Ultrasound Transducer Disinfection Mostly Insufficient
Current methods of ultrasound transducer disinfection are in many cases not sufficient for clinical practice. This is the latest alarming result issued by the Center for Disease Control and Prevention (CDC), 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 MRSA.
In light of this global threat, and with regard to the millions of ultrasound examinations conducted each day, Nanosonics' newest product innovation represents a long-needed milestone in the development of medical devices: due to its unique technology, the Trophon EPR completely 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 drawbacks, 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 recognised 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 Limited, Australia, prior to the impending market launch.
The product technology has been validated by major OEM's (e.g. Philips Healthcare and Siemens Medical Solutions) 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 FDA regulatory approval (510k) is on target for lodgement in December 2008, with anticipated approval later in 2009 allowing marketing within North America.