pot then acts as a shield for the short length of radioactive wire outside the pot). The storage pot support disc material is such that it allows the storage pot to rotate freely about its axis {see Figure 15).

D Take the unused length of brown nylon marker thread and insert into guide funnel until resistance is met. as before. Establish contact with rollers by turning the thumtM/heel in a clockwise direction. The thread will be seen to be moving along the nylon tubing, pushing the x mm length of thread and the y mm length of wire ahead of it, as the thumtMheel is turned.

k) Rotate the thumbwheel until position at end of thread is at z mm on the scale On the case of the example, 60 mm) and cut the thread t:,,, pushing the thumbwheel down. Release the thumbwheel and continue rotating until the thread ~ength x mm) stops against the indent previously made. Rotate the thumbwheel in an anticlockwise direction until the thread is released. Remove the unused marker thread.

Figure15 After loading and cutting wire the lead pot can be 10111111d s,e; lhrough "'90 0 I.Jae lolceps ID grip wire ande!Ublish conacl wilh Pu!h the lhumbwheel rollels down ID aA the wire 14

I) The two lengths of brown marker thread and one length of radioactive iridium wire are now loaded in the inner nylon tubing. Release the loaded tubing by lifting the clamping device. Withdraw the loaded tubing using long forceps until the indent (previously made) is in line with the indenting tool head. L..a.t.<er cutting tool and press with gentle pressure to cut through tubing. Raise cutting tool and making use of the forceps slot (see Figure 16) lift end of the loaded tube with long forceps and withdraw until the far end of the second brown marker thread (z mm long) coincides with the indenting head position. Depress ..

the indenting tool for at least 5 seconds to ensure a permanent seal, then lift the

indenting tool.

m) The loaded inner nylon tubing is na.v ready for use and should be removed from the loading device, with long forceps and placed in a lead shielded pot ready for transfer to the operating theater.

n) A further length of tubing can now be loaded in the same manner.

Figure 16 Indenting

~.... k)0I

. ~

15

& Accessories The following equipment is available for use in the Pierquin/Paine after1oading technique. l:

I I

Product description code Theater pack 1 (gamma sterilized) N.201 2x1 meter outer nylon tubing 160 cm marker wire ,.

I 80 cm nylon thread

Theater pack 2 (gamma sterilized) N.202 t 4 packs each of 6 nylon balls 4 packs each of 6 lead discs '

Theater pack 3 (not sterilized) N.203 7x1 meter inner nylon tubing 5 meters marker thread Bulk supplies Outer nylon tubing On 70x1 meter lengths) N.251 ,

Inner nylon tubing On 70x1 meter lengths) N.254 ...f, Nylon balls (multiples of 100) N.2021 i-'

~

Lead discs (multiples of 200) N.2052 Plain guide needles for implanting the outer nylon tubing length 100 mm N.210 1.

length 150 mm N.215 length 200 mm N.220 :? '

..*.t-1andre! for use with...aba1e length 250 mm N.325 Crimping tool for crimping lead discs N.400 4t Storage pots for use with the Amersham after1oading device N.411 Note: Only theater pack 1 and 2 (Product codes N.201 and N.202 respectively) are pre-sterilized. We recommend that all 0Cher equipment is sterilized, before use. using standard sterilizing solutions and that all equipment is carefuRy inspected before use to check that dirt or grease are not present and that e.-erything appears in good working order.

Amereham Corporation 2636 Scull Clearbrook Oriw Mrqon Heights. llin0il 80005 (1100)323-6695

==~mtted 0lkwle. Orcario LSH 2R3 Amersham

('18) "42*2720 I (1100) 387-4060 (()rWuebec)

(1100) 268-5061 (relt d Canada)

PnnllCI ,n USA Now. 111118 Anwllwn

a tracllnWI<. d

,.,___,.,..,. . . pie 16 I

Handling and cutting .

device for lridium-192 ~ I wire hairpins/single-pins "-"' C\- ~

Product code ASN.200 1\J ~~:?

~ ~~

Caution: Federal law restrk:ta this dwlca to ule by or on the order of a phrllclan.

Ameflham Corporation Amerlham Canada Umited A h

. 2636 SoAl 0eerbrook Drive Mnglon Heqa. Illinois 60005 (1100) 32H695 505 kocJJOi9 Shore Road Oekvlle. 0rurio L6H 2R3 mers am (416) 842-2720 I (8(X1/ 387~ (Orw.Ouebec)

(800) 268-5061 (111191 d Canada) .

amersham9020-4 disk 995 kk teletype

..... Sfiir'MFl!fiW: =* :::wrvmrr nih--ill'Ci "tt-1::r 1r:n-eert:@'P:tnrn***~we:er~n s!Wi?l:IRltii&*B1W,t&r~ee1eNTce,wt#'-t'%ie!Gtii:..rlW:t&!i- :tr::Irtwft::rtf1Fittt11:<5trt::1!?YftQ1?Ci ..

I Intended use Thia device ls Intended to as!st In the safe handllng and accurate cutting of 1921r hairpins and alngle-plna for lnterstltlal brachytherapy.

Description:

Handling device The handling device incorporates a central sprung rod which opens the front jaws of a hairpin/single-pin grip.

The jaws are operated by depressing a button while holding the outer casing of the device by the finger grip. It allows the operator to handle an iridium-192 hairpin or single-pin at a distance with greater ease and accuracy than with forceps.

Inger The handling device is sterilizable and Qll>

can be used in the operating theater.

1 rearjaws

~ ~ - - - lrontjaws

-Roi.---- aluminum toil

.::::::::;;;::;;;;;~~ erM!lope

-+---- ieolopecal Hairpn/llngle-p,n handling dalllc9 baing 1.-c:1 to - an iridun--192 haorp,n lrom 1!'19 liumltu'n laif IIMiope.

2

Halrpln/slngle-pln cutter Halrpnlllngl&-p,n CUling dfvice bang UNd ID cut

- leg al* hairpin ID 40 nm.

The cutter consists of a guillotine with two 0.6 mm diameter clearance holes set at the spacing of the hairpin legs.

With the handling device positioned in the slide track as illustrated. the engraved scale allows accurate measurement of the length to the cutting face in millimeters. A removable tray is provided to take the cut waste ends of the iridium pins. The cutter simplifies and increases the accuracy of cutting iridium-192 hairpins/single-pins to length and prevents loss d the cut The cutter is sterilizable and can be waste ends. used in the operating theater.

Procedures:

Handling procedure The iridium-192 hairpins and single-pins are supplied in aluminum foil envelopes loaded into isotope cans. The handling procedure should be carried out using the radiation protection measures described in Appendix 1.

1) Lift the foil envelope containing the iridium-192 hairpin or single-pin using long forceps.

2) Position the hairpin/single-pin handling device vertically above the foil envelope, as illustrated. It should be held, as sho.vn in the illustration, with the finger grip between the fore-fingers and the thumb on the 'thumb button:

3) Press the 'thumb button' to a,cpose the front jaws d the handling tool. Pass the front jaws through the hairpin, as Ulustrated, and release the 'thumb button:

The hairpin should now be securely held between the front and rear jaws.

(The single-pin can be attached in a similar wa:, using a single front jaw and passing it through the single-pin eyelet.)

4) Withdraw the iridium-192 hairpin/single-pin slowly until it is clear d the foil envelope.

The iridium-192 hairpin/single-pin can OON be taken to the cutting device using radiation protection criteria indicated in Appendix 1. At. all times ensure adequate radiation protection for the operator using criteria indicated in Appendix 1.

I) If a full length d iridium-192 hairpin/single-pin is required, it can be taken directly to the applicator implant (see Hairpin/single-pin applicator loading procedure).

3 j

~

I.

Cutting procedure If the hairpin/single-pin leg lengths are required shorter than that supplied as catalog items, then the cutting device should be used.

Place the cutter behind appropriate shielding before following the hairpin/single-pin handling procedure and observe usual radiation protection measures as outlined in Appendix 1.

1) Lift the guillotine blade using the handle provided.

2) Position the hairpin/single-pin handling device with the pin in line with the

- handle and the engraved cursor line uppermost on the scale track, ensuring that the ends of the legs of the pin are located in the guillotine guide holes (as illustrated under Hairpin/single-pin cutter).

3) Move the handling device along the scale track until the desired leg length on the mm scale is adjacent to the engraved cursor line. The hairpin/single-pin legs/leg should appear over the waste tray.

Cutting both legs

4) Depress the guillotine blade, using the guillotine blade handle, to cut excess length from the pin.

Cutting alngle leg

5) To cut a single leg at this length depress the guillotine blade through a single leg only. (The blade is set at an angle to enable you to do this.)

8) Slide handling device carefully out of the cutter along the scale track and lift the cut hairpin/single-pin dear. It is noN ready for loading into the applicator.

Halrpln/slngla.pln applicator loading procedure *

- 1) Adjust the angle of the hairpin/single-pin with respect to the stem of the handling tool, by pushing the hairpin/single-pin gently against the base of the guillotine, to allow for ease of insertion into the applicator, already in position in the patient.

2) Locate end of pin in pre-positioned applicator with the line of the pin in line with the applicator and slowly push pin into applicator.

S) When the hairpin/single-pin is in position in the applicator, press the button on the top of the handling device mopen the jaws and release the pin.

Unhook the handling device from the

/

pin. The pin is OON in position in the applicator.

lridun* 192 hairpi1 being loacied in1o an applicator in the tongue. USing the hlrdling deviee.

4

I,

Appendix 1 For all source l'TlOWments outside the shielding of the transport container, the fo&loNing points should be noted:

1) An exposure rate monitor should always be readily available and used to check exposure calculations. It is also essential to have one available in case of mishaps.

2) The sources must never be handled directly.

3) Always use remote handling tools.

4) Reduce exposure to personnel by the use of shielding, distance and time as tollows:

a) Shielding WhenE,,,er possible persons moving radiation sources should always work behind radiation shields. In general, the best radiation shields for gamma radiation are made from dense, high atomic number materials. such as lead.

The effectiveness of lead shielding for iridium-192, is sha.vn, in terms of thickness of material required for_ a given transmission factor, in Table 1(a).

Table 1 (a) (b)

Radlonucllde ltanamlsslon factor ltanamlaslon factor 0.5 0.1 0.01 0.001 0.5 0.1 0.01 Thlcknea of lead mm Thlckneaa of concrete mm lridiurn-192 3.5 12 28 47 130 245 390 In cases where it is not possible or convenient to work behind radiation shields, then maximum distance and minimum lime must be used to keep personnel exposure to a minimum. but remember that all materials provide some sort of radiation shielding providing they are between you and the source. Even concrete walls can provide useful additional screening as sha.m in Table 1b and advantage of this should be taken whenever possible.

Sources should not be permanently stored in their transport container without the use of additional shielding. Permanent storage is normally best achieved by the use of a purpose built storage cell or container.

b) Distance Reduction of exposure using distance can be very effective and therefore should be used to advantage whenever possible. .

Oislance protection is based on the inwrse square law. Quite simply, if the dslance is halved, the dose will go up by a factor of 4; and if the distance is doubled, the dose will be reduced to 0.25 of its original value.

5

f

_,

Table 2 gives examples of variations of exposure rate with distance from point sources for typical activities.

'Dible 2 Radionuclide Activity Exposure rate at I dlatance of:

1mm1cm 10 cm 30cm 1m 3m A/min A/min mR/min mR/min µRimi lridium-192 3.7 GBq, 100 mCi 700 7 70 6.3 700 Note: For user convenience, the commonly used unit of radiation expos re (R.

or Roentgen) is given instead of the newer SI unit ot Coulombs/Kilograms.

The values given in "!able 2 indicate quite clearly why sources should never be touched by hand and why forceps ot at least 30 cm in length should be used when handling them.

c) Time

The third factor which can help to reduce exposure to radiation is time. The total dose received during any operation involving radiation sources is directly proportional to the time taken to carry out that operation. Good planning nearly always helps to reduce exposure time to a minimum.

Amersham Corponltion 2636 South Cleerbrook Dm,,e Ameraham Canada Umited

~~~LBH~

A mersham Mngl0n HeiltltS. i.noia 80005 1,(800)323-e695 ~418) 1142.2720 I 1,(800) 387-GIO (On,Ouebec) 1,(800) 268-5061 (rest al Canada)

Plir.iinUSA MIi

"'-"'-**~al Amrllwft ... ,111101 .. plc

{,,

Quantitation of the Amount of Contamination Obtained From Iridium-192 Sources DANIEL F. GRIMM, MS, MICHAEL T. GILLIN, PhD Department of Radiation Oncology. The Medical College of Wisconsin, Milwaukee, Wisoomin lridium-192 in the form of either a wire or pins does not meet standard definitions of a .. sealed source ... This study was designed to measure the am~unt of removable activity from wire and pin sources of m1r under

. - both normal and "destructive" handling procedures. During normal

_r:_.*

handling, only small amounts of contamination were removed from the I

sources. The activity was always below the 185-Bq limit set by the Nuclear Regulatory Commission for sealed sources. Up to eight times this level

~ -

was found for destructive handling. We conclude that the risk of con-

~ -_

tamination is extremely low for either user or patient under routine use \.

~c; of 1' 2lr wires.

J'.. ~t.,: . Key Words: Iridium-192 Pins, Wires, Contamination, I>cstructioll

~ - ~ *..

~ -.:.,-..

Endocurietberapy/HypertbcrmJa Oncology 1988;4:17-21 ridium-192 is an important isotope in contem- Radiation Protection and Measurements bas I poracy radiation oncology. The advantages of 1n1r aver other traditional high energy emitting published the following definition of scaled source:

isotopes inc1ude a lower average photon energy, a A radioactive source sealed in a container or hav-small outer diameter, and the absence of gaseous ing a bonded cover, in which lhe container or decay products. Another practical advantage is the cover bas sufficient mechanical strength to pre-ability to adjust the source length to the dimension vent contact with and dispersion of the radioac-defined by the clinical situation. lridium-192 ii tive material under conditions of use and wear for .

available in the form of seeds, wire, straight pins, which it was designed. a and hairpins. While it may be argued that with lridium-192 does not meet either definition a of proper center-to-center spacing the seed source sealed source for several reasons. The iridium and the wire source arc equivalent, there is no seed wire is encased in a 90% platinum-to~ iridium

-,. *-* ~-

-*-*- substitute for either the straight pin or the hairpin tube. No attempt is made to seal the ends. 1be cas- .

IOUrCCI. ing itself becomes radioactive during the neutron There are at least two definitions of sealed irradiation. A wipe test performed either on the IOUrces being promulgated. The US Nuclear ends of the sources or with sufficient vigor on the Regulatory Commission defines sealed source as central region of the source should result in some

- any byproduct material that is encased in a cap- detectable activity. The purpose of this work was sule designed to prevent lcalcage or escape of the to quantitate the amount of activity removed from byproduct material. 1 The National Council on different types of 192Ir sources under *conditions of both normal and destructive handling:

Address for Reprints: Daniel F. Grimm, MS, Department of Materials and Methods Radialion Oncolon, Medical College or Wiscon- Continuous sources of "2Ir arc available in both sfn/Milwaukcc County Medical Complex, 8700 West Wiscoo-ain Avenue. Milwaukee, WI 53226. wire and pin forms from at least two different sup-lteccived for Publication: May 20, 1987 pliers.* Pins can be obtained as either straight pins

.Aa:q,ccd for Publication: December 2, 1987 or hairpins. The physical characteristics of these Januayt918 ISSN 8756-1687 Copyright C 1988 17

.a

-...i.

Grimm&. Gillin Table 1. Physical Characteristics of lrldium-192 Sources Source Type Diameter, Inner (Core) Sheath mm Dlameter,mm Thickness, mm i

Thin wire Thick wire 0.3 o.s 0.1 0.3 0.1 0.1 f.

r Thick wire Hairpin 0.6 o.s 0.4 0.3 0.1 0.1 t

Straight pin o.s 0.3 0.1

.* . -*-s'

-* ,Ef ~-

f sources are shown in Table 1. In all cases the working surface was scanned for deposits of ac- . -. ~

~- .

o:

iridium core is encased in a 1-mm platinum- tivity. ~ might be expected, there was visible iridium sheath. damage to the sources after this procedure was Ordinary handling of the sources was ac- completed. -=~ ~£...

complished with standard 12-inch tweezers, short **-*_4-locking forceps, and a small scissors. Wipe tests Counting Procedure and Statistics *_ ;

were performed by vigorously scrubbing the wires P.ach wipe sample was loaded in a test tube and *_*:_ _-::=* _~ -~-

and tools with either cotton-tipped applicators or counted in an automatic scintillation well gauze strips soaked in ethyl alcohol. Particular at- counter. t W-mdow level settings of the counter tention was paid to the serrations on the tips of the were adjusted to include all energies from 100 to tweezers or forceps. 500 keV. 1bis range includes all the major gamma .. :~,-c ;;.

rays from 1'2Jr. Calibration of the well counter _* :._~>::*. t.

Handling Procedures was performed using a segment of a calibrated -*-~ "

The various sources were subjected to a series of 1'2Jr source. A calibration certificate for lhe

--*-* ~-

tests. The initial tests involved numerous routine source was obtained from the Laboratorie de -.. t<.} *r handling procedures. Tests progressed to routine Metrologit des Rayonnements lonisants. The total *;'J:i !

cutting activities. The final part of the test in- activity of the calibrated source had an uncertainty , J,[ ~

volved destructive handling of the sources by of +/-6.s1i. . ;. .--d. I vigorous scraping with the serrated edge of the To obtain a very low activity sample for inter- .~~ *~.::-

tweezers while the sources were held in a locked comparison, the mass of the calibrated source was *_:.tJ. f forceps. first measured on an analytical balance to obtain **s.4. _-::_

Wipe tests were performed for each sample after 1he specific activity. Then a small piece approx- ~:~ ~

removal from its shipping container. Each source imately 1_ mm in length was cut off ~d weigh_~* j j -~

was next picked up 20 times using the tweezers The relative~ was used to determine the activi- -~:~ t and then a wipe test of the tweezers was taken. ty of this small sample. The activity of this source . **.-=:~ * ""'.:-<"

Each _wire source was then inserted and pulled at the* start of our wipe tests was approximately .-:7,j** * ~

through a small plastic tube a total of five times 1000 Bq. 1bc uncertainty of the mass was on the *"*

and a wipe test of the tweezers was perfonned. In order of +/-71'. The overall uncertainty in the .- .:

addition, the plastic tube was also analyzed for source calibration was +/-9. 7 %, assuming relative- .. _ ~ :-.

contamination. The plastic tubes were the same ly constant lin_ear activity. . * . . * . .:-~ \:

ones that are used for implant procedures. The The uncertainty of the activity from the vanous * *_ ,;~

next set of tests involved cutting the sources with wipe samples was taken to be a function of the *:~ **

a scissors. Five separate cuts were performed, wipe sample counts and the background counts., _.. if wiping the cut ends of the wires and the scissors The uncertainty, in percent, was taken to be the >t*

blades individually after each cut. The final test in- quotient of the square root of the sum of the sam- ~::

volved grasping the sources wi~ locking forceps pie and background counts by the net counts. .-:f and sliding the tweezers alongthe source while ap- Because of the very low activities anticipated, <

plying pressure. Wipe tests were performed .on the counting was limited to a long preset time rather . -.~:

tweezers after every five scrapes until the source than a preset number of counts. By choosing a *_*.-

broke or until SO scrapes were performed. Finally, time long enough to allow the background to reach j

.the source and the forceps were test wiped. The approximately 1000 counts, we were still able _~i- '°.

-18 .,....., __ .....

~ .H ~

.,I"'"'...... _ ..., Dad. V~

j ~

~ ,_.

I Iridium Conwninatioa

. .!I..:....

Table 2. Wipe Test Results After Normal Handling Type of Source Removable Activity, Bq Source Source .,,. Tweezers After Container Itself _, Grasping 20 Tunes Wire (0.3 mm) 0 4 0

~- si-:.

w.** .

Wire (0.5 mm)

Hairpin 0

0 3

4 0

0 li

.t,'.

-~~-:~ .

~:-*

Straight pin 0 0 0 f ~- * ~ure removable activities as low as 3 Bq to an mm for the 0.3-mm diameter wire and 1.0 mm for

~ .. --~ uncertainty of less than _25 %* For this report, all 0.S-mm wire. For the purposes of this report,

'~!:: activities with an uncertainty of greater than 25% 14-cm lengths of both 0.3-mm and 0.5-mm wire t __ -~-:-~ve been reported as O Bq.

were loaded into and pulled through a plastic rube I

-_::_c:,

five separate times using tweezers and/or forceps.

- __-*~-:c~ :§;:* ~-

Results and Discussion After this procedure, the tubes and wipe tests of f*_*-,:*f :: -~!' ~ the tweezers, forceps, and wires were analyzed for lf.*

The goal of this work was to determine the contamination. Table 3 shows the results of these

.1::*: posS1l>ility of removing activity during handling of tests. The highest amount of removal activity was

-~.,.=- these nonsealed sources. The secondary goal was 28 Bq, which is well below the 185-Bq standard

.2f~- IO detennine the amount of activity present with (0.005 µCi) set by the NRC for sealed sources.'

I .i- .. deliberate destruction of the source. Thus, the first One advantage of the use of iridium wire or pins f ' .'.-.!- -* action was to* wipe test the sources and their pigs is the ability to cut the wire or pin so that it

__ - ** --*: - when the shipping packages were first opened. matches the clinically desired length. A 1t2Ir wire J.. *:_~- . "i:~ - These results, which are shown in Table 2, in- or pin can be cut using a regular scissors. For the t . *~ /~ dicate extremely low activity amounts in the next test, all four different sources were cut a total Ite- .-

-;. : : _* sources and no removable activity from the pigs.

."{-; Our normaJ procedure is to remove the sources of five times with a scissors while holding the source with a tweezers. After each cut, both

-,~? _ from the pig, place them in a calibrated well freshly cut ends of the wire and the scissor blades t_ ___ _:_ -~~ _- ionization chamber, and then into a storage pig. were wipe tested. These results are shown in Table t* ***-' ;--;.: *For the purposes of this report, we picked up each 4. The values show that nonnally a little con-t -.*-~ source a total of 20 times with a pair of tweezers tamination can be removed from either the cut

1 -- *- --:;-.

and then returned it to its pig. The tweezers and wire or the scissor blades. However, two of the 20

.: .~:J:.::;

the source were then wipe tested. There was no cuts resulted in considerably larger amounts of

~-; ".. detectable contamination removed from the contamination on the scissor blades. These values,

. 1~ ** tweezers or any source after this routine handling. 113 and 143 Bq, are still below the level set by the t* *. -~;. Wire sources arc generally placed into small NRC for sealed sources.

! -~*:* plastic tubes before being implanted into the pa- The final test performed on the sources was 1 tient. The internal diameter of the plastic tube deliberately destructive. One end of the source t depends on the diameter of the wire, being 0.35 was firmly grasped with a locking forceps. The l '"-~-

t :.~'>

i ---* :~:-: :-' .

t t

.,c,~:

. -* .* Table 3. Wipe Tests After Tube Loading I,. Source Removable Activity, Bq Forceps Tweezers Wire Tube Wire (0.3 mm) 10 28 6 13 Wire (0.5 mm) NIA 9 0 0

Jaauaay1988 19

Orimm & Gillin Table 4. Wipe Test Results After Cutting Five Times I

1-j Source Activity Removable Activity, Bq Wire Semon Tweezers Range of Average Range of Average At End of Activity Activity Activity Activity Cutting Wire (0.3 mm) 0-12 2 0-18 4 12

.j Wire (0.5 mm) 0-14 5 4-143 34 4 Hairpin 0-36 5 6-133 42 0 . -t.~

. . Straight pin 0-61 20 0 0 0 ----~

-~-,.

. ~.::11 **

source was then grasped tightly with tweezers near the forceps and pulled through the serrated teeth of cesium-137 and radium-226, and does not emit any gaseous decay products. .

.::~-- ~*

the tweezers. After five such pulls, the tweezers The largest amount of contamination found from * ** -::~- :

were wipe tested. Ten groups of five.pulls each all the tests was approximately 1500 Bq. Assum-

_*;*.:2i ;

were performed, unless the source fractured first, ing that this amount would be permanendy , _:~. ;-

which happened with the 0.5-mm wire. In addi- deposited in a patient during an implant, the rcsul- - . _;::::. --~

l ---- tion, the forceps and wire were wipe tested at the tant dose would be approximately .OS Gy. This . -~ )~ _* ~

I - * *.

end of the procedure. Results of these tests are dose is just a fraction of a percent of the dose * *_:*~'~ .-::;;

! shown in Table 5. Under these deliberately delivered during a normal therapeutic interstitial :~~: :;

destructive circumstances,_ it was possible to application. Thus, it bas no clinical signific:aru:c. .;1~----1 remove more activity than is allowed for a sealed IridimI; ~92 in the form of wires and p~ o!fers * :-;i*,_: _:~

i i .*

IIOUrce. many cluucal advantages. We have identified *.'.",.. ,: !

Samples of the work surface cover sheet were special tools for use of these sources, such as *.*_--:. :.~ :: ~-

l counted after the completion of testing for each source. The samples were simply cut and placed in tweezers, forceps, and wire cutters. We have at- ,*_:::~ fi.*

tempted to follow the routine safety measures of /~ .

I test tubes for cou~ting. The maximum activity found on the work surface was 66 Bq.

time, distance, and shielding when using these . _

sources. We routinely manipulate and cut sources .::il~- t

-~~iJ .* ;_

Despite the fact that 192Ir does not meet any to meet the clinical situation at hand. Given nor- *.:~:,. f definition of a sealed source, our results indicate maJ handling of such sources, this work indicates .* ;~~ _!

that for routine handling and cutting the removable contamination is less than that which is allowed for dJat both !he wmkcr and'!'" patient uc !'"-. from -.:* _;l unnecessary exposure owmg to contamination of *-;:~ ** :*

sealed sources, namely, 185 Bq. With destructive cutting and loading of the sources. Cleaning the -~-~ - --. i handling of the sou~, larger amounts of activity cutting device is a reasonable procedure to follow __;:~ -_:"~,,

can be removed. This is not unique. to H 2Ir after 1t2Jr sources have been cut. It is also prudent ,_.;.. - :.*

J sources, for all sources can be destroyed if given to routinely change the paper on the working sur- '....:,,.* -.--:-*.: . ~

inappropriate handling. In fact, 1t2Jr has the ob- face where this cutting is performed. However, *-:-"=* _* i.

vious advantage of being short-lived, relative to Ibis is Just good - practice. This worl< :_'

Table S. Wipe Tests After Destructive Handling by Scraping SO Times Source

Removable Activity, Bq :"I

_,r_:

Tweezers Forceps W"ue _

Range of Average At completion of scraping -~1~ . "l*

I' Activity Activity Wire (0.3 mm) 61-1521 495 17 1il 3

Wire (0.5 mm)36-547 265 8 264 -- __-=-.,*-. . -- -f-~

Hairpin 6-90 135 Straight pin 13-179 56 68 0

0 0 *: ~\ ,:_. f.

~~ **.,,. . *l 20 Endocurie, Hyperthenn, Oncol. Vol. 4 t~

> -~

Iridium Contamination l

indicates that it is not necessary to talce elaborate or expensive precautions in handling and manipulating this material.

I. Title JO, chapter -1;-Code or fedenl Regulations-Energy, pan 30.4(4).

- ~

Acknowledgments

2. Prwction Against Radiation from Brachytherapy Sources, l_ _ '!;..__.

Commissariat a l'Energie Atomique (available NCRP repon No. 40, 1972.

f -".: from CJS-US in the United States) and Amersham. 3. A Handbook or R.dioactivity Measurements Procedures, eel 2. NCRP repon No. 58, 198.5.

<.::-*_. t Packard Auto-Gamma ScintiJJation Spec- 4. Title JO, chapter J, Code or fcdenJ Regulations-Energy, I

. .-;.'" - uomcter model 5220. pen 3S.J4(bXS).

._:;_ - ~ -_:*,~---.' . .

- y~* ~ *.

j l.

- - ** C"' *

. ----- ---1"'~

-:-::* -~~-:-- .

.; -, ... -. .\>!'~~ .

~:~=~-m,.

~.r._ .... ..

-~ ~ _*.-_.-- .....-~-~-

f --~-:: -~~--

-_-_-~-:;-__ -_- __-:1,1way-. 1981 21

-

ML23156A155

Text

REFERENCE:

SUBJECT:

Enclosure:

Dear Dr. Tse:

Dear Mr. Klinger:

Dear Sir,

SUMMARY

Dear Mr. Lamastra,

Dear Hr. Collins:

Enclosures:

SUMMARY

REFERENCES:

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