ML20248G832
| ML20248G832 | |
| Person / Time | |
|---|---|
| Site: | 07002134 |
| Issue date: | 04/16/1998 |
| From: | Adams J GRANDVIEW HOSP. & MEDICAL CENTER, DAYTON, OH |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| References | |
| NUDOCS 9806050355 | |
| Download: ML20248G832 (9) | |
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GIBNDVIEW SOUTHVIEW
'16 April 1998 U.S. Nuclear Regulatory Commission gy Region 111 A'tn.; Chief, Nuclear Materials Safety and Safeguard Branch 801 Warrenville Rd.
Lisle,IL 60532-4351
Dear Sir or Madam:
Tids is to prosid: written report of the loss of material licensed under USNRC License SNM-1603 in accord with regulations specified in 10 CFR 20.2201. This follows my initial telephoned report to Mr. Gould at the NRC Operations Center the anernoon of 19 March 1998 and a similar telephoned report provided to Mr. Go at Region
. Ill the same date.
j At 2 PM EST on 19 March 1998 as facility radiation safety oflicer I was informed of the death of a nuclear pacemaker patient. The pacemaker was of Cordis Omni-Stanicor manufacture and bore model and serial number 184 A-651. This pacemaker was powered by a double encapsulated alpha emitting Plutonium 238 cell with a calibrated activity ofless than 3 Ci at the time ofimplant in 1979.
The patient expired at Grandview Hospital, Dayton, Oldo on 12 January 1998. The body was removed to Tobias mortuary located at 648 Watervliet Avenue in Dayton, Ohio during the afternoon hours of 12 January 1998. The following morning, according to Brent Dacre, a spokesman for Tobias, the pacemaker was removed and placed in a biohazardour waste container. The body was then prepared for cremation which occurred the following day at Woodland Crematorium,118 Woodland Avenue in Dayton, Ohio.
On 15 January 1998, approximately 48 homs after explantation, a driver employed by Stericycle, Inc., a commercial biohazardous waste disposal hauler, removed the waste container from the Tobias premises. Sidpping records obtained from the mortuary show the *aste container identified as " Regulated Medical Waste Class 6.2, UN3291, PGII." It was, therefore, of heavy plastic construction and further identified as being 19x19x32 in dimension and with a net weight of 45 pounds. This was the only biohazardous waste container removed from that location during this time period.
The container was subsequently included with a shipment of similar biohazardous waste containers that were delivered to an infectious waste treatment facility, BMWNC, Inc., located is Matthews, North Carolina on 19 January 1998.~ BMWNC uses micro-Roentgen radiation detectors to monitor all incoming shipments. An on site
. spokrsman has 3tated that no radirtion was detected when this shipment arrived. Verification of that statement can be inferred by the facility's signed acceptance of the waste.
The pacemaker battery manufacturer, at the recommendation of the " United States Atomic Energy Commission",
- conducted impact, crush, temperature and cremation testing on the plutonium powered cells. The outer capsule is a stainless steel-type metal, hastelloy-C276, has a melting point of 2400 degrees F. The inner capsule, a tungsten
. alloy, has a melting point of 5522 degrees F. The stated fire temperature at tle BMWNC plant is insufficient to
' consume either encasing product. It, therefore, must be presumed that the pacemaker sunived the waste incineradon process and was subsequently buried along with other resultant residue on siu.
1 In a conversation with NRC Region II's Mr. Woodruffit was learned that representatives of the North Carolina l
7 Division of Radiation Protection had been at the BMWNC site earlier in March to conduct a survey far other L
i reported lost licensed material. The BMWNC spokesman I inteniewed had indicated the same and stated that "they found nothing." Embedded and shielded by other waste materials and with additional shielding provided by the plastic waste container itself enabled the alpha emitter to escape detection on arrival at the treatnwnt facility.
9806050355 990416 PDR-ADOCK O 4
copathic Health Care l
Grandview
- 405 Grand Avenue
- Dayton, Ohio 45405-4790
- 937 226-3200 Southview
- 1997 Miamisburg-Centerville Road
- Dayton, Ohio 45459-1811
- 937 439-6000 APR 2 i R l
1 Having passed through micro-Roentgen detectors uudetected one can assume no radiation hazard to BMWNC employees. Shielding and distance prosided by the truck cargo area would have, similarly, eliminated the threat of l
i radiation exposure to the Stericycle driver.
l At the mortuary the device resided in the plastic biohazard waste container for no more than 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after removal. A site inspection of the mortuary " prep" room substantiates that no work area within the room is within 1 meter of the waste receptacle. Referring to manufacturer specifications, unshielded the radiation dose rate at one meter "is well below typical USA background. At 50 cm. distance, the dose rate is 0.025 mrem /hr." The mortuary I
spokesman, while no records are available indicating who performed the explant, estimates the explantation time at 3 minutes. If one assumes a contact exposure rate of 6 mrem /hr, maximum exposure to this individual would have not exceeded 0.5 mrem which does not exceed the limits described in 10 CFR 20.1301(a)(2).
Following my notifict. ion of the loss of this device, personal site inspections of, not only the mortuary but, of the crematorium as well were conducted. Using a survey meter equipped with a pancake probe capable of detecting alpha radiation, both areas were thoroughly surveyed as indicated on the attached documents. No radiation in excess of background was detected. Similarly, wipe samples were obtained and forwarded to the hospital's consultant firm for independent analysis. No removable contamination was appreciated.
That retrieval of this desice did not occur at Grandview Hospital after the patient's demise and prior to the body's release to the mortuary constitutes a violation of NRC License SNM-1603. The pacemaker recovery program has been in place for over two decades. The last previous on site removal and recovery was in 1994 and occurred without incident.
Two factors contributed to this loss. The cardiologist who was consulting on the case during the patient's hospitalization was out of town at the time of death. Regrettably, none of the other attending physicians were made aware of fact that the patient had a nuclear powered pacemaker or of the recovery protocol. Secondly, attending nursing personnel, as well as other attending physicians, corroborate that the patient did not wear the required ID bracelet.
To prevent a similar future reoccurrence, computer " flags" are being established for the eight remaining patients with implanted nuclear powered pacemakers under this NRC License. At the time of admission, information services personnel will alert appropriate responsible parties in nursing administration and the radiation safety officer. While this represents an electronic breach of the privileged physician-patient confidential relationship it is the obvious measure to be taken.
Should additional questions arise concerning this report, please contact me at 937-439-6210.
Sincerely,
'fM2
):t IV James D. Adams, Radiation Safety OfIicer pc: Mr. Woodruff, USNRC Region II Encl.(4)
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SITE SURVEY Moduary Preparation Room I
l North Biohazard container Q M
Q "B"
Prep table "B" Holding Area O
Prep table "A" Sini "A" V
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Room size 18' X 22' Area surveys taken with a Ludlum III GM meter equipped with model 44-9 pancake probe:
All area surveys = 0.02 mR/hr Background =
0.02 mR/hr Wipe sample analysis was provided by Associates in Medical Physics LLC, NRC license #
34-26645-01. A Tennelec scaler, Canberra 35 Plus multichannel analyzer display unit and plastic alpha scintillation detector were employed for this analysis. Window was set to detect 4 to 5 meV particles. Background control sample read "0" cpm and "0" dpm.
2 Wipe sampic locations:
Sample #
cpm /100cm dpm T1 = prep. table A 4068 0
0 T2 = prep. table B 4069 0
0 T3 = floor at biohazard 4070 1
1 waste container T4 = Sink A 4071 0
0 T5 = Sink B 4072 0
0
SITE SURVEY a
Crematorium Vehicle entrance Holding aree Retort "B" North Retort "A" Work bench Room size 50' X 50' Area surveys taken with a Ludlum 111 GM meter equipped with model 44-9 pancake probe:
All area survey = 0.02 mR/hr Background = 0.02 mR/hr Wipe sample analysis was provided by Associates in Medical Physics LLC, NRC license #
34-26645-01..A Tennelec scaler, Canberra 35 Plus multichannel analyzer display unit and plastic alpha scintillation detector were employed for this analysis. Window was set to detect 4 to 5 meV particles. Background control sample read "0" cpm and "0" dpm.
2 Wipe sample locations:
Sample #
cpm /100cm dpm W1 = Retort "A" 4073 0
0 W2 = Retort "B" 4074 0
0 W3 = floor at entrance 4075 0
0 to "A" W4 = floor at entrance 4076 0
0 to "B" W5 = floor holding area 4077 0
0
MANIFESTe' Rou 1.
TREATMENT SHIPPING PAPER 53501 I
GescRATORsNAMs TOBIAS FUNERAL HOME enouswUMzRa @ 0 969 a199 GENERATOR'S ADDRESS 648 WATERVLIET AVE GENERATOR s REGISDLATION l
DAYTON OH 45420 CERnnCATe e.
I MONTGOMERY CUSTOMER e yng COumy Description of Waste Container type by (Optional) total Number of dimension Weight or Volume Containers REGULATED MEDICAL WASTE CLAS8 6.2. UN 3291, PO li 17v19v1R REGULATED MEDICAL WASTE CLASS 6.2. UN 3291, Po st 24x15x24 g
REGULATTD MEDICAL WASTE class 6.2. UN 3291, PG !!
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REOULATED MEDICALWAf ICLAS$ 6 2 UN 3m, PC II REGULATED MEDICAL WASTE CLASS 6.2. UN 3291. PG H Supplics Dehvered: I urt,y thes the supplies tuisd hahm== rummind.
IN CASE OF EMERGENCY CALL 800424-9300 amosu Qty item Qty Item Qey asCNI d.
HM2 BAGS 3 RET-L
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RET S h.
- c. CN) B AGS f.
RET-M Osacewar's Ceruncaden.
paalty of enmlaal and civil prosecuijon for the maldag or subndssion fa! unnaments, re ema e, or eni
, I declare that the comaan of dus stupomas are fully and etcunst.ly dcacribed above by proper lag twee and are et fled, packad, owind and labeled, and areis all es is pmper une f transpun igl=sy mocording to state and fateral reguladcas.
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'IltANSPOR1ER 1 COMPANY NAME STERICYCLA INC.
PHONE NUMBER ( B47 ) 945-6550 TRANSPORTER ADDRESS 1419 LAKE COOK ROAD. SUITE 410 TRANSPORTER'S REGISTRATION DEERPIEIE.IL 60015 CERTIFICATE NUMBpA co-Ttio199 TRUCK DECAL #:
TRANSPORTER 1 ACKNOWLEDGEMENT OF RECEIF1 OF MATI. RIALS
& p d r-les 90e Han TitANSPORTER 2 COMPAEINAME 5t Or'lCYC 10. I n d-~
PHONENUMBER ( dU) U4b-bbbU TRANSPORTER ADDRESS 1419 Lake Cook Rd. Suite 410 TRANSPORTER'S REGISTRATION Tian n y. f i e l r4, T f.
ROO 18; CERTIFICATE NUMBER: O OP O O 1 Q Q TRUCK DECAL #:
O I 4 LL4 TRANSPORTER 2 ACKNOWLEDGEMENT OF RECEIFl* 0F M ATERIALS.
TRAILER #:
P> l A d-S m O D,
//998 rruarrn Nam.
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m RANSPORER 3 COMPANY NAME ShiCyc1e. InO PHONE NUMBER ( A 4 '7 ) 945-655n MANSPORM ADDRESS 1410 LGhC 000k Rd, Suite 410 MANSPORTER'S REGISTRATION Lac 1.id, IL 6001, CERECAR NUMBER: gg gg;gg TRUCK DECAL #: -
TRANSPORTER 3 ACKNOWL - E OF OF MATERIALS.
TRAILER #:
signeun f
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OENERATOR DESIONATED INFECHOUS WASTE TREATMErfr FACILYTY AND/OR ALTERNATE INFECTIOUS WASTE TREATMENT FACILITY DESIGNATED FACILITY: BMWNC INC.
ALTERNATE FACI 12TY 3212 RIDGE RD.
MATTHEWS, NC 28105 PHONE NUMBER:
(704) 821-4766 PHONE NUMBER:
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rNFECHOUS WASTETRP.ATMENTFACHRY. 3212 nidge nd, Matth;g,
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l TREATMENTPACILITY ADDRESS INFECTIOUS WASTE TREA FAC11RY ACKNOWLEDGEMENTOF 0
TERIA l
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DISCREPANCY INDICATION:
TREATMENT CERTD1 CATION:THIS 15 TO CERTIFY THAT THE INFECTIOU5 WASTES DESCRIBED ABOVE WERE TR8ATeo IN ACCORDANCE WTTH PARAGRAPH f A) OP RULE 3745 2132 THE CHIO ADMINISTRATIVE CODE.
Phnerfyp Name CY'# 0
$igvistum Das GENERATOR i
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ELECTRONICS PACING SYSTEMS, INC.
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Sunenry of Muclear RTORCELL characteristics and Testing NRHUFRCTURER.
Nuclear Bottery Corporation-9190 Red Oranch Road
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Columbio, nD 21015 I
DESCRIPT10H The RT0nCELL is a Plutonium-238 fueled, thermoelectric generator.
Fusled with alpha particle esitting Plutonium-238 (sith a half-life of 69.6 geces) in the chealcol form Pu02 (Plutonica Orlde) which has been pressed and sintered into o dense pellet.
Greater than 903 pure PU-235 is used eith a less than 0.3 part of PU-236 impurity. Further, precess controla exhange 017 cnd 018 for 0)$ to reduce the neutron rodlation levels. Heutron esission is generally in the 3000 neutrons /sec-gs leuel.
Fuel Iceding le 2.5 curies (150 level milligrams) of Plutonius-238 and the eorious rodletion dose 3 the surface of the battery is less than i ar/h'r neutron and Bassa.
ggG;. gg,5 FUEL. CAPSULE The Pu02 is first contained in a nacil can fabricated iron Tantalus-10 percent tungsten (TR-10u).
This container has head thicknesses tsice that of the cg11ndrical soli to equilibrate stresses from the gradual helium buildup ettendant eith cipha particle decog.
Tantalus-10 tungsten is a high strength refractory alloy possessing a salting point of 55220F and designell l
to withstand seuere mechanical and thermol environments..Each l
container is closed with full penetration melds shich are leak ond.
)
checked and alcroscopically exasined for integrity dge penetront prior to use.
The TR-10LI container is subsequent 1g pieced in a superallog can, C276.
This container is also seided fabricated fras Hestellogla Hestellog-C276 o material much okin to the more elosed.
familiar stainless steels.
It hos high strength, is extremely I
and has a selting point of oxidation and corrosion resistant,is the purpose of this container to prouirre oxi 24000F.
It and corrosion resistance for the TF.-lou and to affect a secondary the possible releasa of Pu0p.
It alli proulde barrier egoinst oxidation protection to 22000F in a fire and Ts, perhaps, the sost l
brine resistent setal kneen to son.
It is felt that the use of pug 7 cnd its subsequent double 0276 prouldes on energy Hostelloy fe against oil credible encapsulation in 78-100 and source for the RT0nCELL shich is sa incidents.
Should inadvertent creaction or burial occur of on "dOO
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l E W W UB TUS B;M M MI-LW HCALL M B0.
303 645 8083 P. 3 RTDMCELL-bearing corpse, there sculd be no hozordous release of I
The source further has the capability of withstanding terminal velocity impoet or the shock from high-powered bullets.
RR013Tl0H '
i
'The radiation levels from the RT0gid. ener19 source sere acasured fiing stendard Eberline neutron serislY7ue (fra badges.
The neutron i
film employed is Kodak Tupe 8 and the gamma radiction is detected by a lithium act ivated TLD, Four badges sere emploued at each distance point and each badge was scanned to de{eralne its localized aoximum and minisua exposure.
R numerical average of the j
noxima and alnlaa mere then obtained to determine the radiation dose levels versus distance from the source.
Attachsent (1) shoss the rodlotion. dose levels achieved from one of 1/82 slope and the rapid decrease of dose rate sit'areement eith the the sourcee versus distance. Hots the excellent c h distance.
One aster from the source, the dose rate is mell belos typical USR background.
At 50 cm distance, the dose rate is 0.025 area /hr, which is belos the guidelines for nuclear powered cardiac pacemakers (both United States Stoalc Energy Consission/Huclear Regulatory Canaission and the European Huelear Energy Agency requirements).
Most of the dose sheen in Rttachment I
is due to neutron (approximately 901) attributable to the (alpha, neutron) reactions eith 017 and B18 in the pug 2 compound.
IMPRCT TESTlHG United States atomic Energy Coemission (Nuclear Regulatory Commission) receneended' impact testing for fuel capsules sietes:
"a.
lapoet - The test shall be performed by projecting the fuel capsule uith an impact velocity of 50a/see onto a flat, essentially unglalding surface (e.g,.,lausgranite, steel or concrete).The ispact target shall have a man mass of 50 times that of the test capsule.'
lapact tests at varying orientations sere performed.
Humber Orient at ion Time Uelocitu 1
End on stud 0.006581 152 ft/sec (46 a/see) 2 Side on 0.003084 320 ft/sec (97 m/see) ~
j 3
End on seld 0.005132 195 ft/sec (59 s/sec) i i
Corner (450) sold 0.005124 195 f t/see (59 m/sec)
{
5 Corner (45e) meld 0.005065 197 ft/sec (60 s/sec) 6 End on stud 0.005204 192 ft/see (58 m/sec) 7 Side on 0.005130 195/ft/sec (59 m/sec) 8 End on Ueld 0.005038 199 ft/sec (60 m/sec) lapoet Test
Conclusion:
The RT0nCELL fuel capsule alli withstand f
lepacts onto granite at velocities for in excess of the 50 m/sec minimum speelfled by the United States Rtcalc Energy Consission l
(Huclear Regulatory Commission) sithout breech of integrity.
There is no orientation shich sould fail the capsule at 50 m/see lepoct onto granlte.
Es the Hastelley-C276 suffered onig sinor bending and ce the Ta-10u inner liner sustained no visible dosage it is concluded that the AT0nCELL fuel capsula elli shot soever'high velocity 1spoet ente o hard surfcce to o feuel sithstand higher than the minisus =pecified.
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303 645 8083 P. 4 cr'ush Testina United States Rtoalc Energy Commission (Muclear Regulatory Commission) recommended crush testing for fuel capsules states:
"b.
Crush - The test shall be corried out by placing the fuel capsule between roughened steel Joss, each at least 2cm thick normal to the direction of the crushing and houing a surface creo shich is large as compared to the area of the capsule fitted to a press proulding a load of 1000kg (2200 lbs). This test shall be corried out in one of three oogs:
,1)
The capsula shall be oriented in the position in uhich it will sustain mariaua demoge
- 2) The test shall be performed eith the capsule gripped in every distinguishable stable orientation between the joes of the press
- 3) Rt least 50 tests ulth condos orientation of the copeule choll be performed This crush test shall be repeated ofter a temperature test consisting of. heating the capsule to 8000C for o period of 30 minutes folloeed by on lanediate mater cuench et roca temperature."
The actual temperature test son conducted by heating the capsule to 5500C for o period of 15 minutes and mater quenching at 680F.
The octual crush test vos performed in 3 orientations (stud, side on and corner-to-corner) sith a 1250kg (276lb) leading.
Crush Test
Conclusion:
Progressive but ainer dosage con be noted as a result of the three crushings.
The first crushing flottened the stud and bulged the capsule at the base near the veld.
The second crush Induced ficttened spots on the laterol corners and the third indented the capsule at opposite ends and on the corners.
The deformation incurred as a result of the three crushings aos greater than that sustained in the lapoet tests but still relatluely minor.
Ulsual examination of the Hostelley-C276 cuter shell at high nognification neueoled no cracking shotsoever.
~
microscopic excaination of the To-100 neuealed no cracks.
As in the case of impact testing, the RTOMCEl.L fuel capsule certainly ulthstood the alniaua levels specified for crushing.. The capsule ses pressed three times sith on adequote norgin of eafety (i.e.
25 percent) and the Hostellog-0276 outer shell aos not even-breeebed.
The To-10t! inner
!!ner aos essentially not even deformed.
Teneerature Test The -United States atoale Eneru Consission (Huclear Regulatory Consission) and European NueTear Enercy Agency recommended temperature test states:
"c.
Temperature Test - The fuel capsule shall be amintained at a temperature of 80000 for o period of 30 sinutes and then lanediately plunged into a large volume of eater at room temperature.
For purposes of this test, the internal pressure of the fuel capsule shall be the anxious ehleh could be ochieved during its design life (10 half-lives of the fuel or 150 geore, shicheuer is smaller.)'
The octual test eas conducted at 8500C for 30 minutes and Quenched I
at reca tssperature, rge* Scud Sdi-E3nN3a of DN13ud S0! NOa10 3"l31 W00 d 69I>I 68. 42 AON
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- 3 ped quoi to Indicate ecpsula pressure to be 1230 ota (18,100 psi) and the stress to be 62,600 psi.
The saterlot properties of To-10u reveal that the 0.2 percent gleid strength at 8160C is 97,800 psi.
This l
acons that the Induced stress could be burdened eith a 50 percent I
margin of safety and still be onlu at the 0.2 percent giald strength point.
By comparision, the D.2 percent yield strength at 13710D is 19,850 psi.
Further, an induced stress of this level elli not cause material failure in less than 16.4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />.
It is therefore concluded that the RTONCELL fuel capsule sill easily eithstand on 800oC temperature environment for one half-hour with o pressure level corresponding to 150 years of helius decog.
Cremation Testing The United States atomic Energy Commission (Huclear Regulatory Consission) ond European Huclear Energy Ageneg reconsend cremotion temperature testing as folloes:
- d.
Cremation Temperature - The pacemaker shall be cointained at a temperature of 130000 for a period of 30 minutes.
For purposes of this test the internal pressure of the fuel capsule shall be the acximus whleh could be achieued during its anticipated useful life.'
The cetual cremation testing ecs performed at 2iODof (131500) for 40 minutes.
Creaction Test
Conclusions:
Stress calculations (en file) Indlecte that alth a 1001 safety margin, capsule stress mill definitely be less then 21,100 psi.
The ability of To-100 to withstand this environment is documented in the acterial property charts and shoe that 40 mil stress relieved Ta-100 alli take 16.4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to rupture at 13160C mitn on Induced stress of 22 000 psl. The results of this test indicott that the To-100' inner Iiner ses not daeaged during the creaction temperature test.
This sunsang is proulded in order that you might have a better understanding of the construction of the ATOMCELL unit as well ce the detailed and rigorous testing required by regulateeg ugencies.
If you have any further cuestions or require any cdditienci interaction, please feel free to contact ee.
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