That’s because the vast majority of scopes – expensive to manufacture – are re-used between patients, introducing the possibility of transferring infections from one patient to another unless the reusable scopes are diligently cleaned between each use.
That’s easier said than done. “Some scopes are more difficult to clean and sterilize than other scopes,” said Pontzer. “As they get more intricate, [there's] more difficulty.”
All was relatively quiet on the infection front until about 10 years ago, when patients began showing signs of infection after undergoing a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP. The use of antibiotics is a common way to treat such infections – however the effectiveness of antibiotics has waned over the years with the prevalence of infections seen to resist antibiotic intervention.
UPMC – a proud collective of health care facilities located throughout the State of Pennsylvania – experienced its own outbreak of antibiotic-resistant infection in 2012. An investigation revealed standard cleaning protocols used at the time failed to eliminate all bacteria. Thus, UPMC switched to a fairly involved sterilization process that today forms the basis of the current standard recommended by the US Food and Drug Administration (FDA).
“We changed procedures and have had no issue since,” Dr. Pontzer said.
The process is involved: the various scopes used are cleaned immediately after use (practically at the bedside). Then they go through a disinfection process and are sterilized – after which a thorough visual exam is conducted to determine if there is anything the previous three procedures may have missed. If anything is detected – such as lingering tissue, or something that just doesn’t look right – the endoscope is processed again.
It’s this degree of diligence that, for the moment and for the past five years, appears to be working for UPMC (and for the FDA, which issued new guidance in 2015 based largely on the UPMC experience).
The concern – and this is of interest to anyone who may have contracted an infection from a ‘dirty’ endoscope, duodenoscope, gastroscope, bronchoscope, cystoscope, or ureteroscope and considering an endoscope lawsuit – is that not all hospitals have the manpower, or undertake the diligence needed to ensure that a reusable scope is completely free of infection from a previous patient.
The stakes are high: duodenoscopes alone (devices which pass into the small intestine) – are used on 500,000 patients each year in the US. There are scopes designed to be disposable – however they are used sparingly, and only on patients at risk for grievous infections. Given the widespread use of scopes for internal diagnostics and biopsy, it would be financially impossible for all scopes to be considered disposable after a single use. Healthcare costs would either rise to the stratosphere, or use of scopes would decline dramatically, eliminating the benefit for a large and growing cohort of patients.
Thus, the strategy is reusable scopes that are cleaned, disinfected and sterilized fully – to the ‘nth’ degree – each, and every time.
However, studies have shown that this isn’t being done uniformly across the nation.
A team of researchers led by Cori Ofstead of Ofstead & Associates of St. Paul, Minnesota, recently updated a study done ten years ago on endoscope reprocessing procedures. In 2007 a large study determined that existing cleaning and reprocessing procedures were not working.
More recently, Ofstead led a study that followed a collection of 20 endoscopes over a 7-month period. The healthcare facilities, at which the endoscopes were employed, were not revealed in the Post-Gazette story.
This past January, Ofstead reported on her findings, and it wasn’t pretty: all scopes studied presented with fluid, discoloration and debris after reprocessing, and 12 scopes – more than half – were seen to have microbial growth after cleaning. Signs of organic residue were at higher levels in the gastroscopes compared to the endoscopes used for colonoscopy.
Another study on flexible ureteroscopes at two large multispecialty health care facilities in the Midwest found that despite reprocessing, all 16 ureteroscopes studied had visible irregularities and contamination with microbial growth, hemoglobin, protein or a chemical indicating the presence of living cells.
The study concluded that there should be regular checks of reprocessing practices, routine cleaning verification tests and visual inspections according to the accepted guidelines. It should be noted that no bedside precleaning was undertaken in the two facilities chosen for the Ofstead ureteroscope study. As noted above, bedside precleaning is one of the hallmarks of the UPMC protocol, which begins with an immediate precleaning.
READ MORE ENDOSCOPE INFECTION LEGAL NEWS
While both the FDA, and the medical community assert that the benefits of endoscopy far outweigh the risks, the research suggests that cleaning and reprocessing reusable endoscopes needs to be a process conducted uniformly with surgical precision by trained experts. Only then will the risk for transferring infection be reduced, or mitigated.
Until that happens on a uniform and consistent basis across the nation, endoscopy patients will always face the risk – small as it is – that they will become the latest unlucky candidate, and unwilling host for a serious infection passed from a dirty endoscope.
And that’s when the endoscope negligence lawsuit happens.