Sanovas Calls For Device Manufacturers To Include "Aided Visual Inspection" In Their Instructions For Use (IFU) Of Their Reusable Medical Devices By Hospitals

SAN RAFAEL, Calif., April 6, 2015 /PRNewswire/ -- Sanovas announced today, in the wake of recent headlines about cross contamination of patients by inadequately reprocessed medical devices, that the medical device industry should be including "aided visual inspection" as an integral part of the "instructions for use" (IFU) of its reusable medical devices.

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"Sophisticated, reusable medical instruments are very difficult to clean," said Ralph Basile, vice president, marketing, Healthmark Industries, an OEM partner of Sanovas and a leading supplier of cleaning verification products to healthcare facilities. "A key step in that process is to visibly inspect to insure there are no residual contaminants on, or inside, the device after cleaning. But this has been nearly impossible to do with only the naked eye."

"Healthcare facilities and medical device manufacturers share a dual responsibilityhealthcare facilities must clean and sterilize devices in compliance with the instructions for use of the device manufacturers; and the device manufacturers must provide instructions that can be realistically implemented by the reprocessing personnel to produce safe and ready-to-use medical devices," said Jahan Azizi, former Risk Management Clinical Engineer, University of Michigan Health System; Director of Regulatory Affairs, Heart Sync. "What's missing is that reprocessing must include aided visual inspection of the areas of devices that are not viewable to the naked eye, to help insure that a device has been effectively reprocessed and is safe to use on the next patient. This has just not been happening."

Now, a new concept in reprocessing, a micro digital camera called the MicroCam, is enabling Healthmark Industries to incorporate this inexpensive and tiny camera into its Flexible Inspection Scope to empower reprocessors to see inside difficult-to-clean medical devices.

The Flexible Inspection Scope with MicroCam is already being used by central processing departments in more than two dozen hospitals around the U.S. so that reprocessors can visually inspect the inside of tough-to-clean medical devices prior to sterilization, to ensure that they are completely clean.

"For the first time, central processing departments are able to see inside of medical devices, then document what they see, and then reprocess the medical device if necessary.  All of this is done to increase patient safety. Patient safety is central to the use of the Flexible Inspection Scope with MicroCam," Ralph Basile said.

"Hospitals are obliged to respect and follow whatever the Instructions For Use are from the medical device manufacturers. Therefore it is incumbent upon the device manufacturers to be the catalyst for change by making inspection of hidden areas of the device a part of their IFU for their reusable medical equipment," Jahan Azizi said.

"Having medical equipment manufacturers making aided inspection a standard in their IFU guidelines will go a long way toward helping hospitals reduce the unacceptable mortality and morbidity rates associated with unclean medical equipment," added Larry Gerrans.

About Sanovas
At the heart of the Sanovas companies' scientific advances is the miniaturization of tools for minimally invasive surgery, or "M-I-S." Its products extend access beyond current limits, enabling physicians to diagnose and perform therapeutic interventions in spaces as small as one millimeter in diameter that have previously been unreachable.

Contacts:
Steve Goldsmith, Sanovas, 415-729-9391 x1023, Email
Ronald Trahan, APR, Ronald Trahan Associates, 508-359-4005 x108, Email

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SOURCE Sanovas