ML19270G250
| ML19270G250 | |
| Person / Time | |
|---|---|
| Site: | 07001717 |
| Issue date: | 03/05/1979 |
| From: | NORWALK HOSP., NORWALK, CT |
| To: | |
| Shared Package | |
| ML19270G245 | List: |
| References | |
| NUDOCS 7906050189 | |
| Download: ML19270G250 (18) | |
Text
.
NORWALK HOSPITAL RESEARCH PROTOCOL FOR CLINICAL INVESTIGATION OF HUCLEAR PACDIAKERS MARCH 25, 1974 REVISED MARCH 5, 1979 790605 0 fiO{
I.
Title of Study Clinical Investigation of Nuclear Pacemaker.
II.
Purnose The purpose of this study is to clinically investigate the performance of Nuclear Radioistotope Powered Cardiac Pacemakers. This clinical investigation is based.on sound biostatistical methodsl and has five major goals which are:
A.
Determine the random failure rate of the nuclear pacemaker and compare it to the conventional battery powered pace =aker.
This determination will also include a characterization of " infant mortality" failure rates and modes.
B.
Determine the failure rate disbritutions and which distributions apply in the statistical treatment of the reliability data. This will in-clude a determination of the accuracy of the Poisson assumptior.s.
C.
Confirmation that there are no long term adverse side effects or other unknown factors associated with nuclear pacemakers.
D.
Determine nuclear pacemaker longevity by characterizing the " wear out" failure rate and mode.
E.
Characterize the practicable aspects of the follow up, traceability and recovery of nuclear pacemakers.
III Description of Pacemaker A.
The nuclear pacemakers to be i= planted during the course of this study are.the ARCO Nuclear Model NU-5, Coratomic C-101 and the Medtronic M. Complete technical data on the tests'under conditions of normal use and conditions of credible accidents are on file with the U. S.
Nuclear Regulstory Cc= mission. Due to the extensive amount of previous testing, the participating medical institutions are not required to perform radiation testing. Under this protocol, the pacenakers con-tain a maximum of 0.5000 grams of plutonium-238 (less than 8 curies).
The resulting dose rate at the maximum point on the pacemaker surface is 6 millirads per hour and 0.4 millirads per hour at 5 centi =eters from the surface along the maximum dose rate line. The pacemakers are available in two types -- fixed rate or demand (R-wave inhibited). Use of.he magnet in thie protocol applies only ts the Model NU-5 demand type pacemaker.
E.
Notify Physics to order a Nuclear Pa'.emaker.
Indicate manufac-turer and model.
1 The ARCO Nuclear Statistical Basis for Clinical Investigation of Radioisotope Pacemakers - August 10, 1973 (Revised March 5, 1979)
IV.
Patient Selection Patients may be of either sex with a maximum age of 65 or minimum age equal to the age of majority for the state of residence (special cases, however, may be considered on an individual basis by the appropriate licens-ing authority for older or younger patients) who,-
A.
Warrant replacement of their existing pacemaker or the insertion of a new pacemaker due to chronic heart block or other cardiac rhythm dis-turbances and B.
Have demonstrated emotional maturity, stability, that they are reliable patients who have a record of stable residence in the community such that they are willing to cooperate in, and are likely to remakin avail-able for the long tens follow-up required and C.
Have no medical condition which in the physician's best judgement would limit life expectancy to less than 10 years.
Exclusions are the presence of a coexisting disease which may potentially linit life - e.g., potentially progressive heart disease, cerebrovascular disease, diabetes with any end organ manifestation or of greater than 10 years' known duration, renal disease, and neoplastic disease.
Probability of lack of full cooperation, high mobility in the population, emotional disturb 9nce, alcholism, or other factors may also contraindicate partici-patio n.
D.
Comments to the above are to be dictated and incornorated into entienr's chart.
V.
Duration of Study It is anticipated that implantations of nuclear pacemakers under this study will continue for about two years and that the minimum time to achieve goals A, 3 and E under Section II is two - three years. Longevit; studies and long term side effects studies =ay raquire much more time, perhaps in excess of ten years, due to the potentially long life capability of the nuclear pacemaker and its design characteristics.
Informed consent shall be obtained from all patients for participation in the program and for the ultimate remeval of pacemaker af ter its expected useful life is exceeded, its failure or the death of the patient, whichever occurs first. The study will continue throughout this period with follow-up by the clinics and rep <.'rting to tha
-a-7-*"-a' on implanted pacemakers.
VI.
Control Grouo In order to accurately compare the nuclear pacemaker with conventional pacemakers sound biostatistical practices require use of control groups.
Therefore, a series of comparable control patients with conventional pace-makers of the same type (i.e., demand or fixed rate, bipolar or unipolar) will be follosed. The control patients will be treated and followed using the same procedure for patient selection, medical procedures, follow-up, and reporting.
The control group will be at least as large as the nuclear pacemaker study group.
( Eevise d Mards 5,19 73)
VII.
Implantation Procedures and Lead Systems Fundamentally, conventional techniques of pacemaker insertion are to be utilized, but with particular attention to insuring that the electrodes and leads utilized have an expected life comparable to that of the pacemaker (in excess of 10 years) and that they have appropriate pacing thresholds.
Because of the 10 or more year goal, it is vital that extreme care be taken to use the best available leads and to insure the best possible lead placement and configura-tion within the body.
Since this is an investigationi program:
and not routine clinical use, it is preferable that a limited number of lead systems be used in order to limit the number of variables in the total pacing system and thus develop more meaning-ful data on longevity and reliabi.1.ity.
Table 1 specifies that.the preferred leads to be used.
It should be noted that the NU-5 pacemaker is of the monopolar type.
In patients with an existing lead, the following shall be done as a minimum, prior to L plantation.
A.
Appropriate chest films must be taken to assess the possibility of unduly sharp curves in leads.
B.
The type of existing electrode must be ascertained and if it is not listed in Table I its use must be approved in advance by ARCO Nuclear.
If doubt exists in the judgment of the re-sponsible physician as to the reliability and/or compatibility of an existing lead, it should be replaced by a new one listed in Table 1 or approved in advance by ARCO Nuclear.
The threshold for pacing shall be tested for all electrodes whether old or new at the time of nuclear pacemaker implant prior to connecting th e lead to the pacemaker.
Only those leads may be utilized in which acceptable thresholds are demonstrated by these tests.
Acceptable thresholds and test procedures are discussed elsewhere in this protocol.
It is important to note that certain information be obtained and recorded prior to and at the time of implantation.
It is, therefore, necessary that the Accountability and Implant Data Form (a copy of which is Figure 1) be fully studied and understood prior to partici-pating in this clinical study.
Thq_ nuclear pacemaker is supplied sealed in gas permeable plastic double bags.
Sterilization procedures prior to shipping are performed in gaseous ethylene oxide.
If the bag is found to be opened or accidentally ruptured, the nuclear pacemaker may be re-sterilized in ethylene oxide gas at temperatures not to exceed 50 C.
Following sterilization at least 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> should elapse prior to implantation to allow complete aeration.
If a pacemaker is dropped, it should not be implanted but, instead, returned to ARCO Nuclear.
1 Revised March 5, 1979)
TPEG I
(
Preferred Isads Ng*
EN D
MD D pter 323-451 Filocardial Fcnopolar Ncra 322-256 Endocardial Fa.cpolar Ncra N
322-620 End cardial Mancpolar Ncra 8
8 322-251 Endocardial Facpolar Fcra 322-261 En W dal htncpolar Ncra 322-281 Endccardial Mcngolar Nera 5814 F?fccardial Bipolar C Wis 331-521 o
t;!
5819 Endocardial Bipolar Card.ts 331-521 6901 Endocardial Bipolar Cbrdis 331-521 6907 Endccardial Fcr_~golar Cordis 331-521 6909 Endecardial Monomlar cow s 331-521 a4
(
bDI'ES:
1, Tb use a lead or >#rter not l'.sted, APID Nuclear appreval is. @ ed.
2.
Fcr bipolar leads, use electredes with lcwest reasured sti:mlatica threshold of pair.
3.
For the Ccrdis 322 series, leads 236 or 620 are preferred dt:e to leer stirmlatien thresholds in general than leads 251,
' 261 or 281.
e
~
VIII.
Threshold Suecifications and Measurements In order to determine if a particular lead can be used with the nuclear pacemaker, its stimulation threshold must be measured and found to be acceptable in addition to meeting all of the previously 6iscussed requirements.
The stimulation threshold must be measured at the time of the nuclear pacemaker insertion but prior to con-nection to the pacemaker.
It is important that both current and voltage stimulation thresholds be measured.
It is also important that battery powered instruments be used in threshold measurements since the e:sposed lead represents a direct current path to the heart and even a minute amount of leakage current from power lines re-presents a potential fibrillation rish if entering the heart directly.
The stimulation threshold will be mueaured utilizing a battery operated pulse generator with adjustable amplitude and width.
The ca_ibrated accuracy should be at least 1 10% and the pulse duration
~
should be adjusted to be in the range of 0.07to 1.00 milliseconds.
The pulse generator rate should be in the range of 65 - 80 ppm.
The negative terminal of the pulse generator is connected to the lead whose threshold is bef.ng measured and the positive terminal of the pulse generator is connected to the indifferent lead which is placed in contact with sabcutaneous tissue.
With the output amplitude of the pulse generater initially set at approximately zero, the amplitude is gradually increased until consistent cap-ture occurs.
The amplitude at which consistent capture occurs is recorded as the stimulation threshold.
Both current threshold and voltage threshold values shall be measured and recorded.
It is sug-gested that an EKG recorder be used to observe consistent capture and that the output of the pulse generator set at threshold values be observed on an oscilloscope and recorded with a scope camera.
Only those electrodes may be utilized in which the measured threshold is no greater than 1.25 ma and 0.90 volts if newly im-planted or 2.50 ma and 1.3 volts if chronically implanted (whether endocardial or myocardial).
IX.
Accountabi_ity and Imolant Data Form In order to insure adequate data for this study it is vital that the Accountability and Implant Data Form (Figure 1) be completed promptly after each implantation and distributed within seven days after implantation as folicws:
Photoco;f to:
Operating Room Copy Surgeon's Copy Patient's Medical Record Manufacturer Physics It should be noted that among other things the pulsing rate of the pacemaker shall be measured and recorded on the Accountability and Implant Dhta Form immediately upon implantation and 12 - 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after implantation.
The rates should be checked by a pulse interval measuring device accurate to Il millisecond or 1 0.1 pulses per minute.
It is recomme rded that the Accountability and Implant Data (Revised March 5, 1979)
NORWALK HOSPITAL NUCLEAR POWERED CARDIAC PACEMAKER ACCOUNTABILITY AND IMPLANT DATA FORM Manufacturer:
ARCO NUS Coratomic C-101 Medtronic 9000 PATiljef lOS4TptCat:CM r - N-e..
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mm.
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_a C27 5:4te To kes Code and Treepw.e Ne6 Retampsh.o to Pneeat Phytestas b) and Mseptal; Neune Crfia Asec.
Civ 1we to hws Code and Te8epPope No.
PACtMAttR Medal Me Serial,na. -
Cate ei Inwtaae PlacemeW. " "_"^^ 1..f estpagnetsulatiestarteurisis/etne sight /se,e posteras/eteena.casteiny emininj/a.encies e
*/ ' 1Aate of Imusmes:
even Mapet
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Castreat ca. PWee negen me.e' Veauge
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HEAAf LEAD Mnesfamwer taegel No.
$ send Ns, Daae et Im.n.
Ptacement.
Epice,cas:
e.gw s et.eair.cre e
treaeameras;tleraanma!.au. net l'rdacydiett we== iesef Preamun Leah: Ipeerest.
huneer. Modes, W taatane Caan?
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Anee. Meece. W imes,.e c uns leone Many Roswees/
,t (Revised tiarch 5,1979).
IX. (cont.)
Form be reviewed in detail prior to participation in this clinical study to insure that all data requested is obtained and reported.
Examples of the type of information required are:
A.
Pacemaken model, type and serial number B.
Date of implantation, surgical procedure and site of implantation C.
Lead identification by type, model and serieal numbers, newly implanted or pre-existing, date of implantation, vein used and location of electrode D.
Threshold measurements and equipment used E.
Stimulation rate of the pacemaker both with and without magnet (if applicable)
F.
History of previous implants, removals of pacemakers or leads, and reasons for such removals.
X.
Follow-Up Data At intervals of every three months during the first year and six months thereafter following nuclear pacemaker implantation each patient shall receive a follow-up examination and the resulting data shall be reported to the manufacturer on the Follow-Up Data Form.
This schedule is to be comoleted orier to discharge of natient.
Copy of schedule to be sert to Phvsics.
Follow-1p of cata includes:
A.
Identification of patient, pacemaker, hospital, physician B.
Date of implanatation and follow-up examination C.
Performance of pacemaker including stimulation rate (with and without magnet, if applicable)
D.
Indication of any malfunction, mudofications or replacements of pacemaker or lead system E.
Physician's opinion and comments on pacemaker and lead system F.
Summary of medical examination G.
Indicate whether patient is carrying ID card and wearing brace-let and whether contact with patient has been maintained since last "ollow-up.
H.
Submit chetoccov of follow-uo form to Physics Ane rollow-up cara snaAA incauce puise Interval measurements (using a device with a 1 1 millisecond or 0.1 ppm accuracy) and a recording of the electrocardiogram (with and without the magnec, if applicable).
The Follow-Up Data form shall be completed and returned to the manufacturer within 10 days of each examination.
In addition, the Follow-Up Data form shall be used everytime the patient is examined even if such exami-(Revised March 5, 1979)
_7_
NORFALK HOSPITAL FOLLOW-UP DATA FORb1 (To be used each time patient is contacted and/or examined including telephone transmission of ECG.)
PATIENT IDENTIFICATION SHEET Patient Name uit Patient Hospital Record No.
ei,ii wi...
Pacemaker Serial No.
Date of implantation Date of Follow-Up Name of Physician Address City State Zip Area Ccde and Telephone No.
, Patient has I.D. Card: Yes No Patient is wearing Bracelet or its Equivalent: Yes No PACEMAKER FUNCTION Satisfactory Unsatisfactory Stimulation Rate: with Magnet w/o Magnet Change from previous rate Change from initial rate MEDICAL EXAMINATION Summary:
i j
(Revised March 5, 1979) *
.j
X.
(cont.)
nations take place more often than the specified frequency including telephone transmissions of ECGS.
The impulse rate of the ~ pacemaker will vary in a predic-table manner due to radioactive decay of the fuel and conse-quent decrease in voltage from the energy source to the elec-tronic circuit or due to slight improvement in the nuclear battery efficiency brough about by gettering action and slight redistribution of thermal hear flow within the battery caused by vigorous patient physical activity stabilize.
If the measured pacemaker rate (either with or without the magnet) deviates from the initial rate recorded after implantation by more than 5 pulses per minute, tha manufacturer shall be noti-fied immediately.
If the pulse fails to capture (during non-refractory phases of the cardiac cycle), *be m=""F="+""a" shall be notified immediately, and the investigators shall seek to pursue the etiology, looking both to potential failures external to the pacemaker and to the pacemaker.
XI.
Explanation Pacemakers will be removed if clinically indicated due to failure, malfunction, development of " Excessive" competition between the pacemaker and normal conducted beats, the death of the patient the anticipated exhaustion of the unit or if the pacemaker rate changes by more than 10 pulses per. minute.
Whenever possible - i.e.,
whenever the patient's welfare is not compromised - tha nanufacturan will be consulted ' prior to the removal of a pacemaker.
Any pace-maker or lead which is explanted or repositioned for any reason shall be reported in writing within 1 week to the manufacturen.
The re-port shall include reasons for action taken, date of action, and associated tests performed.
The pacemaker and, if possible, the intact lead system shall be removed upon death and returned to
+ka manufacturer for evaluation.
If no autopsy is performed, the most probable cause of death shall be stated.
Autopsy findings (if applicable) related to the pacemaker shall be reported and, if possible, the function of the pacemaker and lead system will be determined at autopsy.
All nuclear pacemakers that are explanted for any reason shall be returned to the manufacturer as soon as possible in a shipping package supplied by the nanuracturer and in accordance with labelin,;
and shipping instructions also supplied by *ka m=nufac+urer.
At explantation the nuclear pacemaker rate shall be recorded (with and without the magnet, if applicable) and the manufacturer'shall be consulted, if possible, for additional tests to be performed.
~
XII.
Nctifications The manufacturer and the U.S.N.F.C.
shall be notified by Physics within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the death of any nuclear pacemaker bearer, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads.
The manufacturer and the U.S.N.R.C.
shall be notified within 10 days of loss of contact with a nuclear pacemaker bearer.
(revised March 5, 1979)
-g-
XIII.
R'ecords Data and vital statistics pertaining to the nuclear pace-maker patients shall be maintained as individual files separately from routine hospital records.
These records shall include:
A.
A copy of the Accountability and Implant Data Form B.
Copies of all Follow-Up Data forms C.
A fully executed copy of the document " Informed Consent For Surgical Implantation of Radioisotope Powered Cardiac Pace-maker" (a copy of which is attached)
D.
Any additional information deemed important by the medical staff.
XIV.
Informed Consent All patients shall sign the informed consent statement entitled
" Informed Consent for Surgical Implantation of Radioisotope Powered Cardiac Pacemaker: (a copy of which is attached).
Using this document the patient, or his representative shall be informed and shall agree in writing to the following:
A.
That nuclear pacemakers are under investigation, there are alternative treatments and the patient is willing to partici-pate in the investigation B.
That after the patient's death, or if the useful life of the pacemaker is exceeded, or if it ceases to function effectively for the patient's medical needs, or if the patient requests to have the pacemaker removed, the nuclear pacemaker must be re-turned to the manufacturer.
C.
The patient will always carry the ID ( ard and bracelet on his person, and to notify the hospital or any change in his address or telephone number.
D.
The patient will notify, through the hospital, and the manufac-turer, the appropriate licensing authority prior to any travel outside the United States.
E.
Acknowledgment that the patient has had the opportunity to ask questions pertaining to the surgical procedures, nuclear paci-maker, follow-up procedures, and possib'e alternate methods of treatment.
Copies of the signed consent form shall be given to the patient, to the manufacturer and to Physics and placed in the patient's medical file.
XV. Patient Identification All nuclear pacemaker patients shall carry credentials identi-fying them as nuclear pacemaker patients.
These credentials will include an identification bracelet of.the Medical-Alert type and a (Revised March 5, 1979)
-lo_
d s
URGENT URGE?!T Medica: Alert!
PledicalAlerd (Continued from reverse side) in case of death from any cause or h tha implantaa of a emergency or trauma involving pace.
makers telephone, cottect, the:
Radioisotope Powered Cardiac Pacemaker esCMt f Au Radionudide is 0.6 Plutonium-238 <3 Curies Mdsby W* **
ARCO Nuclear Company Model Number is NU-5 OR tete: bone, collect. the A
SEE OTHER SIDE V ARCO Nuc'earCorrpany FOR EMERGENCY (412) 845 8111 INSTRUCTIONS L**. ** 8 u58 Regulattans require removal of pacemaker upon death.
instruct phone operator call concerns Nuclear Pacemaker - Urgent!
, pacema:ker upon death.Reguta Tons require removal of O
S e
O.
-11_
- Identification of Patient.
Each patient shall carry an I.D. Card-and Bracelet on his or her, person at all times.
Patient may engrave information on bracelet or piece of jewelry of his or her own choice.
These will be furnished to the patient prior to being discharged from the hospital.
1.
The I.D. Card will be a wallet-sized, plastic-laminated card, as follows:
(Front)
I have an implanted Medtronic -isotepic cardiac pacemaker, Laueendicatel Model 9000. It contains 2.5 curies of f's /k Pfutonium 238.
RADihA9RVE la In case of emergency, hospitalisation, or death, call collect:
I e
(Back) 4 Name Address Soc. Sec. fJo.
Paced Rate Date of implant Type of Leads Pacemahee Serial Numtwr_
MC 723dae 2.
The Bracelet (or other piece of jewelry) will be metal and engraved as follows:
I have a nuclear pacemaker - in emergency, hospitalization or death call collect (emergency telephone) and state:
Name of doctor, hospital, city, state Patient's tidme Medt mnic Model 9000
)
Set tal t!..'ber 2,
PATIENT IDENTIFICATION CARDS CORATOMIC C-100 SERIES ISOTOP!C PULSE GENERAT ')RS 4s#
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XV.
(cont.)
wallet sie identification card.
On the bracelet will be engraved the patient's name, the words " Radioactive Pacemaker", the trefoil radiation symbol, the word " Plutonium", and the words "In emergency hospitalization or death call collect (phone number of hospital)".
A facsimile of the identification card is Figure 3 which contains the patient's name, the trefoil radiation symbol, the word " Radio-nuclide", the statement that the patient is the implantee of a Radioisotope Powered Cardiac Pacemaker, manufacturer's name and phone number, pacemaker model number, amount and type of contained radionuclide, the words "In case of death from any cause of emer-gency or trauma involving pacemakers telephone collect (name and phone number of participating institution and doctor (s) in charge)"
the words " Instruct phone operator call concerns Nuclear Pacemaker Urgent'" and the words " Regulations require removal of pacer upon death."
Both the bracelet and identification card will be supplied to the participating institution by the manufacturer following receipt of the A~ccountability and Implant Data Form.
The institution will then give the bracelet and identification card to the patient and remind the patient to always carry them.on his person.
If the cpermanent bracelet and ID card are not available when the patient is discharged from the hospital, a temporary bracelet and ID card containing the same information shall be given to the patient' until the permanent ones are supplied.
For each participating institution the telephone operators will be issued the following instructions:
A.
Any collect calls concerning nuclear pacemakers will be accepted B.
The operator should obtain as much information from the caller as possible including:
1.
Caller's name and where to reach him 2.
Patient's name, condition and where to reach him 3.
If any physician is present, and if so, his name and where he can be reached 4.
Condition of pacemaker, if known (i.e., expelled or still implanted) 5.
Information on patient's ID card, if available C.
Notify immediatelv:
1.
Dr. M.
Krauthamer Ext 2124 or 203 - 655-1416 2.
Cardiac Ca.th Lab Ext. 2109 3.
Radiation Safety Officer Ext. 2714 or officer on call (listed with operator)
Such calls represent potentially severe emergencies and the operator should immediately contact the institution's Radiation Safety Officer and responsible doctor while keeping the caller on the line and standing by.
(Revised March 5, 1979)
~
I understand that the rarlicisotcpe pcwered cardiac pacemaker is an ewi:nental unit.
In order to assess the effectiveness of the devi~ce, and to m:nitor my personal well-being, (Clinic) is interested in collecting data upon the device. Accordingly, I agree to visit (Clinic) in persen or to transmit by telephcne (with the aid of a device supplied to re and applied to the surface of my skin) ry electrocardiogram and an indication of the functiening of the paceraker.
I agree to permit this renitoring to be performd at least cnce every three nonths fcr F..: rirst year and every six ncnths thereafter.
I further agree to pr tide infonration en my clinical ccnditicn as it pertains to the paceraker at no less than six renth intervals. E'urthermore, I consent to disclosure by the clinic of any information acquired by the clinic in regard to the i: plantation of the radioisotcpe pcwered cardiac pacerakers; provided, hcwever, in no event shall such disclosures include my identificatien without my spe W ic written approval.
I unde.rstand and agree that I nust notify (Clinic) prior to any travel cutside of the United States.
I have had the cpportunity to ask any cuestions pertaining to the surgical procedure, the radioisetcpe pcwered cardiac paceraker, and the mandatory follcw-up precedure, and these questiens have been answered to my satisfacticn. Tne possible alternate rethcxis of treat: rent, including the use of conventional chemical battery pcmered pacerakers, have been called to my attention, and I have been given an cpportunity to ask any questicas abcut these alternative rethcds.
With these facts in mind and with the intent of being legally bound, I release any right to cW that the inplantatica of a radioisotc,m pcwered-cardiac pacemaker was not properly authorized, and I agree to the folicw-up procedures and the ultimate return of the unit as detailed above.
I agree to asstre the risk of the inplantation of a radioisotope pcwered pacer and release and discharge _,,
the implanting clinic and my physician frcm failures not caused by th,eir fault er negligence.-
Witness (preferably a relative)
Date Date patient's signature or two Date persens authorized to consent for the patient.
palationships to the patient signing if other than the patient.
I certify that I ha w explained the above procedure.
Dr, DATE
-w
. ~ _....
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t
~-
INED'ID CESCI' EOR SUPSIO1 DIFIJNIATICU OF PADIOISOICPE PCXGD G.PDI1C P;fCM4 I understand that for the treatrent of my cardiac conditien - a disturbance of normal carc'iac ccnduction - a cardiac pacemaker is to be 1:rplanted in re.
I also understand that the surgical prdure (ray /will) r@e the place:mnt of a new elect:tde and lead into or ento the surfa of my heart and the i:rplantaticn of a new cardiac pacemaker, and I understand that while the surgical procedure is not of unreasonable risk, the possibility of ccTplicatiens or even death exists. 'Ihe procedure has been explained to m, in a manner that I cculd understand, and I have had the cpportunity to ask any questicns which I would like.
It is my unders'ading that a radioisotope pcwered cardiac paceraker, which is ncw under ping its initial clinical use in approximately 480 persens, will be utilized for the irplantatien.
I have been told that the pacemaker design has been extensively tested over a pericd of several years.
I have been told that en the basis of these experinents in anirals and in the laboratory, units of this tfpe are predicted to have a reliable life expectancy ccanarable to (and hopefully miderably in excess of) that of current stardW cardiac pacerakers. Ecsever, I understand that it is ingessible to be certain of the paceraker's actual reliability, and no guarantea has been given to ne ccncerning the results which nsy follcw.
I understand that the pa raker does produce radiation, but I have been told by mf attending physician that it is the redical judgrent that this radiatica presents a negligible hazard to nu and the nurbers of my household.
I understand that in censenting to the inplantatien of this paceraker, I am authorizing, as kull, all stard"-d operating procedures, including the administratien of anesthetics which ray be incident to the operation.
For the purpose of advancing redical and scientific kncwledge, I consent to the admittance of cbservers to.the coeratine':ccm.
Ultirately - after rq-death or earliei, if th'e useful N #e of the paceraker is exceeded, if it ceases to functica effectively for my wAimi needs, er if I request to have it rencved - the paceraker nust be recoved and returned to or to its designee, (CliniE)."PA2dbrdingly, I agree to contact i(Clinic) at regular intervals of no less than three ncnths during the first year and every six renths thereafter and whenever I change ntf residence.
I will always carry the apprcpriate identification card en mf person and will at all tinus wear the standard identificatien bracelet.
Notwithstanding my centacting the inplanting clinic follcwing the insertien of a cardiac paceraker of any sort, I agree to remain in pericdic centact with my personal physician.
I will also instruct all rechers of my household and inform those who have extended contact with re that I have received a radioisctcpe p::wered cardiac pacer inplant.
e i
XVI.
Procedure Summary A.
New Patients 1.
Review chart and complete the Nuclear Pacemaker Check List for:
a) Infort i consent b) Comment. on patient selection 2.
Notify Physics to order a Nuclear Pacemaker and state manufacturer and model 3.
Schedule patient for implant not less than two (2) days after expected receipt of Nuclear Pacemaker 4.
Complete the Accountability Form.
Place copy in patient's chart and send copies as follows:
- 0.R.
- Surgeon
- Manufacturer
- Physics 5.
Set up follow-up schedule for patient.
Place copy of schedule in patient's chart.
Send copy of schedule to Physics and add patient to master schedule.
6.
Complete Nuclear Pacemaker check list now for follow-up schedule and Accountability form.
B.
Old Patients 1.
If patient does not keep scheduled appointment attempts are to be made to contact that patient.
If unable to contact patient, notify Physics.
2.
If patient is contacted, set new date for follow-up and notify Physics of the date change.
3.
For each follow-up visit, complete the follow-up form.
Copies of follow-up form to:
a) patient's chart b) manufacturer c) Physics 4
If there is an adverse reaction, notify Physics.
5.
If patient expires, notify Physics and arrange to have the pacemaker explanted.
Y -