Industry Pushes for Addition of Aided Visual Inspection to the IFU of Reusable Medical Devices


In the wake of recent headlines about cross contamination of patients by inadequately reprocessed medical devices, Sanovas and Healthmark Industries are insisting that device manufacturers include “aided visual inspection” as an integral part of the instructions for use (IFU) of reusable medical devices. The recommended mandate would finally preclude reprocessors from having to rely solely on the naked eye to inspect hard-to-clean reusable medical devices.

“Sophisticated reusable medical instruments are very difficult to clean,” says Ralph Basile, vice president of marketing for 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 responsibility-healthcare 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,” adds Jahan Azizi, former risk management clinical engineer at the University of Michigan Health System and director of regulatory affairs for 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 mico 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 re-process 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,” Basile says.

“Hospitals are obliged to respect and follow whatever the IFU 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,” Azizi says.

“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,” adds Larry Gerrans, CEO of Sanovas.

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