New UV-C Disinfection Technology for Ultrasound Probes Earns FDA Clearance

Infection Intel: Staying Ahead With Company Updates and Product Innovations

A recent development in infection prevention technology comes from Germitec, a French MedTech company specializing in high-level disinfection for ultrasound probes. Today, Germitec's device, Chronos, received FDA De Novo Clearance. It is the first chemical-free, UV-C high-level disinfection (HLD) device for ultrasound probes approved for marketing and distribution in the US.

Chronos offers health care professionals a fast, automated, and chemical-free method to disinfect ultrasound probes in about 90 seconds, reducing the risk of cross-contamination. Its UV-C technology penetrates microorganisms, disrupting their DNA, RNA, and cellular proteins, which may contribute to lowering the incidence of health care-associated infections (HAIs). Annually, HAIs affect an estimated 1.7 million patients in the US, posing a significant challenge to healthcare systems.

Chronos is designed to disinfect external and endocavitary ultrasound probes used across various medical specialties, including gynecology, urology, radiology, emergency medicine, anesthesia, and biopsy procedures. The FDA approved the device after a thorough review of the device’s ability to achieve microbial reduction across a broad range of clinically relevant microorganisms, which aligns with the requirements for high-level disinfection.

Addressing Cross-Contamination

Ultrasound probes are classified as semicritical medical devices requiring high-level disinfection to prevent cross-contamination between patients. Proper disinfection is essential to reduce the risk of infections such as hepatitis B, C, and human papillomavirus. Despite disinfection protocols, studies have shown that some ultrasound probes may remain contaminated, even after chemical disinfection with wipes.

According to the press release, “Scientific data indicate that 13% of vaginal probes used with sheaths test positive for HPV even after disinfection with wipes⁵, and up to 70% of HAIs could be prevented with effective infection prevention and control measures. HAIs claim the lives of 99,000 patients annually in the US and pose a serious threat to health care safety, as reported by the CDC. These infections are linked to hygiene practices surrounding the procedure and the management and disinfection of the probes themselves.”

Chronos aims to address this issue by automating the disinfection process and removing potential errors associated with manual chemical disinfection. The device ensures consistent results by providing a standardized, automated disinfection method, making it easier for health care workers to maintain safety standards.

Benefits of the Technology

1. Fast disinfection process: Chronos disinfects ultrasound probes in just 90 seconds, reducing the time between procedures and helping improve workflow efficiency.
2. Chemical-free solution: The UV-C disinfection process eliminates the need for chemical disinfectants, which can pose risks to staff and patients and require additional handling and disposal protocols.
3. Consistent and traceable: The device's automated nature ensures that each disinfection cycle is uniform. It also provides traceability, allowing health care facilities to document and verify the disinfection process.
4. Broad applicability: This technology can be used across multiple medical departments where ultrasound probes are frequently utilized, including gynecology, radiology, and emergency medicine, making it a versatile solution for infection prevention.

Regulatory Milestone

The FDA De Novo Clearance granted to Chronos marks a significant regulatory milestone for Germitec. The approval process evaluated the device's efficacy in achieving high-level disinfection for ultrasound probes without using chemicals. The device is now classified as a Class II medical device and is regulated under 21 CFR 880.6511.

Looking Ahead

Germitec CEO Vincent Gardès expressed optimism about the clearance. “Being granted FDA De Novo is an outstanding achievement for Germitec,” he stated. “This milestone is the result of several years of hard work by a first-class team and our partners. We are excited to introduce this groundbreaking chemical-free technology to the world's largest healthcare market. With the successful completion of the rigorous FDA De Novo process, our UV-C HLD solution offers validated microbial kill efficacy, providing healthcare facilities with a trusted option to protect their patients across all departments where ultrasound exams are performed. Additionally, this clearance paves the way for our future UV-C HLD products designed for long probes used in ENT and Cardiology departments.”