PubMed2005
Transducers are medical products that are categorized as uncritical, semicritical and critical, depending on their applications and perceived risks. Uncritical medical products are transducers that solely come in contact with the intact skin, such as transducers used for sonography of the abdomen or breast. Semicritical medical products are transducers that come in contact with mucosal membranes or diseased skin, comprising transducers used for transesophageal, transvesical, transvaginal, transrectal and perineal sonography. Critical medical products are transducers that come in contact with blood, internal tissues or organs, such as transducers used for intraoperative sonography. Under the most unfavorable circumstances, sonographic transducers can become contaminated with pathogenic agents (e. g., MRSA, HBV, HCV, HIV, Herpes viruses) and turn into a not to be underrated source of infection. For this reason, correct handling as well as cleaning and disinfection of the transducers are indispensable. Depending on the application, the recommended handling of the transducers differs. Transducers counted to the uncritical medical products are adequately cleaned by removal of the applied ultrasound gel with subsequent wipe disinfection (e. g., foam spray). Transducers counted to the semicritical medical products, such as transvaginal or perineal transducers , should be exclusively used after a suitable cover has been applied. A Latex(R) allergy must be excluded before the examination. The cover is to be disposed after completion of the examination and the transducer itself cleaned and disinfected. The disinfecting agent must be antiviral but also compatible with the material (caution: damage to the transducer membrane when using an unsuited alcoholic disinfecting agent). In case of rupture of the protecting cover during the examination, the transducer is considered contaminated with secretion or even blood and must be thoroughly cleaned with subsequent disinfection, whereby ample contact time must be allowed for the disinfecting agent. Coarse contamination of the transducer should be removed with disposable tissue. Above all, dried blood spots should be avoided. Intraoperatively used transducers (= critical medical products), which, for instance, come in contact with abdominal organs, are subject to applicable rules and regulation for cleaning and disinfection. Before each use, an adequately long sterile cover must be placed over the transducer and connecting cable. When the examination is completed, the cover is removed and discarded, and the transducer cleaned and disinfected. The applicability of a reusable medical product implies that each manufacturer is obligated to provide care instruction, including formulated instructions for cleaning and disinfection. This entails that each manufacturer of sonographic equipment must make available a detailed summary of the appropriate disinfectants suitable for the respective transducers. Customarily, recommendations for care and cleaning of the transducers can be found in the manual that comes with the sonographic unit. In the absence of such a manual, a written request should be sent to the manufacturer of the sonographic equipment. Sonographic equipment manufacturers and disinfectant producers prefer disinfecting agents for instruments that are based on glutaraldehyde, aldehydes and quaternary agents, mostly for reason of material compatibility rather than their anti-infective effectiveness. Most recommended disinfectants are not tested for antiviral properties, but this is obligatory when applied to transducers that enter a body cavity potentially harboring a virus load - regardless whether the work is done with protective cover . Further information about the topic "medical products" can be found in the guidelines for hospital hygiene and infection prevention published by the Robert Koch Institute (Section: Required Hygienic Standards for Medical Products ), the website of the Robert Koch Institute for hospital hygiene control and the Rules and Regulation for Medical Products Distributors .
Communicable Disease Control↗