OBJEKTIVNA ODGOVORNOST IN MEDICINSKI PRIPOMOČKI

Marn, Mitja

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Title:	OBJEKTIVNA ODGOVORNOST IN MEDICINSKI PRIPOMOČKI
Authors:	ID Marn, Mitja (Author) ID Keresteš, Tomaž (Mentor) More about this mentor...
Files:	UNI_Marn_Mitja_2011.pdf (1,34 MB) MD5: 42B1335EF0F13C79F4D646F04201AED7 PID: 20.500.12556/dkum/e2cb67d4-8936-48ff-a897-d04a5a7c68d5
Language:	Slovenian
Work type:	Undergraduate thesis
Organization:	PF - Faculty of Law
Abstract:	S hitrim razvojem znanosti se je pojavila možnost nadomestitve nekaterih človekovih organov z umetnimi izdelki. Najbolj se vsem nadomestkom in naprednim tehnologijam približa pojem medicinski pripomoček. Ker gre pri tovrstni industriji za trgovino globalnih razsežnosti, so se pojavile organizacije, ki poskušajo poenotiti termine. Namen organizacij je pospešitev globalno-tržne komunikacije, z možnostjo izmenjave povratnih informacij o delovanju izdelka. Medicinski pripomoček je, kot vsaka druga naprava, podvržen možnosti nastanka napak in okvar. Izdelek, vsajen v človekovo telo, v primeru okvare lahko povzroči smrt ali težjo telesno poškodbo. Javna agencija za medicinske pripomočke na teritoriju Slovenije izdaja potrdila o skladnosti izdelka s standardi in s tem potrjuje kakovost in varnost izdelka. Življenjski cikel medicinskega pripomočka vključuje številne faze, od načrtovanja izdelka do poročanja o njegovi uporabi. Zaradi številnih subjektov, ki sodelujejo v ciklu izdelka, se delo osredotoča na razmerja med proizvajalcem in pacientom, pri čemer se mestoma vključuje tudi prispevek zdravstvene stroke, zaradi neposrednega stika zdravnika z bolnikom. Zaradi specifičnosti problematike ter terminov, so bili sprejeti številni specialni predpisi, ki so večinoma povezani z obstoječimi splošnimi pravili. V diplomi so podrobneje obdelani pojmi: proizvajalec, potrošnik, pacient, stvar in napaka. Posebej poglobljeno je obdelana problematika odškodninske odgovornosti za škodo po izdelku. Tu se pojavi problem razmejitve med pravili Direktive 85/374 EEC, implementirane z Zakonom o varstvu potrošnikov in pravili Zakona o obligacijskih razmerjih. Slednji uvaja domnevo vzročne zveze med nevarnim izdelkom ter nastalo škodo. Oškodovanec bo moral dokazati samo napako in škodo. Na drugi strani Zakon o varstvu potrošnikov uvaja sistem, po katerem bo potrošnik oz. oškodovanec tisti, ki bo imel dokazno breme. Sodišče bo moral prepričati, da izdelek ni zadostil standardu pričakovane varnosti, ki jo potrošnik legitimno pričakuje. Na koncu so predstavljeni še razlogi razbremenitve objektivne odgovornosti, kot jih določata omenjena predpisa, s poudarkom na določbi Zakona o varstvu potrošnikov, v skladu s katero se proizvajalec razbremeni odgovornosti za škodo, če dokaže, da razvoj znanosti v trenutku, ko je bil izdelek dan na trg, še ni bil na nivoju, ki bi omogočal ugotovitev možnosti nastanka škode. Iz pravila izhaja, da je potrošnik stranka, ki trpi škodo zaradi razvojnega rizika. V delu so analizirani interesi subjektov, udeleženih v življenjskem ciklu medicinskega pripomočka. Prikazane so obstoječe rešitve, razporeditve rizikov nastanka škode, ki naj bi najbolj ugodno vplivale na razvoj celotne dejavnosti. Ključen problem ostaja premajhno število rešenih primerov, ki bi obsegali obravnavano tematiko.
Keywords:	Razvojni riziko, interes, odgovornost za škodo po produktu, pacient, potrošnik, proizvajalec, napaka, medicinski pripomoček, nevarna stvar, Zakon o varstvu potrošnikov.
Place of publishing:	Maribor
Publisher:	[M. Marn]
Year of publishing:	2011
PID:	20.500.12556/DKUM-19308
UDC:	34(043.2)
COBISS.SI-ID:	4237611
NUK URN:	URN:SI:UM:DK:W75JCRGS
Publication date in DKUM:	13.07.2011
Views:	4348
Downloads:	402
Metadata:
Categories:	PF
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Secondary language

Language:	English
Title:	PRODUCT LIABILITY OF MEDICAL DEVICES
Abstract:	The possibility of replacement of some human organs with artificial products has emerged with the rapid development of science. In order to describe all replacements and advanced technologies the concept of medical device is chosen in this diploma. Because this industry has reached global extensions, numerous organizations, who wish to unify the terms, have emerged. Their primarily goal is to accelerate the global marketing communication with the possibility of exchanging feedback on how these products are functioning. While using a medical device, as any other device, there is a certain possibility of error and failure, which means that products, implanted in the human body, can cause death or serious bodily injuries, in case of failure. In the territory of Slovenia, certificates of compliance with product standards are issued by Agency for Medical Devices. Agency for Medical Devices also certifies quality and safety of products. The life cycle of a medical device includes number of stages, from products’ planning to report on its’ use. Considering large number of subjects involved in the life cycle of the product, this diploma is focusing on the relationship between manufacturer and patient. On certain points the contribution of health professionals is also included, because of a direct contact doctors have with their patients. Several special rules, associated with the existing general rules, have been passed, due to specificity issues and terms related with medical devices. Detailed consideration in this diploma is given to the terms producer, consumer, patient, things and mistakes, while special attention is also given to the issue of liability for damage caused by product. Here appears a problem in demarcation between the rules of Directive 85/374 EEC implemented with the Consumer Protection Act and the rules of the Code of Obligations, where the latter establishes a presumption of a causal link between dangerous products and damage. On the other side, The Consumer Protection Act establishes a system, whereby the consumer or the handicapped party will carry the burden of proof. Namely, he will have to convince the court that the product did not meet the expected security standard, which the consumer may legitimately expect. Finally, the reasons for exculpation of strict liability are presented, where main stress is made on the provision of the Consumer Protection Act, under which the manufacturer is relieved of liability for the product to the extent it proves that the state of scientific and technical knowledge at the time the product was put into circulation was not sufficient to enable defect to be discovered. This rule clearly states that the consumer is the party, who suffers damage as a result of development risk. The interplay between the interests of individual entities, involved in the life cycle of a medical device, has been analysed and existent solutions, how to distribute the risk and make the most beneficial effect on all parties, was presented. Insufficient numbers of resolved cases, which include the subject matter, still remain as a key problem.
Keywords:	Developmental risk, interest, product liability, patient, consumer, manufacturer, defect, medical device, dangerous thing, The Consumer Protection Act.

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