ML20045A331
| ML20045A331 | |
| Person / Time | |
|---|---|
| Issue date: | 03/13/1991 |
| From: | Cline W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Glenn J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20045A321 | List: |
| References | |
| HPPOS-273, IEIN-90-058, IEIN-90-58, NUDOCS 9306100119 | |
| Download: ML20045A331 (8) | |
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UNITED STATES NUCLE AR REGULATORY COMMISSION R EGION 11 3
d; 101 MARIETTA STRE ET, N.W.
r ATLANTA, GEORGI A 30323 MAR 131991 MEMORANDUM FOR:
John E. Glenn, Chief Medical and Commercial Use Safety Branch, Office of Nuclear Material Safety and Safeguards FROM:
William E. Cline, Chief Nuclear Materials Safety and Safeguards Branch Division of Radiation Safety and Safeguards
SUBJECT:
TECHNICAL ASSISTANCE TO EVALUATE COMMENTS ON NRC INFORMATION NOTICE ON OPHTHALMIC APPLICATORS (N0: 90-58)
At the December 20, 1990, meeting of the Navy Radiation Safety Committee, the Comittee presented coments to the NRC on the subject information notice.
The comments are documents in the enclosed December 10, 1990 memorandum.
The comments suggest that there are contraindications in the published notice; and therefore, a corrected notice should be issued.
As discussed between you and Bruce Mallett on March 8,1991, we ask your technical assistance in reviewing the comments and providing a response to the Comi ttee.
If you have any questions, please contact Bruce Mallett or me.
s f het f
<t/
William E. Cline
Enclosure:
As stated cc w/ encl:
J. P. Stohr B. S. Mallett E. J. McApline C. M. Hosey 9306100119 M 0 PDR ORG PDR l
DEPARTMENT OF THE NAVY U[o~t NrN7
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10 December 1990
%{
3 MEMORANDUM From:
Bureau of Medicine and Surgery Representative, Navy Radiation Safety Committee To:
Executive Secretary, Navy Radiation Safety Committee Subj:
NRC INFORMATION NOTICE NO. 90-58:
IMPROPER HANDLING OF OPHTHALMIC STRONTIUM-90 BETA RADIATION APPLICATORS Ref:
(a) NRC Information Notice No. 90-58:
Improper Handling of Ophthalmic Strontium-90 Beta Radiation Applicators 1.
Reference (a) forwarded descriptions of improper handling techniques for Sr-90 eye applicators and recommends specific
" Rules for Safely Handling a Strontium-90 Eye Applicator".
While the Information Notice may be well intended,.it recommends medical practice that is contraindicated and if followed has a significant risk of serious harm to a patient.
In addition, the Notice contains workload and dose estimates that are not very realistic and exaggerate the risk associated with these devices.
2.
The following comments are germane to reference (a):
a.
NRC " Rule" Number 5.
during treatment, hold the patient's eye lids open with tape or other device, not with your fingers.
Comment:
The use of tape is contraindicated.
Tapes capable of controlling the blink reflex must have a very sticky adhesive because of the strength of the blink reflex and the sweaty surface of the eyelid.
Removal of the tape at the conclusion of the treatment posses the risk of tearing the eye lid.
At the very least, it will pull the eye lashes out of the eye lid.
If the adhesive should co' act the eye during application, it will result in a corneal tec;.
If part of the adhesive should pull l
away from the cloth backing of the tape during removal from the patient then the physician has a difficult problem.
He cannot use solvents or scrub the eyelid because of the tender nature of the freshly operated eye.
k b.
Case 2 states that a physician holding the eye lids open with his fingers and providing approximately 50 treatments per quarter, or 4 treatments per week would exceed the quarterly extremity exposure limit.
j Comment:
Four treatments per week is not a realistic workload estimate.
For example, the National Naval Medical Center, the east coast referral center, performs approximately 7 cases per year; Naval Hospital Portsmouth hasn't performed any
Subj:
NRC INFORMATION NOTICE No. 90-58:
IHPROPER HANDLING OF OPHTHALMIC STRONTIUM-90 BETA RADIATION APPLICATORS cases in the past year:
Naval Hospital Oakland hasn't performed any cases in the past two years; Naval Hospital Great Lakes has performed 2 cases in three years.
Naval Hospital San Diego, the referral center for the West Coast and the Pacific performs about 17 cases per year or about 5-6 cases per physician.
The civilian workload is similar; for example, the busiest center in Tampa, Florida, (250,000 population, southern latitude, older population) performs only 6 cases per year.
c.
The discussion section states that contact with the i
source tip of the applicator could result in a radiation dose in excess of NRC limits.
s Comment:
The NRC limits are for the hands, or skin of the whole body.
The radiation field from a strontium-90 applicator is highly localized.
Contact with the source tip would more closely approach a " hot particle" type exposure for which there is no limit, than an extremity exposure.
Extremity exposure limits are based on the risk of developing some untoward effect from exposure to a surface area as large as the hands.
To reduce the surface area and maintain the same numerical limit is an excursion from the intent and basis of the standard.
d.
The NRC " Rules" require the wearing of personnel dosimeters and finger rings whenever handling the Sr-90 applicator.
Comment:
Naval Hospital San Diego has approximately five years experience of wearing dosimeters shile performing Sr-90 eye applications.
Whole body exposures are typically zero.
Finger ring exposures are typically 5 mrem per treatment or 15 mrem per case.
Neither whole body or extremity exposures approach ten percent of the NRC limits, i.e.,
exposure levels which require the wearing of dosimetry.
The sterilization procedures are not consistent with the e.
recommendations of the Center for Disease control (CDC).
Comment:
This type of instrument should meet the Center for Disease Control's (CDC) recommendations for "High Level Disinfection".
Hepatitis B and HIV viral transmission are the pathogens of concern.
The radiation from the source should be adequate to sterilize or destroy any bacteria on the tip of the applicator.
Mechanical cleaning with an enzymatic detergent followed by a 10 minute soak in a 70 percent ethanol solution should provido adequate disinfection for Hepatitis B per CDC's recommendations.
Using a 35 percent ethanol soak is adequate for HIV.
The tip should be washed with normal saline after sterilization to prevent transferring ethanol into the eye.
2
/
Subj:
NRC INFORMATION NOTICE NO. 90-58:
IM %OPER HANDLING OF OPHTHALMIC STRONTIUM-90 BETA RADIATIOb APPLICATORS f.
The Notice does not discuss corrosion resulting from using chlorinated cleaning compounds.
Some institutions bathe the tip of the applicator in chlorox or other chlorine compounds to prevent transfer of the HIV virus.
The National Institute of Standards and Technology indicate they now see more corrosion of the silver plating on the tip of the applicator than in the past.
This is possibly due to chorine interactions.
This is of concern because of the potential for loosing the integrity of the source and the corroded surface scratching the cornea.
Chlorine based compounds should be avoided because they attack the silver cladding.
g.
The Notice does not discuss the calibration of the applicator.
The National Institute of Standards and Technology has refined their calibration techniques for these applicators.
The nominal calibrated output may change by as much as 15-30 per cent less (60 rads /see today compared to a nominal of 80 rads /sec last year) for the same source strength upon recalibration.
Treatment protocols were developed with the old calibration procedures.
The prescribed dose, nominally 800 rads by three fractions, will need to be changed to 600 rads by three fractions to compensate for this change.
There is no discussion of the calibration change or whether this means previous treatments have been misadministrations or if future treatments using the old prescription protocol but the new calibration data will be a misadministration.
h.
The Notice fails to note or mention that these sources have been in use for approximately the past 70 years without any reported injury to the users.
What is it now that makes the past many years' common practice improper?
3.
I do not believe the NRC Information Notice was well researched or received proper review.
The recommendation to use tape near the eye is certainly the wrong thing to do and may result in a serious injury to the patient.
(The NCRP has clearly recommended against using tape near the eye.)
The sterilization procedures are likewise incorrect.
I am concerned that this Information Notice will become the basis for future inspection emphasis and\\or approval criteria for license applications and amendments.
The Notice recommends bad practice and overstates the hazard represented by the Sr-90 eye applicators.
In addition, the Committee mailed the Notice to our Permittees.
The Permittees may modify their local procedures to match the procedures in the Notice, degradating our medical care.
3
Subj:
NRC INFORMATION NOTICE NO. 90-58:
IMPROPER MANDLING OF OPHTHAlliIC STRONTIUM-90 BETA RADIATION APPLICATORS 4.
Please take appropriate action to bring the Notice's shortcomings to the attention of our Permitees and the NRC.
If you have any questions, I may be reached on 202-653-1182.
JJ. Alv D. GEORGE CAPT, MSC, USN 4
1
SUMMARY
OF NAVY COMMENTS CONCERNING IN 90-58 The following summary reflects our response to the Navy's comments concerning IN 90-58, Improper Handling of Ophthalmic Strontium-90.
Beta Radiation Applicators.
The Navy feels, among other things, that the IN recommends medical practice that is contraindicated and if followed has a significant risk of serious harm to a patient.
The NRC provided the IN following several incidents involving improper handling of the SR-90 applicators and all recommendations for proper handling are based on either manufacturer's instructions or previous "NRC Rules for Safely Handling a SR-90 Eye Applicator".
Comment 2a: Issue of holding the eye open with tape during procedure.
This information was originally submitted by RII in draft.
Our recommendation was based on the following:
1.
Documented by copy of "NRC Rules for Safely Handling a SR-90 Eye Applicator".
2.
NCRP Recommendations There is actually no manufacturer information on the use of tape; only a mention that there is a need to distance the hand from the source with the use of a plastic shield.
Comment 2b: Number of treatments per year vs use of fingertips.
The IN stated that a
physician providing approximately 50 treatments per quarter or 4 treatments per week would exceed the quarterly extremity dose limit of 18.75 rem if the physician handled a typical 100 mci eye applicator with his fingertips.
According to Captain George, this statement is based on an unrealistic workload estimate.
The Navy gave 5 examples of Naval facilities which perform procedures with the eye applicator.
The greatest number of cases handled at any one facility is documented 17 per year or 5-6 cases per physician.
The civilian workload, according to Capt. George, is similar and he goes on to state that the busiest center in Tampa, Florida performs only 6 cases per year.
In a conversation with John Pelchat, RII, it was disclosed that there is no actual research to support these numbers, but that a credible physician passed this information to Capt. George who then uses it to support his argument.
Comment 2c:
Interpretation of " extremity" limits Navy states that the IN statement concerning contact with the
source tip of the applicator resulting in a radiation dose in excess of NRC limits is not consistent with the highly localized radiation field emitted from the source.
NRC
Reference:
NRC Part 20 50 rem / year external or skin exposure 12.5 rem / quarter comment:
Rules requiring personnel monitors According to Capt. George, based on the Navy's experience, no film badges or extremity rings are needed because neither whole body or extremity exposures approach 10% of the NRC limits.
NRC recommends that licensees use personnel monitors until such time that the licensee can document that no individual will exceed 25% of NRC limits (Part 20).
This information is critical for new users, not, perhaps, for experienced users.
Question:
Is the Navy corresponding with ALARA ("..
10% of NRC limits")?
I believe the above comments (2a-2d) and " supporting numbers" quoted by the Navy are an attempt to negate the NRC request / suggestion that certain procedures with respect to methodology and personnel monitoring be incorporated because they are not common practices of the Navy.
(This is not an entity /organisation prone to change or receiving instruction from
" outsiders").
The suggestions in the IN concerning the above comments are t '. thin the scope of the NRC's policy for ensuring safe handling and minimal exposures.
Comment 2e:
sterilising agents t
Navy's concerns are from the perspective of disease control as recommended by the Center for Disease Control (CDC).
NRC is not approaching this issue from the same perspective.
The NRC has based its suggestions for disinfection on the manufacturers i
instructions.
This does not invalidate or minimise the Navy's l
concerns or methods for disinfecting the applicator.
Perhaps the NRC could provide some future documentation on current cleaning procedures that incorporate the perspective of disease control, given its relevance and significance.
Comment 2f:
Corrosion The Navy states that the IN fails to address the issue of corrosion resulting from the use of chlorinated cleaning compounds in order 1
to prevent transfer of the HIV virus.
They " support" this comment with a statement from the NIST re:
the number of corroded applicators due to chlorinated agents used for cleaning.
NRC cannot respond to this statement without being certain of the NIST position and obse rvations.
The silver plating on the applicator tip may be destroyed as a result of such cleaning methods.
This may be information that could be useful.
Perhaps if we provide some information on cleaning / sterilization practices this type of information would be relevant.
Comment 2g:
Calibration The Navy comments that the NRC failed to discuss calibration of the applicator.
The scope of the IN: Safe Handling.
Comment 2h:
Seventy years of use without incident The Navy comments that these applicators have been used for the past 70 years without any reported injury to the users.
Recent events encountered by inspectors (as discussed in the cases) warranted a reminder to licensees.
e
UNITED STATES NUCLEAR REGULATORY CCMMISSION OFFICE OF NUCLEAR SAFETY Af:0 SAFEGUARDS WASHINGTON, D.C.
20555 September 11, 1990 NRC INFORMAT!0N NOT'.CE NO. 90-58:
IMPROPER MANDLING 0F OPHTHALMIC STRONTIUM-9^
BETA PADIATION APPLICATORS A'cressees:
All Nuclear Regulatory Commission (NRC) medical licensees.
Purpose:
This notice is intended to inform users of strontium-90 (Sr-90) eye applicaters of improper handling practices that resulted in unnecessary radiation exposures to the skin.
This notice also serves to remind licensees of the importance of handling devices in accordance with manufacturers' instructions.
It is expected that licensees will review this information for applicability to their own procedures for Sr-90 eye applicator use, distribute this noticc to those responsible for radiation safety and to users of the Sr-90 eye applicator, and consider actions, if appropriate, to preclude similar situations from occurring at their facilities.
However, suggestions contained in this notice de not constitute any new NRC requirements, and no written response is required.
Description of Circumstances:
The following cases illustrate improper handling techniques for Sr-90 eye applicators:
Case 1:
A physiciar sterilized the treatment end of a Sr-90 eye applicator, on six separate occasions, by touching its surface with alcohol swabs held in his fingers. The cumulative dose associated with this technique was estimated to be 50 rem to the fingertip; this is well in excess of the extremity dose limit of 18.75 rem per quarter.
Case 2:
For years, a physician treated patients by opening the eyelids with his bare fingers and positioning the applicator.
By handling a typical 100-rillicurie eye applicator in this fashion, the dose to the fingers per treatment has been estimated to be 0.4 rem. A physician practicing under these circumstances would exceed the quarterly extremity cose limit of 18.75 rem by providing approximately 50 treatments per quarter, or 4 treatments per week.
Case 3:
During routine inspection at a licensee's facility, the physician i
was asked to show his eye applicator to the inspecter.
The physician I
retrievec the applicator from its secured storage location and pointed it j
directly at the inspector, who was standing approximately 18 inches away 1
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The radiat4cn fiele t er from the unshicided source tip of the applicator.
Tc avo'c the applicator, 18 inches away, was approxinately 13 rad per hour.
unnecessary exposure, the applicator shoulc always be shielded or printec away fron individuals, except during actual treatrrent.
Discussion:
i All licensees are reminded of the impcrtance of ensuring the safe perforrance of licensed activities ir cccordance with NRC regulations and the recuircrents Eye applicators are desigred to deliver intense ccses of of their licenses.
The sealed beta radiation for the treatment of superficial eye diseases.
source mounted on the tip of each applicator has a nominal activity of approximately 100 millicuries of strontium and yttrium-90 in equilibrium, anc delivers a contact dose rate on the order of 60 rad per second.
The NRC dose limits for extremities (hands, forearms, feet, and ankles) and skin of the whole body are 18.75 rem and 7.5 rem per quarter, respectively.
Contact between the source tip of the epplicator and the skin cculd result Repetitive activities quickly in a radiation dose in excess of NRC limits.
such as tip sterilization or positioning the applicator for treatment, when performed with bare hands and in close proxinity to the tip of the applicator, over a period of several seconds per event, may result in radiation doses in excess of NRC limits.
Therefore, compliance with hRC license ecmmitments and manufacturers' handling instructions are important in maintaining exposure levels as low as reasorably achievable.
The cases described above illustrate an incornplete understanding of proper handling procedures and the skin exposures that could occur from imprcper NRC regulations recuire that users of eye applicators evaluate handling.
potential safety hazards, ensure safe operations at their facilities, anc follow manufacturers' and NRC's safe handlirg instructions, described below:
Typical Manuf acturer's safe handling instructions:
Sterilize the applicator by either:
(a) immersing the applicator in 1.
alcohol in a shielded container, or (b) placing a cotton swab, sponge, or gauze, dampened with a sterili:ing agent, en a flat surface and wiping the treatment end of the applicetor across the swab, sponge, or gauze, instead of holding it with the finger.
The applicator should only be held by its shielded handle, at all 2.
The beta shield should be positioned as close to the source times.
as possible, during treatment, to minimize exposure to the user.
The active face of the applicator must not be viewed directly, 3.
but only through the shield provided, or equivalent protectiun.
Never point the unshielded treatment end of the applicator toward 4.
any individual, especially toward the eyes, except during patient treatment.
IN 9C-58 September 11, 1990 Fage 3 of a 5.
Use manufacturer-supplied handlirg tongs for the placement and removal rf beam collimating masks on the applicator tip.
The collurator ma sks should be fitted and rereved with the source facing away from the user.
6.
Always minirnze the tire that the applicator is cut of the shielded storage container.
The storage case should be locked and secured, to prohibit unauthorized access to the applicator.
7.
In the event of apparent or probable damage to the scurce. it shoulo immediately be placed into the stcrage case.
The storage case should be wrapped or placed into a plastic bag and secured.
The Radiation Safety Officer should be notified for consultation and action.
In addition to following the manufacturer's handling instructions, licenseee are required to submit rules for safe handling of Sr-90 eye applicators at the time of license application, amendment, or renewal.
Licensees may submit a copy of their own rules for safe handling, or NRC's " Rules for Safely Handling a Strontion-90 Eye Applicator," as described in "Information to be Submitted When Requesting Possession and Use of Sr-90 as Ophthalmic Applicator," dated fiarch 1982, and listed below:
PIRC's " Rules for Safely Handling a Strontium-90 Eye Applicator":
- 1.
Wear your personnel dosimeter (s) whenever you handle the Sr-90 eye applicator.
Finger ring-type dosimeters should be worn with the detector on the palm side of the hand.
2.
Remove the Sr-90 eye applicator from its secured storage location just before use.
Do not leave it out any longer than necessary.
3.
After removing the Sr-90 eye applicator from its secured storage location:
a.
Do not touch the treatment end of the applicator with your hands or other portion of your body, b.
Always hold the applicator by its handle, and c.
Except during patient treatment, do not point the treatment end of the applicator toward another person, especially toward the eyes.
4.
If the applicator is to be sterilized, place on a flat surface, use a cotton swab, sponge, or gauze dampe % with a sterilizing agent, then wipe the treatment end of the applicator across the swab. sponge, or gauze. Do not sterilize by holding the swab or gauze in your hand.
- lt is strongly recommended that Thermoluminescent Dosimeter (TLD) ring or film type badges be worn when handling a Sr-90 eye applicator.
P
IN 90-EE
<eptember 11, :99C Page a of a 4
During treatment, hold the patient's eye lids open with tape or other 5.
device, not with your fingers.
Immediately af ter treatrent and/or resterilization, return the Sr-9C 6.
eye applicator to its storage container and to its secured location (e.g., locked cabinet).
7.
Do not remove any metal or plastic inserts from the manufacturer-supplied storage container. These items are generally a part of the container's shielding.
Removal of these items can lead to excessive and unnecessary radiation exposures.
No written response is required by this information notice.
If you have any questions about this matter, please contact the appropriate regional office or this office.
f
$$w~ yk Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical contact: Janet R. Schlueter, HMSS (301) 492-0633 Hector Bermudez, Region II (404) 331-7880 Attachments:
1.
List of Recently issued NMSS Information Notices 2.
List of Recently Issued NRC Information Notices