A clinical study to evaluate the safe and effective use of a new, single use stethoscope cover to enable reduction in pathogen transmission during auscultation

ObjectivesStethoscopes carry a significant risk for pathogen transmission. Here, the safe use and performance of a new, non-sterile, single-use stethoscope cover (SC), that is impermeable for pathogens, was investigated by different healthcare professionals (HCPs) in the postoperative care setting of an intensive care unit (ICU). MethodsFifty-four patients underwent routine auscultations with the use of the SC (Stethoglove(& REG;), Stethoglove GmbH, Hamburg, Germany). The participating HCPs (n = 34) rated each auscultation with the SC on a 5-point Likert scale. The mean ratings of acoustic quality and the SC handling were defined as primary and secondary performance endpoint. Results534 auscultations with the SC were performed (average 15.7/user) on the lungs (36.1%), the abdomen (33.2%), the heart (28.8%), or other body-sites (1.9%). No adverse device-effects occurred. The acoustic quality was rated at 4.2 & PLUSMN; 0.7 (mean) with a total of 86.1% of all auscultations being rated at least as 4/5, and with no rating as below 2. The SC handling was rated at 3.7 & PLUSMN; 0.8 (mean) with a total of 96.4% of all auscultations being rated at least 3/5. ConclusionUsing a real-world setting, this study demonstrates that the SC can be safely and effectively used as cover for stethoscopes during auscultation. The SC may therefore represent a useful and easy-to-implement tool for preventing stethoscope-mediated infections.Study Registration: EUDAMED no. CIV-21-09-037762.

Automated summary

This study investigated the safe use and performance of a new non-sterile single-use stethoscope cover (SC) in the postoperative care setting of an ICU. The results showed that the SC can be safely and effectively used as a cover for stethoscopes, which helps prevent stethoscope-mediated infections.