Information Notice 1998-10, Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System: Difference between revisions
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| issue date = 03/09/1998 | | issue date = 03/09/1998 | ||
| title = Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System | | title = Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System | ||
| author name = Cool D | | author name = Cool D | ||
| author affiliation = NRC/NMSS | | author affiliation = NRC/NMSS | ||
| addressee name = | | addressee name = | ||
Line 13: | Line 13: | ||
| document type = NRC Information Notice | | document type = NRC Information Notice | ||
| page count = 9 | | page count = 9 | ||
}} | }} | ||
{{#Wiki_filter:}} | {{#Wiki_filter:UNITED STATES | ||
NUCLEAR REGULATORY COMMISSION | |||
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS | |||
WASHINGTON, D.C. 20555 March 9, 1998 NRC INFORMATION NOTICE 98-10: PROBABLE MISADMINISTRATIONS OCCURRING | |||
DURING INTRAVASCULAR BRACHYTHERAPY WITH | |||
THE NOVOSTE BETA-CATH SYSTEM | |||
==Addressees== | |||
: | |||
===All Medical Licensees=== | |||
==Purpose== | |||
: | |||
The U.S. Nuclear Regulatory Commission is issuing this information notice to alert addressees | |||
to two reported incidents that have occurred during the conduct of intravascular brachytherapy | |||
procedures using the Novoste Beta-Cath system. This system uses Strontium-90 high-dose- rate (HDR) source trains that can range between approximately 1 to 10 Gy/min beta dose | |||
output at the surface of the seeds. Licensees should be aware of the potential for similar | |||
failures during the course of patient treatments and the possible risk(s) for misadministrations | |||
and potential patient harm resulting from the inability to retract these HDR sources at the | |||
conclusion of the planned treatment. It is expected that recipients will review the information for | |||
applicability to their facilities and consider actions, as appropriate, to avoid similar problems. | |||
However, suggestions contained in this information notice are not new NRC requirements; | |||
therefore, no specific action nor written response is required. | |||
==Description of Circumstances== | |||
: | |||
NRC has become aware of two reported failures, while using the Novoste Beta-Cath system for | |||
intravascular brachytherapy in multi-center clinical trials. Both of these events are being | |||
investigated as probable misadministrations (wrong treatment sites) as the sources failed to | |||
return to the device storage safe at the conclusion of the treatments. The Sr-90 source train | |||
was observed leaving the treatment site but did not return to the device; in fact, the precise | |||
locations of the sources were unknown for some period of time. A brief summary of the two | |||
reported failures follows: | |||
1. On January 16, 1998, an NRC licensee reported that on January 15, 1998, a | |||
patient receiving treatment with the experimental Novoste Beta-Cath device | |||
received a larger than expected dose to unwanted body areas because of | |||
difficulty in removing the inserted sources. Twelve Sr-90 sources (total activity of | |||
1.3 x 109 Bq (35 mCi)) were inserted in the treatment location via a long catheter. | |||
At the conclusion of the treatment the pellets became stuck in the catheter, | |||
93301 IJm8b01o e8g3&q | |||
Iqq | |||
-1111l 11 lI J1111 | |||
11 III | |||
TA~~gfrv a s | |||
IN 98-10 | |||
March 9, 1998 requiring the immediate removal of the catheter containing the sources from the | |||
patient. Because of the time needed to remove the catheter (estimated to be 65 seconds) the patient received a larger transit dose than expected, as the normal | |||
source transit time is on the order of 3 to 5 seconds; and, | |||
2. On February 9, 1998, the State of Washington notified NRC of a somewhat | |||
similar incident reported by one of its licensees as occurring on December 15, | |||
1997. In this misadministration report the licensee reported that at the | |||
conclusion of a 3-minute and 32-second treatment (18 Gy dose at 2mm) to the | |||
left coronary artery the hydraulic source transport system (syringe) ran out of | |||
saline, stalling the source train in transit. It reported that the source train was | |||
stalled at an unknown location for 1 minute and 32 seconds delivering an | |||
additional unintended 7.8 Gy (maximum) dose to the vessel wall(s). | |||
Although investigation of both of the reported events is ongoing, presently available information | |||
attributes the failure of the source transport system in the first event to crimping of the Novoste | |||
system catheter by over-tightening of the Touhy-Bourst valve used to tighten around the | |||
catheter and prevent the flow of blood out of the insertion point in the patient's femoral artery. | |||
This crimp did not completely close the source lumen in the Novoste catheter, allowing the | |||
saline flow to continue, but it was sufficient to block the sources from returning to the device. | |||
When the saline supply in the delivery syringe was exhausted, an emergency removal of the | |||
Beta-Cath treatment catheter from the patient was performed. | |||
In the second reported incident, the syringe saline supply was also exhausted before the | |||
sources were returned to the device source storage location. In this event, the syringe was | |||
replaced with a fresh supply of saline and the sources were then successfully returned to their | |||
storage location using the device's hydraulic source transport system. It is possible that the | |||
second reported event may have the same root cause as the first, but this has not yet been | |||
determined. | |||
In both events, the respective authorized users report that they do not expect any adverse | |||
health consequences for the patients involved. | |||
Discussion: | |||
Numerous clinical trials are underway to evaluate the feasibility of using intravascular | |||
brachytherapy to prevent restenosis after angioplasty in coronary and peripheral arteries. | |||
These trials involve numerous new and innovative sources of byproduct materials and delivery | |||
systems that, in most cases, have not undergone formal sealed source and device'reviews and | |||
listing in NRC's Registry of Sealed Sources and Devices as approved source(s) and device(s) | |||
for this intended use. | |||
In the first cited event report from our NRC licensee, the immediate cause of the incident | |||
appears to be transient damage to the Beta-Cath system source lumen (catheter), because of | |||
over-tightening of the Touhy-Bourst valve (this is a valve-like device located at the proximal end | |||
of the guide catheter, 15 to 20 cm beyond the external skin surface, and contains an iris-like | |||
IN 98-10 | |||
March 9, 1998 shutter designed to tightly grip the Beta-Cath catheter to prevent leaking of blood around the | |||
catheter). It is necessary to loosen this valve each time the Beta-Cath source train is moved to | |||
or from the transfer device to the treatment site at the distal end of the catheter. Subsequent | |||
simulation of the misadministration incident by the licensee showed that tightening the Touhy- Bourst valve one-half turn beyond ufinger-tight" created a condition where the sources could not | |||
be retracted back into the device. On visual examination, a small depression was clearly | |||
evident on the catheter at the location of the Touhy-Bourst valve. Loosening, or even removing | |||
the valve did not allow retraction of the source train. After about 20 minutes, it was possible to | |||
retract the sources normally with the device's hydraulic transport system. It is believed that, over this 20-minute period, elastic restoring forces reduced the indentation in the catheter to the | |||
point where the sources could be retracted normally. | |||
At this time, less information is available concerning the second event reported by the | |||
Washington State licensee. However, discussions with Novoste revealed that a second source | |||
transfer failure mechanism exists with this device design. | |||
Specifically, if too much pressure is applied to the saline supply syringe during source transport, the supply of saline can be prematurely exhausted before completing the intended source | |||
transport procedure. Thus, it appears that at least two source transport failure modes exist that | |||
can be induced by the improper application of force in the operation of the device by the user. | |||
In the extensive investigation of its event, our licensee identified a number of factors that it | |||
believes contributed to the reported misadministration. These were: (1) The device design | |||
allows for over-tightening of the Touhy-Bourst valve, which can block the source train transport | |||
pathway; (2) excessive intervals of time between training and start of clinical procedures and | |||
successive clinical procedures; (3) less than optimal didactic and practical training; (4) between | |||
extremely limited opportunities for self-practice and rehearsal because of restrictions imposed | |||
by Novoste; and, (5) lack of a detailed checklist, describing all precautionary checks and | |||
warnings, including manipulation of the Touhy-Bourst valve. | |||
During the course of the NRC investigation of these events, an additional possible design | |||
related source transport system failure mode was discovered that should be added to the above | |||
listing. Specifically, when attaching the syringe to the transfer device, over-tightening of the | |||
syringe Luer to the extension connector may cause the sterile sleeve to be pinched, which, could result in the inability to produce sufficient hydraulic pressure. Inclusion of related | |||
operational procedures and warnings, addressing all these failure modes should be included in | |||
the check-list cited in the preceding paragraph. | |||
The following corrective actions, proposed by our licensee's medical physicist, may be | |||
beneficial in addressing radiation safety concerns related to the use of this device in ongoing | |||
clinic trials: | |||
1. Improve radiation oncology training quality, including didactic review of relevant | |||
interventional cardiology procedures and technical details, as well as more | |||
realistic training exercises in a catheterization lab environment; | |||
IN 98-10 | |||
March 9, 1998 2. Develop an appropriately modified version of American Association of Physicists | |||
in Medicine's HDR device quality assurance protocol that gives confidence that | |||
all Novoste treatment equipment is functioning properly. At a minimum, this | |||
should include: (a) daily testing of all treatment units before treating patients; (b) | |||
testing of treatment catheter with the randomly selected radiation afterloading | |||
device (RAL) before positioning the catheter in the patient; (c) where ischemia is | |||
not a problem, test the inserted catheter with the dummy source RAL for | |||
unobstructed passage of the sources before attaching the randomly selected | |||
device to the catheter and administering therapy; and, (d) verification of source | |||
strength and/or prescription dose rate; | |||
3. Be conscious of the possibilities for damaging the treatment catheter before and | |||
during the radioactive source treatment and develop a list of precautions to be | |||
made known to all participants; | |||
4. Develop a check list of essential steps, checks, and precautions to be followed in | |||
executing these treatments and verbally review this list step by step until | |||
procedure frequency and competence are built up; | |||
5. Develop a mechanism for facilitating self-initiated practice and procedure review. | |||
This requires vendor cooperation; | |||
6. Redesign the treatment-to-guide catheter Interface to eliminate the possibility of | |||
catheter damage. | |||
The post-incident investigation and resultant proposed corrective actions appear to be | |||
appropriate. Certain of these actions, specifically numbers 1, 3, and 4, can be unilaterally | |||
implemented by the licensee. However, the remaining three actions require the approval and | |||
support of Novoste Corporation. | |||
All licensees contemplating use of the Novoste Beta-Cath system or any of the other emerging | |||
intravascular brachytherapy procedures should ensure that either: (1) the device(s) and/or | |||
source(s) have undergone a thorough radiation safety review and approval by the NRC or | |||
Agreement State, as required by 10 CFR 35.49(a); or, (2) for broad scope licensees, who are | |||
exempted from the requirements of 10 CFR 35.49(a) through a standard license condition, an | |||
equivalent radiation safety evaluation by a broad scope licensee's radiation safety committee | |||
should be performed in order to fully satisfy the requirements of 10 CFR 33.13(c)(3)(ii). In | |||
addition, licensees should ensure that affected personnel understand all operating parameters | |||
necessary for the safe operation of the system. If significant unaddressed safety concerns | |||
remain, then it would be expected that the licensee would decline to participate in that particular | |||
clinical trial. | |||
IN 98-10 | |||
March 9,1998 This information notice requires no specific action nor written response. If you have any | |||
questions about the information in this notice, pi se t T4he technical contact listed below | |||
or the appropriate NRC regional office. t | |||
AD aid ool, Director | |||
sion of Industrial and | |||
Mdical 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 | |||
Lo Le LA &W | |||
K i | |||
Xffachment 1 IN 98-10 | |||
March 9,1998 LIST OF RECENTLY ISSUED | |||
NMSS INFORMATION NOTICES | |||
Information Date of | |||
Notice No. Subject Issuance Issued to | |||
98-09 Collapse of an Isocam II, Dual- 3/5/98 All medical licensees | |||
Headed Nuclear Medicine Gamma | |||
Camera | |||
98-08 Information Likely to be Requested 3/3/98 All parts 30, 40, 70, 72 and 76 if an Emergency is Declared licensees and certificate holders | |||
required to have a Nuclear | |||
Regulatory Commission approved | |||
Emergency plan. | |||
98-06 Unauthorized use of License 2/19/98 All NRC Licensees authorized | |||
to Obtain Radioactive Materials, to Possess Licensed Materials | |||
and its Implications Under The | |||
Expanded Title 18 of the U.S. Code | |||
98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory | |||
Deliberate Violations of NRC Commission licensees. | |||
Employee Protection | |||
Requirements | |||
98-01 Thefts of Portable Gauges 1/15/98 All portable gauge licensees | |||
97-91 Recent Failures of Control 12/31/97 All industrial radiography | |||
Cables Used on Amersham licensees | |||
Model 660 Posilock Radiography | |||
Systems | |||
97-89 Distribution of Sources and 12/29/97 All sealed source and device | |||
Devices Without Authorization manufacturers and distributors | |||
97487 Second Retrofit to Industrial 12/12/97 All industrial radiography | |||
Nuclear Company IR100 licensees | |||
Radiography Camera, to | |||
Correct Inconsistency in | |||
10 CFR Part 34 Compatibility | |||
97-86 Additional Controls for Transport 12/12/97 Registered users of the Model | |||
of the Amersham Model No. 660 No. 660 series packages, and | |||
Series Radiographic Exposure Nuclear Regulatory Commission | |||
Devices industrial radiography licensees | |||
'- | |||
'--ttachment | |||
IN 98-10 | |||
March 9, 1998 Page 1 of I | |||
LIST OF RECENTLY ISSUED | |||
NRC INFORMATION NOTICES | |||
Information Date of | |||
Notice No. Subject Issuance Issued to | |||
98-07 Offsite Power Reliability 2/27/98 All holders of operating licensees | |||
Challenges from Industry for nuclear power reactors | |||
Deregulation | |||
98-06 Unauthorized Use of License to 2/19/98 All NRC licensees authorized to | |||
Obtain Radioactive Materials, possess licensed material | |||
And Its Implications Under The | |||
Expanded Title 18 of the | |||
U.S. Code | |||
97-45, Supp. 1 Environmental Qualification 2/17/98 All holders of operating | |||
Deficiency for Cables and licenses for nuclear power | |||
Containment Penetration reactors except those licensees | |||
Pigtails who have permanently ceased | |||
operations and have certified that | |||
the fuel has been permanently | |||
removed from the reactor vessel | |||
98-05 Criminal History Record 2/11/98 All holders of operating | |||
Information licenses for power reactors | |||
98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory | |||
deliberate Violations of NRC Commission licensees | |||
Employee Protection requirements | |||
98-03 Inadequate Verification of 1/21/98 All holders of operating licenses | |||
Overcurrent Trip Setpoints in for nuclear power reactors | |||
Metal-Clad, Low-Voltage | |||
Circuit Breakers | |||
98-02 Nuclear Power Plant Cold. 1/21/98 All holders of operating licenses | |||
Weather Problems and for nuclear power reactors | |||
Protective Measures | |||
98-01 Thefts of Portable Gauges 1/15/98 All portable gauge licensees | |||
OL = Operating License | |||
CP = Construction Permit | |||
IN 98-10 | |||
March 9, 1998 This information notice requires no specific action nor written response. If you have any | |||
questions about the information in this notice, please contact the technical contact listed below | |||
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 | |||
* Coordinated with FDA, RIII, State of Washington, and manufacturer | |||
** See Previous Concurrence | |||
OFC IMAB* TK I E DMlI | |||
NAME RAyres 6HM LWCamper JPiewmn | |||
DATE 2/25198 2//98 2/26198 _ I__ _ | |||
*~~ | |||
. | |||
OFC **TechEd I DD/IMNS* I D/IMNS* I I | |||
NAME EKraus FCCombs DACool _ | |||
DATE 2118/98 2/27/98 2/26/98 __________ | |||
C=COVER E=COVERIENCLOSURE N=NO COPY OFFICIAL RECORD COPY: G:UN98XX.RLA | |||
IN 98-XX | |||
February , 1998 If significant unaddressed safety concerns remain, then it would be expected that | |||
the licensee would decline to participate in that particular clinical trial. | |||
This information notice requires no specific action nor written response. If you | |||
have any questions about the information in this notice, please contact the | |||
technical contact listed below 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 | |||
* Coordinated with FDA, RIII, State of Washington, and ma facturer | |||
** See Previous Concurrence M gi g | |||
OFC l IMAB I ICl IAB / l IMAB l l IM-QB 12 NAME RAyres 4 Cvy LWCam__r JPi__e1 DATE 2/2S/98/ _/98 _ _ _ | |||
_2/1//98_ 2/ - /98 OFC **TechEd I D/IMNg-: I | |||
NAME EKrause l a l l iif._}_ _ | |||
DATE 2/18/98 1 2/M1198 j 2A/('/98 l | |||
C-COVER E=COVER\ENCLOSURE N=-NO COPY OFFICIAL RECORD COPY: G:\IN98XX.RLA}} | |||
{{Information notice-Nav}} | {{Information notice-Nav}} |
Latest revision as of 04:44, 24 November 2019
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 March 9, 1998 NRC INFORMATION NOTICE 98-10: PROBABLE MISADMINISTRATIONS OCCURRING
DURING INTRAVASCULAR BRACHYTHERAPY WITH
THE NOVOSTE BETA-CATH SYSTEM
Addressees
All Medical Licensees
Purpose
The U.S. Nuclear Regulatory Commission is issuing this information notice to alert addressees
to two reported incidents that have occurred during the conduct of intravascular brachytherapy
procedures using the Novoste Beta-Cath system. This system uses Strontium-90 high-dose- rate (HDR) source trains that can range between approximately 1 to 10 Gy/min beta dose
output at the surface of the seeds. Licensees should be aware of the potential for similar
failures during the course of patient treatments and the possible risk(s) for misadministrations
and potential patient harm resulting from the inability to retract these HDR sources at the
conclusion of the planned treatment. It is expected that recipients will review the information for
applicability to their facilities and consider actions, as appropriate, to avoid similar problems.
However, suggestions contained in this information notice are not new NRC requirements;
therefore, no specific action nor written response is required.
Description of Circumstances
NRC has become aware of two reported failures, while using the Novoste Beta-Cath system for
intravascular brachytherapy in multi-center clinical trials. Both of these events are being
investigated as probable misadministrations (wrong treatment sites) as the sources failed to
return to the device storage safe at the conclusion of the treatments. The Sr-90 source train
was observed leaving the treatment site but did not return to the device; in fact, the precise
locations of the sources were unknown for some period of time. A brief summary of the two
reported failures follows:
1. On January 16, 1998, an NRC licensee reported that on January 15, 1998, a
patient receiving treatment with the experimental Novoste Beta-Cath device
received a larger than expected dose to unwanted body areas because of
difficulty in removing the inserted sources. Twelve Sr-90 sources (total activity of
1.3 x 109 Bq (35 mCi)) were inserted in the treatment location via a long catheter.
At the conclusion of the treatment the pellets became stuck in the catheter,
93301 IJm8b01o e8g3&q
Iqq
-1111l 11 lI J1111
11 III
TA~~gfrv a s
March 9, 1998 requiring the immediate removal of the catheter containing the sources from the
patient. Because of the time needed to remove the catheter (estimated to be 65 seconds) the patient received a larger transit dose than expected, as the normal
source transit time is on the order of 3 to 5 seconds; and,
2. On February 9, 1998, the State of Washington notified NRC of a somewhat
similar incident reported by one of its licensees as occurring on December 15,
1997. In this misadministration report the licensee reported that at the
conclusion of a 3-minute and 32-second treatment (18 Gy dose at 2mm) to the
left coronary artery the hydraulic source transport system (syringe) ran out of
saline, stalling the source train in transit. It reported that the source train was
stalled at an unknown location for 1 minute and 32 seconds delivering an
additional unintended 7.8 Gy (maximum) dose to the vessel wall(s).
Although investigation of both of the reported events is ongoing, presently available information
attributes the failure of the source transport system in the first event to crimping of the Novoste
system catheter by over-tightening of the Touhy-Bourst valve used to tighten around the
catheter and prevent the flow of blood out of the insertion point in the patient's femoral artery.
This crimp did not completely close the source lumen in the Novoste catheter, allowing the
saline flow to continue, but it was sufficient to block the sources from returning to the device.
When the saline supply in the delivery syringe was exhausted, an emergency removal of the
Beta-Cath treatment catheter from the patient was performed.
In the second reported incident, the syringe saline supply was also exhausted before the
sources were returned to the device source storage location. In this event, the syringe was
replaced with a fresh supply of saline and the sources were then successfully returned to their
storage location using the device's hydraulic source transport system. It is possible that the
second reported event may have the same root cause as the first, but this has not yet been
determined.
In both events, the respective authorized users report that they do not expect any adverse
health consequences for the patients involved.
Discussion:
Numerous clinical trials are underway to evaluate the feasibility of using intravascular
brachytherapy to prevent restenosis after angioplasty in coronary and peripheral arteries.
These trials involve numerous new and innovative sources of byproduct materials and delivery
systems that, in most cases, have not undergone formal sealed source and device'reviews and
listing in NRC's Registry of Sealed Sources and Devices as approved source(s) and device(s)
for this intended use.
In the first cited event report from our NRC licensee, the immediate cause of the incident
appears to be transient damage to the Beta-Cath system source lumen (catheter), because of
over-tightening of the Touhy-Bourst valve (this is a valve-like device located at the proximal end
of the guide catheter, 15 to 20 cm beyond the external skin surface, and contains an iris-like
March 9, 1998 shutter designed to tightly grip the Beta-Cath catheter to prevent leaking of blood around the
catheter). It is necessary to loosen this valve each time the Beta-Cath source train is moved to
or from the transfer device to the treatment site at the distal end of the catheter. Subsequent
simulation of the misadministration incident by the licensee showed that tightening the Touhy- Bourst valve one-half turn beyond ufinger-tight" created a condition where the sources could not
be retracted back into the device. On visual examination, a small depression was clearly
evident on the catheter at the location of the Touhy-Bourst valve. Loosening, or even removing
the valve did not allow retraction of the source train. After about 20 minutes, it was possible to
retract the sources normally with the device's hydraulic transport system. It is believed that, over this 20-minute period, elastic restoring forces reduced the indentation in the catheter to the
point where the sources could be retracted normally.
At this time, less information is available concerning the second event reported by the
Washington State licensee. However, discussions with Novoste revealed that a second source
transfer failure mechanism exists with this device design.
Specifically, if too much pressure is applied to the saline supply syringe during source transport, the supply of saline can be prematurely exhausted before completing the intended source
transport procedure. Thus, it appears that at least two source transport failure modes exist that
can be induced by the improper application of force in the operation of the device by the user.
In the extensive investigation of its event, our licensee identified a number of factors that it
believes contributed to the reported misadministration. These were: (1) The device design
allows for over-tightening of the Touhy-Bourst valve, which can block the source train transport
pathway; (2) excessive intervals of time between training and start of clinical procedures and
successive clinical procedures; (3) less than optimal didactic and practical training; (4) between
extremely limited opportunities for self-practice and rehearsal because of restrictions imposed
by Novoste; and, (5) lack of a detailed checklist, describing all precautionary checks and
warnings, including manipulation of the Touhy-Bourst valve.
During the course of the NRC investigation of these events, an additional possible design
related source transport system failure mode was discovered that should be added to the above
listing. Specifically, when attaching the syringe to the transfer device, over-tightening of the
syringe Luer to the extension connector may cause the sterile sleeve to be pinched, which, could result in the inability to produce sufficient hydraulic pressure. Inclusion of related
operational procedures and warnings, addressing all these failure modes should be included in
the check-list cited in the preceding paragraph.
The following corrective actions, proposed by our licensee's medical physicist, may be
beneficial in addressing radiation safety concerns related to the use of this device in ongoing
clinic trials:
1. Improve radiation oncology training quality, including didactic review of relevant
interventional cardiology procedures and technical details, as well as more
realistic training exercises in a catheterization lab environment;
March 9, 1998 2. Develop an appropriately modified version of American Association of Physicists
in Medicine's HDR device quality assurance protocol that gives confidence that
all Novoste treatment equipment is functioning properly. At a minimum, this
should include: (a) daily testing of all treatment units before treating patients; (b)
testing of treatment catheter with the randomly selected radiation afterloading
device (RAL) before positioning the catheter in the patient; (c) where ischemia is
not a problem, test the inserted catheter with the dummy source RAL for
unobstructed passage of the sources before attaching the randomly selected
device to the catheter and administering therapy; and, (d) verification of source
strength and/or prescription dose rate;
3. Be conscious of the possibilities for damaging the treatment catheter before and
during the radioactive source treatment and develop a list of precautions to be
made known to all participants;
4. Develop a check list of essential steps, checks, and precautions to be followed in
executing these treatments and verbally review this list step by step until
procedure frequency and competence are built up;
5. Develop a mechanism for facilitating self-initiated practice and procedure review.
This requires vendor cooperation;
6. Redesign the treatment-to-guide catheter Interface to eliminate the possibility of
catheter damage.
The post-incident investigation and resultant proposed corrective actions appear to be
appropriate. Certain of these actions, specifically numbers 1, 3, and 4, can be unilaterally
implemented by the licensee. However, the remaining three actions require the approval and
support of Novoste Corporation.
All licensees contemplating use of the Novoste Beta-Cath system or any of the other emerging
intravascular brachytherapy procedures should ensure that either: (1) the device(s) and/or
source(s) have undergone a thorough radiation safety review and approval by the NRC or
Agreement State, as required by 10 CFR 35.49(a); or, (2) for broad scope licensees, who are
exempted from the requirements of 10 CFR 35.49(a) through a standard license condition, an
equivalent radiation safety evaluation by a broad scope licensee's radiation safety committee
should be performed in order to fully satisfy the requirements of 10 CFR 33.13(c)(3)(ii). In
addition, licensees should ensure that affected personnel understand all operating parameters
necessary for the safe operation of the system. If significant unaddressed safety concerns
remain, then it would be expected that the licensee would decline to participate in that particular
clinical trial.
March 9,1998 This information notice requires no specific action nor written response. If you have any
questions about the information in this notice, pi se t T4he technical contact listed below
or the appropriate NRC regional office. t
AD aid ool, Director
sion of Industrial and
Mdical 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
Lo Le LA &W
K i
Xffachment 1 IN 98-10
March 9,1998 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
98-09 Collapse of an Isocam II, Dual- 3/5/98 All medical licensees
Headed Nuclear Medicine Gamma
Camera
98-08 Information Likely to be Requested 3/3/98 All parts 30, 40, 70, 72 and 76 if an Emergency is Declared licensees and certificate holders
required to have a Nuclear
Regulatory Commission approved
98-06 Unauthorized use of License 2/19/98 All NRC Licensees authorized
to Obtain Radioactive Materials, to Possess Licensed Materials
and its Implications Under The
Expanded Title 18 of the U.S. Code
98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory
Deliberate Violations of NRC Commission licensees.
Employee Protection
Requirements
98-01 Thefts of Portable Gauges 1/15/98 All portable gauge licensees
97-91 Recent Failures of Control 12/31/97 All industrial radiography
Cables Used on Amersham licensees
Model 660 Posilock Radiography
Systems
97-89 Distribution of Sources and 12/29/97 All sealed source and device
Devices Without Authorization manufacturers and distributors
97487 Second Retrofit to Industrial 12/12/97 All industrial radiography
Nuclear Company IR100 licensees
Radiography Camera, to
Correct Inconsistency in
10 CFR Part 34 Compatibility
97-86 Additional Controls for Transport 12/12/97 Registered users of the Model
of the Amersham Model No. 660 No. 660 series packages, and
Series Radiographic Exposure Nuclear Regulatory Commission
Devices industrial radiography licensees
'-
'--ttachment
March 9, 1998 Page 1 of I
LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
98-07 Offsite Power Reliability 2/27/98 All holders of operating licensees
Challenges from Industry for nuclear power reactors
Deregulation
98-06 Unauthorized Use of License to 2/19/98 All NRC licensees authorized to
Obtain Radioactive Materials, possess licensed material
And Its Implications Under The
Expanded Title 18 of the
U.S. Code
97-45, Supp. 1 Environmental Qualification 2/17/98 All holders of operating
Deficiency for Cables and licenses for nuclear power
Containment Penetration reactors except those licensees
Pigtails who have permanently ceased
operations and have certified that
the fuel has been permanently
removed from the reactor vessel
98-05 Criminal History Record 2/11/98 All holders of operating
Information licenses for power reactors
98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory
deliberate Violations of NRC Commission licensees
Employee Protection requirements
98-03 Inadequate Verification of 1/21/98 All holders of operating licenses
Overcurrent Trip Setpoints in for nuclear power reactors
Metal-Clad, Low-Voltage
Circuit Breakers
98-02 Nuclear Power Plant Cold. 1/21/98 All holders of operating licenses
Weather Problems and for nuclear power reactors
Protective Measures
98-01 Thefts of Portable Gauges 1/15/98 All portable gauge licensees
OL = Operating License
CP = Construction Permit
March 9, 1998 This information notice requires no specific action nor written response. If you have any
questions about the information in this notice, please contact the technical contact listed below
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
- Coordinated with FDA, RIII, State of Washington, and manufacturer
- See Previous Concurrence
OFC IMAB* TK I E DMlI
NAME RAyres 6HM LWCamper JPiewmn
DATE 2/25198 2//98 2/26198 _ I__ _
- ~~
.
OFC **TechEd I DD/IMNS* I D/IMNS* I I
NAME EKraus FCCombs DACool _
DATE 2118/98 2/27/98 2/26/98 __________
C=COVER E=COVERIENCLOSURE N=NO COPY OFFICIAL RECORD COPY: G:UN98XX.RLA
IN 98-XX
February , 1998 If significant unaddressed safety concerns remain, then it would be expected that
the licensee would decline to participate in that particular clinical trial.
This information notice requires no specific action nor written response. If you
have any questions about the information in this notice, please contact the
technical contact listed below 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
- Coordinated with FDA, RIII, State of Washington, and ma facturer
- See Previous Concurrence M gi g
OFC l IMAB I ICl IAB / l IMAB l l IM-QB 12 NAME RAyres 4 Cvy LWCam__r JPi__e1 DATE 2/2S/98/ _/98 _ _ _
_2/1//98_ 2/ - /98 OFC **TechEd I D/IMNg-: I
NAME EKrause l a l l iif._}_ _
DATE 2/18/98 1 2/M1198 j 2A/('/98 l
C-COVER E=COVER\ENCLOSURE N=-NO COPY OFFICIAL RECORD COPY: G:\IN98XX.RLA