Ultrasound Transducer Disinfection in Many Instances is Not Enough

This is the latest disturbing finding issued by the Center for Disease Control and Prevention (CDC; Atlanta, GA, USA), the leading US public health agency, in its recently published Guideline for Disinfection and Sterilization in Healthcare Facilities. The guideline is the CDC's response to the rapidly evolving epidemiology of hospital-acquired infections such as Clostridium difficile or methicillin-resistant Staphylococcus aureus (MRSA).

In light of this global threat, and with regard to the millions of ultrasound examinations conducted each day, Nanosonics GmbH's (Sydney, Australia, and Hamburg, Germany) newest product innovation represents a long-needed milestone in the development of medical devices because of its unique technology, the Trophon EPR, which satisfies all requirements of the new CDC guideline.

Whereas current methods for high-level disinfection of contaminated transvaginal and transrectal transducers (e.g., aldehydes, alcohol, or chlorine) show considerable disadvantages, the Trophon EPR has been custom designed to disinfect intracavity and surface ultrasound transducers, while combining speed, safety, and convenience. It delivers high-level disinfection plus (HLD+), including sporicidal efficacy, in only six minutes operating time. The fully automated device can be used directly at the point of care, is easy to operate and is environmentally friendly, leaving water and oxygen as the only by-products.

"We recognized the danger presented by the inadequate disinfection of ultrasound transducers, and know that the Trophon EPR will be indispensable for the urgently needed hygiene necessary in the medical sector, to guarantee the safety of each and every patient,” explained David Radford, director and CEO of Nanosonics Ltd, Australia, prior to the impending market launch.

The product technology has been validated by major original equipment manufacturers (OEMs) (e.g., Philips Healthcare [Best, The Netherlands] and Siemens Medical Solutions [Erlagen, Germany]), and dealer commitments have already been approved in several European countries. The European launch of the Trophon EPR is scheduled to start in the first half of 2009. An application for U.S Food and Drug Administration (FDA) regulatory approval (510k) is on target for lodgment in December 2008, with anticipated approval later in 2009 allowing marketing within North America.

The company owns intellectual property relating to unique disinfection and sterilization technologies, which can be suited to a variety of markets including the healthcare industry, food processing, room and space decontamination, and manufacturing.

Nanosonics is currently focused on developing infection control solutions for the global healthcare market. Initial applications are designed for the reprocessing of reusable medical instruments. The Trophon EPR is specifically designed to disinfect intracavity and surface ultrasound probes. Based on the NanoNebulant technology it surpasses the limitations of current methods by killing the most resilient microorganisms, in a fast, safe, and convenient way.

Related Links:
Center for Disease Control and Prevention
Nanosonics