Search for: "mdr" - 47 articles found

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Mobile DR

Del Medical – MDR

Power: 40 kWWidth: 57.6 cmWeight: 435 kgHighlightsAffordable all-in-one mobile digital radiography solution Compact design with fully collapsible column Fully integrated DELWORKS DR workstation with choice of detectors Effortless maneuverability, allowing navigation through tight spaces Motor assisted inching from the tube head On board detector charging Convenient…

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Clinical Chemistry

Nova Biomedical – StatSensor Creatinine

Highlights: Fingerstick capillary testing for creatinineThe StatSensor Creatinine is a handheld analyser and miniaturized, single-use biosensor for whole blood creatinine testing. StatSensor Creatinine’s advanced technology enables simple, rapid, and accurate assessment of renal function by fingerstick capillary blood sampling at the point of care. Available as a fully connected meter,…

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Article • Cyberattacks and countermeasures

Healthcare cybersecurity in the EU and US: a technical, regulatory or political issue?

The pandemic has put a spotlight on the increasing role of cyberattacks and weaknesses in healthcare. In healthcare as in other industries, cybercrime does not stop at national borders. With this idea in mind, the US consulate general in Düsseldorf and the US embassy in Vienna recently invited interested parties to their Cybersecurity in Healthcare Briefing.

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News • 'CRyPTIC' research

Global tuberculosis study identifies genetic causes of drug resistance

Using cutting-edge genomic sequencing techniques, researchers at the University of Oxford have identified almost all the genomic variation that gives people resistance to 13 of the most common tuberculosis (TB) drug treatments. The Comprehensive Resistance Prediction for Tuberculosis International Consortium (CRyPTIC) research project has collected the largest ever global dataset of clinical M.…

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News • Medical Device Regulation

MDR certification for Agfa Class IIa solutions

Agfa HealthCare is proud to be one of the first companies to receive the new European Medical Device Regulation (MDR) certification, which was issued by Intertek on 25 August 2021. This certification, which covers Agfa HealthCare’s Class IIa Enterprise Imaging and Xero Viewer solutions, ensures that Agfa HealthCare can continue to deliver to customers innovative solutions that meet their real…

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Article • A painful divorce

Post-Brexit worries for UK healthcare

Brexit could have a potential impact on healthcare delivery across the UK, according to an expert in the field. Dr Hugh Harvey believes that will be particularly noticeable in the area of Medical Device Regulation (MDR), with the UK and Europe seemingly going in different directions on the subject after the UK left the European Union (EU) at the end of last year.

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Sponsored • OR equipment

A successful decade of operating theatre wall monitors

OPERION from Rein Medical has been an established byword for wall-integrated monitors and workstations for the operating theatre for ten years. Now in their 3rd generation, they stand for hygienic, highly compatible, reliable and intuitive monitor and workstation systems. The extensive product range in sizes from 21.5" to 75" means that perfect hardware packages covering any requirement…

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Article • Medical device regulation revision

MDR: The UK goes it alone

With new Medical Device Regulations (MDR) now in force across Europe, the UK has chosen to retain pre-existing rules while also introducing mechanisms to allow it to draw up separate rulings for the sector in the future. The MDR took effect on May 26, aiming to harmonise and strengthen the pre-existing regulatory regime for medical devices, and enhance protection for consumers.

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News • Medical Device Regulation update

Lessons learned from implementing the MDR

26 May 2021 marks the Date of Application of the European Medical Device Regulation (MDR). Replacing the Medical Devices and Active Implantable Medical Devices Directives, the Regulation is a welcome update for patient safety, transparency, and access to medical devices for Europeans. COCIR has been contributing to the development and implementation of the MDR since the very first discussions in…

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Article • A major update

New medical device regulation comes into force

New regulations covering medical devices are set to come into effect across Europe. Originally intended to be implemented in May 2020, the introduction of the updated Medical Device Regulation (MDR) was delayed because of the coronavirus pandemic. The new regulations – the first major update in three decades – now come into force on May 26, and to mark the date a special conference discussed…

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Article • Medical waste management

Time to “Green Up” for EU Ministries of Health

COVID-19 has rocked health care systems, revealing vulnerabilities in our supply chain, piling up unprecedented costs, and creating an alarming amount of medical waste. The health care sector was already a major source of pollution. The World Health Organization points to the burning and incineration of health care waste as a source of dioxins, furans, and particulate matter emissions that…

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News • Medical device regulation

First hearing implant manufacturer to receive MDR certification

Austria-based cochlear and hearing implants technology company Med-El has become one of the first manufacturers worldwide, and the first and only hearing implant manufacturer in the world, to be granted European Medical Device Regulation (MDR) certification. The company made an initial announcement on the newly earned certification after making an early commitment to adopt the MDR in 2016. For…

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News • Medical Device Regulation

How the new MDR may hurt patients in the short term

The intentions behind the Medical Device Regulation (MDR) are good. Ultimately, the regulations should prevent inferior medical devices, technologies and pharmaceuticals from endangering peoples’ lives while increasing the quality of drugs and devices entering the market. At the same time, MDR could present several serious immediate challenges to European healthcare systems.

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Sponsored • Raising the bar

A new ultra-compact microscopy camera

The MKC-X800 ultra-compact camera is a new addition to Ikegami’s range of medical imaging equipment, which, the firm reports, sets higher than ever standards of imaging quality to capture the precise colour and image detail of surgical operations. Measuring just 28x28x52mm WHD and weighing 100g, it can be mounted on a surgical microscope, lightweight support stand or boom. With its 4K-native…

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Sponsored • Minimising infection risk

Drying in endoscope reprocessing: Essential to patient safety

In practice, the drying of the endoscope is often underestimated and therefore a possible pitfall for hygiene and reprocessing steps. As the importance of endoscopic retrograde cholangio-pancreatography (ERCP) procedures and their impact on patients’ lives remains unwavering, the medical community is continuously looking for ways to improve this field of expertise. What better way to learn more…

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Article • Microbiology & hygiene

HAIs are one problem – MDROs another

In view of the increase of multidrug-resistant organisms (MDRO), the World Health Organisation (WHO) has declared antibiotic resistance one of the biggest threats to global health. MDROs have become a major problem particularly in hospitals. Professor Dr Georg Häcker, President of the German Society of Hygiene and Microbiology (DGHM) and Director of the Institute for Microbiology and Hygiene at…

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Article • Rapid, reliable microbe identification

The Bologna Workflow System

Many countries across the world are challenged with a rising number of incidences of multi-drug resistant (MDR) organisms infecting the population, and for several years, a clear pattern of increased resistance has emerged in southern and eastern European countries. For example, in countries such as Italy, a reduced number of therapeutic options remain available for highly pathogenic infections,…

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Article • Differentiate and select

Myths and truths about antibiotics, antiseptics and vaccination

Sixty-two percent of Germans fear antibiotic resistance, according to a survey recently conducted by the German Federal Institute for Risk Assessment. ‘Patients colonised by multi-resistant pathogens are particularly scared. But many of these fears are rooted in misunderstandings,’ explained Professor Mathias Pletz at the Congress for Infectious Diseases and Tropical Medicine (KIT).

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Sponsored • Equipment

New medical cameras and displays

Designing medical imaging systems for surgical, ophthalmology and microscope-mounting applications, Ikegami Tsushinki Co. Ltd, from Tokyo, Japan, is showing the latest additions to its range of medical cameras and medical-grade displays. ‘The new MKC-X800 is a progressive-scan camera with an ultra-high-sensitivity 4K-native CMOS imager,’ Ikegami reports. ‘Measuring just 34 x 40 x 40 mm, the…

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Article • Cut device-related pressure ulcers

Biomedical designers must increase safety

Whilst acknowledging that state-of-the-art bioengineering approaches are being applied in preventing Medical Device Related Pressure Ulcers (MDRPUs), Professor Amit Gefen, from the Department of Biomedical Engineering at Tel Aviv University, believes there are gaps in knowledge and technology in this area and therefore more must be done to improve patient care and avoid additional healthcare…

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News • New FDA info

Can breast implants increase lymphoma risk?

The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin's lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, M.D., director of…

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Article • Regulation

Implementing MDR is complex and expensive and holds little reality

By 2020 medical devices manufacturers must document the clinical effectiveness of their devices more extensively. The Medical Device Regulation (MDR) presents a fundamental impact on innovation and price calculation for medical devices. Since the faulty PIP breast implants scandal in France (March 2010), there have been frequent calls for tighter licensing regulations for medical devices within…

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Article • Side-effects of global mobility

Multi-drug resistant bacteria: Dangerous travel companions

Trips around the globe, healthcare tourism, migration; we are mobile – and so are bacteria. Particularly dreaded are multi-drug resistant bacteria that ‘hop’ on their host during a hospital stay and are carried across the border. At MEDICA 2017 Labmed Forum Dr Andreas Ambrosch, Head of the Central Lab at Krankenhaus Barmherzige Brüder in Regensburg, Germany, will discuss these unwelcome…

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Article • MRSA and refugees

Screening, isolation, hygiene equal money well spent

Comprehensive examinations of 143 refugee patients hailing mostly from Afghanistan and Syria, which were conducted between June and December 2015, showed a high prevalence of MRSA, ESBL and MDRGN upon hospital admission. The figures exceed not only those of the general population but, alarmingly, also those found in high-risk groups, such as residents of nursing homes or home care service…

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News • MDR

Medical Device Regulation Adopted

COCIR welcomes the adoption of the Medical Device Regulation (MDR) after successful vote during the European Parliament Plenary Session today. These new rules should allow for continuing improvement to the safety of medical devices, benefitting patients and ensure timely access to innovative healthcare technology.

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Article • Legislation

IVDs under the microscope

European regulators have turned the world of in vitro diagnostics (IVDs) upside down with new legislation that will come into effect at the end of this year. The new EU legislation gives manufacturers five years to meet strict standards. That may not be enough time.

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Overcoming multidrug-resistant cancer with smart nanoparticles

Multidrug resistance (MDR) is the mechanism by which many cancers develop resistance to chemotherapy drugs, resulting in minimal cell death and the expansion of drug-resistant tumors. To address the problem of resistance, researchers at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) have developed nanoparticles that…

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Endogenous bacteria

Is chlorhexidine still the best decolonisation method? For many decades decolonisation – be it selective intestinal, oral or skin decolonisation – has been the accepted procedure to prevent infections by endogenous bacteria. Report: Brigitte Dinkloh

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US trails Europe in facilitating novel antibiotics development

While the Generating Antibiotic Incentives Now (GAIN) Act of 2012 has been a significant step in the right direction for encouraging novel antibiotics research, the US Food and Drug Administration (FDA) remains one step behind its European equivalent, the European Medicines Agency (EMA), according to an analyst with research and consulting firm GlobalData.

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Seeing is believing

Virtual observation of patients taking prescribed TB medication could prove an effective technique to ensure they effectively complete their treatment course, according to research presented at the European Respiratory Society (ERS) Annual Congress held in Barcelona.

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Risk Reduction and Inter-professional Collaboration for TB Infection Control

The International Council of Nurses (ICN) has launched an exciting, informative and practical toolkit for everyone involved in TB care and control. Entitled “Risk Reduction and Inter-Professional Collaboration for TB Infection Control”, it comes at a time when increasing numbers of health care workers are falling victim to this preventable and curable disease.

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Drug resistant tuberculosis test within hours

GenoType® MTBDR plus, a new molecular test for multidrug-resistant tuberculosis has recently been approved in Europe. The test, developed by the Foundation for Innovative New Diagnostics (FIND) and Hain Lifescience, offers a fast solution to detect MDR-TB and XDR-TB at a reasonable price, a good condition for the application in poorer countries.

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Nurses receive award for their work in tuberculosis

By putting the World TB Day slogan 'I am stopping TB' into action, 11 nurses have earned the 2008 ICN/Lilly Award, for their outstanding work in fighting tuberculosis (TB) and multi-drug resistant TB (MDR-TB)[1]. The award recipients come from six TB affected countries: from Kenya (Diana Jelegat Kipsoisoi), Lesotho (Likhapha Ntlamelle ), Malawi (Chrisie Bwazi, Rodwell Gundo and Shouts Simeza),…

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