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ANALYSIS AND IMPLEMENTATION OF ISO 15883-1:2024 STANDARD: TYPE TEST OF AN ENDOSOCPE WHASER
No full textreservedIl crescente utilizzo di dispostivi medici riutilizzabili, in particolare gli endoscopi flessibili, pone importanti sfide in termini di riprocessamento, controllo e prevenzione dalle contaminazioni. La presente tesi è stata sviluppata a partire dalle attività svolte durante lo stage di 6 mesi presso l'azienda Steelco S.p.A., uno dei principali produttori mondiali di sistemi di sterilizzazione per l'assistenza sanitaria, il settore farmaceutico e i laboratori di ricerca.
Gli endoscopi flessibili termolabili vengo classificati, secondo Spualding, come dispositivi semi-critici e, per questo motivo, devono essere adeguatamente riprocessati. A tal proposito, le lava-endoscopi sono dei dispositivi medici che consentono l'automatizzazione e la standardizzazione del riprocessamento, garantendo livelli elevati di prevenzione dalle infezioni. Per assicurare tale livello di sicurezza le lava-endoscopi, come tutte le altre lavastrumenti, devono essere conformi alle normative attualmente vigenti, tra cui il Regolamento (UE) 2017/745 (MDR) e la serie di standard ISO 15883. L'MDR è una nuova serie di norme introdotta per garantire una progettazione sicura ed efficace dei dispositivi medici immessi nel mercato europeo; mentre l'ISO 15883 è una serie di standard, suddivisa in 7 parti, che specificano i requisiti generali per la pulizia e la disinfezione di dispositivi medici riutilizzabili. In particolare, la Parte 1 descrive i requisiti generali per la progettazione, costruzione, funzionamento e validazione delle lava strumenti. La Parte 4 di questa normativa si concentra sulle performance delle lavastrumenti specificatamente utilizzate per il riprocessamento degli endoscopi termolabili. Infine, la Parte 5 definisce le procedure e i metodi da utilizzare per dimostrare l'efficacia di pulizia delle lavastrumenti e dei relativi accessori.
La seguente tesi descriverà in modo specifico e dettagliato le tecniche e i metodi impiegati per la verifica della confromità dei dispositivi medici rispetto alla norma ISO 15883-1:2024, a seguito del suo aggiornamento rispetto alla versione precedente: la ISO 15883-1:2006.The increasing use of reusable medical devices, particularly flexible endoscopes, poses major challenges in terms of reprocessing, control, and contamination prevention. This thesis was developed from activities during a 6-month internship at Steelco S.p.A., one of the world's leading manufacturers of sterilization systems for health care, pharmaceutical and research laboratories.
Thermolabile flexible endoscopes are classified, according to Spualding, as semi-critical devices and, for this reason, must be properly reprocessed. In this regard, endoscope washers are medical devices that allow automation and standardization of reprocessing, ensuring high levels of infection prevention. To ensure this level of safety, endoscope washers, like all other washer-disinfectors, must comply with current regulations, including Regulation (EU) 2017/745 (MDR) and the ISO 15883 series of standards. The MDR is a new set of standards introduced to ensure safe and effective design of medical devices placed on the European market; while ISO 15883 is a set of standards, divided into 7 parts, specifying general requirements for cleaning and disinfection of reusable medical devices. Specifically, Part 1 describes the general requirements for the design, construction, operation, and validation of instrument washers. Part 4 of this standard focuses on the performance of instrument washers specifically used for reprocessing thermolabile endoscopes. Finally, Part 5 defines the procedures and methods to be used to demonstrate the cleaning effectiveness of instrument washers and their accessories.
The following thesis will describe in specific detail the techniques and methods used to verify the confromity of medical devices against ISO 15883-1:2024, following its update from the previous version: ISO 15883-1:2006
Cleaning efficacy test on washers disinfectors according to the UNI EN ISO 15883-5:2021 standard
No full textreservedQuesta tesi è il risultato di 6 mesi di stage presso l'azienda Steelco S.P.A., uno dei principali produttori mondiali di sistemi di lavaggio e sterilizzazione in ambito sanitario, farmaceutico e nei laboratori di ricerca.
Le lavastrumenti vengono utilizzate per il riprocessamento di diverse tipologie di strumenti medici (critici, semi-critici e non critici). La conseguenza della classificazione è una specifica tecnica di riprocessamento. Inoltre, le lavastrumenti sono dispositivi medici, quindi devono essere conformi ad alcuni regolamenti, come l'MDR e la UNI EN ISO 15883. L'MDR, acronimo di Medical Device Regulation, è una nuova serie di norme che regolano la produzione e la distribuzione dei dispositivi medici in Europa e ha sostituito la direttiva sui dispositivi medici (MDD). La UNI EN ISO 15883 è una norma composta da sette parti che regolamenta le diverse tipologie di lavastrumenti (come conseguenza della varietà di articoli da riprocessare). In particolare, la parte 5 di tale norma specifica i requisiti di prestazione e i criteri dei metodi di prova per dimostrare l'efficacia di lavaggio. A seguito del recente aggiornamento di questa parte (UNI EN ISO 15883-5:2021), sono state eseguite delle prove di efficacia di lavaggio su diverse tipologie di lavastrumenti per confermarne la conformità.
Questo abstract riassume brevemente parte del lavoro svolto durante il mio tirocinio e spiegato in dettaglio in questa tesi.This thesis is the result of a six-month internship at Steelco S.P.A., one of the world's leading manufacturers of washing and sterilisation systems for healthcare, pharmaceuticals and research laboratories.
Medical washer-disinfectors are used for the reprocessing of different types of medical instruments (critical, semi-critical and non-critical). The consequence of the classification is a specific reprocessing technique. In addition, medical washer-disinfectors are medical devices, so they must be confirmed to certain regulations, such as the MDR and UNI EN ISO 15883. The MDR, which stands for Medical Device Regulation, is a new set of regulations governing the manufacture and distribution of medical devices in Europe and has replaced the Medical Device Directive (MDD). UNI EN ISO 15883 is a seven-part standard that altogether regulates the different types of washer-disinfectors (as a consequence of the variety of items to be reprocessed). In particular, the part 5 of this norm specifies the performance requirements and test method criteria for demonstrating the cleaning efficacy. Following the recent update of this part (UNI EN ISO 15883-5:2021), cleaning efficacy tests were carried out on various models of medical washer-disinfectors to confirm compliance.
This abstract briefly summarises part of the work carried out during my internship and explained in detail in this thesis
Analysis and implementation of EN ISO 15883 technical standard: execution of type tests on medical devices for thermal-disinfection and development of a prototype
Get PDFopenAnalisi e applicazione della norma tecnica EN ISO 15883: esecuzione di prove interne su dispositivi medici per la termo-disinfezione e sviluppo di un progetto prototipaleAnalysis and implementation of EN ISO 15883 technical standard: execution of type tests on medical devices for thermal-disinfection and development of a prototyp
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Get PDFWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Get PDFWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
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