View source for Information Notice 1999-24, Broad-Scope Licensees' Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices

{{Adams
| number = ML031040396
| issue date = 07/12/1999
| title = Broad-Scope Licensees' Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices
| author name = Cool D
| author affiliation = NRC/NMSS/IMNS
| addressee name = 
| addressee affiliation = 
| docket = 05000003, 05000010, 05000029, 05000133, 05000155, 05000171, 05000206, 05000213, 05000219, 05000220, 05000237, 05000244, 05000245, 05000247, 05000249, 05000250, 05000251, 05000254, 05000255, 05000259, 05000260, 05000261, 05000263, 05000265, 05000266, 05000267, 05000269, 05000270, 05000271, 05000272, 05000275, 05000277, 05000278, 05000280, 05000281, 05000282, 05000285, 05000286, 05000287, 05000289, 05000293, 05000295, 05000296, 05000298, 05000301, 05000302, 05000304, 05000305, 05000306, 05000309, 05000311, 05000312, 05000313, 05000315, 05000316, 05000317, 05000318, 05000320, 05000321, 05000322, 05000323, 05000324, 05000325, 05000327, 05000328, 05000329, 05000330, 05000331, 05000333, 05000334, 05000335, 05000336, 05000338, 05000339, 05000341, 05000344, 05000346, 05000348, 05000352, 05000353, 05000354, 05000361, 05000362, 05000364, 05000366, 05000368, 05000369, 05000370, 05000373, 05000374, 05000382, 05000387, 05000388, 05000389, 05000390, 05000391, 05000395, 05000397, 05000400, 05000409, 05000410, 05000412, 05000413, 05000414, 05000416, 05000423, 05000424, 05000425, 05000437, 05000438, 05000439, 05000440, 05000441, 05000443, 05000444, 05000445, 05000446, 05000454, 05000455, 05000456, 05000457, 05000458, 05000461, 05000482, 05000483, 05000498, 05000499, 05000508, 05000528, 05000529, 05000530, 05005228
| license number = 
| contact person = 
| document report number = IN-99-024, NUDOCS 9907070034
| document type = NRC Information Notice
| page count = 15
}}
{{#Wiki_filter:K>
                                           UNITED STATES

NUCLEAR     REGULATORY         COMMISSION

OFFICE OF NUCLEAR MATERIAL             SAFETY       AND SAFEGUARDS

WASHINGTON,       D.C.    20555 July 12, 1999 LICENSEES' RESPONSIBILITIES

NRC INFORMATION NOTICE 99-24: BROAD-SCOPE AND APPROVING UNREGISTERED

FOR REVIEWING

SEALED SOURCES AND DEVICES

==Addressees==
:
                                                      materials licensees.

All medical licensees of broad-scope and master

==Purpose==
:
                                                       is issuing this information notice to alert

The U.S. Nuclear Regulatory Commission (NRC)
                                                           of either sealed sources or devices which

addressees to NRC's expectations about their uses                   on sealed sources and devices. It is

are not listed in the registry of radiation safety information

for applicability to their facilities and

expected that recipients will review this information

issues. However, suggestions contained in

consider actions, as appropriate, to address these             therefore no specific action nor written

this information notice are not new NRC requirements;
response is required.

==Description of Circumstances==
:
                                                            intravascular brachytherapy radiation

With the advent of new investigational studies using                 arteries after balloon angioplasty, treatments to prevent restenosis of coronary and peripheral

unregistered sealed sources and/or devices.

there has been a significant increase in the use of

patient misadministrations and other events

There has also been a marked increase in reported

misadministrations in early 1998, relating to device failures. After two reported patient

there have been additional patient

discussed in detail in NRC Information Notice 98-10,                  by the unexpectedly high rate of

misadministrations, and events reported. NRC is concerned sources and/or devices being

reported events for a relatively small number of unregistered

used in these trials.

the failure of the broad-scope licensees to

A primary contributing factor in these events, was

sources and/or devices, the treatment

perform appropriate radiation safety reviews of the           trials. These reviews directly contribute

protocols, and the procedures to be used in the clinical

to provide your radiation safety committee

to the safe use of material, and must be performed

your participation in the proposed human

with the information necessary to properly evaluate

research trial.

to use sealed sources and/or devices

NRC has granted broad scope licensees the authority

without prior NRC or Agreement State review

that you have fabricated or obtained from vendors

(;907;?PDQ             In (F 90T649q _Da                          qq 01111

I,                                      W-'J

IN 99-24 July 12,1999 these activities

and registration. However, you also have the responsibility for conductingreview and approval

requires   the

responsibly and safely. For example, 10 CFR 33.13(c)(3)(iii)
                                                                                A specific licensees of

of these safety evaluations by the radiation safety committee, for Type

broad-scope.

then it is clearly your

If you fabricate and use source(s) and/or device(s) of your own design, if they can be safely used

responsibility to review the source(s) and/or device(s) and determine

any   procedures or restrictions

for their intended use(s). This includes developing and enforcing                        but frequently

important, deemed necessary for the safe use of the source/device. Equally                                 safety

radiation

overlooked, are your responsibilities for performing these same essential

external suppliers, such as

reviews when using unregistered source(s)/device(s) obtained from

the sponsors of clinical trials.

Discussion:
                                                                             (RSC) when reviewing

What are the responsibilities of my Radiation Safety Committee

source(s) and/or

an application for approval of a specific medical use of sealed

device(s)?

are set forth in

The requirements for radiation safety evaluations, reviews and approvals

license of broad

10 CFR 33.13(c)(3)(ii) and 10 CFR 33.13(c)(3)(iii) for Type A specific

is required  to insure   that   a proper radiation

scope. Thus, your radiation safety committee

use  of the  source(s)     and/or devices have

safety evaluation commensurate with the intended

been performed.

safety evaluation of a

How do I determine whether or not I need to perform a radiation

source or device?

of Sealed Sources

Check if the source and/or device is presently listed in NRC's Registry

accessed online

and devices as approved for your intended use. The registry can be

through the NRC web page or at the following URL address:
      http://www.hsrd.ornl.gov/nrc/ssdr/ssdrindx.htm.

intended use, If it is registered by NRC or an Agreement State and is approved for the

then no radiation safety evaluation by your institution  is required.

and/or device

If either the source and/or device has not been registered or, the source               you must

has not been approved for your intended use, then, to use this source/device, to your

perform the appropriate radiation safety evaluation and submit it for approval

RSC.

approved for use

Caution: You must insure that both source and device are registered, a source is approved for

together, and approved for your intended use. In at least one case

afterloading device

intravascular brachytherapy use. However, the corresponding manual

In  such    instances, you must

for this source is not approved for intravascular brachytherapy.

impact     on  the radiation safety

perform the necessary evaluation of the device, including any

RSC    for approval.

of using the source in the device, and submit your evaluation to your

.I    J

Y)
                                                                                              In 99-24 July 12, 1999 Is there guidance available on how to perform a review?

States are

The requirements for performing these evaluations by the NRC and Agreement

these   reviews  is   contained      in

set forth in 10 CFR 32.210. The guidance for performing                                                  for

NUREG-1556, Vol. 3, "Consolidated Guidance About Materials Licenses                -  Applications

is

Sealed Source and Device Evaluation and Registration." The applicable guidance

The full

summarized in the following questions and answers for both sources and devices.

content of the NUREG is on the NRC web site at the following URL address:
     http://www.nrc.gov/NRC/nucmat.html.

intended

We expect a review that determines if a source/device can be safely used for its

risk   that could

use at your institution. This review should be commensurate with the level of

accident

be reasonably anticipated from the source/device for your intended use and likely

of reviews,   you may   not  need     to  conform     to

conditions. Since the guidance covers all types

the same rigorous review process that is referenced.

It is your responsibility to perform this review, obtain any necessary design and test

discover

information from the vendor and, if needed, conduct operational or other tests to

and evaluate potential radiation safety    hazards.

should

The results of this review, along with any necessary conditions or limitations on use, safety  officer,   for   approval.

be submitted to your radiation safety committee or radiological

procedures for

We have found that it is useful to develop appropriate written administrative

your radiation

the conduct of reviews and the approval or disapproval of the intended use by

safety committee.

How do I perform the radiation safety review for sealed sources?

use and in

Evaluate the likely environments to which the source will be subjected in normal

use, likely accident conditions. Normal use and likely accident conditions should include

handling, storage, and transportation.     Particular  attention  should  be given    to  the   chemical

various

and physical environments to which the source is exposed, such as normal saline, and  mechanical      stresses     that

body fluids, sterilization procedures (temperature extremes),
                                                                             to contain    and    effect   source

may be placed on the source (particularly by any devices used

with any

exposures). Perform this radiation safety evaluation of the source, commensurate

perceived risks from the failure of, or damage to, the source encapsulation.

design

To properly conduct this source evaluation, you will almost certainly require detailed

test data,   if available,     could

and construction information from the source vendor. Vendor

significantly reduce the effort required to perform the necessary radiation safety evaluation.

between

However, if essential design or test data are unavailable, you may have to chose

your

more extensive testing or withholding approval of the proposed use. It is also

responsibility to verify the accuracy of the data   used  to achieve   the prescribed       treatment

dose values through either: (1) direct measurement with         an  appropriately    calibrated

A

measurement system; or, (2) a thorough review of the vendor's calibration procedures. it

within    which

thorough knowledge of the radiation profiles from the source and any device

personnel

is used is essential. Specific conditions of use should be developed to ensure

exposures do not exceed 10 CFR Part 20        limits.

IN 99-24 July 12, 1999 How do I perform the radiation safety review for devices?

shield, and control

A safety evaluation must also be performed for a device used to contain, be commensurate

should

exposures of the source. The scope and depth of this evaluation

must  also  consider any operational

with the risks from failure of the device. The evaluation

to  unintended    exposures to

limitations inherent in the device design that could lead

design     and construction

radiation. This would require, at a minimum, sufficiently detailed

of the device and its

data to allow a full understanding of the construction and operation

components and safety features.

mean the

Integrity of the source/device under normal conditions does not necessarily or unusual

to an  accident

product will perform its intended function after being subjected

still ensure that the

conditions. Under accident or unusual conditions, the design should

protective source

byproduct material is not dispersed, the source remains within the

to be considered in

housing, and the shielding integrity is not comprised. Items that need

this evaluation include:
                                                                                      corrosion (i.e.,
        a. Use of dissimilar materials that are incompatible and could cause

is avoided;
            aluminum and stainless steel in a marine or saline environment)
                                                                                            to radiation or

b. The materials used in the construction are not degraded by exposure

other conditions of use;
        c. Fixed shielding cannot be easily moved or become dislodged;
                                                                                      to ensure they will

d. All moving parts [including the source(s)] have adequate spacing                      of the

not bind during use. This would include use conditions, such as bending the device

to

source transport system, and any external forces that could be applied

and/or transport system during use;
                                                                                        but not in an

e. If applicable, the device can be locked in a closed (safe) condition, open (unsafe) condition;
                                                                                        exposed or in a

f. Indicators are present that clearly identify whether the source(s) is

safely shielded condition;
                                                                                        accidental

g. Safety interlocks, barriers, or guards are used sufficient to prevent

exposures in excess of those specified in the regulations;
                                                                                       filtration, relief

h. If pneumatic or hydraulic systems are used, there are appropriate

valves, and operating pressures;
                                                                                            in the system

I. The device is designed to be fail-safe (i.e., loss of power or a failure

and, would return the source to, or leave it in, the fully shielded position);
                                                                                             or moisture.

j. If applicable, the device is hermetically sealed from foreign materials

IN 99-24 July 12, 1999 or other risk

I completed my safety evaluation and discovered design weaknesses

conditions of use.

factors that could pose radiation safety hazards during the anticipated

What do I do?

One or more of the following options will usually be available to you:
          a. Withhold authorization for the requested use;
          b. Correct any discovered design limitations or defects; or, source to

c. Adopt mandatory written procedures and/or limitations on the use of the

compensate for, or avoid, any radiation safety hazards discovered.

Administration

I Intend to participate In a clinical trial under an approved Food and Drug

FDA's   IDE  review    and approval

(FDA) Investigative Device Exemption (IDE). Doesn't the

source device

process eliminate the need for me to perform a corresponding sealed

review?

safety reviews.

No, the FDA IDE review does not substitute for sealed source and/or device

10  CFR   Part   30 and, in

IDE or 510K device approvals do not satisfy the requirements in

turn, 10 CFR Part 32.

entire protocol, The FDA review process focuses on the medical safety and efficacy of the

to the patient.  The    NRC review

including any sources and/or devices used, with respect

radiation  safety  of the   device. In

and approval process takes a more broad review of the                                       as well

general    public

particular the NRC review focuses on the protection of workers and

such   devices.

as the protection of the patient from unintentional radiation exposures from

IDE process for

The FDA reviews devices under several different processes, such as the                     for routine

human research applications, the 510K, or pre-market     approval    (PMA)   processes

requirements    are   met.   Similarly, patient treatments, as appropriate, to ensure its regulatory

NRC and/or Agreement State reviews are performed to ensure         that the  Commission's

regulatory requirements are satisfied.

for routine

Dual FDA and NRC reviews are regularly performed for sources and devices

approved   under   the 510k,  or  similar  process by

medical use. After a device is reviewed and

or an  Agreement     State,  before

the FDA, it must then be reviewed and registered by NRC

their use  by   NRC   or a

medical licensees of limited specific scope can be authorized for

broad scope licensee is relieved of performing its own radiation safety evaluations.

IN 99-24 July 12, 1999 resources

What are my options If I either do not have or, do not wish to commit, the

necessary to perform these full radiation safety evaluations?

safety

If NRC broad-scope licensees do not wish to become involved in the radiation

applications,  then    they can

evaluation of unregistered sources and/or devices in medical

devices     to those

elect to restrict their use of sealed sources of byproduct materials and/or

as

that have been reviewed by NRC or an Agreement State and listed in the Registry

approved for the licensee's intended use.

not the

The use of either a registered source or a device for a use that is similar to, but

proposed   use    differs little

same as, an approved use, may be a feasible alternative. If your

fairly  simple.

from the approved use, then the necessary radiation safety review could be

sealed sources

Why this emphasis on performance of proper radiation safety reviews of

and devices by broad scope licensees at this time?

events

NRC has observed a considerable increase in patient misadministrations and other

related to the use of unregistered sealed sources     and  devices  in the new  intravascular

the

brachytherapy clinical trials. In nearly all of these events, a failure on the part of

of source/device      used

licensee's RSC to require an appropriate radiation safety evaluation

scope   licensees     seem

was at least a contributing factor. We have observed that our broad

information

to rely too heavily on the source/device vendor to provide most, if not all, of the

review of

necessary for the radiation safety committee to properly perform a radiation safety

the source/device.

98-10, if our

For example, in the patient misadministrations cited in NRC Information Notice

that  was

broad-scope licensee had, before the event, performed the device evaluation

its radiation

performed after the event, and presented the reported corrective actions to

this would

safety committee as recommended conditions for approval of the intended use, approval  process  expected   of  such    a licensee

have constituted the type of review and RSC

and the event might well have been prevented.

,    J                                       J

IN 99-24 July 12, 1999 any

This Information Notice requires no specific action nor written response. If you have

listed below

questions about the information in this notice, please contact the technical contact

or the appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

===Technical Contact:===

===Robert L. Ayres, NMSS===
                      301- 415-5746 E-mail: rxal @nrc.gov

Attachments:
1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

Attachment 1 IN 99-24 July 12, 1999 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information                                     Date of

Notice No.         Subject                      Issuance  Issued to

licensees

99-23       Safety Concerns Related To          7/6/99    All U.S. NRC

autorze     to- medical

use rw riuia

Repeated Control Unit Failures                autnorized to use~d lrcyLI VI Oy

of the Nucletron Classic Model                sources in Nucletron Classic

High-Dose-Rate Remote                         Model high-dose-rate (HDR)
            Aferloading Brachytherapy                     remote afterloaders

Devices

10 CFR 34.43(a)(1): Effective       6/25/99   Industrial Radiography Licensees

99-22 Date for Radiographer Certification

and Plans for Enforcement Discretion

Contingency Planning for the        6/25/99   All material and fuel cycle

99-20
            Year 2000 Computer Problem                    licensees and certificate holders

Update on NRC's Year 2000           6/14/99   All material and fuel cycle

99-18 Activities for Materials Licensees            licensees and certificate

and Fuel Cycle Licensees and                  holders

Certificate Holders

Federal Bureau of Investigation's   5/28       All U.S. Nuclear Regulatory

99-16- Nuclear Site Security Program                  Commission fuel cycle, power

reactor, and non-power reactor

licensees

Incident Involving the Use of      4/16/99    All medical use licensees

99-11 Radioactive Iodine-131 Problems Encountered When           3/24/99   All medical licensees authorized

99-09 Manually Editing treatment Data               to conduct high-dose-rate (HDR)
             on the Nucletron Microselectron-               remote after loading

HDR (New) Model 105-999                        brachytherapy treatments

1998 Enforcement Sanctions as      3/19/99    All U. S. Nuclear Regulatory

99-06 a Result of Deliberate Violations              Commission licensees

of NRC Employee Protection

Requirements

Inadvertent Discharge of Carbon    3/8/99     All holders of licenses for nuclear

99-05 Dioxide Fire Protection System                 power, research, and test reactor, and Gas Migration                              and fuel cycle facilities

' -)                                     Attachment 2 IN 99-24 July 12,1999 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information                                          Date of

Notice No.            Subject                        Issuance   Issued to

7/6/99     All U.S.~ NRC    medical  licensees

99-23            Safety Concerns Related To                          --       4   -        kAk_.

Repeated Control Unit Failures                 auxtoneUU     to UZOV WI MA ly 1.1 I -Ly

of the Nucletron Classic Model                 sources in Nucletron Classic

High-Dose-Rate Remote                          Model high-dose-rate (HDR)
                 Aferloading Brachytherapy                      remote afterloaders

Devices

10 CFR 34.43(a)(1); Effective       7/6/99     Industrial Radiography Licensees

99-22 Date for Radiographer Certification

and Plans for Enforcement Discretion

Recent Plant Events Caused         6/25/99    All holders of licenses for nuclear

99-21 By Human Performance Errors                   power, test, and research reactors

Contingency Planning for the       6/25/99    All material and fuel cycle

99-20                                                             licensees and certificate holders

Year 200 Computer Problem

Rupture of the Shell Side of a     6/23/99     All holders of operating licenses

99-19 Feedwater Heater at the Point                  or construction permits for nuclear

Beach Nuclear Plant                            power reactors

Update on NRC's Year 2000           6/14/99    All material and fuel cycle

99-18 Activities for Materials Licensees              licensees and certificate holders

and Fuel Cycle Licensees and

Certificate Holders

Problems Associated with Post-Fire 6/3/99      All holders of OL for nuclear

99-17 Safe-Shutdown Circuit Analyses                 power reactors, except those who

have permanently ceased

operations and have certified that

the fuel has been permanently

removed from the reactor

Federal Bureau of Investigation's  5/28        All U.S. Nuclear Regulatory

99-16- Nuclear Site Security Program                  Commission fuel cycle, power

reactor, and non-power reactor

licensees

OL = Operating License

CP = Construction Permit

IN 99-24 July 12, 1999 have any

This Information Notice requires no specific action nor written response. If you

listed below

questions about the information in this notice, please contact the technical contact

or the appropriate NRC regional office.

(Orig. signed by)
                                                         Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

===Technical Contact:===

===Robert L. Ayres, NMSS===
                             301- 415-5746 E-mail: rxal @nrc.gov

Attachments:
    1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

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June XX, 1999 Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

===Technical Contact:===

===Robert L. Ayres, NMSS===
                            (301) 415-5746 E-mail: rxal @nrc.gov

Attachments:
    1.       List of Recently Issued NMSS Information Notices

2.       List of Recently Issued NRC Information Notices

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===Robert L. Ayres, NMSS===
                          (301) 415-5746 E-mail: rxal nrc.gov

Attachments:
     1.     List of Recently Issued NMSS Information Notices

2.     List of Recently Issued NRC Information Notices

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