Key Takeaways
- Germitec’s Chronos® device has achieved the first-ever FDA De Novo clearance for a UV-C High-Level Disinfection chamber, providing a chemical-free and automated solution for the disinfection of ultrasound probes.
- Chronos® effectively targets a range of pathogens, reducing healthcare-associated infections in critical environments, meeting the highest standards for infection prevention.
- This FDA clearance marks a major milestone for Germitec, establishing Chronos® as a trusted, efficient, and sustainable solution for the disinfection of external, transvaginal, and transrectal ultrasound probes, with future products planned for ENT and cardiology.
Germitec, a French MedTech company specializing in High-Level Disinfection (HLD) for ultrasound probes through its proprietary UV-C technology, has announced that its Chronos® device has received the Food and Drug Administration (FDA) De Novo clearance. This marks the first-ever FDA clearance for a UV-C High-Level Disinfection chamber, offering a chemical-free, automated solution for the disinfection of ultrasound probes.
Infection prevention remains a critical public health issue, with healthcare-associated infections (HAIs) affecting 1.7 million patients annually in the U.S. and resulting in 99,000 deaths. Chronos® was rigorously evaluated through the FDA’s De Novo process, demonstrating its effectiveness against a range of pathogens, including bacterial spores, mycobacteria, yeast, and viruses. The UV-C disinfection device achieved significant microbial log reduction, meeting the high standards required for High-Level Disinfection.
Chronos® UV-C System Provides Rapid, Chemical-Free Disinfection for Ultrasound Probes, Addressing Growing Need in Medical Diagnostics
The Chronos® system offers healthcare professionals a user-friendly, traceable, and chemical-free solution for disinfecting external, transvaginal, and transrectal ultrasound probes. In just 90 seconds, the device delivers effective disinfection, addressing the growing demand for ultrasound procedures across medical fields such as gynecology, radiology, urology, and emergency medicine.
As ultrasound becomes increasingly vital in medical diagnostics, with a market projected to exceed $4 billion by 2024, proper disinfection of probes is essential to prevent HAIs such as hepatitis B, C, and human papillomavirus (HPV). Data show that improper cleaning of vaginal probes with sheaths can still result in HPV contamination in 13% of cases, highlighting the need for advanced disinfection methods. UV-C HLD offers an efficient alternative, with studies showing it can prevent up to 70% of HAIs when implemented effectively.
Chronos® Becomes First FDA-Approved UV-C HLD Device, Setting a New Standard for Safe and Efficient Ultrasound Probe Disinfection
Chronos® is the first and only UV-C HLD chamber to be granted FDA approval for use in healthcare environments. The device provides a safe and efficient way to disinfect ultrasound probes, significantly reducing the risk of cross-contamination and improving patient safety. Germitec’s mission is to raise the standards of care by offering innovative, effective, and sustainable infection prevention solutions.
Dr. David J. Weber, a leading expert in infection prevention, praised the technology: “UV-C HLD is a proven, efficient technique, supported by multiple studies. With the growing demand for ultrasound exams, this product offers healthcare professionals a faster, cost-effective, and sustainable solution that ultimately enhances patient safety.”
Vincent Gardès, CEO of Germitec, expressed pride in the achievement: “Being granted FDA De Novo clearance is a remarkable milestone for Germitec. Our team has worked tirelessly to bring this groundbreaking technology to market, and we are thrilled to offer this chemical-free solution to the U.S. healthcare system. This clearance validates Chronos® as a trusted option for protecting patients across departments where ultrasound exams are performed.” The FDA De Novo clearance sets the stage for the introduction of future Germitec UV-C HLD products, designed for long probes used in specialties such as ENT and cardiology.
Resource: Germitec, September 04, 2024
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