ML20214M473
| ML20214M473 | |
| Person / Time | |
|---|---|
| Site: | 07002199 |
| Issue date: | 08/29/1983 |
| From: | James Smith VETERANS AFFAIRS, DEPT. OF (FORMERLY VETERANS ADMINIS |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20213D562 | List: |
| References | |
| 22735, NUDOCS 8609110131 | |
| Download: ML20214M473 (6) | |
Text
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Department edicine Washington D.C. 20420 and Surgery 7s-my K Veterans N Administration 4)MI In Reply Refer To:
'83 AUG 29 A10:44 August 26, 1983 Ms. Patricia C. Vacca Material Licensing Branch Division of Fuel Cycle and Material Safety U.S. Nuclear Regulatory Conmission Washington, DC 20555
Dear Ms. Vacca:
Thank you for your letter of Auoust 8, 1983 in which you returned the Washinoton, DC VAMC's application for amendment to their pacemaker License No. SNM-1605.
We are pleased to inform you that the recision of the nuclear pacemaker portion of the VA program on explanted cardiac pacemaker prostheses has been accomplished. For your information, we are enclosing the original VA Circular 10-83-66, April 15,1983, on this progran in addition to the August 3,1983 VA Telegraphic Message which deletes the nuclear pulse generators from the VA Circular 10-83-66.
We appreciate the time and patience which you have extended to the Veterans Administration on this issue.
Since ely, gd U#
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J IESJ.SMIJH,,M.D.
irector,NtglearMedicineService(115)
Enclosures 8609110131 860829 REGI LIC70 SNM-1605 PDR
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TELEGRAPHIC MESSAGE ew.a Os Aos o pasa.e,a seCuany QAssniCAriON VACO 1 ASHING' ION DC P
seO.
ACCOUpmMG QA&&fPICAftON DATE PattAetD FILE 8/3/83 POR INFORMATION Call
"^"' GERRIT W.H. SCHEPERS, M. D.
" " h 9-2550 O ='a's O noon E A.u.tt.m..s.
m TNis $ PACE FOR USE OF COM MUNICA TION UNIT MESSAGE TO N TRAN5MITTED (Use d We ep. ring end allsspraelletsm)
TO: DIRECTORS, ALVA'!C, AND REGIONAL OFFICES WITH OUTPATIENT CLINICS, _
i (REGIONAL DIRECTORS) 00/111 'IHIS IS SUPPLEMENT NO.1 'IO CIRCUIAR 10-83-66 (DTD 8-16-83).
SUBJ: EXPIANTED CARDIAC PACEMAKER PROSWESES (ECPP)
- 1. EPPECTIVE DMEDIAELY, ON PAGE 2. OF PARAGRAPH 3.a.(2), DEIEIE
'1HE LORDS "OR NUCLEAR PUISE GE2 ERA'IORS" ON LINES 4 AND 5.
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- 2. THIS SUPPLEMENT EXPIRES ON APRIL 16, 1984.
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V3torona Administratien Circulcr 10-83-66 Department of Medicine and Surgery i
Washington, D.C.
20420 April 15, 1983 i
i TO:
Regional Directors; Directors, VA Medical Center Activities, Outpatient i
l Clinics, and Regional 0ffices with Outpatient Clinics J
l l
SUBJ:
Explanted Cardiac Pacemaker Prostheses (ECPP) j 1.
Purpose.
It is the intent of this circular to define new procedures to be followed in disposing of certain explanted cardiac pacemaker prostheses (ECPP), including all that are still under warranty.
2.
Background.
a.
Cardiac pacemaker prostheses (CPP) are acquired by the Veterans Administration with the understanding that their batteries have a limited life expectancy, but a presumption that these expensive prostheses are in other i
respects properly manufactured.
VA medical centers explant in excess of one thousand CPP each year.
Most of these are removed to be replaced by new CPP; some are i
also removed because they are no longer needed.
1 b.
The manufacturers' warranties are required to be quite explicit and are summarized in the Marketing Center 3
i Decentralized Schedule governing the acquisition of CPP l
by VA medical centers.
The VA is entitled to reimburse-ment for the unexpired time of the CPP warranty, if pre-mature failure, occurs.
Until recently, there has been no mechanism by which explanted CPP could be tested other than by the manufacturers.
The precise defects that lead to clinical failure of the CPP frequently are not l
reported to the VA.
The recent establishment of the Cardiac Pacemaker Surveillance Centers (see Circular 10-82-72 and Professional Services Letter (11-82-27) has provided the VA with means to evaluate ECPP directly.
3.
Procedures and Responsibilities.
Individual Veterans Administration Medical Facilities:
(1)
Beginning April 1, 1983, all ECCP which are removed because of evidence of clinical failure while j
still under warranty will be sent by registered mail by the Chief of Supply of VA medical centers within Regions 1, 2, 3, and 4 to the Eastern Cardiac Pacemaker Surveillance Center (CPSC), 50 Irving Street, N.W.,
Washington, D.C.
20422, Attn:
Ross D. Fletcher, M.D.
TilIS CIRCULAR EXPIRES ON APRIL 16, 1984
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i Circular 10-83-66 April 15, 1983 Similarly, VA medical centers of Regions 5 and 6 will mail such ECPP to the Western CPSC, San Francisco, CA, Attn Edward Gertz, M.D.
Accompanying the ECPP should be a fully completed VA Form 10-0049.
A copy of this form is attached so that you can reproduce it locally until such time as you receive an initial distribution from the Forms and Publications Depot.
In addition, a shipping label to the manufacturer will be provided together with a request by the VA medical center for reimbursement against the unexpired portion of the warranty.
I (2) ECCP with expired warranties should also be sub-mitted if there is evidence of premature failure, if other unexplained malfunctions have occurred, or if l
they are dual chamber pulse generators or nuclear pulse generators.
These will be analyzed for research purposes.
b.
Cardiac Pacemaker Surveillance Centers:
The centers will subject each ECPP received to non-invasive, non-destructive electronic analysis to determine the extent of depletion of the battery charge and the integrity of its electronic circuitry.
The center staff will then forward the ECPP still under warranty to the manufacturer by registered mail in the same shipping container in which l
it arrived, using the mailing label provided and including the request for reimbursement.
A report on the operating characteristics of each ECPP received will be sent to the originating VA medical center.
The postal registration receipt will accompany this report for ECPP still under warranty.
Copies of reports will also be sent to the manufacturer.
4.
Reports.
On conclusion of each fiscal year a summary report of findings will be sent by each CPSC to reach VA Central Office Medical Service (III) by the last work day of December.each year.
In turn, i
l VACO Medical Service will disseminate the important findings to each health care facility and other appropriate offices, including the FDA t
cnd HHS Bureau of Device Regulation.
RCS 11-67 is assigned.
5.
Assistance with the implementation of this program may be obtained from Dr. Gerrit Schepers, VACO Medical Service, FTS 389-2550.
3 Attachment DISTRIBUTION: COB: (10) only
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FLD: MA-5 each and RD, OC,
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W. J BY,JR.,M.h.
00 8 EX: Box 44-6, Boxes 60 Deputy Chief Medical Director i
54, 52-1 each & 63-5 t
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Att[chmentA CIRCULAR 10-83-66 April 15, 1983 EXPLANTED CARDIAC PACEMAKER PROSTHESIS (ECPP) DATA Date Referring VAMC Station Ident. No.
Address
[
Contact Person Phone No.
Name of Patient SSN Date of Implant Date of Explant Reason for Explants i
Premature Failure (under warranty); number of months remaining under warranty As noted on CPSC Data Revision Form Other t
(Include pertinent rhythm strip or ECG in failure mode.)
Manufacturer of Pacemaker Serial No.
Model No.
Acquisition Cost l
Shipping Label to Manufacturer included?
l l
Request for Reimbursement against unexpected portion of warranty included?
Warranty not applicable.
Sent for research only l
I VAMCs from Regions 1, 2, 3 and 4 will mail this form and the ECCP tot i
VA Eastern Cardiac Pacemiker Surveillance Center (688/005-2) i 50 Irving Street, N.
W.
l Washington, D.C.
20422 ATTN:
Ross D. Pletcher, M. D.
VAMCs from Region 5 and 6 will mail this form and the ECCP tos l
VA Western Cardiac Pacemaker Surveillance Center 4150 Clement Street 6an Francisco, CA 94121 ATTN:
Edward Gertz, M. D.
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