ML20210V243
| ML20210V243 | |
| Person / Time | |
|---|---|
| Site: | 07001500 |
| Issue date: | 12/23/1986 |
| From: | Shiver J WASHINGTON HOSP. CENTER, WASHINGTON, DC |
| To: | Jason White NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20210V227 | List: |
| References | |
| NUDOCS 8702180726 | |
| Download: ML20210V243 (6) | |
Text
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THE WASHINGTON HOSPITAL CENTER b
December 23,1986 John R.
White, Chief Nuclear Materials Safety Section C U. S.
Nuclear Regulatory Commission 631 Park Avenue King of Prussia, Pennsylvania 19406 Dear Mr. Whiter In response to your letter dated December 10, 1986, and in reference to the letter sent to us by Dr. Laurence F.
Friedman dated Oct. 22, 1986, we would like to offer the following information concerning our plans in the following of patients whom have nuclear pacemaker implants in accordance with License No.SNM-1446:
1.
Due to Dr. Smyth's retirement we have appointed Dr. Edward Platia with the responsibility of managing the nuclear pacemaker program.
Attachment
'A' is a copy of a letter sent to Dr. Platia, dated December 3, 1986, which outlines his responsibilities for this program.
The Radiation Safety Office is currently working with Dr.
Platia in the development and documentation of guidelines, policies and procedures to be followed for patient follow-up and in the recovery of pacemakers.
Once completed, copies of these procedures will be submitted for your review.
If necessary, a license amendment will be made.
2.
Attachment
'B' outlines recommendations submitted by H.P.S.I.
in their recent audit of our program.
These recommendations have been reviewed and adopted for implementation in support of our plans for ensuring the proper following of nuclear pacemaker patients.
3.
Initial plans for the 40 patients requiring follow-up are as follows:
- 27 have decided to be seen here at Washington Hospital Center
- 2 patients will be followed via Datacorp telephone service
- 1 patient will be seen by private physician
- The remaining 10 patients have not responded to our initial
{
mailings requesting information, nor were we able to contact i
them by phone. In our attempt to establish contact we sent these patients a registered letter on December 17, 1986 (Attachment
'C').
Receipts of delivery and acceptance of these registered letters will serve to verify correct, updated addressed for these patients.
Those who fail to respond in writing or by phone by January 5, 1987, will be considered as lost, and proper NRC notifications will be made.
G702180726 B70210
! llE3 I L IC-7 0 l
9 g gyyG fDk 10 IRVING ST., N.W., WASHINGTON, D.C. 20010 j
We submit this information for your review of our efforts in revising our procedures for the following of these patients with nuclear pacemakers.
Once our guidelines, policies and procedures are complete we will forward a copy to your. office, along.with a license amendment, if.so required.
If there'are any questions regarding this matter, pleare do not hesitate to contact the undersigned.
P Sincerely,
[
J h Sdi r
Associate Administrator for Clinical Affairs cc: Laurence F.
- Friedman, Ph.D.,C.H.P.,
N. R. C.
Chairman, Radiation Safety Committee Radiation Safety Officer Dr. Edward Platia, Cardiology Administrative Director, Washington Heart Assistant Administrator for Ambulatory Services I
ATTACHMENT A
THE WASHINGTON HOSPITAL CENTER eb TO:
Dr. Edward Platia 12/3/86 Arrhythmia Center FROM:
Jay Shiver Associate Administrator
SUBJECT:
Nuclear Pacemaker Patient Follow-Up Enclosed is a copy (Attachment A) of the audit report conducted by H.P.S.I.
as it pertains to NRC Special Nuclear (Pacemaker) Material License SNM-1446.
The report provides an evaluation of WHC's past compliance with license conditions and offers suggestions and recommendations concerning the revision of procedures in lieu of Dr.
Nicholas Smyth's ret irement.
As agreed you will be responsible for periodically evaluating and maintaining records of contact with the patients listed in attachment B.
In the event that NRC notification for ' loss of patient contact' is required you will need to inform the Radiation Safety Office (RSO) of the circumstances.
The RSO will then be responsible for insuring that proper NRC notifications are made.
In the event of a pacemaker malfunction or patient death you are required to contact the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
We are also responsible for insuring that the pacemaker is returned to the manufacturer upon explantation.
The patients family should therefore be instructed to notify your office should either of these occur.
The actual orchestration of the device return and submission o# final written report to the NRC will be coordinated by the Radiation Safety Office.
The NRC has requested that we submit to them our procedures that will be used in patient follow-up and pacemaker recovery (see attachment C).
This needs to be done immediately.
The Radiation Safety Office will assist you in the development and documentation of these procedures.
If there are any questions regarding these matters, please feel free to contact Suzanne Krueger at extension 6537.
cc:
Suzanne Krueger, Radiation Safety Office David M.
Dickey, Biomedical Engineering Dr.
J.
Lindsey, Cardiology Mr.
P.
Stiefel, Washington Heart Mr.
K.
Williams, RSO 110 IRVING ST., N.W., WASHINGTON, D.C. 20010
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.... _., -., ___ ATTACHMENT.B
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' A meeting with Cardiac Datacorp, Inc. was held in August 1986.
Cardiac Datacorp, Inc.-was in the process of enrolling several~
patients into their telephone monitoring service.
Copies of pacemaker evaluations done by'this. service could be sentLto the WBC so as to satisfy their. requirement to continue. follow up.
Cardiac Datacorp requests that a physician from' the WHC be designated as the physician to contact in the event of their d
detection of any problem involving the pacemaker. 'To date, the 4
Inc. is u.of patients intending to enroll with Cardiac Datacorp, identity nknown.
On September 29, 1986, a representative.of HPSI transferred the appropriates files f rom Dr. Smyth.'s of fice to. WHC.
A li.st of 40-patients implanted with nuclear pacemakers authorized under license No. SNM-1446 was compiled.
The following plan for ensuring compliance with license conditions is suggested:
~
- 1. Name a; physician (Cardiology-Specialist) to be-responsible for following nuclear pacemakers.
This 1
~~ physician'will.either evaluate' electrocardiograms.
performed-in house or information supplied by other means.
The pacemaker performance infoimation can!b~e"'~ '~
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supplied by a telephone service.such as Cardiac Datacorp
_(
which was, recommended to the -patients by Dr. -Smyun or~.by '
private ~ physicians seeing~the patients.on~a routine basis.
In either case, WHC must-arrange to receive-copies of th'e 4
-electrocardiograms.
The frequency of evaluation should i
be that specified by the pacemaker manufacturer.
2.-Contact the patients..at least semi-annually:to insure; =
that they are carrying / wearing identification / notification information.
The identification currently worn by these patients references WHC, Dr. Nicholas Smyth and Dr. Smyth's office telephone number.
Updated information should be issued to all patients to ensure contact with the WHC and.
j appropriate individuals is made in the event of pacemaker malfunction or patient death.
1
- 3. Notify the pacemaker manufacturers of new individuals responsible for following patients.
The manufacturers l
are required to maintain similar records and would be able to provide the WHC with valuable.information l
pertaining to the status of pacemakers authorized and procedures for return of pacemakers after explantation.
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- 4. Transfer responsibility for continued replacement procedures to another NRC licensee if a patient has moved out of this area.
If a patient is. transferred to another NRC licensee, the following information.should be submitted to the NRC and pacemaker manufacturer.
l... Nuclear pacemaker manufacturer, model and serial number 2.
License number of facility agreeing to accept the patient.- -
- x...
3.
Letter of confirmation'from the facility accepting-the patient.
- 5. Notify the NRC of the revised procedures for the follow up_of patients necessitated by the retirement of Dr.
Smyth.~.
The~ procedures and recofds pertaining:to license No. SNM-1446'
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should be reviewed periodically by the RSO.or.his designee.
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e ATTACHMENT C
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December 16,.1986 f
Dear (patient name):
As you know, Dr.. Nicholas Smyth has retired from the practice of.
l cardiac surgery and is no longer monitoring your nuclear-powered pacemaker.
As required by.the United States Nuclear Regulatory Commission, the Washington Hospital Center must periodically evaluate your pacemaker and insure its proper return for disposal when eventually removed.
In order for us to fulfill our federal commitments, we must maintain contact as agreed by you prior to implantation of the device.
We have already made several attempts to conta'ct you for an-appointment but have been unsuccessful.
It is.therefore imperative that you contact my office at (202) 541-7685 upon receipt of this letter.
If we fail to. hear from you, we will need to inform the N.R.C.
that contact has been lost.
t Sincerely, f
h? 0 !k.
o w n ul.; u n M Edward V. Platia, M.D.
Director, Cardiac Arrhythmia Center EVP lw 4
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