ML20235H013
| ML20235H013 | |
| Person / Time | |
|---|---|
| Site: | 07001500 |
| Issue date: | 01/27/1987 |
| From: | Shiver J WASHINGTON HOSP. CENTER, WASHINGTON, DC |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20235G901 | List: |
| References | |
| 106747, NUDOCS 8707140458 | |
| Download: ML20235H013 (9) | |
Text
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THE dHINGTON HOSPITAL CLkTER o
1 t ' y) DY M January 27, 1987 I
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Nuclear Regulatory Commission gj
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Radioactive Materials Licensing Branch W
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601 Park Avenue j
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7, King of Prussia, Pa.
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RE:
Radioactive Material License No. SNM-1446 Washington Hospital Center FEE BEMPT kvLA -
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Gentlemen PJease amend the above referenced license to include the following:
1.
As you are aware, Dr. Nicholas Smyth has retired from the practice of cardiac surgery. The principal physician to perform nuclear pacemaker patient follow up in lieu of Dr. Nicholas Smyth's retirement will be Dr. Edward Platia.
P1(ase refer to attachment A for details of Dr. Platia's training and experience.
2.
To date, there are forty-one pacemaker patients requiring follow up per license condition #15.
Thirty-two patients will be followed by Dr. Platia at the Washington Hospital Center. The remaining nine patients will be followed by their private physician.
Our policies and guidelines for patient follow up, pacemaker replacement and recovery has been enclosed as attachment B.
To provide for proper notification in the event of pacemaker malfuncion or patient death, new patient identification cards and brucelets are being obtained (refer to attachment C).
Any quastions regarding this amendment request should be directed to 1
the undersigned.
Sincerely, a o"0EIAL RECORD CDPY"
)1 a, Shiver, Associate Administration,$ Clinical Affairs
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l 8707140458 070311 p=geg i
REG 1 LIC70
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FEB 0 61987 110 IRVING ST., N.W., WASHINGTON, D.C. 20010 h
TRAINING & EXPERIENCE NAME:
EDWARD V.
PLATIA SPECIALITY:
CARDIOLOGY BOARD CERTIFICATION:
INTERNAL MEDICINE, CARDIOLOGY YEAR' 1979, 1981 PREVIOUS EXPERIENCE WITH IMPLANTATION AND FOLLOW UP OF PACEMAKERS:
DURATION & APPROXIMATE NUMBER OF FOLLOW UP CASES:
over 2 years, 75 pacemakers DURATION & APPROXIMATE NUMBER OF PACEMAKERS IMPLANTED:
since 1981, 200 pacemakers AFFILIATION:
Director, Cardiac Arrhythmia Center Washington Hospital Center Attachment A l
THE dHINGTON HOSPITAL CbER m si NUCLEAR PACEMAKER RETURN GUIDELINES
- 1. )
The Radiation Safety Office (RSO) will be contacted by Dr.
Plat ia's of fice in the event that a pacemaker is to be explanted.
- 2. )
If the pacemaker is to be explanted at the Washington Hospital Center (WHC), the RSO shall
- a. )
Ensure proper storage of the pacemaker until it is returned to the manufacturer,
- b. )
Contact the appropriate manufacturer and request the necessary paperwork and shipping container.
c.)
Upon receipt of the shipping container, the pacemaker will be packaged in accordance with manufacturer's instructions.
d.)
Prepare shipping papers to accompany the pacemaker and make arrangement for a carrier.
- 3. )
If the pacemaker is explanted at a facility other than the WHC, the RSO shall
- a. )
Contact the individual expected to remove the pacemaker and instruct them to return
+-
the device to the manufacturer.
- b. )
Contact the manufacturer and request that shipping papers and a shipping container be sent to the facility,
- c. )
Request a written report from the manufacturer verifying that the nuclear pacemaker was received.
4.)
The RSO will submit a written report to the Materials Licensing Branch, within 30 days of the initial notification of malfunction / death.
l l
l Attachment B
THE dHINGTON HOSPITAL CbER rs NUCLEAR PACEMAKER FOLLOW UP/ REPLACEMENT GUIDELINES
- 1. )
Dr. Edward V.Platia will provide follow up at the Washington Hospital Center 2.)
Follow up will be provided every 3 or 6 months as specified by the manufacturer.
Information will be recorded on a Follow -Up Data" form and forwarded to the manufacturer.
A copy of this form will be maintained on file in Dr. Plat ia's of fice.
This for'm establishes patients' clinical status, pacer rate and function.
This form also verifies that the patient has proper identification card and bracelet.
Follow up will be done either iri person or by a telephone monitoring system.
3.)
Private physicians of those patients who do not wish to come to the Washington Hospital Center have been requested to provide Dr.
Platia's office with follow up information.
The information received will be recorded of the " Follow-Up Data" form and forwarded to the manufacturer.
A copy of the form will be maintained on file in Dr.
Plat ia's of fice.
- 4. )
If a patient fails to keep their scheduled appointment, they will be contacted within one week by telephone for possible rescheduling.
If the patient cannot be reached by telephone, a letter will be sent requesting their immediate response.
If the patient fait.s to respond within 2 weeks of the date of the unkept appointment, contact with that patient will be considered loss.
Dr. Plat ia's of fice should contact the Radiation Safety Office on or before the 2 week grace period.
The RSC will submit a written report to the Nuclear Regulatory Commission (NRC) within 10 days after the & week period.
- 5. )
If follow up information, from private physicians is not received by Dr. Plat ia's of fice as expected, the private physician will be contacted by telephone and requested to forward the information as soon as possible.
In the event that cooperation with private physicians breaks down, Dr. Platia's of fice will attempt to contact the patient directly.
If follow up information cannot be ascertained, contact with the patient will be considered loss.
D r.
Plat ia's of fice should contact the RSO after all attempts to obtain follow up information have been made.
If the attempts are unsuccessful, the RSO will submit a written report to the NRC within 10 days of the date they are notified by Dr. Plat ia's of fice.
110 IRVING ST., N.W., WASHINGTON. D.C. 20010
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- 6. )
In the event of patient death or pacemaker malfunction, Dr.
Platia's office should be notified as stated on patient identification cards and bracelets.
The following infortnat ion should be obtained from the person reporting patient death or pacemaker malfunctions
- name of patient
- name of facility to which the patient was taken
- name of the attending physician
- name of individual expected to remove the pacemaker
- telephone number and address of person removing pacemaker Within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of this notification, Dr. Platia or his designee shall verbally report the incident to the Materials Licensing Branch at (301)427-4112.
Dr. Platia or his designee shall contact the RSO at extension 5631 or page operator.
The RSO will then be responsible for contacting the individual expected to removed the nuclear pacemaker and coordinating its return to the appropriate manufacturer in accordance with
" Nuclear Pacemaker Return Guidelines".
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l Attachment B
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?. ' *y THE WASHNGTON HOSPITAL CENTER l
Cardiology O 110 Irving Street NW Washington, DC 20010 0 (202) 541 7685 January 9, 1986 i
i Mr. John Klingensmith Coratomic, Inc.
300 Indian Springs Rd.
P.O. Box 434 Indiana, PA 15701
Dear Mr. Klingensmith:
We would like to request new patient identification cards and bracelets for the nuclear pacemaker patients previously followed by Dr. Nicholas Smyth and now transferred to my care.
I am concerned that all the patients will not make this request on their own.
Thank you for your attention to this matter.
Sincerely, f
hI Ov'JTL/iFi l,, d4'A N Edward V. Platia, M.D.
Director, Cardiac Arrhythmia Center EVP:1w i
1 Attachment C
. Post Omce Box 625700.
- Miami FL 33102 5700. USA 4;./, -
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Telephone 305 5512000 Tdn 6811112 -
December 31, 1986 i
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yh Edward Platia, M.D.
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Mashington' Hospital Center 110 1rving St., N.W.
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Dear Doctor Platiai
$b Recently, we were informed by your Cordis Representative, Mary
- Ti' Millette, that you are now monitoring the patients implanted with 5"-
Cordis' nuclear-powered pacers (model 184) who were formerly under-
. f" Doctor N.P.D. Smyth's care._ I am writing to outline the, Nuclear
- ?-
' Regulatory Commission (NRC) requirements that are associated with the care of these patients, specifically, 1) patient follow-up, t omf
- 2) out-of-service pacers, and 3) identification cards and j ewelry.
A copy of the Protocol and Instructions for Use are f
enclosed for your reference.
.$d The NRC requires that patients be seen at least twice a year.
. Pursuant to this regulation, we will request that follow-up forms be completed in April and October of each year.
This information t,
will be included in semi-annual status reports that we submit to the NRC in June and December.
The names of patients lost to follow-up, i.e.,
not seen for over a year, will be identified in j
these reports.
In the event of a patient expiration or pacer explantation, you must notify the NRC verbally within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> and submit a written Y
report'within 30 days.
These communications should be directed to Ms. Patricia Vacca at (301) 427-4112.
Cordis must also be notified so that we can forward the appropriate paperwork to,you for. completion and provide you with the necessary shipping containers for return of the pacer.
All out-of-service pacers must be returned to Cordis for appropriate disposition of the nuclear power source.
The NRC closely monitors the recovery of these pacers including those associated with patient expirations.
f i
Finally, patients are required and should be periodically I
reminded to carry their identification cards and wear the j
identification jewelry that was provided to them.
New ID cards with your name and telephone number are enclosed for distribution to your patients.
New jewelry with similar modifict.tions is being prefered and will be sent to you under separate cover.
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Attachment C j
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l Edward Platia, M.D.
December 31, 1986
'Page 2
-lh.a Enclosed is a list of patients who had Cordis nuclear-powered pacers implanted,at Washington Hospital Center.
With the
- jjc, exception;of Mr. Lee Clagett, who is under the care of Doctor d t.
David Allen in Leonard Town, MD, all of these patients were being
- 'followed by Doctor Smyth..
.gg j 76 Mary Millette is f amiliar with thase procedures and will be happy p
to provide any additional information or assistance.
If you h;.-
Prefer, you may contact me directly at 1-800-327-2490, extension 2401.
'Thank you:for youricooperation.
Sincerely, Ck.
Norma L. Orr Department Administrator Clinical Research MLW/djb cc M. M111ette
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BETWEEN! William O. Miller, Chief y,,7(, g License Fee Management Branch
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Office of A. administration John E. Glenn, Chief Nuclear Materials Section 8 Division of Engineering and Technical Programs LICENSE FEE TRANSMITTAL A.
REGION y 1.
APPLICATION ATTACHED Applicant / Licensee: N O N i m b n N rf Odck FMPC J
Application Dated:
) 27 W7 Control No.:
Ib67d7 i
License No.:
M,m - 14L) L 2.
FEE ATTACHED Amount:
O Check No.:
O 3.
COMMENTS Signed RQmMti Mn4ke Date Q c) Tl o
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LICENSE FEE MANAGEMENT BRANCH
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Fee Category and Amount:
E)( 7C-pfgQud 2.
Correct Fee Paid. Application may be processed for:
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Amendment N k
Renewal License Signed t
Date S IS Nl REGION I FORM 213 (MARCH 1983)
,