Information Notice 1999-24, Broad-Scope Licensees' Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices: Difference between revisions
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| issue date = 07/12/1999 | | issue date = 07/12/1999 | ||
| title = Broad-Scope Licensees' Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices | | title = Broad-Scope Licensees' Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices | ||
| author name = Cool D | | author name = Cool D | ||
| author affiliation = NRC/NMSS/IMNS | | author affiliation = NRC/NMSS/IMNS | ||
| addressee name = | | addressee name = | ||
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| page count = 15 | | page count = 15 | ||
}} | }} | ||
{{#Wiki_filter:K>UNITED | {{#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== | ==Addressees== | ||
:All medical licensees of broad-scope and master | : | ||
materials licensees. | |||
All medical licensees of broad-scope and master | |||
==Purpose== | ==Purpose== | ||
:The U.S. Nuclear Regulatory Commission (NRC) | : | ||
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== | ==Description of Circumstances== | ||
:With the advent of new investigational studies using | : | ||
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:=== | ===Technical Contact:=== | ||
Attachment | ===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 | |||
IN 99- | 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 | |||
97/4vtZ7P | |||
DOCUMENT NAME: G:\Ayres\99-24.in | |||
* Se previous concurrence | |||
MSIB TechED* I OGC*I MSIB* I D/IMNS I | |||
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RAyres7/1 EKraus STreby LWCamper DACool | |||
NAME | |||
7/1/99 031/99 | |||
03DATE 04/21/99 04/27/99 7/1/99 OFFICIAL RECORD COPY | |||
IJ | |||
IN 99-XX | |||
July XX, 1999 DOCUMENT NAME: A & G\Ayres\IN99a-aa.WPD | |||
* See previous concurrence | |||
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NAME | |||
03/31/99 04/21/99 04/ 27/99 07// /99 DATE 1 / o ( /99 OFFICIAL RECORD COPY | |||
IN 99-XX | |||
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 | |||
DOCUMENT NAME: A & G\Ayres\IN99a-aa.WPD | |||
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DATE C I2 /99i 03131/99 04/21/99 04/27/99 05/ /99 OFFICIAL RECORD COPY | |||
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IN 99-XX | |||
June XX, 1999 DOCUMENT NAME: A & G\Ayres\IN99a-XX.WPD | |||
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===DATE 2=== | |||
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IN 99-XX | |||
May XX, 1999 | |||
===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 | |||
DOCUMENT NAME: A & G\Ayres\IN99a-XX.WPD | |||
* See previous concurrence _ _/__/__ _ d- OFC MSIB l TechED JI OGC* I MSIB3 I D/IMNS I | |||
NAME RAyres/Ill EKraus STreby LWCamper DACool | |||
DATE I /Sd /99 03/31/99 I 04/21/99 04/27/99 05/ /99 OFFICIAL RECORD COPY | |||
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IN 99-XX | |||
April XX, 1999 Attachments: | |||
1. List of Recently Issued NMSS Information Notices | |||
2. List of Recently Issued NRC Information Notices | |||
DOCUMENT NAME: A & G(I:\):IN99a-XX.WPD | |||
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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
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
97/4vtZ7P
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IN 99-XX
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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IN 99-XX
May XX, 1999
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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IN 99-XX
April XX, 1999 Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices
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