Renishaw’s neuromate stereotactic robot, incorporating neuroinspire surgical planning software, has received EU Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution.
Founded in March this year, Orion Medical, based in Cham, Switzerland, has been established as a specialist in 3D printing for the medical devices industry. The company is closely linked to Orion Additive Manufacturing (Orion AM), an established manufacturer of 3D printing systems for high-performance polymers based in Berlin, Germany.
Clarius Mobile Health is first to introduce a third-generation product line of high-performance wireless ultrasound scanners in the European Union and United Kingdom. Now 30% lighter and smaller, the new pocket-sized scanners that connect with Apple and Android devices are available with new features that will put premium handheld ultrasound into the hands of more doctors. Clarius has replaced the complex knobs and buttons found on traditional ultrasound systems with an app that uses artificial intelligence and intuitive touch-based controls. Thousands of first and second generation Clarius scanners are already in use across the continent to improve diagnostic speed and accuracy and improve procedural safety.
“Clinicians in Europe and the UK have been early adopters of Clarius wireless ultrasound, and we know excitement has been building for our new miniaturized Clarius HD3 because we’ve had a long list of customers eagerly waiting for CE certification,” says Clarius Founder Laurent Pelissier. “Our mission has always been to improve patient care by enabling more clinicians to use ultrasound. Now that Clarius is reduced to the size of an iPhone, easier to use, and costs less, we’re expecting more clinicians will use ultrasound to deliver the best patient care.”
In emergency environments, the Clarius C3 HD3 multipurpose scanner saves lives. Dr Wolfgang Fleischmann, an anaesthesiologist and emergency medicine physician, describes why the Red Cross chose Clarius when it sought to equip its emergency services vehicles with hospital-grade portable ultrasound.
“We had the opportunity to extensively test the Clarius scanner in our prehospital emergency environment. The product impressed us with its image quality, its reliability, its short start-up time, and good price-to-performance ratio. It prompted us to equip all our emergency doctors’ cars and ambulances with the Clarius ultrasound device.”
Clarius sets itself apart from other handheld ultrasound systems with exceptional imaging quality that rivals expensive cart-based systems, wireless connectivity, and specialty scanners with Software-as-a-Service (SaaS) designed to optimize clarity and workflows for different anatomy and applications.
Clarius offers software packages designed for many specialty applications including Advanced Breast, Musculoskeletal, Obstetrics, Primary/Critical Care, Vascular, Veterinary Packages, and Aesthetics. They deliver dedicated presets, advanced workflows, comprehensive measurements, and fined tuned imaging, leveraging artificial intelligence and SaaS to deliver a complete handheld ultrasound solution that’s connected to the cloud.
Clinicians can choose from seven ultrasound scanners, each designed to meet the specific requirements of a broad range of medical specialties.
With best-in-class MSK imaging, the Clarius L15 HD3 high-frequency linear scanner is a top choice amongst orthopaedic surgeons. Dr Rudolf Berlakovits, MD, PhD, an orthopaedic surgeon in Vienna, Austria, describes the advantages of the new Clarius HD3 for safe, procedural guidance.
“To me as an orthopaedic surgeon, the Clarius HD3 is a highly recommended device for interventional orthopaedics and ultrasound guided orthopaedic surgery. There is no cable, making it easy to keep aseptic, and the probe provides perfect handling. Another great benefit is the possibility to share the findings with colleagues all over the world in real-time with Clarius Cloud exam management.”
Dr Ines Verner, an Aesthetic Dermatologist based in Tel-Aviv, uses the Clarius L20 wireless ultrasound scanner to prevent complications such as vascular occlusions during aesthetic procedures like cosmetic fillers. She was among the first to try the Clarius L20 HD3 for facial aesthetics.
“It’s a breakthrough in the field. Clarius is a good fit for aesthetics because it lets me clearly see fine facial anatomy, it’s easy to use, the image quality is good, it’s wireless, and it’s small so I can take it with me from room to room,” Dr Verner says. “Ultrasound is a gamechanger for the aesthetics industry because we can really see what we need to see instead of injecting blindly, which is what most of us used to do. Now, we can inject knowing where we’re going and not to inject where we don’t want to inject.”
Clarius has introduced a new Clarius Membership bundle that makes the entry price lower and enables new users to fast-track ultrasound proficiency.
Clarius HD3 wireless scanners now start at €2875 with a €575 annual membership in Europe or £2440 with £490 membership annual membership in the United Kingdom. Members gain access to all advanced SaaS, enhanced education options, and unlimited exam management in the Clarius Cloud. A three-year standard warranty is included with enhanced warranty options available through Clarius Care.
Owen Mumford, a global leader specialised in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech and generics industries, has signed an exclusive agreement with Stevanato Group, a global provider of drug containment, drug delivery and diagnostic solutions for the Aidaptus auto-injector.
The agreement makes Stevanato Group an exclusive manufacturing partner for the Owen Mumford designed auto-injector, offering a full set of capabilities to its pharmaceutical customers. Stevanato Group will mould the components for Aidaptus and provide final and sub-assembly equipment, while also offering market-leading pre-filled syringes to enable pharmaceutical customers to create the final product for patient use. Assembly of the components will be undertaken by both Stevanato Group at its global manufacturing sites and by Owen Mumford at its automated assembly centre of excellence in the UK.
The collaboration is intended to bring added value to customers, matching world-class device expertise with premium manufacturing capabilities. It is expected to streamline device production and deliver the full value of the innovative Aidaptus platform to the market.
Aidaptus is a 2-step, single use auto-injector with a versatile design that accommodates both 1mL and 2.25 mL prefilled glass syringes in the same base device. It also features plunger sensing technology with a self-adjusting plunger rod that automatically adapts to the individual plunger positions and different fill volumes in each syringe, with no change parts required. The auto-injector is also able to accommodate a unique variety of drug viscosities.
“Aidaptus will help patients to self-administer their individual therapies using a simple and easy to use device,” said Adam Mumford, Director of Owen Mumford. “At the same time, this auto-injector can help to reduce complexity, minimise supply chain risk and simplify final assembly for pharmaceutical and biotechnology companies thanks to its ability to adapt to different viscosity, syringe sizes and fill volumes. Often during development or life-cycle management of injectable drug products, changes in these parameters can occur. Now for the first time, the device does not have to be changed as well.”
Mauro Stocchi, Chief Business Officer of Stevanato Group, commented: “We believe this agreement is an important step in enhancing and growing the opportunities in our drug delivery systems portfolio as we broaden our capabilities in this key market. As we are constantly working with our customers to satisfy their needs, we continue to experience an increase in demand for auto-injectors. With this agreement, we will exploit the full breadth of Stevanato Group integrated capabilities being able to offer device manufacturing, assembly equipment, together with pre-fillable syringes and inspection systems.”
Steven Kaufman, VP for Drug Delivery Systems at Stevanato Group, added: “The Aidaptus auto-injector platform combines ease of use for patients with faster time-to-market access for pharma organisations. We aim to be the strategic partner with which to develop innovative combination products as we continue the expansion of our integrated capabilities in the drug delivery space, and for this reason we are very excited to work with Owen Mumford and provide access to its exciting new auto-injector platform.”
Choosing the best medical PC for operating room use is an important decision for hospitals around the globe. Thankfully, advances in medical PC design and operation have lifted their hygienic-friendliness to an impressive level that is welcomed by healthcare professionals. This article will take a look at how medical PC design has changed and what factors should be considered for your next purchase.
For many years, plastic was used to cover PC monitors and keyboards in operating rooms to ensure hygienic use. It was then removed, thrown away and replaced with fresh plastic after each use. The utilitarian design and construction of PCs with various cracks, crevices and attachment points did not take well to hygienic cleaning and disinfection. Sensitive monitor screens could not withstand aggressive cleaning procedures and keyboards hid dirt and debris between the keys, which made them extremely hard to clean and disinfect.
Hospitals stepped away from these legacy systems when medical PC manufacturers started producing systems specifically designed for hospital use. The latest systems are designed with cases that are smooth, sealed, free of vents or fans, and come with Class 1 medical device approval. Interfaces are also completely sealed and come with IP protection to prevent cleaning and disinfectant liquids from entering the case and damaging electronics.
Although the hygiene of PCs was always important for hospitals, the current pandemic has made hygiene more crucial than ever before.
Although the threat of nosocomial infection in hospitals cannot be compared to the current pandemic, it is still an important consideration.
For example, patients with infections acquired from intensive care units in developed countries range from 3.5% to 12%, with a frequency rate up to 17 episodes per 1000 patient-days. Undeveloped countries have a range from 4.4% to 88.9%, with a frequency up to 42.7 infections per 1000 patient-days. This gives us a total of 6.2 infections per 365 patient-days in developed countries and 15.58 infections per 365 patient days in undeveloped countries. These infections account for 37,000 deaths in Europe and 99,000 deaths in the USA.
Compared to 207,784,507 infections and 4,370,424 deaths worldwide due to the pandemic as of 17 August 2021, infections in hospitals seem to be very minor. But even after the exit of the pandemic, these infections will still be with us. Therefore, reducing health-care related infections is, and will remain, a major task for hospitals around the globe and one that must be addressed to help save lives.
One new approach is the use of UV light as a disinfectant. UV-C light, specifically, is being used in operating rooms for reducing germs and viruses. Research carried out by Dr. Anthony Griffiths, Associate Professor of Microbiology at Boston University School of Medicine, has shown that viruses exposed to a radiation strength of 0.849 mW/cm2 at a level of 7.64 mJ/cm2 for just nine seconds can render them inactive. It is a good way to sterilize the air in an operating room, or disinfect smaller devices, but it is not fully effective when eliminating pathogens on larger medical devices like medical PCs. Therefore, the process of physical cleaning and disinfection in these cases is still necessary.
Dirt accumulates in computer vents
Advances in PC technology have made it possible to design high-performance PCs that are completely sealed, which means no vents or fans that could serve as agents for germ distribution. Although this passive cooling design is extremely advantageous for cleaning and disinfection, it limits the PC’s performance to a maximum of 150 watts. Medical PC manufacturers must therefore incorporate components and operations that deliver the highest performance possible without crossing the 150 watt border. Thanks to sophisticated designs and highly efficient embedded components, today’s medical PCs provide enough computing performance to even render high resolution 3D images during operations, while remaining very energy efficient, which is very advantageous for use on patient care carts that utilize batteries for power.
A sealed, passively-cooled case is an important part of the hygienic PC formula, but is not the only thing to consider. An equally important component is the display panel. Today’s best design principle for medical PCs is the use of touchscreens that feature edge to edge coverage, which eliminates the gaps that normally exist with screens recessed in the housing. The result is a display that is much easier to clean and disinfect on a regular basis.
It’s crucial to use robust glass for the touchscreen, so it holds up to aggressive cleaning and disinfection without scratching or dulling. The glass surface should also be antireflective to reduce light source reflections that could interfere with the clear display of images. The best solution is to use etched glass with a minimum hardness of 7H, instead of applying a sensitive antireflective coating to the glass that is prone to scratches and wear and can lose its effectiveness over time. And lastly, keep in mind that the touchscreen should be sensitive enough to recognize touches with surgical rubber gloves.
Although a completely sealed case is important for hygiene, it should also be extra sturdy and offer a high level of impact-resistance in the sometimes fast-paced and hectic operating room environment. As the PC system is normally mounted on a flexible arm in operating rooms, it’s exposed to bumps and hits during use, such as by a moveable light. The case should therefore withstand a 250 g drop from a 40 centimeter height, which corresponds to an impact resistance level of IK06.
An active antibacterial coating on the surface of the case adds to the hygienic design. Such coatings contain silver, which provides an effective level of protection against pathogens and should have an effective service life of more than five years.
A recent innovation that contributes to an even higher level of hygiene is invisible housing connections that were developed and patented by Adlink Technology. With the use of this connection system, hard to clean cracks, crevices and low-lying screw heads make the cleaning and disinfection process not only more effective but also quicker and easier.
Instead of using screws, the case panels are magnetically attached. A spring-loaded latch holds the case together and does not feature any external components. The latch could be designed, for example, as a pin that can slide into place for attachment of the touchscreen. Alternatively, it could be an integrated part of the case. Attachment of the touchscreen to the PC base is therefore fully secure. It can only be decoupled intentionally and not by accident.
The patented connection system replaces external screws with internal bolts that are magnetically positioned from the outside of the case. The magnetic safety bolt (5), with magnetic piston (5.1) and locking pin (5.2), lock the case cover (3) to the base (4). An external magnet (10.2) pulls the safety bolt against the force of the spring to decouple the two halves of the case. When closing the case, the locking pin automatically goes into the hole (4.4) to secure both halves of the case to each other.
This purpose of this article was to provide the reasons why MDR Class I certification of a medical PC, as well as its observance of EN60601-1 and EN60601-1-2 technical standards, are not the only important considerations when deciding on your purchase. A range of additional criteria should be considered by IT Managers in hospitals and other health-care facilities when assessing the hygienic design and operation of a medical PC to help ensure they make the best choice.
April 2024
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