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How a Tiny Camera Could Prevent Deadly Superbug Outbreaks

Kristopher Sturgis

April 9, 2015

3 Min Read
How a Tiny Camera Could Prevent Deadly Superbug Outbreaks

A new mandate recommended by the firm would prevent reprocessors from relying solely on visual inspection of hard-to-clean reusable medical devices.

Kristopher Sturgis

Following the superbug outbreak that killed two patients and infected five more, minimally invasive device maker Sanovas (San Rafael, CA) is calling for a new inspection protocol for reusable devices such as duodenoscopes, which were implicated in the recent hospital acquired infections.The protocol would rely on what the company calls "aided visual inspection," which would provide inspectors with substantially better visual acuity than they would have with the naked eye alone. Such enhanced visual inspection should become an an integral part of the "instructions for use" (IFU) of all reusable medical devices, the company says.

"Visual inspection has always been one of the key standards for determining if a device is clean, safe, and ready for further processing," said Ralph Basile, vice president of sales for Healthmark Industries, an OEM partner of Sanovas and a supplier of cleaning verification products to healthcare facilities. "Many of these troublesome devices are difficult to clean because they have hidden crevices, corners, transition points, and internal channels. Further complicating the process is that these areas can not be visually inspected with the unaided eye."

Micro Imaging

The MicroCam digital camera from Sanovas can be used to inspect the inside portions of reusable medical devices.

Healthmark Industries is hoping to broaden the concept of visual inspection with the introduction of a tiny digital camera called the MicroCam. Healthcare facilities could incorporate the inexpensive, flexible inspection scope to help empower people cleaning reusable devices to see inside difficult-to-clean medical devices, and verify that they are completely sterile, safe, and ready to be reused.

The scope makes use of the MicroCam digital camera, which is positioned at the end of a long, thin, and flexible shaft, according to Basile. "With magnification, lighting, and a PC computer and monitor, healthcare sterile processing professionals can now closely inspect areas that heretofore could not be visually inspected."

The flexible inspection scope with MicroCam technology is already being used by central processing departments in more than two dozen hospitals around the country, allowing reprocessors to visually inspect the inside of various tough-to-clean medical devices in an effort to ensure they are sterile.

From tiny implantable devices, to small robotic surgical tools, the medtech industry is regularly producing devices and instruments that are becoming increasingly difficult to clean and effectively reprocess. Slowly, we're seeing industry standards groups recommend the use of aided inspection devices, including the use of flexible borescopes. Just last month the Food and Drug Administration reinforced this idea with the release of the FDA guidance document for device reprocessing, with a specific section emphasizing the importance of visual inspection.

"In the end, it will be the joint efforts of device manufacturers, industry standards groups, government regulators, and most importantly, the healthcare professionals themselves," said Basile. "Demanding and implementing this practice will make it widespread, and will be a key to better patient care and outcomes."

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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About the Author(s)

Kristopher Sturgis

Kristopher Sturgis is a freelance contributor to MD+DI.

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