ML20214M490
| ML20214M490 | |
| Person / Time | |
|---|---|
| Site: | 07002199 |
| Issue date: | 06/22/1983 |
| From: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Webb Patricia Walker NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20213D562 | List: |
| References | |
| NUDOCS 8609110139 | |
| Download: ML20214M490 (6) | |
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JUN 221983 FCHL:PCV 070-02199 HEMORANDUM FOR: Willian J. Walker, Jr., Ph.D.
Section Leader Medical and Acadenic Section FROM:
Patricia C. Vacca tiedical and Acadenic Section
SUBJECT:
VETERANS ADMINISTRATION (VA) PLAN FOR CENTRALIZED TESTING 0F ALL EXPLANTED PACEMAKERS CONVERSATIONS IN JAN'JARY 1983 On or about January 17, 1983 John Bowman, Radiation Safety Officer (RS0) for Veterans Administration (VA) tiedical Center, Washington, DC, called ne to discuss a plan proposed by a cardiologist (Dr. RossFletcher)at the VA Hashington. Mr. Bownan called because he was concerned whether the proposal could be inplemented under the current authorizations and requirements of VA Washington's license SNM-1605.
e The plan called for having all VA hospitals ship their explanted
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pacenakers (both conventional and nuclear units) to the VA Washington where the staff would conduct certain testing of the units and then return then to the nanufacturer. A similar center was to be set up to receive units explanted at VA hospitals west of the 111ssissippi. The goals of this plan were:
1.
To have an early indication of failures or other problens with pacemakers.
J 2.
To return defective units or units used for a short tine to the nanufacturer for rebate.
j Obviously, the vast najority of units involved would be non-nuclear pacenakers. However, a sna11 fraction would be nuclear units.
I expressed concern about the nuclear units being included in the plan.
My reservations were based on the fact that:
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Willian Walker JUN 221983 1.
The nanufacturers' current protocols call for sending the nuclear units to the manufacturer for proper disposal; 2.
11edical institutions holding licenses for nuclear pacenakers are connitted to following the nanufacturers' protocols; 3.
The nedical institutions' licenses contain a special condition requiring that the nuclear units be returned to the manufacturer; 4.
fiany people, not only in the licensees' facilities, but also outside of then (e.g., undertakers, D. C. tiedical Exaniner), know that nuclear units go back to the nanufacturers and have nade arrangenents for shipping the units to the appropriate locations.
If the plan proposed by the VA Washington were inplenented, not only would VA Usshington's license need to be anended to authorize this activity, but so also would all of the other VA licenses.
In addition, a massive educational progran would have to take place to train people within the VA systen to send nuclear units to VA Washington, not to the nanufacturer.
At the time of fir. Rownan's original call to ne on this matter, this proposal scened to be a research study.
I questioned how long the VA Washington staff would have the interest, staff and resources to continue the project. Would it " fold" after only a few months or a year or two, only to have to re-anend all VA licenses and to retrain everyone to send the nuclear units back to the nanufacturer?
In ny discussion with ffr. Bowman, I suggested that if the VA Central Office decided to inplenent the proposal:
1.
Nuclear units should be excluded; or 2.
If nuclear units were included in the proposal, then all VA pacenaker licenses would need to be anended and a large-scale trainirg progran inplemented to retrain VA people as to where to send nucler r units.
fir. Bovsian appreciated receiving ny thoughts and said he would relay then to the proper people at VA Washington.
t.ater the sane day Dr. Ross Fletcher, the cardiologist at VA Washington who seened to originete this proposal, called. He discussed the proposal, ny reservations about it and the alternatives I saw for dealing with the natter. Dr. Fletcher's attitude was not one of cooperation; he apparently saw little need to bother with licenses, etc.
for this project.
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willian Walker JUN 221983 Because of his attitude and ny concern about the project, I called VA Central Office and discussed all of these natters with Dr. Jaues Smith and his assistant, Helen Palaskiewicz. Dr. Smith agreed that ay concerns were valid and said he would be sure that any such directives issued by VA Central Office exclude nuclear units.
CONVERSATIONS IN JUNE 1983 At this point I believed that NRC would have no further problens with the natter. However, on June 7,1983, Jin Nicolosi, Region I, called to alert ne that a directive had been issued (by either VA Washington or VA Central Office) and the directive said that all pacenakers were to be sent to one of two centers, one being VA Washington. ffr. Micolosi said he obtained this information fron fir. Bownan, who had called to inquire about NRC's possible enforcenent actions in the natter. Mr. Nicolosi said that he had told Mr. Bowman that, if VA Washington obtained nuclear units in accordance with the recently issued directive, VA Hashington would be in violation of its license.
In view of prior discussions of the natter with flRC, !!RC could consider the violations to be " willful and knowing" and could take actions such as issuing an order to nodify or suspend VA Washington's license (s) and/or to issue a civil penalty.
I inforned Mr. Hicolosi of ny prior conversations with Mr. Bortman, Dr.
Fletcher, and Dr. Smith and promised to try to straighten the natter out.
I called Mr. Bownan on June 7,1983 and learned the following. He had conveyed ny concerns to the Chief of Staff's office at VA Washington who coordinated the issuance of the directive from VA Washington. Ilowever, the final directive was sent out without getting !!r. Rownan's input. He said that the VA San Francisco is to receive explanted pacenakers fron VA hospitals west of the flississippi; he called the Radiation Safety Officer at VA San Francisco who did not know about the directive.
If the directive is not changed to exclude nuclear units, Mr. Bowman is concerned that the shipping address used in the directive is not proper for nuclear units sent to VA Washington; the sane situation probably exists at VA San Francisco even though VA San Francisco does not have a Part 70 license. Also, Mr. Bownan is concerned about the lack of instructions for conplying with Departnent of Transportation regulations on the shipping of the nuclear units.
If the directive is not changed, then VA Vashington's license nust be anended because it authorizes only Cordis and Coratonic units and it only authorizes use of these units in accordance with each manufacturer's protocol.
It does not authorize possession ARCO or ftedtronic units nor does it pernit testing of any of these units.
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Willian Walker JUN 221983 In support of ar, anendment request, I told fir. Bowman that VA Washington should provide the following:
1.
A requast for the specific nuclear units (by manufacturer's nane and model number); the nunber of each unit to be authorized.
2.
A description of the testing to be done and a comitnent to ship the units, as soon as the testing is conpleted, to the respective nanufacturers and to ship the units in accordance with Departnent of Transportation (DOT) regulations.
3.
Identifit.ation of the person (assumed to be Dr. Fletcher) at VA Washington who will be responsible for the nuclear units during the testing process and a description of this individual's training and experience.
4 Description of receipt and shipping procedures that ensure that !!r.
Bownan as RSO will know when each specific nuclear unit is received and when it is shipped out and will be able to ensure that packag-ing and shipping are in accordance with Departnent of the Transpor-tation regulations.
5.
Written assurances that Dr. Fletcher (or whoever will be i
responsible for testing of the nuclear units) is familiar with the procedures described in response to Iten 4 above and agrees to l
follow these procedures.
I also discussed with fir. Bownan the reed for VA San Francisco to apply for a license (or an anendment to its broad license) to possess nuclear-powered pacenakers and for the other VA licensees to anend their licenses.
On June 7,1983, I also discussed these natters with Helen t'alaskiewicz; Dr. Snith was out of the office at the Society of fruclear tiedicine neeting in St. Louis. Dr. Snith's office was not aware of the directive l
having been sent out. Helen said she would bring these natters to Dr.
Smith's attention. She asked for a listing of the VA facilities whose licenses need to be anended; these facilities are the VA fiedical Centers at Buffalo, Dallas, New Drleans, Cincinnati, Brooklyn, San Diego and Los l
Angeles.
In support of anendnents to their licenses, each hospital should send MRC a letter, signed by the hospital director, requesting an anendnent to its license and specifying the license r. umber.
The letter should:
1.
Explain the requirenents of the new directive.
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Willian J. Walker JUN u 1983 2.
Specify that explanted nuclear units will be packaged and shipped in accordance with 00T requirements to VA Washington or VA San Francisco, depending on the licensee's geographical location.
3.
Describe training to be given to the staff to ensure that all appropriate nenbers of the staff are inforned of the new procedure (i.e., send to VA Hashington or VA San Francisco, as appropriate, not directly to nanufacturer).
On June 8,1983, fielen Italaskiewicz called ne to say that she spoke to Dr. Gerrit Schepers, Progran Chief for Cardiovascular Diseases, fledical Service, VA Central Office. She explained the situation to Dr. Schepers and she thought he would call ne to discuss the natter further.
On June 9, 1983, Dr. Schepers called.
I outlined our concerns and stated that we had brought these concerns to the attention of various VA personnel before the directive was issued. Dr. Schepers said that he was not aware of our concerns and apologized that they had not been factored into the directive. Dr. Schepers provided one new piece of information -- the setting up of these two regional centers to evaluate pacemakers is nandated by Congress and the operation of the centers has been funded by Congress.
I nade the following reconnendations to Dr. Schepers:
1.
Consider anending the directive to exclude nuclear pacenakers.. In this case the directive should renind VA hospitals of the need to send the nuclear units directly to the nanufacturer and to package and ship the units in accordance with 00T regulations.
2.
If nuclear units renain included in the directive, then:
a.
Take action as soon as possible to have VA Washington's and VA San Francisco's licenses anended to authorize their receipt and testing of explanted nuclear units and their packaging and shipping of the nuclear units to the respective nanufacturers.
g b.
Take action as soon as possible to have the other VA hospitals' licenses anended to authorize shipping the explanted nuclear units to one of the two central VA testing facilities, rather than directly to the respective banufacturer.
c.
Anend the directive to provide for the correct shipping address for nuclear units sent to VA Washington and to VA San Francisco with a reninder of the need to conply with 00T requirements when packaging and shipping the nuclear units.
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. AN 22 1983 Willian J. Ualker!
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I suggested that Dr. Janes Smith's office night be helpful in "getting the word out" to the respective VA hospitals.
I also offered to work with Dr. Schepers and/or Dr. Snith's office to develop a listing of specific points to be addressed in each anendaent request.
By the end of our conversation, Dr. Schepers had not indicated exactly what action he would take on the directive. He scened to recognize the need to act promptly to straighten out the licenses. He seened inclined to discuss the natter further with Dr. Jares Snith when Dr. Snith returned to his office late in the week of June 12, 1983.
Original Signed P7 PATRICIA C. VI.OCA Patricia C. Vacca flaterial Licensing Branch Division of Fuel Cycle and Material Safety cc: Dr. Janes Snith, VA Central Office J. Nicolosi, Region I R. Thomas, Region V
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Note as of June 22, 1983 Helen called today and said th'at the Director of the Medical Service at VA Central Office has decided that nuclear units should be excluded from the directive on pacemakers. After some administrative problems are resolved, a modified directive should be sent out.
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