MEDICAL DEVICE DAILY™ / MONDAY, JUNE 27 , 2016 VOLUME 20, NO. 123 / Cut the blame game, infection control is a shared problem By Amanda Pedersen, Senior Staff Writer
Superbugs tend to evoke a lot of finger pointing and the blame often spreads as wide and fast as the outbreaks themselves. But if the medical device industry learned anything from last year’s high-profile duodenoscope debacle it’s that infection control is a shared responsibility. Manufacturers, third-party reprocessing firms, hospitals, regulatory bodies and lawmakers all have a role to play in protecting patients from these deadly diseases.
For one of the largest endoscopic device makers, owning up to its share of that responsibility has proven to be a remarkably lengthy and costly lesson. Olympus Corp. of the Americas is in the middle of a major recall of its TJF-Q180V duodenoscopes because the scopes have been linked to widespread carbapenem-resistant Enterobacteriaceae (CRE) infections. Some CRE bacteria have become resistant to most available antibiotics, and are able to kill up to half the patients they infect, according to the U.S. Centers for Disease Control and Prevention (CDC). The Center Valley, Pa.-based company allegedly warned European regulators in 2013 and 2014 about the device’s potential to spread infection, but did not alert U.S. hospitals until a U.S. Senate investigation brought the issue to light earlier this year. The report, which came from the office of U.S. Sen. Patty Murray (D-Wash.), cited 25 outbreaks of infections across the country and in Europe involving nearly 200 U.S. patients. (See Medical Device Daily, Jan. 19, 2016.)
The Senate report came out soon after the FDA cleared a new, easier-to-clean version of Olympus’ duodenoscope that features a redesigned component intended to provide a tighter seal in an effort to reduce the risk of infection. Olympus said it will replace the sealing mechanism on about 4,400 devices currently in use by August.
While Olympus has taken the most heat for the problem, all duodenoscopes – including those sold by Fujifilm and Pentax – are inherently difficult to clean because of the moving elevator mechanism at the tip where patient fluids and tissue can potentially get inside the device. Duodenoscopes provide a minimally invasive way of draining fluids from pancreatic and biliary ducts that are blocked by problems like tumors or gallstones. Similar reusable endoscopes, such as bronchoscopes and colonoscopes, also carry a risk of transferring pathogens.
Hospitals like the University of California Los Angeles’ Ronald Reagan Medical Center have started to sterilize duodenoscopes with ethylene oxide, but that method requires more wait time between use because the gas is so toxic. The longer sterilization process has driven up the demand for the devices, which are used in up to 600,000 U.S. procedures every year.
MAKING LEMONADE FROM DEADLY LEMONS
Just as combat needs often drive medical innovation, disease outbreaks have opened up a big market opportunity for new infection control products. From tiny cameras that can see inside endoscopes, to mobile apps and analytics software that tracks infectious patients during their hospital stay, med-tech companies can’t be accused of sitting out of the superbug fight.
Patient Safe Inc. has developed a new class of small diameter, near field inspection scopes designed to provide access to and imaging of the interior chambers, lumens, and working channels of surgical devices, including endoscopes.
The Sausalito, Calif.-based company was already in the process of bringing its Steriview infection control system to the U.S. market even before Olympus’ duodenoscope CRE problem surfaced, CEO Larry Gerrans told Medical Device Daily. The system includes the company’s Stericam line of software powered cameras for visual confirmation that endoscopes and other surgical tools are free of bacteria and fluid.
Cleaning these devices after they have been inside of a patient is no easy task. Gerrans likened it trying to get burnt cheese off a frying pan. Fluid tends to cook, or burn, inside the operating channel of endoscopes during a procedure and if those sticky spots are not completely cleaned off before it will inevitably slough off into the next patient, he said.
The idea behind Patient Safe’s technology is that the visual inspection it provides will prompt hospital staff to do a better job cleaning the scopes before an infection spreads.
The Steriview was born from another company Gerrans leads, Sanovas Inc., which initially developed the small diameter scopes as a means of going deep into a patient’s lungs to diagnose and treat disease.
The technology has been on the market as an infection control system for about a year and the uptake has been quite positive, Gerrans said. In a recently published study, the device found 613 out of 860 inspected instruments to be dirty. That study included endoscopes as well as other laparoscopic devices and tubes.
In addition to infection control, Gerrans said Patient Safe’s technology also helps hospitals inspect the integrity of these devices, which are also prone to nicks and scratches that can rust out over time or provide a breeding ground for bacteria.
It’s really a multi-faceted problem, Stephen Schimpff, Patient Safe’s board chairman, told MDD. Schimpff, the retired CEO of the University of Maryland Medical Center, spent the bulk of his medical career researching the causes, prevention, and treatment of infections in cancer patients undergoing chemotherapy. The first challenge with device-related infection control is being able to see the contaminated parts of an endoscope or other device. The next problem is figuring out how to get the bacteria or residual biomaterial out without damaging the device.
“It turns out, in some cases, you can’t just put a scope brush down there or a piece of steel wool because you’re going to damage the inside of the scope,” Schimpff said. “It’s a pickle.”
ENDOSCOPE CLEANING: THERE’S AN APP FOR THAT
In an age where mobile apps are a regular part of daily living, it’s not too surprising that there is an app designed to track an endoscope through each step of the cleaning and sterilization process. What is surprising, perhaps, is the fact that such an app wasn’t on the market sooner.
Philadelphia-based Prairie Dog Tech LLC launched the PD Vision in June as an optional enhancement to its previously released infection control app called The Observer. Together, the apps are designed to help hospital staff document the process of disinfecting reusable scopes by creating a database of images that can be searched by time and date, or scope ID.
Prairie Dog Tech’s founding member, David Bassion Jr., told Medical Device Daily that the idea for a Bluetooth-based endoscope tracking system came from walking around at an endoscopy convention last year and noticing that there were a lot of tracking systems on the market, but most – if not all – of the existing systems relied on information manually recorded by a clinician.
Bassion’s team decided to create a tracking system that truthfully tracks the scope through each step of the sterilization process and alerts the staff of potential problems.
“We want everyone to know everything,” Bassion said.
OPGEN LIGHTS THE WAY
Opgen Inc. offers a multidrug-resistant organism (MDRO) management system, the Acuitas Lighthouse, that helps hospitals navigate infection control issues.
Kevin Krenitsky, president of Opgen, told Medical Device Daily the cloud-based Lighthouse system leverages the company’s bioinformatics analytics software to track and prevent the spread of infection from the time an infectious patient enters the hospital. Hospitals can use the system in conjunction with Opgen’s rapid MDRO gene test to screen patients for superbugs and other infections, like Clostridium difficile (C. diff) as soon as they walk through the door.
The Lighthouse system not only helps hospitals track the location of threats but guides preventative actions to nip infections in the bud before they spread.
SEND IN THE ROBOTS
Germ-zapping robots that use ultraviolet (UV) light to disinfect hospital rooms grabbed Medical Device Daily’s attention a couple of years ago in the wake of the Ebola epidemic. In 2014, San Antonio, Texas-based Xenex Disinfection Services LLC offered its UV robots to Emory University and the CDC to disinfect the rooms where U.S. Ebola patients were treated and the airplanes that transported those patients. (See Medical Device Daily, Aug. 7, 2014.) The Xenex robot is a portable system designed to penetrate the cell walls of microorganisms including bacteria, viruses, mold, fungus, and spores, destroying all the superbugs and pathogens that could be lurking in a hospital room – including the operating room or the emergency room – in five to 10 minutes. The robot is operated by hospital housekeeping staff. After cleaning the room first through traditional methods, the robot is rolled in as an added layer of patient safety, disinfecting high-touch surfaces and difficult-to-clean nooks and crannies. The company launched the first version of its robot in 2010 and a new version of the robot in late 2013.
According to the company, the Xenex robot is powered by xenon, an environmentally-friendly gas, instead of mercury, which is what most of the competing systems on the market use. In addition to being toxic, mercury-based UV robots only operate in one spectrum and can take hours to disinfect a single room, Xenex said. Yet, according to one of such competitor, Tru-d SmartUVC LLC, of Gaithersburg, Md., the fear around mercury is a misconception.
Tru-d bulbs use ultra-low levels of mercury vapor that are consistent with modern fluorescent and compact fluorescent bulbs found throughout virtually every U.S. hospital that are endorsed by the Environmental Protection Agency and the Department of Energy. No mercury byproduct is emitted by the bulbs either, CEO Chuck Dunn said.
Until recently, Tru-d’s biggest adoption barrier was a lack of evidence showing a direct correlation between the elimination of MDROs and the reduction of infections throughout a facility using no-touch disinfection technology. The randomized BETR-D study (Benefits of Enhanced Terminal Room Disinfection), funded by the CDC, eased those concerns, Dunn said.
BETR-D compared four methods of terminal room-cleaning strategies at nine hospitals over 22,000 patient days. The researchers found that Tru-d reduced the cumulative number of hospital-acquired infections by about 30 percent for patients who stay in rooms previously occupied by an infected patient.
Dunn told MDD that the company’s Sensor360 technology sets Tru-D apart from its peers in the UV disinfection space. The technology measures the amount of UV energy that is reflected back to the robot, he said, enabling it to overcome room variables such as size, shape, and contents to deliver the precise, lethal dose of UVC light needed. Tru-d touts that its device kills up to 99.9 percent of pathogens in a room from a single position with a single cycle of UV energy.