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Annual ECRI List Of Top 10 Health Technology Hazards Underscores Critical Need For Vision-Sciences' EndoSheath(R) Technology

ORANGEBURG, N.Y., Nov. 18, 2013 (GLOBE NEWSWIRE) -- Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, announced today that for the fourth consecutive year, the ECRI Institute listed "Inadequate Reprocessing of Endoscopes and Surgical Instruments" among the top ten most dangerous technology hazards.

"Our EndoSheath technology pre-empts the hazard of inadequate reprocessing by encasing the flexible endoscope in a sterile, protective EndoSheath micro-barrier," said Howard Zauberman, Interim Chief Executive Officer of Vision-Sciences, Inc. "After the procedure, the user removes and disposes of the EndoSheath barrier, and the flexible endoscope is cleaned using our simple three-step cleaning process. Three recent research studies, one in cystoscopy 1 and two in the bronchoscopy setting 2, 3, demonstrated that our technology has a low risk of pathogen transmission and high patient safety.

"We applaud the ECRI Institute for its efforts to focus the attention of the medical community on the most significant current risks facing the industry. We continue to work diligently to increase our market share, and hope that over time the paradigm will shift to where all flexible endoscopic procedures in the markets we serve employ our 'always ready, always sterile' EndoSheath technology to protect patients against the hazards of inadequate endoscopic reprocessing."

The ECRI Institute is a non-profit patient safety organization that publishes this annual list, available online at www.ecri.org/2014hazards. The Inadequate Reprocessing hazard is described as follows:

  • Healthcare facilities clean and disinfect thousands of reusable surgical instruments and devices every day.  
  • Flexible endoscopes, in particular, are complex devices with narrow, hard-to-clean channels, and are therefore particularly challenging to decontaminate or "reprocess" for subsequent use.  
  • When reprocessing is not performed properly, however, patient cross-contamination is possible, potentially leading to the transmission of infectious agents and the spread of diseases such as hepatitis C, HIV, and tuberculosis.

1 Peter Hjorth Jørgensen, Slotsbjerg T et al. A microbiological evaluation of level of disinfection for flexible cystoscopes protected by disposable endosheaths. BMC Urology 2013, 13:46; DOI:10.1186/1471-2490-13-46. Accessed online 14 Nov 2013.

2 Scientific poster presented 19 Oct 2013 by Dr. Flavia Petrini, Universita Gabriele d'Annunzio Chieti-Pescara at the 67th National Congress of the Societa Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI).

3 Lieutenant Colonel Andrew McDonald Johnston et al. Evaluation of a disposable sheath bronchoscope system for use in the deployed field hospital. J R Army Med Corps 08/2013; DOI:10.1136/jramc-2013-000125. Accessed online 14 Nov 2013.

The hazards outlined in the ECRI's annual list demonstrate a critical need for the EndoSheath technology. Vision-Sciences' proprietary reusable flexible endoscope is combined with a single-use, sterile protective EndoSheath disposable, which is placed over the patient contact area of the scope: it's 'always ready, always sterile' EndoSheath technology reduces the risk of cross-contamination associated with the reuse of conventional endoscopes.

This technology allows healthcare providers to perform a rapid, simplified reprocessing routine after use, avoiding the elaborate high level disinfection/sterilization routines required by the U.S. Food and Drug Administration (the "FDA") for conventional endoscopes. The FDA requires that all conventional flexible endoscopes be reprocessed according to FDA-cleared manufacturers' regulations and organizational guidelines, whether they are used in hospitals, clinics or office settings. The EndoSheath technology enables healthcare professionals to reduce the steps needed to reprocess flexible endoscopes from approximately 27 to three, thereby saving time and lowering costs.

The EndoSheath Technology allows for a rapid and less damaging cleaning process and provides a multitude of benefits to healthcare practitioners, such as: lower capital equipment investment; less service and maintenance costs of capital equipment; less staff exposure to toxic chemicals; increased patient scheduling flexibility and throughput; improved staff productivity; and, a more practical implementation of endoscopy.

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