“Aided Visual Inspection” Should be in IFU of Reprocessable Devices, says Camera Company

A couple of months ago we saw Sanovas and its OEM partner, Healthmark Industries introducing their medical imaging system, designed to aid in visual inspection of the smallest nooks and crannies of medical devices during processing for re-use. Now they’re determinedly attempting to increase the size of its own market (and who can blame them) by suggesting that such devices should carry an “aided visual inspection” requirement on their instructions for use (IFU).


Reprocessing of medical devices is one of those subjects that rears its ugly head every few years, especially in the wake of headlines about cross contamination of patients by inadequately handled devices.

The aforementioned MicroCam™, a micro digital camera has been incorporated into the Healthmark Industries Flexible Inspection Scope, a move that opens up more of the difficult to access areas of instruments to visual inspection.

Healthmark says 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.

Healthcare Provider comments

“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,” 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.”

“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.”

Company comments

“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.”

“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.”

Larry Gerrans, co-founder, president and CEO of Sanovas, and inventor of the MicroCam system 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.”

We say

It’s tough to argue that medical devices should not be as clean as physically possible, an argument that is all too real for anyone who’s suffered an infection as a direct consequence of poorly processed instrumentation. If you’ve been in the device industry and offered any form of repair/refurb/returns programme for your re-usable metalwork, you’ll be only too familiar with the view down the inside of metal cannulae, or shaver handpieces. It’s usually pretty yuck, despite these devices having been processed prior to their return. So any attempt to improve matters by debulking these nooks and crannies of the major lumps of other patient that reside therein, must be a good thing. It’s more complicated than that though. You see, removing gunge is one thing…demonstrating that this will improve patient outcomes is another. And if you remove a piece of detritus that is visible, what’s to say you’ve even got ten percent of what’s in there, either less visible to the micro camera, or hidden in other orifices. And then there’s the processing itself. All these devices will be cleaned and decontaminated, and then sterilized prior to re-use, leaving us less concerned about bacterial contamination, and more concerned about those heat-resistant prions….oh and those bits of bristle cleaning brush that were found in one cited case.

One is left wondering whether supposedly device-driven infections are really all that device-driven. However, if I was in need of some instrumental inpokery, I’d want it looking pretty clean please, so when a new technology looks like it can deliver, why not? There can be little doubt that gunge is bad …it’s certainly not likely to be good… and this of course raises questions about device design and re-use per se. Adding aided visual inspection might well be a good thing, but while it may help in reducing infections by a tiny amount, it may also mean healthcare costs go up as new equipment is required and staffing levels expand to meet the extra demand. Just look at the bonanza for device industries that has occurred in recent years since the old corner steriliser (remember the Little Sister?) was banned, and central reprocessing sprung up.


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