Robotic coronary and intra-cardiac surgery has been available for more than 25 years. In this period, multiple studies have demonstrated the beneficial effects of robotic surgery over conventional open surgery. Throughout the years, technical developments have enabled us to perform totally endoscopic coronary artery bypass (TECAB) grafting. But these techniques remained in the hands of a small group of pioneers because of a lack of structured training programs and the absence of long-term results at that time. Currently, a renewed interest and a wide dispersion of robotic platforms, thanks to use of robotics in other disciplines, has led to an exponential increase in robotic cardiac centers both in Europe and USA. Nonetheless, this increase was slowed down in Europe as a result of the uncertainty introduced by the implementation of a revised regulatory framework for medical devices [Regulation 2017/745, 'Medical Device Regulation' ('MDR')]. The MDR was introduced with the goal of increasing patient safety and supporting innovation. Implementing the MDR has proven to be exceptionally challenging and risks to the supply of essential devices have been identified. Changes to both regulatory and market dynamics led to a circumstance where the only available robotic platform for cardiac surgery decided to cease marketing of essential accessories for conducting surgery. This resulted in the disappearance of dedicated tools such as the Endowrist stabilizer, essential for TECAB, and the atrial retractor which is essential for intra-cardiac surgery. In the mean-time, further clinical evidence was published demonstrating the superiority of robotic cardiac surgery over other minimally invasive approaches. This has demonstrated the need to better define the clinical evidence requirements for regulatory purposes to ensure that dedicated tools for evidence-based interventions in robotic coronary surgery remain available such that TECAB can continue in Europe.

• Publication type
• Journal Article MeSH
• Review MeSH

Cévní mozková příhoda je jednou z nejčastějších příčin získané disability. Představuje závažný socioekonomický problém, který může mít závažný dopad na různé oblasti života. Včasná a dostatečně intenzivní rehabilitace po CMP významně přispívá k optimálním funkčním výsledkům a zlepšení kvality života pacientů. Nové neurorehabilitační přístupy založené na technologiích a virtuální realitě (VR) umožňují navrhnout individualizovaný intenzivní rehabilitační trénink a zlepšit motorické učení prostřednictvím multimodální zpětné vazby. Rehabilitace ve VR je vysoce motivující terapie s řadou výhod pro pacienta a zvyšuje také compliance pacienta k terapii. Představuje bezpečnou formu terapie a po náležitém edukování pacienta není nezbytně nutná fyzická přítomnost fyzioterapeuta. Díky tomu je možné využití VR v domácím cvičení a telerehabilitaci. Cílem tohoto přehledového článku je poskytnout aktuální poznatky a stručné informace o neurorehabilitaci po CMP založené na VR s důrazem na na MDR (medical device regulation) certifikovaný VR rehabilitační zdravotnický prostředek, který byl vyvinut ve spolupráci FN Ostrava a společnosti VR Life.

Stroke is one of the most common causes of acquired disability. It represents a major socio-economic problem that can have a serious impact on different areas of life. Early and sufficiently intensive rehabilitation after stroke contributes significantly to optimal functional outcomes and improves the quality of life of the patients. New neurorehabilitation approaches based on technology and virtual reality (VR) make it possible to design individualized intensive rehabilitation training and improve motor learning through multimodal feedback. Rehabilitation in VR is a highly motivating therapy with many benefits for the patient. It also increases patient compliance to therapy. It is a safe form of therapy and after proper education of the patient, the physical presence of a physiotherapist is not necessarily required. This makes the use of VR in home exercise and telerehabilitation possible. The aim of this review article is to provide up-to-date knowledge and brief information on VR-based neurorehabilitation after stroke, with emphasis on the medical device regulation (MDR)-certified VR interface, which was developed in collaboration between the University Hospital Ostrava and VR Life.

• MeSH
• Activities of Daily Living MeSH
• Clinical Studies as Topic methods   MeSH
• Quality of Life MeSH
• Humans MeSH
• Neurological Rehabilitation methods   MeSH
• Stroke Rehabilitation * methods   MeSH
• Virtual Reality * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: Manufacturers and diagnostic companies often recommend on-site verification of analytical performance in the clinical laboratory. The validation process used by manufacturers is rarely described in detail, and certain information on analytical performance is missing from the product sheet, especially for immunoanalytical methods. We describe an approach to the detailed validation of an ELISA method for the measurement of proprotein convertase subtilisin/kexin type 9 (PCSK9) plasma concentrations. We compared manufacturers' claims of analytical performance with data obtained in the field laboratory using several approaches. METHODS: We used the Human Proprotein Convertase 9/PCSK9 Quantikine ELISA diagnostic kit (R&D systems, Bio-Techne Ltd., Abingdon Science Park, Abingdon, UK) and three levels of quality control solution Quantikine Immunoassay Control Group 235 (R&D systems, Bio-Techne Ltd., Abingdon Science Park, Abingdon, UK) to verify precision. We measured the concentration of PCSK9 using the DS2 ELISA Reader (Dynex Technologies GmbH, Denkendorf, Germany). We used analysis of variance (ANOVA) and the R statistical package (R core team, version 1.4.5). Statistical analysis and terminology were performed according to protocol CLSI EP15-A3, and the reference interval was checked according to CLSI/IFCC C28-A3c. RESULTS: We found a significant difference between the manufacturer's claims of analytical performance and real data measured in the routine clinical laboratory. The calculated CV (%) for repeatability (calculated by simple estimation of the mean and SD, as used by the manufacturer) was between 5.5% and 7.4%, but the manufacturer's claim was between 4.1% and 6.5%. Using ANOVA, the true repeatability was between 5.0% and 6.9%. Similarly, ANOVA revealed values of CV (%) for within-laboratory imprecision between 6.5% and 9.1%, while the manufacturer's claims were between 4.1% and 5.9%. The recovery ranged from 105.5% to 121.8%. The manufacturer's recommended reference interval was checked and we didn't find any significant difference between men and women. CONCLUSIONS: We describe a comprehensive approach to verify the analytical performance of an ELISA method using the measurement of PCSK9 plasma concentration as an example. We found differences between the results of this approach based on the CLSI EP15-A3 protocol and data provided by the manufacturer. We recommend the verification of analytical performance by more complex statistical tools in laboratory practice.

• MeSH
• Enzyme-Linked Immunosorbent Assay * standards   methods   MeSH
• Humans MeSH
• Proprotein Convertase 9 * blood   immunology   MeSH
• Reagent Kits, Diagnostic standards   MeSH
• Reproducibility of Results MeSH
• Quality Control MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Validation Study MeSH

• MeSH
• Liability, Legal MeSH
• Legislation, Medical MeSH
• Publication type
• Monograph MeSH
• Geographicals
• Czech Republic MeSH

• Conspectus
• Právo
• NML Fields
• právo, zákonodárství
• veřejné zdravotnictví

Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.

• MeSH
• Humans MeSH
• Commerce MeSH
• Decision Support Systems, Clinical * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Comment MeSH
• Geographicals
• Europe MeSH

MASK-air® , a validated mHealth app (Medical Device regulation Class IIa) has enabled large observational implementation studies in over 58,000 people with allergic rhinitis and/or asthma. It can help to address unmet patient needs in rhinitis and asthma care. MASK-air® is a Good Practice of DG Santé on digitally-enabled, patient-centred care. It is also a candidate Good Practice of OECD (Organisation for Economic Co-operation and Development). MASK-air® data has enabled novel phenotype discovery and characterisation, as well as novel insights into the management of allergic rhinitis. MASK-air® data show that most rhinitis patients (i) are not adherent and do not follow guidelines, (ii) use as-needed treatment, (iii) do not take medication when they are well, (iv) increase their treatment based on symptoms and (v) do not use the recommended treatment. The data also show that control (symptoms, work productivity, educational performance) is not always improved by medications. A combined symptom-medication score (ARIA-EAACI-CSMS) has been validated for clinical practice and trials. The implications of the novel MASK-air® results should lead to change management in rhinitis and asthma.

• Publication type
• Journal Article MeSH

Se vzrůstajícím významem umělé inteligence (AI) ve zdravotnictví přicházejí i nové perspektivy v primární péči. Včasné odhalení diabetické retinopatie (DR), jedné z mikrovaskulárních komplikací diabetu mellitu, může jednak předejít vývoji do komplikovaných forem, jednak vést ke včasnému pátrání po dalších komplikacích diabetu. AI přináší slibné řešení, které může zvýšit dostupnost screeningového vyšetření diabetické retinopatie více pacientům. Klíčové je úspěšné uvedení řešení do klinické praxe, což je náročný proces s několika fázemi zajišťujícími, že výsledný zdravotnický prostředek bude účinný a bezpečný pro použití u pacientů. Software Aireen využívá umělou inteligenci k provádění screeningu DR na snímcích sítnice z optických fundus kamer. Tento zdravotnický prostředek (ZP) splňuje evropské nařízení o zdravotnických prostředcích 2017/745 a v roce 2023 byl uveden na trh. Klíčovou roli v procesu celého jeho životního cyklu sehrála spolupráce mezi lékaři a vývojovým týmem. Lékaři se podíleli na definovaní určeného účelu použití ZP, analýze rizik, anotace dat určených pro učení a validaci softwaru a také klinické zkoušce. Klinická zkouška byla provedena na 1274 pacientech s diabetem 1. a 2. typu, kde ZP Aireen dosáhl senzitivity 94,0 % a specificity 90,7 % ve srovnání s referenčním hodnocením. Klinická zkouška tak potvrdila potenciál Aireen zvýšit dostupnost screeningu DR a zlepšit včasný záchyt onemocnění.

With the growing significance of artificial intelligence in healthcare, new perspectives are emerging in primary care. Diabetic retinopathy, a microvascular complication of diabetes mellitus, often remains unnoticed until patient is facing complications. Artificial intelligence presents a promising solution that can enhance the accessibility of diabetic retinopathy screening for a broader range of patients. The key challenge lies in successfully integrating the solution into clinical practice, a demanding process with multiple phases to ensure the resulting medical device is effective and safe for patient use. Aireen software uses artificial intelligence to perform diabetic retinopathy screening on retinal images captured by optical fundus cameras. The medical device complies with European Medical Device Regulation 2017/745 and was introduced to the market in 2023. Collaboration between physicians and the development team played a crucial role throughout the entire lifecycle of the medical device. Physicians were engaged in defining the intended use of the medical device, risk analysis, data annotation for training and software validation, as well as throughout a clinical trial. A clinical trial was conducted on 1,274 patients with type 1 and type 2 diabetes mellitus, where Aireen medical device achieved a sensitivity of 94.0% and a specificity of 90.7% compared to the reference evaluation. This clinical trial confirmed the potential of Aireen to enhance the availability of diabetic retinopathy screening and early disease detection.

• Keywords
• software Airreen,
• MeSH
• Diabetic Retinopathy * diagnostic imaging   MeSH
• Humans MeSH
• Software Design MeSH
• Vision Screening MeSH
• Artificial Intelligence * MeSH
• Check Tag
• Humans MeSH

Článek se zabývá vývojem právní úpravy a praktickými postupy při předepisování zdravotnických prostředků pro vlhké hojení ran v ambulantní péči a problematikou praktické komunikace se zdravotní pojišťovnou ve věci úhrady těchto zdravotnických prostředků z veřejného zdravotního pojištění v České republice.

The article concerns with the development of legal regulations and practical procedures in prescribing medical devices for "moist" wound management in outpatient care and the issue of practical communication with health insurance companies in the matter of reimbursement of these medical devices from public health insurance in the Czech Republic.

• MeSH
• Ambulatory Care economics   MeSH
• Wound Healing * MeSH
• Humans MeSH
• Bandages, Hydrocolloid economics   MeSH
• Universal Health Insurance economics   legislation & jurisprudence   MeSH
• Check Tag
• Humans MeSH

Kosmetické přípravky patří mezi velmi významné obchodované komodity, a to nejen v zařízeních poskytujících lékárenskou péči. Cílem tohoto článku je definovat kosmetické přípravky, jejich společné znaky a vymezit jejich rozdílnost od léčivých přípravků a zdravotnických prostředků. Nejen uvádění na trh, ale také tvrzení o vlastnostech a účincích kosmetických přípravků jsou upravovány podle zvláštní legislativy, jejíž základní teze tento článek vysvětluje. Tato publikace si však neklade za cíl poskytnout kompletní právní výklad všech platných předpisů, ale má pomoci farmaceutovi a farmaceutickému asistentovi zorientovat se v oblasti kosmetických přípravků, které tvoří nedílnou součást lékárenského sortimentu. Cílem tohoto článku je také charakterizovat tzv. přírodní kosmetické přípravky a poukázat na jejich odlišnosti od konvenčních (syntetických) kosmetických přípravků.

Cosmetic products are an essential traded commodity in different facilities, including pharmacies. This article defines cosmetic products, their common features, and their differences from medicinal preparations and medical devices. The presented paper aims to explain the basics of marketing procedures and claims about the properties and effects of cosmetics governed by specific legislation. However, this article does not provide a complete interpretation of all applicable regulations. Still, it should direct the pharmacists and pharmaceutical assistants to cosmetics, which form an essential part of the pharmaceutical range. This article also aims to characterize natural cosmetics and differentiate them from conventional (synthetic) cosmetics.

• MeSH
• Cosmetics * chemistry   classification   MeSH
• Beauty Culture standards   legislation & jurisprudence   MeSH
• Humans MeSH
• Plant Extracts therapeutic use   MeSH
• Plant Preparations chemistry   MeSH
• Check Tag
• Humans MeSH

Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease-related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice.

• MeSH
• Drug Industry * MeSH
• Pharmaceutical Preparations MeSH
• Humans MeSH
• Multimorbidity MeSH
• Polypharmacy * MeSH
• Aged MeSH
• Drug Development MeSH
• Check Tag
• Humans MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH