ML20236P801
| ML20236P801 | |
| Person / Time | |
|---|---|
| Site: | 07001331, 07001409 |
| Issue date: | 04/30/1987 |
| From: | Droske R VETERANS ADMIN. MEDICAL CENTER, BUFFALO, NY |
| To: | NRC |
| Shared Package | |
| ML20236P784 | List: |
| References | |
| 120230, NUDOCS 8708130057 | |
| Download: ML20236P801 (5) | |
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- 3495 Bailsy Avenue Buffalo NY 14215
,l<.c ' 4 G lM l f f dy veterans
. Administrate. ion c?.,57 pat in Reply Refer To:
' April 30, 1987
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Nuclear Materials Section Division of Engineering and Technical Program US Nuclear Regulatory Commission Washington, D.C.
20555 Gentlemen:
In response to your letter dated March 2, 1987, we have 1
included the following information for:
(1) renewal to continue follow-up procedures for patients with implanted pacemakers; (2) follow-up of patients with nuclear pacemakers; and (3)-two physicians to be added to our license with their signed statement to follow the protocol.
SNM-1305 expires 6/30/87.
/, License no.
License no.
SNM-1376 expires 4/30/88.
Request is made to: (1) renew license no. SNM-1305 which deals with both Medtronic 9000 and Coratomic C101 nuclear pacers; (2) Combine the above license with license no. SNM-1376 which governs Arco Nuclear NUS pacers; (3) Continue follow-up of patients with nuclear pacemakers including their explant and return to the manufacturer for proper disposal when indicated; (4) Retain Dr. Andrew A. Gage as the. physician responsible for nuclear pacer follow-up; and (5) Add Dr. Jacob Bergsland and Dr. Joseph Caruana as a physician also responsible for nuclear pacer follow-up.
Note that at present only 5 patients with nuclear units are being actively followed in the pacemaker clinic.
These include:
- 1) Peck, Robert - Medtronic 9000 2 ) Tasca, A.. - Medtronic 9000
- 3) Traina, O.S. - Medtronic 9000
- 4) McNamara, Carlton - Arco NU 5
- 5) Geiger, Timothy - Coratomic C101
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REG 1 LIC70
, Mg SNM-1376 PDR "Off,.1AL RECORD CDPy" 1
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' America is #1-Thanks to our Veterans"
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Physicians requested to bc added to our license:
- 1) Dr..' Jacob Bergsland Cardiothoracic Surgeon Chief, Cardiothoracic Surgery, VAMC - Buffalo 3495-Bailey Avenue Buffalo, NY 14215
-(716) 834-9200-Licensed _fo practice in New York and Florida,.and=.; - - "
Norway and Sweden-Certified through ths American Board of Surgery (1983) and American Board of Thoracic Surgery (1984)
Six years experience working with cardiac pacemakers (1981)
- 2) Dr. Joseph Caruana General Surgeon Chief, Surgical Service, VAMC - Buffalo 3495 Bailey Avenue Buf f alo, NY 14215' (716)834-9200-Licensed to practice in New York State.
Certified through the American. Board of Surgery (1978)
Ten year exposure to cardiac pacemaking (1977)
RICHARD S.-
DROSKE Medical Center Director Enclosures i
O I am familiar with the Manufacturer's NRC-approved protocol and agree to follow that protocol.
//V AC B BERGSLAND, M4 t
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JOSE PH A.
- CARUANA, M.D.
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v TER4ItATIGI, RENIL7d, AND. FEE ItEOR*RTIQ3 IOR ItSTI'IUTIGAL tlXIEAR PACEMAKEIC
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A.
You request tennination of pur license i.f:
1 1.
You 'do 'not want to implant' nuclear pacetakers in the ' future AND 2.
You have never,, received any pacemakers OR 3.
All pacemakers 'that were rcceived weEe returned to'Ehe narufacturer before implant lin a' patient AND/OR
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All pacemakers implantsd in patients have been recovered and returned
..to the mmufact. urer.
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s B.
'Ib request tennination of your license, please"seni us a_ short letter signed by the hospital ad:ninistrator..Your letter slould be received by NRC before yodr license' expires. ' Ycur letter'sinild"specify y3ur license ru:rber ani chould clearly explain the cirosnstances at your hospit.al...'t. ha,i. it. eke'te. ri..c_i.na^ tion appropr.i. ate. -'.f
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Please reqmst,tenninatio:n:.of your lice.a:~-.nse rather than simply allcwing j
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detennin'ii[pa cr51re. '.!NRC,expertis 'a'sii ni.ficant'iitedh't'.of effort in the license 3
l thE st5tiis'of materials authorized by eipiFed licenses, rl
. th'eir'. disposition, 'etc.', and in' nekirg appropriate' chang'es in cnr records. We would appreciate your help in this matter.
II.
RENEMAL A. gRenewal of your license is appropriate if:
y,,,,gl.,....You need to continue the folloa-up procedures for patients with implanted pacemakers AND/OR 2.
You have one (or rtore) pacemakers in your passession (e.g.,
avaiting shipping instructions ard materials fran the manufacturer)
AND/OR
, ' '3. You sont to maintain the option of implanting pacemakers.
To -rec [uest'TanewalmofWJ41 cense l**please eend das'ndetter/. signed B.
by.g2ia%os)LtalWM 6taf. Your letter should be received by NRC at least*30 days before your 1.icense expires ani child contain the folloairy information in sup,mrt of your reneaal rqmst:
3.
Na-6er of your license that is to b2 rene,e 3.
ED":B, Enclosure 1
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b.)
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b.
Your lnst tution's name and unilirg address as they sinuld appear in Items 1 ard 2 of your renewed license.
The number of pacemakers to be auttorized. If you are c.
autierized for nere than one manufacturer's unit, specify th number of each manufacturer's pscemakers we siculd lorize. Be sure that the numbers you specify are sufficient to cover all patients with implanted paccmakers and any extra you may wint for future implants,
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d.
Activities to ba oxducted under pur 1.icense. The prim-i,ml reasons for renseirg pacenaker licenses are:
(1) to contirne the authorized activities (i.e., receive ani implant pscemakers, follos patients with implanted
, devices, return explanted pacemakers to the manufacturer for pecper disposal), and (2) to follos patients with implanted pacemakers and to return explanted pacemkers to the manufacturer for proper disposal (but not to implant pacanakers in the future). Please explain
' '.., : %. aexactly;diati you'wish to'do with pacemakers.*# 2 J" M P* i
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e.
Updata"of the listing of physicians 4x2 are involved in your.--he program. 'Ihe names of the physicians are found in correspxdence listad in corx11 tion 16. of
' ' ' '., -.' *,"your licenseU.Fbr each nee physician to' be'added to [~ -
5' MhEcify the ' physician's~ nir5e/ of fice"2 -
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2 I""h* your ' lice'ns,addres5. $d"t'elepfene ; umber, " state in Utich licensed.to practice medicine, ~ specialty board certificatic'n, position with your institution, ard describe the physician's previous experience with pacenakers (not necessarily nuclear pacemkers).
You stould also subnit a statenent signed by each nea physician certifying that the physician is fa:ailiar with the nunufacturer's NRC-apprcued protocol and agrees to
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follos that protocol.
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f.
Description of any changes in the ccmmi.tments contained in the correspondence listed in Condition 16. of your license.
III. FEE A.
No fee is required for tenninations.
B.
No. fee'is required for 'rermaal' of a nuclear /. pacemaker-license..if.
M h'bs% thi }nids panahar y J W.
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C.
A renacil Ecc is requirext by 10 CFR 170.31 if yoar inspital do?s not hold arother NRC license.
(Renewal fee shoold ace >nyny renatal requant.)
l W.ILIN. G I..N..,S.,T.RIETIONS IV.
Mail your. application to the appropriate address shosn in 10 CFR Sections 30.6, 40.5, or 70.5.
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