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Disposable GI scopes will hit market in 2017

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December 22, 2016

Hospitals under fire to review and revamp their policies and procedures in the wake of dangers faced from deadly infections borne from improperly reprocessed diagnostic scopes may soon have a new weapon in their arsenal. The FDA in September cleared the first ever single-use colonoscopy scope for use in endoscopy and endoscopic surgery.

The Invendoscope SC200, as the device is called, was created by Invendo Medical of Germany as part of the company’s Invendoscopy E200 system. The new scope is being marketed as a safer alternative to reusable scopes; Invendo claims its use presents a lower risk of infection. The product was approved in September and will be released for sale in 2017 at a cost of around $200 per scope.

 “Our one-of-a-kind technology provides a platform specifically tailored to address the need for device sterility during endoscopies, the importance of which has been underscored by various recent ‘superbug’ outbreaks in multiple U.S. hospitals,” said Timo Hercegfi, CEO of Invendo Medical, in a press statement.

“The FDA clearance of the Invendoscope E200 System continues its pathway of validation, enabling our company to now provide endoscopists in the U.S. with a revolutionary technology that will allow them to perform colonoscopies with a system that significantly improves medical staff and patient safety while enhancing physician comfort during procedures,” Hercegfi added.

While widespread use of the disposable devices is probably a long way off—the costs of storage and disposal for facilities that perform hundreds or thousands of procedures annually are among concerns cited—their invention represents a major breakthrough and alternative for facilities struggling to figure out how to keep patients safe from improperly disinfected scopes.

Colonoscopy scopes and other diagnostic scopes are some of the most frequently used medical devices in America—they are employed approximately 55 million times per year, including 14 million annual colorectal cancer screenings. Currently, all colonoscopy scopes are reusable and require high-level disinfection and controlled storage between uses. They usually cost around $40,000 each.

Because of the nature of their use—being inserted into the gastrointestinal (GI) tract of a patient—the danger of bacterial infections is very high if the scopes aren’t properly cleaned and disinfected, a routine known as reprocessing.

The topic of improperly sterilized endoscopes was highly publicized in 2015, when Virginia Mason Hospital in Seattle sued Olympus, Inc., which manufactures about 85% of the scopes used in U.S. hospitals. The suit claimed that patients were put at risk because Olympus failed to disclose design flaws in its endoscopy scopes that, through scope contamination, led to superbug infections in patients between 2012 and 2014, ultimately causing 39 people at the hospital to contract infections from E. coli bacteria. Eleven of those patients died.

Earlier in 2015, a lawsuit was also filed by patient Aaron Young, who became sick after undergoing procedures at The University of California’s Ronald Reagan Medical Center in Los Angeles. Young claims he was one of nearly 180 people exposed to an outbreak of carbapenem-resistant Enterobacteriaceae (CRE), which is highly resistant to antibiotics and reportedly can kill up to 50% of infected patients. Two patients died in that outbreak. Also in 2015, officials at Cedars-Sinai Medical Center in Los Angeles discovered that four patients were infected with CRE and 67 other people may have been exposed.

The lawsuits led to recalls of Olympus’ TJF-Q180V duodenoscope model, in addition to the company reissuing proper procedures for cleaning and reprocessing the instruments.

Scopes not easy to clean

In recent years, manufacturers have added more powerful tools to scopes, such as guide wires that can be used to carry stents and tubes to clear infections and blockages in the digestive tract. The drawback to the technology is that extra grooves and channels in the scopes can trap infection-causing bacteria that can be difficult to remove.

The scopes can be cleaned, disinfected, and ready for reuse in as little as two hours, but reprocessing instructions need to be followed exactly as supplied by the manufacturer, and they usually involve several steps: pre-cleaning with special fluid, forcing air through the scopes to check for leaks, and intense brushing to remove residue before disinfection and drying procedures. In some hospitals, personnel dedicated to scope disinfection are specially certified, but safety experts say this certification is not required, and many smaller clinics don’t have the luxury of dedicated personnel.

“In addition to the clinical benefits associated with reducing potential cross-contamination, the ergonomic design of the Invendoscope SC200 offers a ScopeController that contours to the physician’s hand and can be used attached or detached to the endoscope,” says John Cifarelli, chief commercial officer of Invendo Medical. “This unique control body coupled with the light weight of the colonoscope provides a more comfortable and less tiring procedure for the healthcare provider. The Invendoscope SC200 also includes a unique tip for full retroflection in various segments of the colon, enabling inspection behind colonic folds, which is key to a comprehensive diagnosis during colonoscopies.”

In a press release citing 2008 CDC data, Invendo Medical said patients are only placed at risk of endoscopy-associated infection at a rate of one in 276,000 GI procedures. This April, an FDA report found approximately 350 patients at 41 medical facilities worldwide had been infected through dirty GI scopes between 2010 and 2015. The report comes on the heels of a Senate investigation that, in the same time span, identified 250 infections in 25 U.S. and European hospitals.

There isn’t a single, simple solution to ensure scopes are correctly reprocessed, said William Rutala, MS, MPH, PhD, director of the hospital epidemiology, occupational health and safety program at the University of North Carolina Health Care System in Chapel Hill, who was a guest speaker in an ECRI Institute webinar.

“We must do more or additional outbreaks will continue,” Rutala said. “I believe and we believe doing nothing is not an option.”

That said, disposable colonoscopy scopes could be a boon for treating immunocompromised patients or those who pose additional infection risks. This benefit could become a deciding factor for clinics, particularly those struggling to meet CMS and Joint Commission standards on minimizing infection risk.

Marge McFarlane, PhD, MT(ASCP), CHSP, CHFM, HEM, MEP, CHEP, principal of Superior Performance in Eau Claire, Wisconsin, says she hasn’t had a chance to use the SC200 scope. “However, folks must ensure the disposable scopes are stored at the proper temp and humidity and that all manufacturer's recommendations are followed,” she says.

Steve MacArthur, a safety consultant at The Greeley Company in Danvers, Massachusetts, says the idea of a single-use scope could really enhance patient safety. The current method of disinfection and reprocessing of scopes is fraught with peril, he adds. Still, there are economic factors to consider.

“I think the financial viability will depend a lot on the volume of procedures,” he says. “They can't leave [reprocessable] scopes hanging around forever. I believe it's seven days before they would need to reprocess. So there would certainly be a benefit of having some [disposable scopes] on hand in case there is an issue with the reprocessing process; maybe equipment-related, maybe staff-related. Depending on the shelf life of the disposables, using the product probably makes way more sense than not.”
 




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