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

Broad-Scope Licensees' Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices

ML031040396
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, 05005228, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	07/12/1999
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-99-024, NUDOCS 9907070034
Download: ML031040396 (15)

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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

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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

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

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

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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Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

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2. List of Recently Issued NRC Information Notices

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