Search for: "mdr" - 46 articles found

Photo

Mobile DR

MDR

HighlightsAffordable 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 storage for wireless detector, grids…

Photo

Article • Custom parts made in the lab

3D printed implants on demand

A custom-made new hip, a knee or maybe a piece of bone? The technology and possibilities for 3D printing are (almost) there. And such an implant from a 3D printer has many advantages, not only for the patient, but also for the surgeon who has to perform the operation. Koen Willemsen, physician, and medical engineer at the University Medical Center Utrecht (UMCU), was at the cradle of the 3D lab…

Photo

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.

Photo

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.…

Photo

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…

Photo

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.

Photo

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…

Photo

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.

Photo

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…

Photo

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…

Photo

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…

Photo

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…

Photo

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.

Photo

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…

Photo

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…

Photo

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,…

Photo

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).

Photo

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…

Photo

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…

Photo

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.

Photo

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.

Photo

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…

Photo

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.

Photo

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.

Photo

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.

Photo

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.

Photo

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),…

Subscribe to Newsletter