IMPLANTACTIFSETCREMATION:Unproblème !bien!réel! · etc.!En!faitactuellementon!estvraimenten!route!vers!l’homme!bionique!qui!va ... !stimulateurs!cardiaques!implantables,!prothèses!de!hanche,!lentilles!intraE

Didier Gottignies 3 mars 2011

1

Introduction

Implants actifs :

Définition

Législation

Information Batterie

Types d’implant actuellement sur le marché

Zones d’implantation classiques

Implants et crémation

Que dit la loi

Responsabilité

Quel est le risque pour l’installation

Accidents reportés

IMPLANT ACTIFS ET CREMATION: Un problème bien réel...


2

Introduction

C’est un fait. De plus en plus souvent, on retrouve des objects singuliers dans les cendres des crématoriums. Dents, tige de colonne vertébrale, arthrodèse, visses et plaques, électrodes, pacemaker, pompes à morphine, prothèse de hanche, genou etc. En fait actuellement on est vraiment en route vers l’homme bionique qui va pouvoir compenser ses déficits, pallier à des manques et augmenter ses capacités déficiente. C’est la chirurgie augmentative.

Evidemment ces artifices ne vont faire que pallier un temps les déficits mais la grande faucheuse reste bien au bout de chaque chemin.

La problématique des déchets se fait alors d’actualité. Quel sera le devenir de ces déchets dans le sol ou de plus en plus fréquemment dans l’incinérateur?

Devrez-‐vous démonter toute cette chirurgie pour la recycler ? probablement que oui, un jour, mais quand ?

Définition implant:

Implants (art. 28 et 35 de la loi du 14/09/1984) : « Un implant est un dispositif médical qui est implanté partiellement ou totalement par une intervention dans le corps humain ou une ouverture naturelle ou qui remplace une partie du tissu épithélial. Il est destiné à demeurer en place après l’intervention pendant une période d’au moins trente jours. L’implant ne peut être retiré que par une intervention chirurgicale ou médicale ». Exemples : stimulateurs cardiaques implantables, prothèses de hanche, lentilles intra-‐oculaires, valves cardiaques, stents, .


3

Implant Actif

Tout dispositif médical dépendant pour son fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle générée directement par le corps humain ou par la pesanteur et agissant par conversion de cette énergie. Ne sont pas considérés comme des dispositifs médicaux actifs les dispositifs médicaux destinés à transmettre de l'énergie, des substances ou d'autres éléments, sans modification significative, entre un dispositif médical actif et le patient.

Législation

3 JUIN 2010. -‐ Arrêté du Gouvernement wallon déterminant les conditions sectorielles relatives aux crématoriums et modifiant l'arrêté du Gouvernement wallon du 30 juin 1994 relatif aux déchets d'activités hospitalières et de soins de santé 14. Tout implant fonctionnant sur pile est enlevé de la dépouille; 14 MAI 2004. -‐ Arrêté du Gouvernement flamand portant organisation, aménagement et gestion des cimetières et établissements crématoires Art. 28. Lorsque le défunt porte un implant qui fonctionne sur pile, celle-‐ci doit être enlevée avant l'inhumation ou la crémation.

Information Batterie

En ce qui concerne les stimulateurs cardiaques ou tout autre appareil alimenté par une batterie, il est nécessaire de prendre en compte le type de batterie utilisée. Les batteries sont placées à l’intérieur d’un boîtier en métal qui contient le matériel et les composants électroniques. Les principaux types de batterie utilisés pour les pacemakers sont les suivants : 1°) Les batteries au lithium à longue durée (cinq – dix ans) sont les plus communes. Si exposées aux fortes températures de crémation, elles se décomposent en produisant des petites déflagrations qui normalement n’endommagent pas les structures réfractaires des équipements de crémation. Les expériences qui ont été menées indiquent que le processus de crémation peut être tenu sous contrôle à des températures opérationnelles normales, et ce, sans créer de problème particulier au four de crémation.


4

2°) Les batteries à durée de vie brève (deux ans) normalement utilisées jusque dans les années septante étaient à base de mercure/zinc et/ou nickel/cadmium. Aujourd’hui, elles ne sont, normalement, plus utilisées dans les implants. 3°) Les batteries alimentées par des radionucléides (généralement l’isotope du plutonium Pu-‐238) sont encore utilisées dans de nombreux pays comme les USA et les pacemakers qui utilisent ce type de batterie doivent obligatoirement être enlevés avant le processus de crémation. Il s’agit ici d’une mesure de sécurité qui est obligatoire dans de nombreux pays européens même si la fabrication du pacemaker (normalement en titane) assure qu’il est à même de supporter les températures de crémation sans risquer d’être endommagé ou de subir des altérations structurelles.

Qu’est-‐ce qu’une pile au Lithium ?

Une pile au Lithium est constituée d’un boitier étanche en Titane, dans lequel est empilé : -‐ Le fond de boite en Titane qui sera le pôle positif. -‐ Au fond, on place la cathode en dioxyde de manganèse. -‐ Puis l’électrolyte. -‐ Vient ensuite Un séparateur. -‐ Par-‐dessus l’anode en lithium -‐ Et pour finir le couvercle étanche en Titane avec son joint qui sera le pôle négatif.

Dans ce type de pile, n’ayez aucune crainte il n’y a rien de radioactif, cependant elles sont très dangereuses. Les constituants de ces piles. Le lithium (Li) est un métal blanc, appartenant à la famille des alcalins, il est le plus léger de tous les corps solides, sa densité est de 0,53. Il fond à 180,54 °C, et entre en ébullition à 1336°C. Le dioxyde de manganèse (MnO2) se trouve à l’état naturel de couleur noire ou brun, chauffé en présence d’air le dioxyde se décompose vers 535°C en Mn2O3, c’est un composé très réactif, qui réagit vivement à chaud notamment avec des produits tels le soufre et les sulfures qui se dégagent des corps lors d’une crémation, ou d’une incinération, et peut provoquer une explosion. Ce produit est de plus classé nocif pour la santé par inhalation, et ou ingestion.


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Types d’implants actifs

Pacemaker, défibrillateur, neurostimulateur, pompe implantable

Neurochirurgie Pompes programmables implantables Pompes avec débit constant Neurostimulateurs (douleur) Neurostimulateurs rechargeables Valves d'hydrocéphalie Oto-rhino-laryngologie Implants cochléaires Implants cochléaires bilatéraux Prothèses de la parole Urologie Stimulateurs de la vessie Neurostimulateurs pour dysfonction des voies urinaires inférieures + électrodes et accessoires Sphincter urinaire artificiel Chirurgie de l'abdomen et pathologie du système digestif Stimulateurs pour incontinence fécale - graciloplastie

Stimulateurs pour incontinence fécale – stimulation du nerf sacré

Sphincter anal artificiel

Chirurgie du thorax et cardiologie Stimulateurs cardiaques Valves cardiaques Tuteurs coronaires Chirurgie des vaiseaux sanguin Endoprothèses

Neurochirurgie Neurostimulateurs DBS Stimulateurs du nerf vague Neurostimulateurs ischémie Neurostimulateur et accessoires en cas de trouble obsessionnel compulsif (obsessive compulsive disorder) (C) Chirurgie du thorax et cardiologie Coeur artificiel Moniteur cardiaque implantable

Neurochirurgie Chirurgie de l'abdomen et pathologie du système digestif Vidéocapsules endoscopiques 01-03-2010

Convention de revalidation

Défibrillateurs cardiaques Electrodes pour défibrillateurs cardiaques (D)


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Zones d’implantation classique

Attention à contrôler également dans le haut des fesses

Types d’implants :


7

Quels sont les risques ?

⇒ pour le personnel ⇒ pour l’installation ⇒ pour l’environnement ⇒ Pour le souvenir du défunt

De tels dispositifs sont souvent considérés comme potentiellement dangereux pour les structures du four de crémation ainsi que pour la santé et le bien-‐être des opérateurs travaillant sur l’équipement de crémation. De même que toute personne défunte ayant subi des traitements à base de substances radioactives doit être mise en quarantaine avant d’être incinérée. En effet, lorsqu’un pacemaker est soumis à de fortes températures, son conteneur en métal peut se casser et dégager des gaz qui s’épandent rapidement (accompagnés de petites explosions) susceptibles de provoquer l’extinction de la flamme des brûleurs. D’ailleurs, il est nécessaire d’informer les opérateurs de la présence d’un pacemaker dans le corps du défunt avant qu’il ne soit incinéré. Avant toute chose, il faut retirer le pacemaker du corps du défunt avant la crémation. Dans l’éventualité où ce type d’appareil serait identifié et ne puisse être enlevé, la crémation doit être menée comme d’habitude mais en prenant malgré tout quelques précautions : -‐ L’opérateur doit rester en proximité du four afin de pouvoir, si nécessaire,

rallumer rapidement les brûleurs dont la flamme se serait éteinte accidentellement durant le processus ;

-‐ L’opérateur ne doit, pour aucune raison, regarder à travers les portes d’inspection ou les fenêtres de contrôle à l’intérieur de la chambre de crémation. En effet, en cas de rupture du pacemaker, il est possible que les gaz dégagés dans la chambre de crémation s’épandent très rapidement. L’opérateur risque alors de blesser gravement ses yeux.

-‐ Dans les piles Mercure/zinc d’ancienne génération, une production d’hydrogène est réalisée lors de la décharge de la batterie. L’hydrogène étant un gaz explosif, il concours à augmenter la puissance de l’explosion. Sans compter que l’explosion produit des gaz toxiques et une projection de matière potentiellement contaminée du corps. Les batteries au lithium ont remplacé les mercure/zinc mais en restant toujours aussi si pas plus dangereuses. D'une part, cette situation entraîne un traumatisme moral pour la famille du défunt, dont le travail du deuil sera entaché par cet incident.

-‐


8

Mais alors que doit on faire ?

Dans le cas du décès d’un porteur de stimulateur cardiaque, cet appareil doit obligatoirement être retiré soit par un médecin, soit par un thanatopracteur. En effet, le lithium contenu dans la pile du stimulateur va exploser à partir de 180°C (point de fusion du lithium) laissant libre accès aux composants du boitier, sachant que la température d’un four de crémation varie de 600 à 1100°C, il y aura une violente réaction du dioxyde de manganèse dès 535°C, et cela constitue un risque majeur pour le personnel et l’installation du crématorium. Même dans le cas où il devrait y avoir inhumation, le retrait du stimulateur cardiaque est obligatoire du fait qu’il se peut que la famille demande ultérieurement une exhumation aux fins de crémation. Très important ! Il faut se rappeler qu’entre les années 1972 et 1989 des stimulateurs cardiaques à combustible nucléaire ont été implantés, certains corps inhumés dans cette période peuvent être porteur de ce type d’appareil radioactif, mais aussi de 1990 à nos jours des corps inhumés peuvent être porteur d’un stimulateur à pile au lithium, la législation de cette époque n’exigeait pas le retrait. La plus grande prudence est requise pour toute exhumation avec ou sans crémation des restes humains.

Un pacemaker non retiré provoque une « explosion » qui risque de déplacer les briques du four et surtout un glaçage de ces briques qui les empêchera de rayonner la chaleur pour les prochaines crémations… quand l’appareil n’est pas mis totalement hors d’usage.


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Les Pompes = Bombes !

Types de Pompes :

Pompe à Gaz (N-‐Butane)

Ce sont des pompes mécaniques contenant un gaz à l’intérieur (N-‐Butane car le Fréon est devenu interdit à cause de la couche d’ozone… ). Le réservoir de gaz pousse le produit vers l’extérieur et est limité par un fin capillaire.

Pompe électronique

Ce sont des pompes avec batteries Lithium mais en plus avec du gaz ! On combine les risques. La batterie alimente un moteur qui va contrôler l’administration de médicament


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Accidents reportés

1 Pacemaker explosif !

Sudden pain on pacemaker pocket followed by explosion in a patient with a permanent pacemaker.

Ruiz-‐Santana S, Aguado-‐Bourrey JM, Martin-‐Rodriguez A, Perez-‐Arriaga M.

Abstract Une femme de 81 portant un pacemaker alimenté par une batterie mercure/zinc à ressentit une violente douleur à son pacemaker suivi d’une violente explosion.

PMID: 3816328 [PubMed -‐ indexed for MEDLINE]Free Article

a hand-held metal detector might be useful in identifyingpacemakers in mortuaries.

R E S U L T S

The overall questionnaire response rate was 78%. Though47% of the 188 crematoria staff who responded hadpersonal experience of pacemaker explosions at some pointin their career, those explosions were reported to beuncommon (Table 1). Indeed, 41% of staff, when asked toestimate event frequency, reported no events and 27%estimated events once in every 10 years. However, 5% ofrespondents reported pacemaker explosions occurring onceor more a year.

Of the 71 crematoria that had reported distress ordamage as a result of pacemaker explosions, the commonestconsequences were the noise of the explosion and damageto the cremator doors and brickwork—32 (45%) and 30(42%) crematoria, respectively. The cremator was damagedbeyond repair in 3% of cases and in one case the explosionscaused injury to staff. The remains of pacemakers werefound after 15% of explosions.

The procedure for checking that pacemakers wereremoved before cremation was as follows. 99% ofcrematoria staff check the cremation forms to ensure thatthe doctor signing the form has confirmed that there is nopacemaker in the body. 54% of crematoria staff also discussthe case with the funeral director to check that thepacemaker has been removed from the body. Only 9% ofcrematoria staff ask the relatives whether a pacemaker ispresent. 16% make other enquiries (e.g. speaking to thecoroner’s office, mortuary staff, hospital, or medical refereeor placing a reminder slip with the cremation form for theattention of the attending doctor).

Most crematoria staff believe that checking thecremation form is the best method of ensuring thatpacemakers have been removed before cremation. How-ever, only 5% of them knew about implantable cardiacdefibrillators and their explosive potential (one centre

reported a large explosion caused by the cremation of abody containing an implantable cardiac defibrillator). 54%believe that a hand-held metal detector might help identifypacemakers and other implantable devices that couldexplode.

D I S C U S S I O N

This is the first published report of the frequency andconsequences of pacemaker explosions in crematoria.Though these explosions are infrequent, in some crematoriathere is more than one explosion per year. Pacemakerexplosions can damage the cremator, breaking doors orbrickwork. The noise of an explosion may cause distress.Sometimes, pacemaker remains are found. Injury to staff isfortunately rare.

Today, most pacemakers are driven by the lithium/iodine-PVP energy source. At room temperature thesedevices are benign. However, during cremation, whentemperatures reach 1300 8C (2400 8F) for 90 minutes,iodine forms a gas that rapidly expands, causing thepacemaker casing to burst. A chemical reaction also causesan explosion: at 180.5 8C lithium melts and reacts with thegaseous iodine to release in less than 1 second the energywhich would be expended over several years (about64 kcal/mol).

Pacemakers now in the design stage will be potentiallymore explosive and also more difficult to detect postmortem: both manufacturers and patients favour smallerpacemakers that have greater energy. Solid cathode, liquidelectrolyte systems such as the lithium/carbon mono-fluoride and lithium/manganese dioxide pacemakers havegreater gravimetric energy density (watt h/mm3) and aretherefore likely to be future cardiac pacemaker powersources10.

Cremation forms must be completed by medical staff toprevent the inappropriate cremation of pacemakers. Ourstudy demonstrates that most crematoria staff rely on acompleted and accurate cremation form to ensure thatpacemakers are not present in the body. Since it is againstthe code of practice of crematoria staff to open sealedcoffins, they depend on others to provide accurateinformation. Indeed, many crematoria staff discuss theissue of pacemakers with funeral directors, who are able toinspect the body in an attempt to prevent the cremation ofpacemakers.

As a result of the first reported incident, in 19765, twosupplementary questions were added to form B of theCremation Act certificate. They remain in use and ask (a)Has a pacemaker or any radioactive material been insertedin the deceased (yes or no)?; (b) If so, has it been removed(yes or no)? If (b) is answered in the negative, the medicalreferee may, under Regulation 12 of the Cremation354

J O U R N A L O F T H E R O Y A L S O C I E T Y O F M E D I C I N E V o l u m e 9 5 J u l y 2 0 0 2

Table 1 F r e q u e n c y o f p a c e m a k e r e x p lo s io n s in c r e m a t o ri a in t h e U K a se s ti m a t e d b y c r e m a t o ri a s t a ff

F r e q u e n c y o f e x p l o s i o n so c c u r r i n g i n t h e U K

C r e m a t o r i a s t a f f r e p o r t i n ge v e n t a t t h i s f r e q u e n c y ( % )

N e v e r 4 1

O n c e e v e ry 1 0 y e a rs 2 7

O n c e e v e ry 5 y e a rs 1 4

O n c e e v e ry 2 y e a rs 6

O n c e a y e a r 3

G r e a t e r t h a n o n c e a y e a r 2

N o t a n s w e r e d 7


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Pacemaker Blamed As Explosion Inside Coffin Halts Cremation

Saturday, 27 May 2006

A MINOR explosion in a coffin rocked Carlisle’s crematorium after a funeral service yesterday afternoon. The cause is still being investigated – but it is believed to have been the result of a pacemaker being left inside a body.

It is understood that members of the family involved have been informed of what happened.

No-‐one was hurt in the incident and there was no disruption to funeral services or cremations.

The crematorium, in Dalston Road, is operated by the city council’s bereavement services department. It is the only one in north Cumbria.

*Fmm the Intensive Care Unit and the Radiodiagnostic Service,Hospital de M#{233}rida, Badajoz, Spain.

Reprint requests: Dr Ruiz-Santana, c/Felix Valverde Lillo No. 8-3#{176},Edxficio Aihambra, Merida (Badajoz), Spain 06800

CHEST I 91 I 3 I MARCH, 1987 467

were practically the same as those of his brother (Table 1).Both were subsequently treated with mechanical ventilation by

pneumobelts during the night and two other resting hours duringthe day time. A trial ofusingjackets instead ofpneumobelts was notacceptable to the patients. Their symptoms gradually improved andthey returned to their work and to a quite acceptable normal life. Thelast examination (Table 1) showed only mild improvement of respira-tory muscular strength and alveolar ventilation in the first patientand an improvement in lung volume, alveolar ventilation and inmuscle strength in the second. However, it should be emphasizedthat there was no evidence of recovery of the diaphragmatic activityon EMG or any change in the snifftest at fluoroscopy in both of them.During a four-year follow-up of patient A and about 18 months inpatient B, no evidence of systemic neuromuscular disease or othermetabolic, degenerative or proliferative disorders appeared.

DIscussIoN

The diagnosis of bilateral paralysis of the diaphragm in

these cases is supported by: 1) the patient’s complaint ofsevere dyspnea in the supine position, in the absence of heartfailure; 2) contraction of the inspiratory accessory musclesduring inspiration and contraction ofabdominal muscles dur-

ing expiratory, in the absence of obstructive lung disease; 3)

marked reduction oflung volume, without evidence of lung

and heart disease or thoracic deformity; 4) significant de-crease of VC in the supine as compared to the upright

position; 5) significant loss ofinspiratory muscle strength; 6)

paradoxic upward movement of both diaphragms during

sniffing at fluoroscopy; 7) absence ofdiaphragmatic response

to electric stimulation of the phrenic nerve.

At this stage of the disease, it was not possible to distin-guish between primary muscle or nerve lesion. The etiology

remained obscure. No other concomitant or previous infec-

tion, metabolic, degenerative or proliferative neuromuscular

or systemic disorder was found. It appears, thus, to be anisolated lesion ofgenetic origin. Its precise onset could not beestablished, but it is most unlikely to be congenital because

evidence exists that both patients were in excellent physical

condition up until the last few years. It is possible that the

paralysis developed gradually over the years and that for a

while the accessory muscles compensated for the deteriorat-ing function of the diaphragm. The clinical manifestations

only became apparent when the overloaded accessory mus-

des failed to accomplish their compensatory task. This

hypothesis of muscular fatigue is supported by the fact that

after resting with mechanical ventilation, the accessory

muscles regained their functional capacity, which led to asignificant improvement in one patient and partial improve-

ment in the second.To the best of our knowledge, similar cases of familial

bilateral paralysis of the diaphragm of late onset have notbeen previously described.

REFERENCES

1 Norio R, Kaariainen H, RapolaJ, Herva R, Kekomaki M. Familialcongenital diaphragmatic defects. Am J Med Genetics 1984;17:471-83

2 Toriello HV, Higgins JV, Jones AS, Radecki LL. Pulmonary anddiaphragmatic agenesis. Am J Med Genetics 1985; 21:87-92

3 Derenne J PH, Macklem P1 Rousos CH. The respiratorymuscles: Mechanics, control and pathophysiology, part III. AmRev Respir Dis 1978; 118:581-601

Sudden Pain on Pacemaker Pocketfollowed by Explosion in a Patientwith a Permanent Pacemaker*S. Ruiz-Santana, M.D.; J, M. Aguado-Bourrey, M.D.;

A.Martin-Rodriguez, M.D.; and M. Perez-Arriaga, M.D.

An 81-year-old woman with a mercury-zinc powered perma-nent pacemaker experienced the sudden pain on herpacemaker pocket followed by an explosion. We are awareof no other report of the spontaneous and symptomaticbursting of a generator battery with fracture of the pulsegenerator capsule.

n 81-year-old woman with a permanent pacemaker wasadmitted after having experienced, while she sat sew-

ing comfortably in her house, a sudden intense pain in her

pacemaker pocket followed by an explosion, as ifthe roof hadfallen down on her, together with protrusion of the adjacentskin. The patient had received a Medtronic permanent VVI

pacemaker, model 5951, with a unipolar lead six years earlier.

FIGURE 1 A and B. Posteroanterior and lateral chest roentgenogramtaken on admission show the burst battery protruding from thefractured pulse generator capsule (arrow), gas in the pacemakerpocket (double arrow) together with subcutaneous emphysema(multiple arrows) and multiple metallic fragments produced afterthe spontaneous bursting of one of the generator batteries.

© 1987 American College of Chest Physicians by guest on February 13, 2011chestjournal.chestpubs.orgDownloaded from

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I

468 Sudden Pain of Pacemaker Pocket (Ruiz-Santana et a!)

This mercury-zinc-powered pacemaker had been implantedbecause of complete heart block associated with sympto-matic bradycardia. She denied any kind of trauma or infec-tion. Otherwise, the patient’s medical history was non-contributory. Physical examination revealed subcutaneousemphysema over the pacemaker pocket, regular pulse rate at40 bpm, and blood pressure of 170/70 mm Hg. The re-mainder of the physical examination and the screening

laboratory tests were unremarkable. An ECG demonstratedthird-degree atrioventricular block and failure of the pacing

system. A PA and lateral chest x-ray examination obtained

during admission is shown in Figure 1, A and B.

Posteroanterior and lateral chest roentgenogram show theburst battery protruding from the fractured pulse generatorcapsule, gas in the pacemaker-pocket together with sub-cutaneous emphysema, and multiple metallic fragmentsproduced after the spontaneous bursting of one of themercury-zinc pulse generator batteries.

Pacemaker complications are usually classified in two

major categories: medical complications,’ and those relatedto improper function of the pacemaker.2 Among the latter,spontaneous fracture ofthe pulse generator capsule has beenreported only rarely,3’4 and attributed to defective manufac-ture.4 However, spontaneous and symptomatic bursting ofone ofthe generator batteries originating or releasing gas that

FIGURE 2. Pacemaker pulse generator showingthe burst battery and the capsule fracture.

produced subcutaneous emphysema, has not, to our knowl-edge, been previously reported. We also consider it of

interest to point out that gas (hydrogen) formation has been,

among others, one of the most relevant problems with the

mercury cells. This stimulated the introduction of newerenergy sources, such as lithium, that do not evolve any gas.2

Because of the patient’s symptoms, we inserted a tempo-rary pacemaker and removed the malfunctioning generator(Fig 2), while she was in the intensive care unit.

Several days after admission the patient received a perma-nent lithium-iodine powdered Medtronic pacemaker and,

soon after, she was discharged without further incidence.

REFERENCES

1 Phibbs B, Marriott H. Complications of permanent transvenouspacing. N Engl J Med 1985; 312:1428-32

2 Steiner RM, Tegtmeyer CJ. The radiology ofcardiac pacemakers.In: Morse D, Steiner RM, Parsonnet V. eds. A guide to cardiacpacemakers. Philadelphia: FA Davis Company, 1983:27-70

3 Rickards A, Norman J. Clinical classification of generator andelectrode failures. Pace 1980; 3:17-23

4 Rubio-Alvarez J, Fuster-Siebert M, Salgado-Conde JL, Sierra-Q uiroga 1’Iglesias-Carreno C, Garcia-Bengochea JB. Causas pocofrecuentes del malfuncionamiento de marcapasos: Presentaci#{243}nde dos casos. Estimulaci#{243}n cardiaca 1982; 3:168-171


\

4

I

468 Sudden Pain of Pacemaker Pocket (Ruiz-Santana et a!)

This mercury-zinc-powered pacemaker had been implantedbecause of complete heart block associated with sympto-matic bradycardia. She denied any kind of trauma or infec-tion. Otherwise, the patient’s medical history was non-contributory. Physical examination revealed subcutaneousemphysema over the pacemaker pocket, regular pulse rate at40 bpm, and blood pressure of 170/70 mm Hg. The re-mainder of the physical examination and the screening

laboratory tests were unremarkable. An ECG demonstratedthird-degree atrioventricular block and failure of the pacing

system. A PA and lateral chest x-ray examination obtained

during admission is shown in Figure 1, A and B.

Posteroanterior and lateral chest roentgenogram show theburst battery protruding from the fractured pulse generatorcapsule, gas in the pacemaker-pocket together with sub-cutaneous emphysema, and multiple metallic fragmentsproduced after the spontaneous bursting of one of themercury-zinc pulse generator batteries.

Pacemaker complications are usually classified in two

major categories: medical complications,’ and those relatedto improper function of the pacemaker.2 Among the latter,spontaneous fracture ofthe pulse generator capsule has beenreported only rarely,3’4 and attributed to defective manufac-ture.4 However, spontaneous and symptomatic bursting ofone ofthe generator batteries originating or releasing gas that

FIGURE 2. Pacemaker pulse generator showingthe burst battery and the capsule fracture.

produced subcutaneous emphysema, has not, to our knowl-edge, been previously reported. We also consider it of

interest to point out that gas (hydrogen) formation has been,

among others, one of the most relevant problems with the

mercury cells. This stimulated the introduction of newerenergy sources, such as lithium, that do not evolve any gas.2

Because of the patient’s symptoms, we inserted a tempo-rary pacemaker and removed the malfunctioning generator(Fig 2), while she was in the intensive care unit.

Several days after admission the patient received a perma-nent lithium-iodine powdered Medtronic pacemaker and,

soon after, she was discharged without further incidence.

REFERENCES

1 Phibbs B, Marriott H. Complications of permanent transvenouspacing. N Engl J Med 1985; 312:1428-32

2 Steiner RM, Tegtmeyer CJ. The radiology ofcardiac pacemakers.In: Morse D, Steiner RM, Parsonnet V. eds. A guide to cardiacpacemakers. Philadelphia: FA Davis Company, 1983:27-70

3 Rickards A, Norman J. Clinical classification of generator andelectrode failures. Pace 1980; 3:17-23

4 Rubio-Alvarez J, Fuster-Siebert M, Salgado-Conde JL, Sierra-Q uiroga 1’Iglesias-Carreno C, Garcia-Bengochea JB. Causas pocofrecuentes del malfuncionamiento de marcapasos: Presentaci#{243}nde dos casos. Estimulaci#{243}n cardiaca 1982; 3:168-171



12

A council spokesperson said: “There was a minor explosion within the crematorium’s cremator yesterday afternoon.

“The machinery continued to operate normally and there was no lasting damage.

“Staff members overseeing the machinery were unharmed and are investigating the possible cause.

“Cremations continued as planned and there were no disruptions to services.”

It is understood that prior to cremations, it is the responsibility of the family and funeral director to ensure that nothing is within a coffin which may cause an explosion.

In this instance, it is believed the go-‐ahead for the cremation had been given by two doctors.

Pacemakers should be removed before cremation.

http://www.newsandstar.co.uk/news/viewarticle.aspx?id=364828

les defibrillateur explosent encore plus fort


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September 14, 2010 Cremation following Prostate Brachytherapy The BC Cancer Agency has been performing prostate brachytherapy using seeds of radioactive Iodine-125 since July 1998 at its Vancouver Centre. Patients have been issued with wallet cards indicating that they have received the implant and requesting that the BCCA Radiation Safety Officer be contacted for information should the patient require surgery or expire within a two year period post-implant. During their pre-implant consultation, these patients are advised that cremation will not be permitted should they die within two years. The two year period was adopted after discussions with the Registrar, Cemetery and Funeral Services, Ministry of the Attorney General, based on an analysis1 of four possible scenarios which could result from cremation of an implanted patient. In a recent article, William Que2 concludes that the body of a prostate implant patient may be safely cremated at any time, based on the assumption that the seeds rupture at the temperatures encountered in cremation and the radioactive Iodine is released through the stack of the crematorium into the atmosphere. The article cites two currently unavailable reports to the U.S. Nuclear Regulatory Commission (USNRC) and the analysis and conclusions appear to be based on USNRC regulations rather than those of the Canadian Nuclear Safety Commission. A recent case in the lower mainland indicates that the assumption that the seeds rupture during cremation is not necessarily valid. In early December, a deceased prostate implant patient was cremated nineteen (19) months post-implant. The crematorium operator detected radioactive material among the remains using a hand-held geiger counter and contacted the BC Cancer Agency for assistance. Ultimately, 99 apparently intact seeds, 2 visibly damaged seeds, and 6 radioactive fragments of seeds were recovered from cremated remains of the patient and the next body cremated and the cremation chamber itself. The original implant had consisted of 108 seeds. Subsequent assay of the apparently intact seeds demonstrated that the activity was mostly confined to the interior of the seeds with very minimal surface

Whitehead, in socioeconomic deprivation andhealth.As a short report our article must be regarded as

preliminary; we now have further data acceptedfor publication regarding metabolic control ofdiabetes and deprivation, and we are extending ourstudy to consider those diabetic patients whom wedo not usually see, to allow for possible referralbias. We agree that geographically defined diseaseregisters are desirable,4 and we would be happy toshare ideas with other research workers.We were not shown the critical letter before

publication'; this would have been courteous andwould have given us the right of concurrent reply.Finally, we agree with Douglas Altman that weshould all strive for high standards in researchwork.'

WILULAM KELLYMIRANDA KELLY

RASHADMAHMOODDiabetes Care Centre,Middlesbrough General Hospital,Middlesbrough TS5 5AZ

STEVE TURNERKEITH ITOT T

Cleveland County Council Research and Intelligence Unit,Middlesbrough TS1 2YW

1 Jones R, Scouller J, Grainger F, Lachlan M, Evans S, TorranceN. The scandal of poor medical research. BMY 1994;308:591.(26 February.)

2 Kelly WF, Mahmood R, Kelly MJ, Turner S, Elliott K.Influence of social deprivation on illness in diabetic patients.BMJ 1993;307:1115-6.

3 Robinson N, Edouard 1, Diehl A, Fuller JH. Social class andrisk factors for vascular disease in diabetes. Diabetes Metab1984;10:245-9.

4 Killalea D, Davis A, Hanstock G, Hanson J. Disease registersvaluable if geographically defined. BMY 1993;307:1499.

5 Altman DG. The scandal of poor medical research. BMJ1994;308:283-4. (29 January.)

Journals are full ofunoriginal andunimportant researchEDrroR,-I read Douglas G Altman's editorialwith a profound sense of deja vu.' Publications thathave documented the scandal of bogus scientificresearch stretch back to, and possibly beyond,Gulliver's Travels.2 Swift's allegorical account ofscientific research, depicted in Gulliver's visit tothe grand Academy of Lagado in the land ofBalnibarbi, was based on a visit in 1710 to theRoyal Society in London.

Errors in the design of studies and the analysis ofdata, misinterpretation of results, selective report-ing, and selective citation of the literature incontemporary published research are the tip of theiceberg. One of the main problems confrontingclinicians and researchers today is the enormousvolume of published material. This has increasedalmost exponentially in my specialty (anaesthesia),which I suspect is representative of many others:in 1991, 53 anaesthetic journals were publishedworldwide, compared with two in 1923.' Althoughanaesthesia has expanded enormously over thistime, each journal seems to be publishing researchthat is increasingly unoriginal, unimportant, andinvalid. Greene pointed out that many journalslaunched recently are sponsored by publishinghouses rather than professional societies.'This trend has resulted in different goals andperspectives for some journals; profit makingpublications are inevitably under pressure, how-ever subtle, to continue publishing enough articlesto stay in business.

I have two suggestions to improve moraleand reduce the number of publications. Firstly,reputable biomedical journals should publishinfornation on the number and quality of rejectedpapers. In addition, a selected number of papersthat would otherwise be rejected should be pub-lished, without modification, accompanied by aneducational and critical review. Secondly, authorsshould remain anonymous until their article has

been accepted or rejected for publication. Thisapproach might dispel the notion that the inclusionof a well known person in the list of authorsfavourably influences the acceptability of sub-mitted research.There is little more depressing for a young

researcher than to see unoriginal, unimportant,and invalid material being presented or published.Altman concludes that we need less research,better research, and research done for the rightreasons. The impetus for these changes has tocome from the top or we will discourage a wholegeneration ofdoctors from undertaking research.

IAN H LEWISShackleton Department ofAnaesthetics,Southampton University Hospitals,Southampton S09 4XY

1 Altman DG. The scandal of poor medical research. BMJ1994;308:283-4. (29 January.)

2 Swift J. Gudiver's travels. London: Penguin Classics, 1985:223-41.

3 Greene NM. Anesthesiology journals, 1992. Anesth Analg 1992;74:116-20.

Metal implants and cremadonEDrTOR,-Matthew Barry reports the metal resi-dues after cremation.' The guidance notes forthe Environmental Protection Act 1990 (PG5(9 1))define the cremation process, and all crematoriumsin the United Kingdom must comply by 1 April1998. The guidance notes refer to a minimumtemperature of 850° C in the secondary chamber,but do not give any guidance on temperatures inthe primary chamber, where any metal residueswould remain throughout the cremation process.Modem cremators that comply with the

Environmental Protection Act are computercontrolled, and it would be impossible for tem-peratures to reach 1600° C in either the primary orthe secondary chamber. The refractory brickworkwould not be stable above 1500° C. It would beextremely unusual for temperatures to approach1200° C in the primary chamber, and I have neverexperienced a case of implants reaching theirmelting point.

I have regular contact with the Department ofthe Environment, and there is no suggestion thatthe minimum temperature in any of the cremationchambers will be increased. For these reasons Icannot see the need for implants to be removedbefore cremation in the future.

JON P LUBYFederation of British Cremation Authorities,Carshalton,Surrey SM5 3HA

1 Barry M. Metal residues after cremation. BMJ 1994;308:390.(5 February.)

Collecting data on cancerED1TOR,-Few people would disagree with S JKarp's plea for improving the collection of data onpatients with cancer.' The case Karp makes for theclinical oncology information network, however, isunconvincing. One justification claimed for thenetwork is that three studies came to erroneousconclusions in auditing the outcomes of carebecause they used data for cancer registries.2 Thisis incorrect; Karp has misunderstood the studies'design.

All three studies were based on review of casenotes; the cancer registry was used as all or part ofthe sampling frame. The third paper Karp quotes,by Chouillet et al, did not examine outcomes atall. The two others (which did) interpreted thedifferences in survival and disease free intervalwith care. Moreover, these and other studies thathave used data from cancer registries augmented

by case notes have made important observationsabout the treatment of cancer." Data from cancerregistries should not be used uncritically but willcontinue to be valuable for health services research.A new information system is not a magic

solution to the problems of inaccurate and poordata. Most errors in data result from a lack of, orpoor quality, information in the case notes. Theclinical oncology information network would bejust as dependent as Korner and cancer registrieson returns of clinical data.Most worryingly, Karp suggests that the net-

work would "belong to the Royal College ofRadiologists," which would own the summary dataand control access to them. That is unlikely to bethe best way of improving services. Althoughpeer review may be important, the evidence thatit produces a sustained improvement in healthservices in the absence of other incentives ismixed.7 The lack of improvement in care notedin the recent confidential inquiry into maternalmortality emphasises this.The reforms of the health service have resulted

in health authorities being required to commissionquality health care on behalf of their residents,which necessitates an informed dialogue betweenpurchasers and providers. For that to happen,health authorities must have adequate informationabout needs, effectiveness, and the outcome ofservices. Health authorities, general practitioners,and patients need greater openness about informa-tion. Improving our current systems (includingcancer registries) is a better investment than dupli-cating them.

IAN BASNETrCamden and Islington Health Authority,London NWI 2LJ

ALLYSON M POLLOCKDepartment of Public Health Sciences,St George's Hospital Medical School,London SW17 ORE

MIKE GILLBrent and Harrow Health Authority,Harrow,Middlesex HAl 3UJ

1 Karp SJ. Clinical oncology information network. BMJ 1994;308:147-8. (15 January.)

2 Basnett I, Gill M, Tobias JS. Variations in breast cancermanagement between a teaching and a non-teaching district.EurJ Cancer 1992;28A: 1945-50.

3 Gulliford MC, Petruckevitch A, Bumey PGJ. Survival withbladder cancer, evaluation of delay in treatment, type ofsurgeon and modality of treatment. BMJ 1991;303:437-40.

4 Chouillet AM, Bell CMJ, Hiscox JG. Management of breastcancer in southeast England. BMY 1994;308:168-70.

5 Gulliford MC, Barton JR, Boume HM. Selection for oesophagec-tomy and post-operative outcome in a defined population.Quality in Health Care 1993;2:17-20.

6 Connolly CK, Jones WG, Thorogood J, Head C, Muers MF.Investigation, treatment and prognosis of bronchial carcinomain the Yorkshire region of England. Br J Cancer 1990;61:579-83.

7 Lomas J. Teaching old and not so old docs new tricks: effective waysto implement research findings. Ontario: Centre for HealthEconomics and Policy Analysis, McMasters University, 1993.(Working paper 93-4.)

Collapse ofthe health service inGeorgiaEDrrOR,-Like its neighbours Armenia andAzerbaijan, Georgia struggles with the politicaland economic backlash of the disintegration of theSoviet Union. Planning for most sectors of societywas previously done in Moscow, and the economywas based on imports from Russia, includingtourists and vaccines. Relations with Russia arestrained at present, and trade is much reduced.Last year the violent secession of Abkhazia andSouth Ossetia forced 300 000 Georgians to flee andseek refuge in Georgia, which is an additionalburden for the government.The state run health system is grinding to a halt.

During winter there is a lack of energy for heatinghospitals and clinics. Patients rarely visit healthinstitutions anyway owing to lack of transport,

BMJ VOLUME 308 19 MARCH 1994 791


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contamination. The presence of apparently intact seeds in the cremated remains effectively changes the issue from one of public health (exposure to radioiodine released through the crematorium stack) to one of occupational health (potential exposure of crematorium staff to free radioiodine if the remains are processed in the normal manner). A typical implant would require a period of twenty (20) months to decay to the point where the total activity remaining in the implant was equal to the Annual Limit of Intake (ALI) of Iodine-125 by inhalation for workers. At this time, the BC Cancer Agency considers it prudent to maintain our recommendation that cremation not be permitted for two years post-implant. This provides an additional two half-lives and results in 1

Kennelly, G.M., “Prostate Brachytherapy and Cremation: An Estimate of Hazards”, presented at the Annual Meeting of the Canadian Radiation Protection Association, Montreal, June 2000. Que, W., “Radiation safety issues regarding the cremation of the body of an I-125 prostate implant patient”, Journal of Applied Clinical Medical Physics, Vol. 2, No. 3, Summer 2001, pp.174-177. 2a typical implant containing one-quarter of an ALI. The actual fraction of the activity in the remains which is likely to be inhaled by a worker is unknown at this time. A further recommendation to the funeral service providers will be that only major bone fragments - which are unlikely to contain any seeds - be processed. While the wallet cards carried by patients have resulted in physicians contacting the BC Cancer Agency for information if future surgery is contemplated, they have - at least in the case above - failed to provide the desired level of information to funeral service providers. Although the therapy completion letter currently sent to the referring physicians by the BCCA radiation oncologists contains a request that the presence of the implant be noted on the “Medical Certificate of Death”, this has not always been the case. The BC Cancer Agency would greatly appreciate the assistance of the physicians and members of the Coroner’s Service in the province in ensuring that the funeral service providers receive notification regarding the presence of a radioactive implant via the “Medical Certificate of Death”. Rather than worry about post-implant time frames, physicians and coroners should simply note the presence of any implants known to them. This notification will alert funeral service providers to contact the BC Cancer Agency for information regarding the implant and any recommended procedures to follow based on the actual activity remaining at the time. Wayne A. Beckham PhD MACPSEM FCCPM Adjunct Professor, UVic Physics & Astronomy Dept. UVic/BCCA Medical Physics Graduate Program Director Provincial Medical Physics Leader Radiation Safety Officer BC Cancer Agency, Vancouver Island CentreJune 7, 2010nt.

Conclusion.

Oui, le risque est grand d’oublier un implant actif dans le corps humain et oui, il y a un risque pour l’installation d’incinération.

Le dépistage et la traçabilité des implants requièrent toute notre attention pour le bien de la famille, du personnel, de la nature et des installations de crémation.

Documents

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