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Handling of medical devices’ customer complaints on the example of companies based in Poland

Feliczek Patryk, Górna Justyna, Buszczak Aleksandra

Zeszyty Naukowe. Organizacja i Zarządzanie / Politechnika Śląska

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2022

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z. 160

159--172

EN

Purpose: The main purpose of this article was to identify and analyze correction activities and corrective actions, taken by medical devices’ companies, as a result of a customer complaint. Design/methodology/approach: The article presents the results of the study conducted among medical devices’ companies, operating on the Polish market. These companies have implemented and certified quality management system in accordance with the requirements of ISO 13485. In addition, these companies, as part of their activities, carry out various processes related to medical devices, but performing production process was the main criteria for qualifying the company for the study. On this basis, 209 companies, meeting these criteria, have been defined. The study was conducted using a survey questionnaire, available in electronic form. As part of the survey, 90 correctly completed survey questionnaires were received, what means that the response rate of surveys reached the level of 43%. Findings: The most important correction activities, indicated by the surveyed companies, include verification of suspicious products throughout the whole supply chain and replacement of a defective product with a new one. From the corrective actions perspective almost 70% of respondents indicated trainings of production employees. This is strongly related to the identified root causes, by these companies, as operators’ errors (50% of the causes lie with such errors). Almost 50% of respondents declared the update of work instructions as a corrective action, which is also related to the high number of indications for operator trainings. Originality/value: The article presents main activities, that are taken by the medical devices’ companies in Poland to increase the safety and performance of medical devices, if an abnormality occurs. The article may be treated as an benchmark for medical devices companies once reviewing their approach to implementing corrections and corrective actions.

2

Development of a field-based earthworm mark-release-recapture technique for biomonitoring

Lowe Ch. N., Butt K. R., Cheynier K.

Polish Journal for Sustainable Development

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2017

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T. 21, cz. 1

33--40

EN

Biomonitoring in soil systems presents difficulties in retrieval and differentiation of test organisms from local populations. The aim of this study was to develop a simple method of in situ containment and efficient retrieval of earthworms. Visible Implant Elastomer (VIE) tags were used to identify earthworms Lumbricus rubellus and Aporrectodea caliginosa introduced to unpolluted pasture or a polluted site. Containment PVC tubes of different height (inserted differently into the soil and covered or not covered by a mesh) were used. Highest recovery rates for both species came from use of 0.3 m tubes (100% for A. caliginosa and 71% for L. rubellus). This study confirmed the feasibility of using VIE tags to identify and aid recovery of introduced earthworms from field experiments. Results suggested that recovery rates were influenced by behavioural differences in ecological groupings and site-specific factors. There is scope for further improvement in the tagging procedure, mortality assessment and investigation of containment for earthworms.

PL

Biomonitoring systemów glebowych stwarza trudności w odnajdywaniu i odróżnianiu organizmów testowych od miejscowych populacji. Celem badań było opracowanie prostej metody zatrzymywania dżdżownic in situ oraz ich skutecznego odnajdywania. Oznaczone implantem VIE dżdżownice: epigeiczny Lumbricus rubellus i endogeiczny Aporrectodea caliginosa wprowadzono do nie zanieczyszczonego pastwiska lub terenu zanieczyszczonego. Stosowano ograniczenia z rury PVC o różnej wysokości i głębokości wprowadzenia w glebę, a także zamknięte lub nie. Najwyższe wskaźniki odzysku dla obu gatunków pochodzą z zastosowania rur 0,3 m (100% w przypadku A. caliginosa i 71% w przypadku L. rubellus). Zastosowanie pokrywy siatkowej (próba 2) nie poprawiło odzysku A. caliginosa, ale zwiększyło odzysk L. rubellus z 0% do 70% w nieskażonej glebie. Badanie potwierdziło możliwość polowego użycia znaczników VIE w celu identyfikacji i odzyskiwania dżdżownic. Wyniki sugerują, że na współczynniki odzyskiwania wpływ miały różnice zachowań w grupach ekologicznych i czynniki specyficzne dla danego obszaru. Stwierdzono konieczność dalszych badań nad poprawą procedury znakowania, oceny śmiertelności i możliwości zatrzymywania dżdżownic wprowadzanych do gleby.

3

Analiza wpływu prędkości na poziom powstrzymywania drogowych barier ochronnych

Małek E., Dziewulski P., Niezgoda T., Szymczyk W.

Magazyn Autostrady

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2016

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Nr 5

46--48

PL

W pracy podjęto próbę rozwiązania problemu związanego z wpływem prędkości na stopień powstrzymywania drogowych barier ochronnych dla tych prędkości, które nie zostały uwzględnione w kryteriach badań zderzeniowych dotyczących pojazdu według normy PN-EN 1317. Ze względu na ograniczony zakres zmiennych (prędkość, kąt uderzenia i rodzaj pojazdu), przy których bada się bariery, nasuwa się pytanie, jak zmienią się podstawowe parametry funkcjonalne systemów dla innych prędkości, kątów uderzenia czy mas pojazdów.

EN

The purpose of the paper is to present an attempt to solve the problem of the impact of velocity on the containment level of road traffic barriers for those velocities which were not included in the criteria of crash tests according to PN-EN 1317 standard. Due to a limited range of variables (velocity, angle of impact and the type of vehicle) for which traffic barriers are tested, the question arises: how the basic functional parameters of systems will change for other velocities, angles of impact and masses of vehicles. The conducted analysis shows that the number of levels of containment has been significantly reduced, because at velocities lower than those included in the standard there is no need to use such high levels of containment.

4

Completeness Results for Generalized Communication-free Petri Nets with Arbitrary Arc Multiplicities

Mayr E. W., Weihmann J.

Fundamenta Informaticae

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2016

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Vol. 143, nr 3/4

355--391

EN

We investigate gcf-Petri nets, a generalization of communication-free Petri nets allowing arbitrary arc multiplicities, and characterized by the sole restriction that each transition has at most one incoming arc. We use canonical firing sequences with nice properties for gcf-PNs to show that the RecLFS, (zero-)reachability, covering, and boundedness problems of gcf-PNs are in PSPACE. By simulating PSPACE-Turing machines by gss-PNs, a subclass of gcf-PNs where additionally all transitions have at most one outgoing arc, we ultimately obtain PSPACE-completess for these problems in case of gss-PNs or gcf-PNs. Additionally, we prove PSPACE-completeness for the liveness problem of gcf-PNs. Last, we show PSPACE-hardness as well as a doubly exponential space upper bound for the containment and equivalence problems of gss-PNs or gcf-PNs.

5

Some fragments of second-order logic over the reals for which satisfiability and equivalence are (un)decidable

Grimson R., Kuijpers B.

Reports on Mathematical Logic

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2014

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Vol. 49

23--34

EN

We consider the Σ10 -fragment of second-order logic over the vocabulary [+;x; 0; 1; <; S1; …..., Sk], interpreted over the reals, where the predicate symbols Si are interpreted as semi algebraic sets. We show that, in this context, satisfiability of formulas is decidable for the first-order THERE EXISTS-quantifier fragment and undecidable for the THERE EXISTS*FOR ALL- and FOR ALL*-fragments. We also show that for these three fragments the same (un)decidability results hold for containment and equivalence of formulas.

6

Efficiency of selected methods of hydrogen removal from a nuclear reactor's containment building

Bury T.

Journal of Power Technologies

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2014

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Vol. 94, nr 5

96--104

EN

Large amounts of gaseous hydrogen may be released into the containment building during a severe accident in a water cooled nuclear reactor. The main methods of hydrogen removal from the containment are described in brief in this paper. HEPCAL - an in-house lumped parameter computer code - was used for simulation purposes and the results were used to evaluate the efficiency of various hydrogen removal systems.

7

A model of hydrogen passive autocatalytic recombiner and its validation via CFD simulations

Orszulik M., Fic A., Bury T., Składzień J.

Archives of Thermodynamics

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2013

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Vol. 34, no. 4

257--266

EN

Passive autocatalytic recombiners (PAR) is the only used method for hydrogen removal from the containment buildings in modern nuclear reactors. Numerical models of such devices, based on the CFD approach, are the subject of this paper. The models may be coupled with two types of computer codes: the lumped parameter codes, and the computational fluid dynamics codes. This work deals with 2D numerical model of PAR and its validation. Gaseous hydrogen may be generated in water nuclear reactor systems in a course of a severe accident with core overheating. Therefore, a risk of its uncontrolled combustion appears which may be destructive to the containment structure.

8

Validation of the heat and mass transfer models within a pressurized water reactor containment using the International Standard Problem No. 47 data

Bury T., Składzień J., Fic A.

Archives of Thermodynamics

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2012

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Vol. 33, no. 2

23-46

EN

A lumped parameter type code, called HEPCAL, has been worked out in the Institute of Thermal Technology of the Silesian University of Technology for simulations of a pressurized water reactor containment transient response to a loss-of-coolant accident. The HEPCAL code has been already verified and validated against available experimental data, which in fact have been taken from separate effect tests mainly. This work is devoted to validation of the latest version of the HEPCAL code against experimental data from more complex tests. These experiments have been performed on three different test rigs (called TOSQAN,MISTRA and ThAI) and a part of them became the basis of the International Standard Problem No. 47 (ISP-47) dedicated to containment thermal-hydraulics. Selected experiments realized within the framework of the ISP-47 project have been simulated using the HEPCAL-AD code. The obtained results allowed for drawing of some important conclusions concerning heat and mass transfer models (especially steam condensation), two-phase flow model and buoyancy effects.

9

Thermodynamic consequences of hydrogen combustion within a containment of pressurized water reactor

Bury T.

Archives of Thermodynamics

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2011

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Vol. 32, no. 4

67-79

EN

Gaseous hydrogen may be generated in a nuclear reactor system as an effect of the core overheating. This creates a risk of its uncontrolled combustion which may have a destructive consequences, as it could be observed during the Fukushima nuclear power plant accident. Favorable conditions for hydrogen production occur during heavy loss-of-coolant accidents. The author used an own computer code, called HEPCAL, of the lumped parameter type to realize a set of simulations of a large scale loss-of-coolant accidents scenarios within containment of second generation pressurized water reactor. Some simulations resulted in high pressure peaks, seemed to be irrational. A more detailed analysis and comparison with Three Mile Island and Fukushima accidents consequences allowed for withdrawing interesting conclusions.

10

Immobilizacja metali ciężkich w osadach dennych

Malina G., Szwedowski D.

Inżynieria i Ochrona Środowiska

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2005

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T. 8, nr 2

135-158

PL

Przedyskutowano techniczne metody immobilizacji (unieruchamiania) metali ciężkich w osadach dennych. Omówiono mechanizmy związane z zanieczyszczeniem osadów dennych metalami ciężkimi z uwzględnieniem procesów wzajemnego oddziaływania między wodą a osadami dennymi oraz ekologicznych zagrożeń powodowanych przez zanieczyszczone osady denne. Dokonano przeglądu i charakterystyki metod oraz oceny możliwości immobilizacji metali ciężkich w osadach dennych w celu redukcji zagrożenia dla środowiska. Przedstawiono metody immobilizacji metali ciężkich w osadach dennych w warunkach ex-situ z uwzględnieniem technologii wydobywania osadów (po osuszeniu i bez osuszenia). Omówiono immobilizację na zimno z użyciem spoiw organicznych i nieorganicznych oraz immobilizację termiczną (witryfikacja i krystalizacja). W przypadku metod in situ scharakteryzowano zestalanie i stabilizację, przykrywanie oraz izolację zanieczyszczonych osadów dennych. W metodzie przykrywania osadów szczególną uwagę zwrócono na funkcje warstwy przykrywającej i rodzaje stosowanych materiałów. Metody in situ immobilizacji metali ciężkich stanowią najintensywniej rozwijającą się obecnie grupę technologii ograniczania zagrożenia związanego z zanieczyszczonymi osadami dennymi. Mimo wykazanej w praktyce skuteczności zestalanie i stabilizacja osadów dennych zanieczyszczonych metalami ciężkimi są stosowane sporadycznie i przegrywają w konkurencji z innymi metodami in situ. Przykrywanie osadów dennych wydaje się najskuteczniejszym sposobem unieruchamiania metali ciężkich w warunkach in situ.

EN

The technically applicable methods used for immobilisation of heavy metals in sediments were discussed. First, the mechanisms were outlined that are related to sediments contaminated with heavy metals, including relations between sediments and water bodies and ecological hazards, An overwiew and characteristics of methods were made, as well as the feasibility study of immobilisation of heavy metals in sediments to reduce hazards to environment and human health. The ex-situ immobilisation of heavy metals comprises, both: excavation and dredging technologies, prior to cold (with organic and inorganic binding materials), or thermal immobilisation (leading to vitrification/crystallisation). The in situ techniques that were discussed include: solidification and/or stabilisation, capping and containment. In the case of capping, the focus was on functions of capping layers and materials used (sands, clays, gravels, non-contaminated sediments, geotextiles, etc). Based on the examples, the feasibility of diverse immobilisation techniques was evaluated. In situ immobilisation of heavy metals is the fast developing approach to reduce environmental hazards from contaminated sediments. Although proven in field conditions, in situ solidification and/or stabilisation are not commonly used, and are not concurrent to other in situ techniques. In situ capping appears to be one of the most effective and promising technologies of heavy metals immobilisation in sediments.