Zakonske podlage za delo, sledljivost in nadzor kakovosti v zobnem laboratoriju : diplomsko delo

Lesjak, Lovro (avtor), Rojko, Franc (mentor), Bohinc, Peter (recenzent)

Uvod: Potrošnik od vsakega izdelka oz. proizvoda pričakuje varnost in kakovost. Za opravljanje dejavnosti, povezanih z medicinskimi pripomočki, v Sloveniji skrbi Javna agencija Republike Slovenije za medicinske pripomočke (JAZMP). Evropsko zakonodajo je bilo zaradi znanstvenega napredka treba prilagoditi in posodobiti. Nova Uredba o medicinskih pripomočkih 2017/745 predstavlja pregleden in trajnosten regulativni okvir, ki je nadomestil Direktivo o medicinskih pripomočkih 93/42/EEC. Uredba spada med pravne akte, ki se takoj po začetku veljavnosti neposredno in enotno uporabljajo v vseh državah EU. Nadgradnja uredbe se kaže predvsem v usmerjenosti na klinične podatke, transparentnosti, identifikaciji in sledljivosti posameznega pripomočka. Namen: Namen diplomskega dela je izdelati kovinsko-porcelanski mostiček s sodobnimi tehnologijami CAD/CAM in predstaviti skladnost protetičnega nadomestka s predpisi, ki se nanašajo na izdelavo medicinskih pripomočkov. Metode dela: Diplomsko delo temelji na pregledu domače in tuje strokovne literature, ki smo jo iskali v knjižnicah, spletnih portalih in spletnih bazah. Praktični izdelek je bil izdelan v zobnem laboratoriju. Opredelili smo postopke za nabavo in prevzem materiala, postopke za izdelavo medicinskega pripomočka, postopek za distribucijo, postopek za vigilanco in načrt PMCF. Rezultati: Izdelali smo medicinski pripomoček za posameznega uporabnika, kovinsko-porcelanski mostiček na zobeh od 45 do 46, in sicer z digitalnim oblikovanjem in rezkanim ogrodjem. Pri izdelavi smo pozornost namenili predvsem sledljivosti postopkov in uporabljenih materialov ter kakovosti izdelave. Razprava in zaključek: Zobozdravstvo se je z leti razvilo v zelo kompleksno področje. Zdravje je izredno pomembno za državljane EU, medicinski pripomočki pa imajo pri tem bistveno vlogo, saj znatno vplivajo na zdravje in kakovost življenja. Vsi proizvajalci medicinskih pripomočkov so zavezani k spoštovanju in izvajanju Uredbe o medicinskih pripomočkih.

• Jezik: Slovenski jezik
• Ključne besede: diplomska dela, laboratorijska zobna protetika, medicinski pripomočki, zakonodaja, uredba, MDR, direktive, pripomočki izdelani za posamezne uporabnike
• Vrsta gradiva: Diplomsko delo/naloga
• Tipologija: 2.11 - Diplomsko delo
• Organizacija: ZF - Zdravstvena fakulteta
• Kraj izida: Ljubljana
• Založnik: [L. Lesjak]
• Leto izida: 2024
• Št. strani: 61 str., [1] str. pril.
• PID: 20.500.12556/RUL-166022
• UDK: 616.31
• COBISS.SI-ID: 219594243
• Datum objave v RUL: 18.12.2024

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Legislation required for work, traceability and quality assurance in dental laboratory : diploma work

Izvleček

Introduction: A consumer of any product or products expect safety and quality. The Public Agency for the Republic of Slovenia for Medical Devices (JAZMP) is responsible for carrying out activities in the field of medical devices in Slovenia. European legislation had to be adapted and updated due to scientific progress. The new Medical Devices Regulation 2017/745 represents a transparent and sustainable regulatory framework that replaced the Medical Devices Directive 93/42/EEC. The Regulation is one of the legal acts that are directly and uniformly applied in all EU countries immediately after their entry into force. The upgrade of the Regulation is mainly reflected in the focus on clinical data, transparency, identification and traceability of individual devices.Introduction. Purpose: The purpose of the diploma thesis is to produce a metal-porcelain bridge using modern CAD/CAM technologies and to present the compliance of the prosthetic substitute with the regulations relating to the field of medical device manufacturing. Methods: The diploma thesis is based on a review of domestic and foreign professional literature, which was searched in libraries, online portals and online databases. Practical work was carried out in a dental laboratory. We have prepared procedures for the procurement and acceptance of material, procedures for the manufacture of a medical device, a procedure for distribution, a procedure for vigilance and a PMCF plan. Results: We made a custom-made medical device, a metal-porcelain bridge on teeth 45 to 46, with digital design and a milled framework. In the production itself, we paid attention mainly to the traceability of the procedures and materials used, as well as the quality of the production itself. Discussion and conclusion: Over the years, dentistry has developed into a very complex field, health is extremely important for EU citizens and medical devices play a very important role in this because they have a significant impact on health and quality of life. All manufacturers of medical devices are obliged to comply and implement the Regulation on Medical Devices.

• Ključne besede: diploma theses, laboratory dental prosthetics, medical devices, legislation, regulation, MDR, directives, custom-made medical devices