by
Nancy Ryerson, Staff Writer | January 14, 2013
From the January 2013 issue of HealthCare Business News magazine
“We called it the ‘dirty picture show,’” says AMDR president Dan Vukelich. “[Refuting the pictures] was a big part of my job for about 10 years, but now of course that’s water under the bridge. There’s a role for the original manufacturers and there’s a role for us. If they didn’t make great products, we wouldn’t have products to reprocess.”
Matson says the involvement of such large and trusted companies has given SUD reprocessing a further boost. Besides the two major reprocessors, other companies such as Hygia and Northeast Scientific have cropped up that cover specific device categories or only reprocess one device.
Phil Nalbone,vice president
of corporate development at
Vascular Solutions.
“We’re targeting niche opportunities, things that the larger players haven’t thought of or gotten around to yet,” says Phil Nalbone, VP of corporate development at Vascular Solutions, which reprocesses the Closure- Fast radiofrequency ablation catheter.
The art of reprocessing
Reprocessing a device is not as simple as wiping it off and sending it on its merry way, of course. First, a device must be cleared for reprocessing by the FDA. For most devices, the reprocessing company must prepare a separate 510(k) submission for the FDA, detailing how that device will be disassembled and cleaned, inspected, function tested and sterilized. The report must prove that the device is “substantially equivalent” to the original device. In total, more than 150 individual SUDs have been cleared for reprocessing.
The sterilization process differs from device to device, but most chemical usage involves primarily biodegradable detergents that are easily disposed of in the normal waste stream.
“Our target devices are non-invasive, so by nature reuse of a blood pressure cuff is less risky than reuse of a heart catheter,” says Scott Comas, CEO of Hygia, a reprocessing company that works with non-invasive devices. “Our processes are very patient-friendly in that we use mostly water, very few chemicals, so there are few residuals, carcinogens or allergens. In all of our operations, our byproduct is just run out into the sewer system.”
Benefits for price and planet
