Medical Device Dailys

Nine medical devices have advanced to a hospital-based evaluation by England's National Health Service (NHS) for effectiveness in screening and preventing healthcare-associated infections (HCAIs).

NHS research concluded up to 8% of incoming patients at hospitals are carriers of one superbug, methicillin-resistant Staphylococcus aureus (MRSA), compared to just over 1% who are infected while they are in hospital.

Several NHS hospital trusts have mandated screening of all incoming patients to combat the spread of this superbug as well as five other pathogens responsible for in-hospital infections.

In a systemwide effort, the NHS Purchasing and Supply Agency set up the Smart Solutions program to identify innovative technologies from different industry sectors with the potential to fight hospital bugs.

Almost 250 applications were submitted and the nine selected devices will be evaluated in a hospital setting starting soon at more than 30 NHS hospitals that offered to serve as an evaluation site for the Smart Solutions program.

An international HCAI Technology Innovation Summit is set for Feb. 26 as a kickoff for the evaluation program and to highlight innovations and technological developments in the field.

The finalists in the competition represent diverse approaches to controlling infection and the evaluations will not result in a single winner but recommendations with all nine companies potentially earning the prize of supplying the entire NHS network if they prove to be effective.

Among the selected technologies are products developed by Baxter Healthcare (Deerfield, Illinois), Chemspec (Baltimore), GE Healthcare (Chalfont St. Giles, UK) with Medixair (Brierley Hill, UK), UV Light Technology (Oldbury, UK), Inov8 Science (Buckingham, UK), Quest International UK (Ashford, UK), TwistDx (Cambridge, UK), Ergomedica (Bucks, UK), and Nanopool (H lzweiler-Schwalbach, Germany).

Baxter is proposing the V-link luer-activated device with VitalShield protective coating, an antimicrobial needle-free IV connector using the controlled release of silver particles effective in killing the six most common pathogens causing catheter-related bloodstream infections as a result of IV therapy.

Medixair proposes use of a high-intensity ultraviolet germicidal irradiation through wall-mounted and portable units with UV tubes from GE for eradication of airborne bacteria, viruses, yeasts and mold.

Ergomedica's MedMat is a self-contained changing mat developed by a surgeon from the Royal London and Barts Hospital Trust that protects both patient and caregivers from cross contamination during procedures that requires a sterile field.

Nanopool proposes a liquid glass layering technology for enhancing working surfaces with new anti-microbial properties by applying ultra thin nano layers of silicon dioxide, the primary element in common glass, modified by aluminium oxide, potassium oxide, calcium oxide and other components. The nano coatings are transparent and super-durable glass, with characteristic having what the company calls "massive implications for healthcare environments."

TwistDx has developed a novel point-of-care test technology using recombinase polymerase amplification, an evolution of the widely used diagnostic technique polymerase chain reaction that the company says is faster, taking from 10 to 15 minutes, with a portable instrument that brings the test to any setting to be administered by caregivers rather than by trained technician in a laboratory.

European OK for MedWaves

MedWaves (San Diego, California) reported receiving CE-mark certification for its Microwave Coagulation/Ablation System. The certification includes the Microwave power generator/controller and 16, 14, 11 and 9 gauge single-use probes.

The company said the certification, in addition to the earlier FDA clearance of the system for surgical applications, sets the stage for rapid expansion of its product portfolio.

The system and single-patient-use devices enable surgeons and interventional radiologists to treat soft tissue problems, such as tumors, using microwave thermal ablation.

MedWaves is focused on the development of minimally invasive devices in wide ranges of size, shape and flexibility intended to meet clinicians' requirements for treatment of tumors in bone, liver, lung and other locations.

The company said microwave ablation "can be adjunctive or a replacement for the curative and/or palliative therapies of standard therapies, such as chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size, location or patient condition."

CE mark for Carillon system

Cardiac Dimensions (Kirkland, Washington) reported that it has received the CE mark for its Carillon Mitral Contour System from KEMA Quality BV, a Notified Body located in the Netherlands. The system is a percutaneous treatment for functional mitral regurgitation (FMR).

The company said the CE-mark approval is an important milestone, and that it is now developing plans for commercialization in Europe.

Cardiac Dimensions also recently obtained ISO 13485 (2003) certification, the international standard for quality management systems for medical devices.

The Carillon system combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. It is delivered percutaneously via jugular vein access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve, thereby reducing mitral regurgitation.

Pre-clinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements in other key parameters, including NYHA class, 6-minute walk distances and quality of life.

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