ML20207N029
| ML20207N029 | |
| Person / Time | |
|---|---|
| Site: | 07001397 |
| Issue date: | 10/13/1988 |
| From: | Edwards S ST. MARYS HOSP., RICHMOND, VA |
| To: | NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM) |
| References | |
| NUDOCS 8810180466 | |
| Download: ML20207N029 (6) | |
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October 13, 1988 ST. MARY'S HOSPITAL A Bon Secours Hea'm Care Facility U.S. Nur. lear Regulatory Commission aLL... Document Control Desk Washington, DC 20555 l
Dear Sir:
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Docket Number 070-01397 License Number SNM-1375 Reply to a Notice of Violation This response is to a Notice of Violation (NRC Inspection Report No. SNM-1375/88-01 ) issued September 19, 1988, regarding the death of a patient containing a nuclear-powered (Plutonium-238) pacemaker and the subsequent burial of the patient with the pacemaker. This is to provide formal notification of the incident along with the actions taken to date.
History of Events On March 4, 1988, Yale H.
Zimberg, M.D. was notified of the death of a patient who had a nuclear-poworod cardiac pacemaker.
The patient had died on March 3, 1988. Upon notification of the patient's death, Dr. Zimberg contacted the local field represent-ative of Medtronic, Inc., the manufacturer of the pacemaker, and notified him of the patient's death. The Medtronic representative informed Dr. Zimberg that due to changes in the regulations it was no longer necessary to remove the nuclear-powered pacemaker I
from the patient prior to burial; that burying the pacemaker with the patient was now considered to be an acceptable means of disposing the pacemaker. Following this advice, the patient was buried with the pacemaker.
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The Hospital's Radiation Safety Officer, Marcus A. Gilbert, was l
not notified of the patient's death.
Instead, he found out about the incident in the following way.
On April 27, 1988, Mr.
Gilbert sent routine letters to two cardiologists requesting follow-up care inform 2'. ion for their respective patients who have nuclear-powered pacemakers (copies attached).
On June 27, 1988, l
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U.S. Nuclear Regulatory Commission October 13, 1988 Reply to a Notice of Violation Page 2 Mr. Gilbert's secretary received a call from one Cardiologist's office informing her that his patient had died and had been buried with the nuclear-powered pacemaker.
Mr. Gilbert spoke with the cardiologist's office and followed-up with Dr. Zimberg to gather information regarding the patienc's death and subsequent burial.
Mr. Gilbert then contacted the Modtronic field representative and confirmed with him the information that he had given Dr. Zimberg.
Following this, Mr. Gilbert telephoned Medtronic headquarters and reviewed the incident with Mr. Tom Hawkinson, the corporate radiation safety officer.
Mr. Hawkinson confirmed that the nuclear-powered pacemaker should have been removed from the patient prior to burial and returned to Medtronic for proper disposal.
Mr. Gilbert telephoned the U.S. Nuclear Regulatory Commission Region II office and reviewed the incident with Mr. John Potter on June 28, 1988.
A follow-up interview was conducted with Mr.
Gilbert and me by Mr. Robert A.
Brown, also of the Region II office, on August 4, 1988.
Corrective Action In an effort to prevent recurrence of this type of problem in the future, Mr. Gilbert reviewed the incident and its consequences with Dr. Zimberg.
Following their discussion, a letter (copy attached) was sent to Dr. Zimberg stressing the need to follow the requirements of our NRC Materials License and the importance of notifying the Hospital's Radiation Safety Officer when an incident occurs involving a nuclear-powered pacemaker patient.
Mr. Gilbert also reviewed the incident and its repercussions with the Medtronic field representative to insure that he would not provide erroneous advice in the future.
Please note that in the attached letters to the cardiologists providin7 patient follow-up care, the importance of notifying the Hospital s Radiation Safety Officer when an incident occurs with a pacemaker patient is again stressed.
Thesu letters are sont to the cardiologists every six months to insore that proper care is provided for each patient with a nuclear-powered pacemaker.
St. Mary's Hospital will continue to possess and use all licensed materials in accordance with the provisions of our NRC Materials License and all applicable regulations. We will also continue to be committed to the model program for maintaining occupational radiation exposures at medical institutions as low as is reasonably achievable (ALARA).
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U.S. Nuclear Regulatory Commission October 13, 1988 Reply to a Notice of Violation Page 3 Thank you for your attention to this reply.
Please feel free to contact me if you have questions or need additional information.
Sincerely, c'
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Mr. Stuart A. Edwards Radiology Administrator cc:
Dr. Ronald Calkins Mr. Ronald E. Terry l
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April 27, 1988 Dr. rdward D. Partirosian ST. MARY'S HOSPITAL bbdical Associates of Richmond, Inc.
A em sms Hea*.h Care Fadl4 7605 Forest Avenue Richmond, Virginia 23229
Dear Dr. Hartirosian:
In 1973, St. Mary's Ibcpital was gianted a license by the U.S. Nuclear Regulatory Ocnmission (U.S. tEC) for the implantation of four Plutonium-238 bbdtronic bbdel 9000 nuclear-powered pacomkers. To date we are still required to unintain tnis license for the possession of these paccrakers and for the explantation, recovery ard disposal of each paccmiker. bboting the conditicns of our licenso reqaires that every six (6) months each patient receives a follow-up examination which includes the securing of an electrccardiogram and observing patennker functions before and follcuing application of the nugnet to induce asynchronous cperation of the devicq. We follcu-up exan.inations cust continue for the life of each patient and, follcuing the death of a tutient, we are reqaired to impiccent procedtres for the explantation and prepar disposal of the nuclear-powered paccmaker.
We following patient is currently under your nrd cal care:
Mr. Banurd Parker 1603 lielmsdale Drive Rich.und, Virginia 23233 Per the regairarents of cur U.S. tac liccase, please forsurd to nu a written report indicating when Mr. Parker was seen in your office, his physical condition, results of his electrocardiogram, results of the test perfomx1 to induce asynchrcoous oparation of the paoxnker and your overall evaluation of the con-lition of his nuclear-powered paccrnker.
Propar dispccal of $r. Parker's nuclear-powered pacconker requires that the incenaker to renoved ard returno3 to the nanufacturer. In the event tint you feel this pacenaker should be replaced or uren the death of Pr. Parker, please contact ne or the Nuclear nx11 cine de[urtnent inmcdiately by calling 281-8251 or 281-8264 or 281-8233.
I will initiato steps to insure pro;ur handling a:d disposal of the pTecnaker.
'nunk you for your assistance in this nutter. Please feel free to contact ne shcrald you hwe any gaestions.
Sincerely ycrars, 714ww // A&W m rcus A. Gilbert, M.Sc, Radiation Safety Officer 5mommam noc-m yensecrucon c.nn a moe.
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i April 27, 1988 ST. MARY'S HOSPITAL Dr. Hamid M. Al-Abdulla A om secoss ma m cve ramy 3604 tbnument Avenue Richmeni, Virginia 23230 Dcor Dr. Al-Ah3ulla:
In 1973, St.
Pary's lbspital was granted a license by the U.S. thiclear Regulatory Carmtission (U.S. lac) for the implantation of four Plutonit:n-238 tbdtronic bbdel 9000 nuclear-pnured paccrrakers. To date we are still required to ruintain this license for the possession of these pacemakers and for the explantation, recovery and disposal of each pacem1ker.1beting the conditions of our license requires that every six (6) months each patient receives a follcu-up examination which incitdes the securing of an electrocardiogram aM cbrearving paconuker functions before and follcuing application of the tragnet to iMuoe asynchronous cperation of the devicq. 'Ihe follcu-up examinations must continue for the life of each patient and, ) follcuing the death of a patient, we are required to implcm2nt proceddres for the explantation and propar disposal of the nuclear-powered pacmuker. l 1
'Ihe following retient is currently uMer your axlical care:
Mr. Dteard Connelly 2515 Parkside Avenue RichToni, Virginia Per the requircrrents of our U.S. ICC license, please forward to n3 a written report iMicating when Pr. Connelly was seen in your office, his physical coMition, results of his electrocardiogram, results of the test perforntd to iMuce asynchronous operation of the pacanker and your overall evaluation of the condition of his nuclcar-psured pacamker.
Prepar disposal of Pr. Connally's nuclear-pmured paccruker requires that the pTectraker ba renovul and returned to the nntrafacturer. In the event that you feel this pacauker should te replaced or upon the death of Mr. Connelly, plcose contact nu or the Nuclcar !Ldicine derartm2nt inmadiately by calling 281-8251 or 281-8264 or 281-d233.
I will initiate steps to insure proper lua311ng and dispasal of the pacennker.
Dunk you for your assistance in this rutter. Plcuse foal frw to contact tu shculd you have any questions.
Sincerely yours,
) ) f ?,t n w i Farcus A. Gilb2rt, M.Sc.
R1diation Safety Officer n a t ix w n a
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August 29, 1988 ST. MARY'S HOSPITAL A Bon Secours Hea th Care Fac+t>
Yale H. Zimberg, M.D.
St. Mary's Medical Office Building Suite 208 5855 Bremo Road Richmond, Virginia 23226
Dear Dr. Zimberg:
In 1973, St. Mary's Hospital was granted a license by the U.S.
Nuclear Regulatory Commission for the implantation of four Plutonium-238 Medtronic Model 9000 nuclear-powered pacemakers. To date we are still required to maintair.
this license for the possession of these pacemakers and for the explantation, recovery and disposal of each pacemaker.
i Meeting the conditions of our license requires that every six (6) months each patient receives a
follow-up examination which includes the securing of an electrocardiogram and obsetving pacemaker functions before and following application of the magnet to induce asynchronous operation of tha device. The follow-up examinations must continue for the life 04 each patient and, following the death of a
- patient, we are required to implement procedures for the explantation and proper disposal of the nuclear-powered pacemaker. Proper disposal of each pacemaker requires that the pacemaker be removed from the patient and returned to the manufacturer, Medtronic, Inc.
In the event that you are contacted about the death of a nuclear-powered pacemaker
- patient, please contact me or the Nuclear Medicine department immediately by calling 281-8251 or 281-8264 or 281-8233.
I will initiate steps to insure proper handling and disposal of the pacemaker.
Thank you for your assistance in this matter. Please feel free to contact me should you have any questions.
Sincerely yours,
)h.t tu<y Marcus A. Gilbert, M.Sc.
Radiation Safety Officer MJ1 B1Tc Acas R chmonc Vgraa 23226 804 285 2011 GmJ N' p toime + reed srce 1824
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ATL ANTA, GEORGI A 30323 SEP 191988 Docket No. 070-01397 License No. SNM-1375 St. Mary's Hospital ATTN: Mr. Stuart Edwards Radiology Administrator t
a 5801 Bremo Road Richmond, VA 23226 Gentlemen:
SUBJECT:
(NRC INSPECTION REPORT N0 SNM-1375/88-01) l This refers to the inspection conducted on August 4,1988, at St. Mary's Hospital, Richmond.
The inspection was conducted to review the circumstances associated with violations involving the apparent failure to remove a previously implanted nuclear pacemaker from a deceased individual prior to burial in March 1988.
These apparent violations were reported to the NRC by a member of your staff and discussed with Mr. M. Gilbert, Radiation Safety l
Officer, at the conclusion of the inspection.
4 The violations are described in the enclosed Notice. The NRC is concerned that l
adequate control of the nuclear pacemaker program was not exercised at your j
facility.
If such control is not adequately improved and a similar violation j
occurs, the NRC will consider escalated enforcement actions, including issuance i
of civil penalty or an order suspending your license.
The importance of l
reporting these matters to the NRC was discussed by Mr. W. Cline, Chief of l
Nuclear Materials Safety and Safeguards Branch, with Mr. M. Gilbert, Radiation 3
Safety Officer, via telephone on September 8, 1988, t
In accordance with Section 2.790 of the NRC's "Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and its enclosure l
will be placed in the NRC Public Document Room.
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The responses directed by this letter and its enclosure are not subject to the i
i clearance procedures of the Office of Management and BMget as required by the Paperwork Reduction Act of 1980, Pub. L. No.96-511.
l Should you have any questions concerning this letter, please contact us.
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Sincerely, l
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hilip S o r, 0 4ect r
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pi ision of Radiation Safety
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9 St. Mary's Hospital 2
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Enclosure:
Notice of Violation cc w/ enc 1:
Commonwealth of VA 1
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ENCLOSURE j
NOTICE OF VIOLATION St. Mary's Hospital Docket No. 070-01397 Richmond, VA License No. SNM-1375 During the Nuclear Regulatory Comission (NRC) inspection conducted on August 4, 1988, violations of NRC requirements were identified.
In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions " 10 CFR Part 2. Appendix C (1988), the violations are listed below:
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A.
Condition 14 of License No SNM-1375 requires that during the lifetime of any patient implanted with a nuclear pacemaker, the licensee shall i
continue patient follow-up and replacement procedures for each nuclear pacemaker, including adherence to procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer upon the death of the patient.
Further, 10 CFR 20.301 requires that the licensee dispose of licensed material only by certain specified procedures set forth therein.
Contrary to the above, upon the death on March 3,1988, of a patient i
previously implanted with a nuclear pacemaker, the pacemaker, which contained milligram quantities of plutonium-238, was not recovered and returned to the manufacturer for authorized disposal and was' buried with the individual, a method of disposal not authorized by 10 CFR 20.301.
t This is a Severity Level IV violation (Supplement IV and VI).
B.
Condition 12 requires the licensee to report to 'he NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />,
'l the death of any nuclear pacemaker patient.
Contrary to the above, the death of a nuclear pacemaker patient on March 3, 1988, was not reported to the NRC until June 28, 1988.
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This is a Severity Level IV violation (Supplement V!),
i Pursuant to the provisions of 10 CFR 2.201, St. Mary's Hospital is hereby required to submit a written statement or. explanation to the Nuclear Regulatory Comission, ATTN:
Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region II, within 30 days of the date of the letter transmitting this Notice.
This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation:
(1) admission or l
dental of the violation, (2) the reason for the violation if admitted (3) the i
corrective steps which have been taken and the results achieved. (4) the i
corrective steps which will be taken to avoid further violations, and (5) the date when full compliance will be achieved.
Where good cause is shown, j
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consideration will be given to extending the response time.
If an adequate reply is not received within the time specified in this Notice, an order may be issued to show cause why tne license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken.
FOR THE NUCLEAR REGULATORY COMMISSION
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. Phi ip. ohr, Direc or Didisiono Radiation Safety
'and Safeguards Dated at Atlanta, Georgia this /9/fday of September 1988 r
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