Information Notice No. 94-17: Strontium-90 Eye Applicators: Submission of Quality Management Plan (Qmp), Calibration, and Use

UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C.  20555

March 11, 1994


NRC INFORMATION NOTICE 94-17:  STRONTIUM-90 EYE APPLICATORS:
                          SUBMISSION OF QUALITY MANAGEMENT
                     PLAN (QMP), CALIBRATION, AND USE


Addressees

All U.S. Nuclear Regulatory Commission Medical Use Licensees.

Purpose

The NRC is issuing this Information Notice to remind licensees authorized to
possess Sr-90 for authorized uses described in 10 CFR 35.400(e) of the need
to: (1) implement and submit a quality management plan (QMP) that includes
policies and procedures to meet the requirements described in 10 CFR 35.32;
and (2) inform all licensees of recent information regarding the use and
calibration of Sr-90 eye applicators.

Description of Circumstances

There has been confusion as to the need for a QMP for Sr-90 eye applicators
used for patient treatment procedures.  The NRC's Office of the General
Counsel advised the technical staff that because the QM program requirements
in 10 CFR 35.32 apply to "any brachytherapy dose," the use of Sr-90 eye
applicators, as described in 10 CFR 35.400(e), requires submission of a QMP.
This Information Notice reminds Sr-90 eye applicator licensees of the
requirement to submit and implement a QMP that meets the requirements of 10
CFR 35.32.

Additionally, this letter alerts licensees to possible discrepancies
associated with the calibration of Sr-90 eye applicators and reminds licensees
of the regulatory requirements associated with their calibration and use.

Discussion

Submission of a Quality Management Plan

If you are licensed for and using a Sr-90 eye applicator, the NRC's
regulations require you to submit a QMP that meets the requirements of 10 CFR
35.32.  The QMP should provide high confidence that radiation from the Sr-90
eye applicator will be administered as directed by the authorized user.  The
submitted QMP should include written policies and procedures that meet the
five objectives, as described in 10 CFR 35.32(a):



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1.That prior to administration, a written directive, signed and dated
by an authorized user, is prepared for each applicable
administration.

(A written directive for Sr-90 eye-applicators means an order, in
writing, for a specific patient, dated and signed by an authorized
user prior to administration of radiation.  It must include the
radioisotope, the treatment site, source strength (corrected for
decay), and exposure time (or equivalently, the total dose).

2.That prior to each administration, the patient is identified by more
than one method as the individual named in the written directive.

3.That final plans of treatment and related calculations are in
accordance with the respective written directive.

4.That each administration is in accordance with the written
directive.

5.That any unintended deviation from the written directive is
identified and evaluated, and appropriate action taken.

Additionally, to meet the requirements of 10 CFR 35.32(b), you need policies
and procedures for conducting a review of the QMP to verify compliance of all
aspects of the program at intervals no greater than 12 months.  The review is
to include a representative sample of patient administrations, all recordable
events and all misadministrations, and any corrective actions taken.

Licensees may make modifications to their QMPs to increase the program's
efficiency provided the program's effectiveness is not decreased.
10 CFR 35.32(e) requires licensees to submit modifications to their QMP to the
appropriate NRC regional office within 30 days after the modification has been
made.

If you are licensed for a Sr-90 eye applicator, but are not, or do not intend
to use it, you may submit a "negative declaration" in lieu of a QMP.  This
written declaration must commit to your submission of a QMP to NRC prior to
use of the Sr-90 eye applicator for patient treatment procedures.



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Calibration and Use of Strontium-90 Eye applicators

The NRC staff has had discussions with and received correspondence from
researchers at the National Institute of Standards and Technology (NIST) about
large discrepancies among calibrated outputs assigned to Sr-90 eye
applicators.  The manufacturer's original calibrations may have been in units
that are no longer used or have little relationship to System Internationale
units in use today.  Further, comparisons between units from different
manufacturers may be meaningless and misleading.  Finally, discrepancies
larger than 10 percent still exist when comparing output measurements between
competent measurement labs using state-of-the-art techniques.

The above information was provided to NRC's Advisory Committee on Medical Uses
of Isotopes (ACMUI) at its November 1 and 2, 1993, meeting.  The ACMUI members
advised the staff that calibration was not a critical factor in the use of
Sr-90 eye applicators for treating pterygium because licensees treat for
response rather than to tolerance.  The ACMUI recommended that NRC inform
licensees of the potential problems associated with calibration of Sr-90 eye
applicators.  The Committee also recommended cautioning licensees that if they
use an applicator, other than the one currently in their possession or buy a
new one, their current technique may not be applicable to another device
because of variances in stated and actual exposure rates for the different
applicators.

NIST offers a service for the calibration of Sr-90 eye applicators that
provides: (1) the calculation of the emission rate, and (2) a mapping of the
Sr-90 distribution across the face of the applicator in order to ascertain
uniformity of dose.  For further information on the NIST calibration service,
contact either Dr. Christopher Soares at (301) 975-5589 or Dr. Bert Coursey at
(301) 975-5584.  Although NIST is, to the best of the staff's knowledge, the
only provider of such a service, there may be others.  NRC is not requiring
that licensees participate in the NIST program, and accepts calculations of
exposure time based on the original vendor's calibration, corrected for
radioactive decay.

Since 10 CFR 35.400(e) identifies the Sr-90 eye applicator as a brachytherapy
device, licensees are reminded that 10 CFR 35.59, "Requirements for possession
of sealed sources and brachytherapy sources," does apply to Sr-90 eye
applicators.  Specifically, licensees must perform applicable leak tests and
surveys described in 10 CFR 35.59.  Additionally, 10 CFR 35.400(e) limits the
use of Sr-90 eye applicators to "treatment of superficial eye conditions."
Licensees are reminded that NRC authorization for use of a Sr-90 eye
applicator for patient procedures does not authorize its use on treatment
sites other than the eye.

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This Information Notice requires no specific action or written response.  If
you have questions about the information in this notice, please contact the
appropriate technical contact listed below.

/S/'D  by Carl J. Paperiello


                    Carl J. Paperiello, Director
                    Division of Industrial and
                      Medical Nuclear Safety
                    Office of Nuclear Material Safety
                      and Safeguards

Technical contacts:  Jim Dwyer, RI                Jacqueline Burks, RIV
               (215) 337-5309                (817) 860-8132

               John Pelchat, RII            James Montgomery, RV
                   (404) 331-5083                (510) 975-0249

               Cassandra Frazier, RIII      Sally L. Merchant, NMSS
                   (708) 790-5704                (301) 504-2637

Attachments:
1.  List of Recently Issued NMSS Information Notices
2.  List of Recently Issued NRC Information Notices