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Ongoing Efforts to Improve Endoscope Disinfection May not be Enough

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Ivyland, PAIt was just about a year ago, on May 29 2016 that the Sunday Telegram of Massachusetts highlighted the trials and tribulations of a manufacturer and their endoscope cleaning machine. Custom Ultrasonics Inc., based in Ivyland PA., had been previously taken to task by the US Food and Drug Administration (FDA) with regard to an endoscope cleaning machine tied to outbreaks of superbugs. The FDA, six months prior, had directed that all System 83 Plus cleaning machines manufactured by Custom Ultrasonics should be taken off the market out of a concern for public health and safety, as many an endoscope lawsuit will attest.

Then in May of last year, the FDA reversed itself. The System 83 Plus is okay for cleaning endoscopes, but not duodenoscopes – an even more intricate version of an endoscope that is flexible, widely used and even harder to clean. That fact was borne out in a 2015 study published in the Journal of Clinical Microbiology, which looked at the challenges of cleaning and disinfecting reusable devices such as endoscopes and especially duodenoscopes. The study concluded that further reductions of infection from endoscope and duodenoscopes going forward will likely be realized from a combination of diligent manual and automated cleaning, and improvements in device design that will help to mitigate entrapment of bacteria from previous patients that could be spread to the next patient when the device is reused.

For any patient fighting an endoscope lawsuit, the legal landscape is a minefield of issues related to potential design flaws with reusable equipment, automated cleaning machines and the diligence – or lack thereof – on the part of hospital staff with regard to adherence to cleaning protocols.

That assumes current cleaning protocols are enough to mitigate the transference of infection.

Pundits will agree that the only surefire way to eliminate infection inherent with endoscopy is to come up with a device that is used once, and then disposed – never to be used for another patient. Economically, this is impossible given the costs associated with manufacturing a single device. Thus, do you put an end to endoscopy altogether in an effort to completely eradicate infection? Or do you maintain an imperfect system that carries infection rates hovering in the minority?

A basic tenet and function of the FDA is risk management. To wit, it is always assumed there is risk in use of medical devices, or ingestion of pharmaceuticals – but so long as the risk is outweighed by the benefit for the intended patient constituency the drug, or medical device deserves its place in the market.

The FDA will say – and most healthcare providers will agree – that more lives are saved from endoscopy, than a minority of individuals felled by the transfer of bacterial infection. Which means there will always be those who acquire an infection transferred from an unclean endoscope or duodenoscope, followed in most cases by an endoscope infection lawsuit.

The about-face last year by the FDA suggests just how complex the issue is. In December of 2015, the regulator was saying that Custom Ultrasonics should take its System 83 Plus automated cleaning machine off the market, because it was a threat to public health. Then it reversed its stance in May of last year, and by August had issued a formal communique to the healthcare industry maintaining the System 83 Plus was adequate for cleaning endoscopes, but not for duodenoscopes. A warning label, mandated to be affixed to “each System 83 Plus unit in a prominent location,” was to state:

“WARNING:[sic] This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer.”

To that end, on its website advertising the System 83 Plus 2 automated cleaner, Custom Ultrasonics duly denotes the FDA warning, in its entirety, in bold font at the top of the page.

Other manufacturers, of interest to patients or any plaintiff bringing an endoscope negligence lawsuit, are putting the word out that efforts are continuing to improve device design. A ‘Letter from Olympus’ posted on its website by one of the largest manufacturers of endoscopes and duodenoscopes in the world, sings the virtues of endoscopes and duodenoscopes for saving the lives of millions, with some 600,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures performed in the US each year, “with roughly 500,000 performed using an Olympus device,” the manufacturer said. “The reported incidence of infection following an ERCP procedure remains extremely low, with a medical device report incidence rate of well less than 0.1 percent in the United States.

“At the same time, we recognize that the world of medicine is imperfect and complications that affect patients can occur following procedures involving our products. Most recently, duodenoscopes have been linked to certain incidents of infection.”

Olympus goes on to say they continue to work with the FDA, hospitals and healthcare providers in an effort to understand the causes of infection. “As part of these efforts, we implemented a corrective action in 2016 to replace the forceps elevator mechanism of our TJF-Q180V duodenoscopes. At the same time, we updated our instructions for use, which now include an annual inspection for the TJF-Q180V Duodenoscope.”

Part of those efforts, Olympus continues, is to “implement reprocessing enhancements designed to further reduce the risk of infections to patients and to educate health care professionals about the importance of strictly adhering to our Instructions for Use of Olympus duodenoscopes.”

And yet, a study published on February 1st of this year in the American Journal of Infection Control suggests that strict adherence to cleaning protocols isn’t necessarily enough. The researchers stressed the need for thorough visual inspections, together with verification tests to ensure a reusable endoscope is free from damage and debris prior to use on the next patient.

The study found that even after rigorous cleaning and reprocessing techniques were carried out according to protocol, organic residues were often left behind on the devices, from the previous patient.

“Even though top-notch methods were used,” said lead study author Cori Ofstead, “the endoscopes in this study had visible signs of damage and debris, and tests showed a high proportion were still contaminated.

“These findings bolster the need for routine visual inspection and cleaning verification tests recommended in new reprocessing guidelines.”

Those new reprocessing guidelines are exactly what Olympus is talking about, and is a further indication that the manufacturing and healthcare industry are working on new protocols to ensure reusable endoscopes and duodenoscopes are properly cleaned. Hospitals will be called upon to ensure their staff undertakes the updated protocols to the nth degree.

Any plaintiff fighting an endoscopic infection lawsuit will be watching these developments carefully, together with the observation, found as part of the study titled ‘Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures,’ that 20 percent of infected endoscopes in each group tested had actually exceeded post-cleaning benchmarks for protein residue.

In other words, even exceeding current benchmarks for cleaning, wasn’t enough.

While endoscope and duodeoscope patients may be cheered by the efforts underway to improve device cleaning protocols, it is reasonable to assume absolute risk of infection will never be completely resolved, and endoscope lawsuits will continue until the day when endoscopes and duodenoscopes will be used once – dedicated for each individual patient such as a syringe, then discarded. Given the economics and challenges of manufacturing a completely disposable device, that day may never arrive…


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