BACKGROUND: In the sense of Act No. 123/2000 Coll., as amended (hereinafter referred to as "the Act"), a medical device is understood to be a wide range of resources, especially medical equipment. To implement innovative technologies in practice, it is becoming extremely important to be cost-conscious and effective. The aim of the article is to use an ultrasonographic device case study in a selected hospital to show the possibility of solving the use effectiveness of medical devices. METHODS: Within the first step, a summary of the use of ultrasonographic devices is developed in terms of performance number and time. Also, a summary of all costs for the last 5 years has been created. The analyzed ultrasonographic device set is evaluated in terms of activity indicators, profitability, and Du Pont decomposition. Revenues from the operation of individual instruments and payroll productivity are taken into account. All of this is evaluated in the context of the requirements of the department and the spectrum of ultrasonographic devices. RESULTS: The results show that the economic evaluation of device use efficiency, comparing the requirements of the department and spectrum of the devices, suggests a major revision in use of these devices and savings. CONCLUSION: The new design of the most profitable system differs significantly in the arrangement of individual ultrasonographic devices. The benefit of the study is not just a newly designed organization-specific arrangement, but it can be perceived as a modeling approach that can be used to analyze other sets of medical technology.

• Klíčová slova
• effective deployment, medical devices, medical equipment, profitability, ultrasound,
• MeSH
• analýza nákladů a výnosů metody   MeSH
• ultrasonografie přístrojové vybavení   MeSH
• vynálezy MeSH
• zdravotnické prostředky MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.

• Klíčová slova
• medical devices market legislative aspects development.,
• MeSH
• Evropská unie MeSH
• lidé MeSH
• zdravotnické prostředky * etika   normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Geografické názvy
• Čína MeSH
• Japonsko MeSH
• Spojené státy americké MeSH

Antimicrobial biocompatible polymers form a group of highly desirable materials in medicinal technology that exhibit interesting thermal and mechanical properties, and high chemical resistance. There are numerous types of polymers with antimicrobial activity or antimicrobial properties conferred through their proper modification. In this review, we focus on the second type of polymers, especially those whose antimicrobial activity is conferred by nanotechnology. Nanotechnology processing is a developing area that exploits the antibacterial effects of broad-scale compounds, both organic and inorganic, to form value-added medical devices. This work gives an overview of nanostructured antimicrobial agents, especially silver ones, used together with biocompatible polymers as effective antimicrobial composites in healthcare. The bactericidal properties of non-conventional antimicrobial agents are compared with those of conventional ones and the advantages and disadvantages are discussed.

• Klíčová slova
• antimicrobials, biocompatibility, medical devices, modification, nanostructures, polymers,
• MeSH
• antiinfekční látky aplikace a dávkování   chemie   MeSH
• biokompatibilní materiály chemie   MeSH
• dezinfekce * metody   MeSH
• infekce spojené se zdravotní péčí mikrobiologie   prevence a kontrola   přenos   MeSH
• lidé MeSH
• nanostruktury * chemie   ultrastruktura   MeSH
• nanotechnologie MeSH
• polymery * chemie   MeSH
• povrchové vlastnosti MeSH
• stříbro * chemie   MeSH
• zdravotnické prostředky * mikrobiologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Názvy látek
• antiinfekční látky MeSH
• biokompatibilní materiály MeSH
• polymery * MeSH
• stříbro * MeSH

We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medical devices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects.

• MeSH
• biofyzika výchova   MeSH
• elektrokardiografie přístrojové vybavení   MeSH
• elektronické zdravotní záznamy * MeSH
• fyzika výchova   MeSH
• krevní tlak MeSH
• lékaři * MeSH
• mikroskopie přístrojové vybavení   MeSH
• on-line systémy MeSH
• počítačová rentgenová tomografie přístrojové vybavení   MeSH
• sluchové testy přístrojové vybavení   MeSH
• stenty MeSH
• studium lékařství pregraduální metody   MeSH
• systémová integrace * MeSH
• ultrasonografie přístrojové vybavení   MeSH
• zdravotnické prostředky * MeSH
• zrakové testy přístrojové vybavení   MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

• MeSH
• elektrofyziologické techniky kardiologické přístrojové vybavení   MeSH
• legislativa o zdravotnickém vybavení organizace a řízení   MeSH
• lidé MeSH
• postmarketingový dozor MeSH
• využití zařízení a materiálu zákonodárství a právo   MeSH
• zdravotnické prostředky normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• úvodníky MeSH
• Geografické názvy
• Evropa MeSH

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to "non-medical" products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.

• Klíčová slova
• SME, innovation, medical devices, patient safety, regulation, risk,
• MeSH
• lidé MeSH
• marketing * MeSH
• průmysl * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH

Medical devices in wound healing V: Special types of wound plasters II Patches represent a broad category of medical devices with versatile applications that go far beyond their traditional function as wound dressings. This article focuses on the other possible utilization of patches, such as fixation patches for cannulas, patches for epicutaneous tests, warming and cooling patches, patches for acne, anti-snoring patches, and mosquito-repellent patches. In addition to their specific functions, the article highlights the importance of correct application, which represents crucial knowledge not only for pharmacists and pharmacy assistants but also for other healthcare professionals who work with these patches in practice.

• Klíčová slova
• acne pat-ches, anti-snoring patches, cannula fixation patches, epicutaneous test patches, medical devices., mosquito-repellent patches, warming/cooling patches,
• MeSH
• hojení ran * MeSH
• lidé MeSH
• transdermální náplast MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

Medical devices must be tested before marketing in accordance with ISO EN 10993-10 in order to avoid skin sensi­tization. This standard predominantly refers to the in vivo test but does not exclude the use of in vitro methods that have been sufficiently technically and scientifically validated for medical device testing. It is foreseen that, due to the complexity of the sensitization endpoint, a combination of several methods will be needed to address all key events occurring in the sensitization process. The objective of this pilot study was to evaluate the sensitization potential of selected medical devices using a combination of in chemico (DPRA, OECD TG 442C) and in vitro (LuSens, OECD TG 442D) methods in comparison with the in vivo (LLNA DA, OECD TG 442A) method and to suggest a possible testing strategy for the safety assessment of medical device extracts. Overall, one of the 42 tested samples exhibited positive results in all employed test methods, while 33 samples were predicted as non-sensitizing in all three performed methods. This study demonstrated good agreement between in vitro and in vivo results regarding non-sensitizing samples; however, some discrepancies in positive classification were recorded. A testing strategy is suggested in which negative results are accepted and any positive results in the in chemico or in vitro tests are followed up with a third in vitro test and evaluated in accordance with the “2 out of 3 approach”. This strategy may reduce and replace animal use for testing the sensitization potential of medical devices.

• Klíčová slova
• mechanistic-based risk assessment, extracts, in vitro and in vivo toxicology, medical devices, public health, skin sensitization,
• MeSH
• alergická kontaktní dermatitida * MeSH
• alternativy testů na zvířatech * MeSH
• biotest MeSH
• kůže MeSH
• pilotní projekty MeSH
• techniky in vitro MeSH
• zvířata MeSH
• Check Tag
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH

Several irritants were used in the in vitro irritation medical device round robin. The objective of this study was to verify their irritation potential using the human patch test (HPT), an in vitro assay, and in vivo data. The irritants were lactic acid (LA), heptanoic acid (HA), sodium dodecyl sulfate (SDS), Genapol® X-80 (GP), and Y-4 polymer. Dilute saline and sesame seed oil (SSO) solutions of each were evaluated using a 4 and 18 h HPT and the EpiDerm™ SIT-MD RhE assay; results were then compared to existing rabbit skin irritation test data. Results from the 4 h HPT were negative in most cases except for GP and SDS, while the 18 h HPT also identified some LA, HA, and GP samples as irritants. EpiDerm™ SIT-MD correctly identified all irritants except GP in SSO due to limited solubility. Data from cutaneous rabbit irritation tests were negative, while all intracutaneous results were strongly or weakly positive except for the most dilute GP solutions. These findings indicate that EpiDerm™ SIT-MD results correlate with those from the rabbit intracutaneous test and confirm that RhE assays are suitable replacements for animals in evaluating the tissue irritation potential of medical devices.

• Klíčová slova
• EpiDerm SIT-MD, Human patch test, ISO 10993-10, Medical devices, Skin irritation,
• MeSH
• alternativy testů na zvířatech MeSH
• benchmarking MeSH
• dodecylsíran sodný toxicita   MeSH
• dráždivé látky toxicita   MeSH
• králíci MeSH
• kůže účinky léků   MeSH
• kyselina mléčná toxicita   MeSH
• kyseliny heptylové toxicita   MeSH
• lidé MeSH
• náplasťové testy metody   MeSH
• polyethylenglykoly toxicita   MeSH
• polyvinylchlorid toxicita   MeSH
• reprodukovatelnost výsledků MeSH
• testy kožní dráždivosti metody   MeSH
• zdravotnické prostředky * MeSH
• zvířata MeSH
• Check Tag
• králíci MeSH
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• dodecylsíran sodný MeSH
• dráždivé látky MeSH
• genapol X 080 MeSH Prohlížeč
• kyselina mléčná MeSH
• kyseliny heptylové MeSH
• polyethylenglykoly MeSH
• polyvinylchlorid MeSH

This study aimed to characterize Clostridium difficile isolates cultured from stool samples of patients with C. difficile infection (CDI) and swabs from a medical environment in a gastroenterology center in Tehran, Iran. A total of 158 samples (105 stool samples from hospitalized patients and 53 swabs from medical devices and the environment) were collected from January 2011 to August 2011 and investigated for the presence of C. difficile by direct anaerobic culture on a selective media for C. difficile. C. difficile isolates were further characterized by capillary electrophoresis (CE) ribotyping and toxin gene multiplex PCR. Of 158 samples, C. difficile was cultured in 19 of 105 stool samples (18%) and in 4 of 53 swabs (7.5%). C. difficile PCR ribotype (RT) 126 was the most common RT in the study (21.7%). Further RTs were: 001, 003, 014, 017, 029, 039, 081, 103 and 150. RTs 126, 001, 150 were cultured from both the stool samples and swabs of medical devices and the hospital environment which suggest a possible route of transmission.

• Klíčová slova
• Capillary electrophoresis ribotyping, Clostridium difficile, Iran, PCR ribotype 126, PCR ribotype 150,
• MeSH
• bakteriální toxiny genetika   MeSH
• Clostridioides difficile klasifikace   genetika   růst a vývoj   izolace a purifikace   MeSH
• feces mikrobiologie   MeSH
• genetická variace * MeSH
• lidé MeSH
• nemocnice MeSH
• polymerázová řetězová reakce MeSH
• ribotypizace * MeSH
• zdravotnické prostředky mikrobiologie   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Írán MeSH
• Názvy látek
• bakteriální toxiny MeSH