ML20127J456

Discusses to Jn Grace Re IE Info Notice 85-01, Continuous Supervision of Irradiators. Consequences of Incident Involving Radiopharm Could Far Outweigh Cost of Trained Supervisor Attendance During Irradiator Operation

ML20127J456
Person / Time
Issue date:	03/19/1985
From:	Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Dietz G ISOMEDIX, INC.
Shared Package
ML20127J422	List: ML20127J456 ML20127J486
References
IEIN-85-001, IEIN-85-1, NUDOCS 8505210473
Download: ML20127J456 (7)

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Pn ATTACHMENT A P.AR 191385 s

!*r. G:arga R. Dietz Extcutive Vice President Isc::ifx Inc. ' ~

11 /p:llo trive L'hippi.ny, l:w Jcrsey 07931 l

Daar fir. Dietz: .

This refers to your letter d:tod Fchruary 28, 1935, to Mr. J. .'icl:en ~

Crace con:erning IE Inforcation f otice No. 85-01; Continuous Supervision-cf Irradiators.

Regardless of the design of lcrge irradiators which contain tegacuries of radicactive material, there is r.a system, imaver redundant, which cannot fail. If an event cccurred r.hich could affect pablic h2alth and safety, th2re n?.>Js to b2 an 1.icliviisal present H:3 cr.n take progt action

. s:ithout tha n:cd for ' calling ot! ar p;rcons. As discussed in tha inforta-tion natice, this is tha intant of 10 CFR Sectian 20.203(c)(6)(iii). We do not agree that an auteuted talcp!rane lina or rquiring sceurity p::sonnel to call ses:n2 in the event of an abnai. 211ty substitutes id3g:tely for the physical preser,:e of a person t::.o etn tale prcept cnd appropriate action.

It has alr ys been our intent + hat an irradiator under Nuclect Rc;ulatory Cc=fssion's (NP.C) jurisdiction should have trained supervisors on the pec ;ises when the irradiator is in cperation. The info m tion r.otice did rot establish ne.f policy, but t: rely restated existing policy.

This c.itter is also discussed in the enclosed draft regulatcry guida.

You c:y wish to prcYide forcal co:t: Tits On th? $0id2.

l The use of r.:gcurie e,"tutitics of r:dic :tive tetcrial dict.tes that ra act in a p.ud at ard cans:.rvttive i: r.wr. Tha consequ2nces of an incidant f involving tha radioactive tatarial cculd hsya a profound effect, ard the cost of an incident could far outr:2fgh the cost of attendance of a trained l supervisar schile an irradiator is in operation.

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TAR 10 E25 George R. Dictz /

If you wish to discuss this tatter further, please contact Mr. Var.dy L. '

• I ' tillier, Chief, lhterial Licensing Branch, on (301) 427-4002 to set up a.rdtually convenient time for a toeting.

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f origina'. 51rned'"Y Ip p.R.Ch rell j Riclard E. Cunnin'hrn. Director Divis*0n of Tcal Cicle and ihtcrial S-fety

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ATTACHMENT B flMSS r/f JHickey VLHiller PVacca HEHORAHDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety FROM: Vandy L. Miller, Chief Material Licensing Branch Division of Fuel Cycle and Material Safety

SUBJECT:

LEAKING 3M I-125 SEEDS This memorandum closes out our review of several reports of leaking iodine-125 seeds manufactured by 3M Company (See Enclosure 1. MemoranducP.

to Mr. Davis dated June 30,1982). As discussed in Enclosure 2, we have concluded that the primary cause of these incidents was rough handling by medical licensees as opposed to manufacturer's defects.

The only additional action we recomend is for 3M to improve the instructions to licensees who receive the iodine seeds. The 3M distribution license Ho. 22-00057-59MD is currently being renewed, and the instructions can be improved as part of the renewal.

We have discussed the case with FDA. They performed an independent inspection in 1981, and are satisfied that the seeds are being manufactured properly. FDA does not plan any further action. No leakage incidents were reported in 1982 or 1983. If 3M agrees to improve its instructions to users as part of its license renewal, we will consider this case closed (unless additional incidents occur).

Original Signed By VANDY L. MILLER Vandy L. Miller, Chief

- Material Licensing Branch Division of Fuel Cycle and Material Safety

Enclosures:

1. Memorandum to Mr. Davis dated June 30, 1982

2. - Supplemental Evaluation of*

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ENCLOSURE 1 ..

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WASHINGTON. D. C. 20535

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- MEMORA"DUM FOR: John G. Davis, Director Office of Nuclear "aterial Safety and Safeguards FROM: Richard E. Cunningham, Director Division of Fuel Cycle and.

Material Safety Office c,f Nuclear Material Safety and Safeguards

SUBJECT:

AE00 REVIEll 0F 10 DINE-125 SOURCE LEAKAGE INCIDENTS We have reviewed the AE00 report enclosed with Mr. Michelson's memorandum dated May 25, 1982, discussing iodine-125 sealed source leakage incidents.

As discussed in the AE00 report, NMSS wrote to 3M in July,1981 concerning the leakage incidents, and u- a result 3M added a warning notice for users of the . iodine-125 seeds. To our knowledge, no incidents have been identified since the warning notice was added. H,owever, it is entirely possible that incidents have occurred, but were not recognized by the licensees. In any case, we still consider this to be an unresolved problem.

Our preliminary evaluation is as follows:

1. The iodine-125 seeds are inherently fragile, and the leaks were probably caused by rough handling. However, we have not ruled out the possibility that a manufacturing defect is involved.

We agree with AE00 that the test data provided by 3M is not con-clusive.

2. The seeds may need to be inherently fragile, in order to be medically effective. Therefore, if 3M is required to make the seeds stronger, the medical effectiveness could be reduced.

3. A leaking seed can deliver a dose of up to 100 rads to the cancer patient's thyroid. This potential risk must be balanced against the medical benefit of the cancer therapy. Tnere is also the risk of laboratory contamination prior to implantation of the seeds.

4. For perspective, a diagnostic thyroid scan using I-131 delivers 65 to 90 rads to the thyroid. Treatment of hyperthyroidism involves doses .in excess of 1000 rads to the thyroid. -

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s JUN 3 0 i332 In order to resolve these issues, we plan to take the following actions:

1. As recommended by AE0D, we will coordinate with IE to develop .

a supplemental information notice for medical licensees.

2. We will inform 3M of our preliminary evaluation, and request sup-plemental information and comments as to their evaluation of the problem. '

3. As suggested by AE00, we will obtain a medical consultent to assist in our independent evaluation. Dr. Peter Almond of the Anderson Hospital and Tumor Institute has informed us that he is available to provide this assistance. Dr. Almond is presently under contract to NRC as a consultant in medical physics.

4. After obtaining appropriate information and recorreendations, we will complete our risk / benefit analysis, and identify what requirements, if any, should be imposed upon 3M and/or medical licensees.

We anticipate that the IE information notice will be sent to licensees within 30 days, and that input can be obtained from 3M and our consultant within 60-90 days. Within 30 days thereafter, we should be able to identify the requirements which should be impos'ed, if any. However, this schedule depends on our ability to use Dr. Almond within current limits placed on " full' tire equivalents".

./ $ p, Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety

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EilCLOSURE 2 SUPPLEllEtiTAL EVALUTI0'l 0F LEAKIllG 10DIrlE SEEDS

Contact:

John flickey, N!4SS FTS 427-4093 Decenber 13, 1933 BACKGR0tRID U During 1980 and 1981, several incidents occurred where cancer therapy seeds ,

containing iodine-125 leaked, resulting in exposures of up to tens of rads '

to the patients' thyroids.

An IE Information !!otice was issued on October 10, 1980. Ilevertheless, additional incidents occurred in July,1981, and 3'1 added a stronger warning notice to the seeds. AE0D identified the incidents as a potential generic problem in May,1982. IlMSS worked with IE to issue a second Infomation Ilotice in October,1982.

ilMSS retained a medical physics consultant to review the case, and his report was completed in January,1983. tiMSS Visited 3M with Region III in Augus t,1983. We have also discussed the case with FDA, who reviewed the problem and inspected 3M in February,1931. FDA did not identify any manu-facturing problems.

tio leakage incidents for todine-125 seeds were reported in 1982 or 1983.

DISCUSSI0i1 The results of our follow-up actions are:'

1. The FDA inspection in February,1981 did not identify any problems related to the incidents. Subsequent discussions with FDA indicate that they do not plan any further-regulatory action.

2. Our medical physics consultant, Dr. Peter Almond of M.D. Anderson llospital and Tumor Institute, concluded that the problem lies more with the users of the seeds than with the supplier. lie raises the question as to whether the applicator used to insert the seeds into patients is at fault. lie also recomends that patient bioassay be considered if difficulties are encountered during implantation.

3. We talked to Felix Mick of flew York, who supplies an applicator conmonly used with the iodine seeds. lie acknowledged that the old-style Mick applicator could jam if not tightly assembled, and he has modified the design to eliminate this problem. All of his customers have been notified in writing of availability of the new design. We conclude that both devices are adequate if properly used, and no furthee-acMon-is-necessary.

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4. We discussed the case with Sti, and Dr. William Walker accompanied Region III on an inspection in August,1983. They concluded that the seeds are being manufactured properly, and that no further regulatory action is necessary. .

C0HCLUSI0tl The seeds are being properly manufactured and should not leak or rupture if nornal care in handling is exercised. However, the instructions to users can be improved to emphasize the need to avoid rough handling. j RECGMMENDATION i .

As part of renewal of 3M license number 22-00057-59MD, 3M should be requested tosimprove instructions to users as follows:

1. Add a statement to the instructions, stating that patient bioassqy and

^ thyroid blocking procedures should be considered in cases where difficulties are encountered in implants, or where surgery is performed in the implant area within 120 dqys after seeds are implanted.

2. Modify warning to read as follows: Do not force iodine-125 seeds into or out of any implant tube, needle or cartridge. Do not exert excess forcep pressure or other crushing force. Such rough handling mAy damage seeds and cause release of iodine-125 into body fluids if the seed is implanted. If a seed is damaged in any way, discard it inr.ediately to radioactive waste and check the area for radioactive contamination. Never_ implant a damaDed seed.

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