As many are aware, the number of infections linked to improperly processed and contaminated flexible endoscopes in the past few years have resulted in heightened scrutiny from watchdog organizations and medical oversight boards, as well as individual practitioners.
To prevent future infections, groups such as the ANSI/AAMI, the AORN and SGNA have adopted new reprocessing standards that, when taken together, are far-reaching and extensive. They include guidelines on what kind of fluid-resistant clothing and masks should be worn when reprocessing endoscopes to biochemical cleaning-verification tests, to how to store products and document the process.
These guidelines are in place for patient safety, which of course takes priority, but by default, they make any procedure involving an endoscope more complicated.
There’s no way around it: Even with these new reprocessing guidelines, endoscopes are just hard to clean. Martin Favero, Director of Scientific and Clinical Affairs at Advanced Sterilization Products, described flexible endoscopes as “the device from hell,” when it comes to cleaning and disinfecting them.
Manual cleaning is considered the most important step in reprocessing this equipment. It is also the most labor-intensive and the part of the process that is most susceptible to an oversight or misstep that will lead to an infection. If the instrument is not properly cleansed, the disinfection or sterilization will not be effective, and the instrument will still be dirty.
By requiring users to brush the channels multiple times and, once they have finished cleaning, to check their work by using a biochemical cleaning-verification test, the new guidelines make manual cleaning even more intensive. One result of these extra steps in an increase in labor costs. It’s now estimated that reprocessing a flexible endoscope to standards takes about 76 minutes of hands-on staff time per instrument.
A recent study1 which leveraged insights from several highly-respected International Association of Healthcare Central Service Material Management (IAHCSMM) leaders confirmed what many private practitioners and hospital staff already knew: The cost to comply with these new standards and reprocess flexible endoscopes is higher than ever.
This financial burden, coupled with how complicated it has become to safely reprocess a flexible endoscope, has made many in the field look for an alternative.
An alternative exists. And it’s safer and more cost-effective than most expect.
What if endoscope reprocessing was less complicated and took less time? What if there was a simple way to provide a sterile solution for every patient? These are key advantages offered by the PrimeSight Endoscopy System from Cogentix Medical. When used in conjunction with the single-use EndoSheath® Protective Barrier, the PrimeSight endoscope does not come into direct contact with the patient. Rather, all patient contact areas, including the working channel, are part of the EndoSheath barrier which is discarded after the procedure.
Because the scope does not come in direct contact with the patient, reprocessing the PrimeSight endoscope is a relatively simple procedure that can be completed in less than five minutes — at a fraction of the cost and with a fraction of the equipment.
But the EndoSheath protective barrier is more than a good idea, it’s a product that recognized for proven performance. More than 5 million EndoSheath products have been sold without a single reported case of cross contamination and the technology has been the subject of 30+ clinical studies. In addition, EndoSheath is included in the ANSI/AAMI ST91:2015 National Standards for Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities, VHA Directive 1116 on Sterile Processing Services (SPS), and are FDA Cleared, CE Marked, and CDC recognized.
1. Ofstead, C.L., Quick, M.R., Eiland, J.E., Adams, S.J. (2017). A glimpse at the true cost of reprocessing endoscopes: Results of a pilot project. Communiqué, Jan/Feb, 63-78.