Novosti na področju zakonodaje medicinskih pripomočkov v ortotiki in protetiki : diplomsko delo

Rudolf, Blaž (author), Lampe, Tomaž (mentor)

Uvod: Področje ortotike in protetike se pri nas, kot tudi drugje po svetu, hitro razvija. K boljšim rezultatom so doprinesla predvsem nova spoznanja v načinu izdelave in uporabe materialov, spremembe v zakonodaji in dobro usposobljen kader. Za dobro in predvsem kakovostno zdravstveno oskrbo, ki stremi k zagotavljanju enakosti zdravljenja glede na zahteve okolja, so ključnega pomena normativi, harmonizirani standardi in sprejeta zakonodaja. Namen: Pregled literature obstoječe zakonodaje, normativov in harmoniziranih standardov na področju medicinskih pripomočkov (MP) v ortotiki in protetiki ter predstaviti cilje, zahteve in novosti nove zakonodaje. Metode dela: Pri pisanju diplomskega dela je bila uporabljena deskriptivna oz. opisna metoda dela. Podatke in literaturo smo iskali s pomočjo podatkovnih baz, kot so Google Učenjak, Web of Sience in Medline. Pri tem smo se sklicevali na izbrane ključne besede: kompetence, standardi, zakonodaja, ortotika in protetika. Rezultati: Ugotovili smo, da se z novo zakonodajo uveljavljajo novosti na področju klasifikacije MP-ja, dodelitve znaka CE in postopka ugotavljanja skladnosti. Prav tako se s sprejetjem nove uredbe uveljavljajo novosti za ostale sodelujoče, kot so priglašeni organi ter gospodarski subjekti. Na podlagi primerjave sprejete nove zakonodaje z obstoječo pa smo opazili novosti na področju nadzora in spremljanja informacij iz poproizvodne faze. Razprava: Ugotovili smo, da je namen novosti v zakonodaji boljša zaščita javnega zdravstva in odprava nekoherentnosti, odprava nejasnosti, odprava neenake zaščite bolnikov v Evropski uniji (EU), distorzija notranjega trga, zapolnjevanje pravne praznine, boljša podpora inovacijam, boljša koordinacija, transparentnost sistema in globalno usklajevanje. Zaključek: Za trženje MP-ja in lažjo izmenjavo blaga in storitev z izločanjem tehničnih ovir trgovanja ter hkrati zagotavljanja varnosti uporabnikom je treba proizvod najprej strokovno oceniti in ugotoviti, ali je v skladu z zakonodajo. V ta namen se uporabljajo postopki ugotavljanja skladnosti, standardi, normativi in certifikati, ki pa se s tehnološkim napredkom, novimi proizvodi na trgu ter potrebah po zagotovitvi bolj jasnih in preprostih pravil spreminjajo.

• Language: Slovenian
• Keywords: standardi, ortotika, protetika, klinične smernice, zakonodaja
• Work type: Bachelor thesis/paper
• Organization: ZF - Faculty of Health Sciences
• Year: 2019
• PID: 20.500.12556/RUL-110277
• COBISS.SI-ID: 5683563
• Publication date in RUL: 13.09.2019

Secondary language

• Language: English
• Title: Legislation amendments in the field of orthotic and prosthetic medical devices : diploma work

Abstract

Introduction:The fields of orthotics and prothetics are fast developing, both in Slovenia as well as elsewhere around the world. The reasons for better results in these fields are mainly new findings in the production and use of materials, regulative changes and well-trained talent. Norms, harmonised standards and appropriate passing of legislature are crucial for high-quality and equal care. Purpose: The aim of this paper is to review the literature on existing legislation, norms and harmonised standards in the field of medical devices in orthotics and prothetics as well as to present goals, requirements and novelties in the new legislation. Methods:This paper used a descriptive method. The data and literature was researched using databases such as Google Scholar, Web of Science and Medline. The keywords used in this research were “competencies”, “standards”, “legislature”, “orthotics” and “prosthetics”. Results: We found that the new legislature introduced novelties in the classification of medical device, nomination of CE sign and the testing of compliance. The passing of new regulation also introduces novelties for other participating, yet also notified bodies and economic agents. Based on the comparison of new legislation with the existing one we noticed novelties in the controlling and monitoring of information from the post-production phase. Discussion: We found that the aim of novelties in legislation includes the following: better protection of public healthcare, removal of incoherence, removal of vagueness, removal of unequeal protection of patients in the EU, distortion of the internal market, filling of the void in legislation, better support for innovation, better internal coordination, transparency of the system, better global coordination. Conclusion: A product first needs to be thoroughly reviewed and its compliance to legislation needs to be determined. Only then can we market the medical device, enable easier exchange of goods and services as well as enable the security to the users. In that aim one uses processes of determining compliance, standards, norms and certificates. These change with technological innovation, new products on the market and increased needs of ensuring more clear and simple rules.

• Keywords: standards, orthotics, prothetics, clinical guidelines, legislation