One-Year Study Demonstrates Vision-Sciences' EndoSheath Technology Protects Against Bacterial Contamination Of Bronchoscopes

ORANGEBURG, N.Y., Oct. 22, 2013 (GLOBE NEWSWIRE) -- Vision-Sciences, Inc. (Nasdaq:VSCI) announced today that the detailed findings of a twelve-month evaluation of its EndoSheath ® technology in the critical care setting were presented by Dr. Flavia Petrini, Professor of Anaesthesia and Intensive Care, Università Gabriele d'Annunzio Chieti-Pescara (Italy), in a scientific poster at the 67 th National Congress of the Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI).

Of the 53 bronchoscopy cases conducted there were no cases of bacterial contamination of bronchoscopes, excluding two deliberate contaminations by the bronchoscopists for control purposes. "These highly positive study outcomes add to the growing body of data on the microbiology validation of our EndoSheath technology, and further support the advantages of using our sterile, disposable technology over conventional, difficult to clean and disinfect endoscopes," stated Howard Zauberman, Interim Chief Executive Officer of Vision-Sciences.

This study was conducted by researchers at the Università Gabriele d'Annunzio Chieti-Pescara Hospital Intensive Care Unit (ICU) to examine the impact of the EndoSheath technology on reducing the bacterial contamination of the bronchoscopes and the potential for eliminating the need of routine high-level disinfection (HLD) in reprocessing.  During the twelve-month study period, investigators used Vision-Sciences' bronchoscope with EndoSheath technology to perform bronchoscopic procedures (n=53) including bronchial aspirate (BAS) (n=19), bronchoalveolar lavage (BAL) (n=31), and percutaneous tracheostomy (PCT) (n=3).  The device was cultured three times for each procedure: before the application of the EndoSheath; after the procedure and removal of the EndoSheath; and, after enzymatic cleaning, drying and disinfection with 70% ethanol. A sterile pledget was wiped on the entire surface of the insertion tube and a second one on the entire surface of the control head. Both were placed in sterile specimen containers for culture. 

The operator deliberately contaminated two (3.8%) results for control purposes by touching several areas and other devices in the ICU. As expected, these two results tested positive for bacterial contamination with Staphylococcus (CoNS) or Sphingomonas paucimobilis. The remaining 51 procedures (96.2%) tested negative for bacterial contamination.

Overall performance of the device was also measured by the bronchoscopist after each procedure using a semi-quantitative linear score (0=minimum; 5=maximum). The device was judged positively for performance in terms of visualization (defined by clarity of the image and brightness), suitability (defined by general comfort and easiness of use) and function usefulness (defined by potency of aspiration and injection, tip movements). The mean scores for these criteria were as follows:
   
Visualization 3.9 (95% CI: 2.2-5.6)
Suitability 3.0 (95% CI: 1.6-4.4)
Function usefulness 3.1 (95% CI: 1.7-4.5)

A comparative study is planned to confirm this data on bacterial reduction.

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