post-market surveillance studies expected an overall contamination rate of. 4 percent for scopes, but, in fact, showed 5.4 percent of samples contained organisms of high-concern alone! The study showed an overall contamination rate of 9 percent.
A human factors study on Olympus, the primary manufacturer of duodenoscopes in the U. S., was ordered by FDA. The study showed that, even when following the manufacturer’ s instructions, 75 percent of precleaning tasks were not successfully performed for one device model, 81 percent for another, and 68 percent for yet another. A scientific review of the literature found a 15.25 percent contamination rate among all patientready duodenoscopes. Given these statistics, it is no surprise that“ more healthcare-associated outbreaks have been linked to contaminated endoscopes than to any other medical device.”
STUDIES OF OUTBREAKS
Perhaps the best way to understand the significance of these numbers is to examine outbreaks documented in scientific literature. Importantly, these are not hypotheticals created by labbased academics, but real-world examples of outbreaks linked to contaminated scopes.
In July 2022, an outbreak of OXA-181 carbapenemase-producing K. pneumoniae was detected in a tertiary care hospital in Northern Germany. This nasty pathogen constitutes“ a major threat for public health and [ is ] strongly associated with high rates of mortality.” Eighty-four percent of the first 19 patients identified with the outbreak strain had undergone a scope procedure within the previous weeks. An audit of reprocessing procedures and a systematic inspection of reprocessed endoscopes resulted in no abnormalities. In August 2022, the outbreak strain was isolated from a reprocessed ready-to-use colonoscope.
All scopes older than 10 years were replaced, yet the strain was again isolated from an endoscope that had been reprocessed in accordance with the instructions for use. By the end of the outbreak, 32 patients were known to have been infected, 13 suffered infection, and 6 died, including three whose cause of death was reported as most likely being K. pneumoniae.
In November of 2014, 25 unique cases of multidrug-resistant( MDR) Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae were identified in a Pittsburgh Medical Center. Pseudomonas are a group of bacteria commonly found in the environment, and P. aeruginosa can cause infection in the blood, lungs, urinary tract, or other parts of the body. According to the CDC, treatment options are limited for MDR P. aeruginosa, and in 2017, it caused an estimated 2,700 deaths in the United States. Investigators found that 76 percent of patients in the outbreak were exposed to the same bronchoscope.
All scopes were immediately removed from service, cultured, and underwent borescopy to visualize the internal structure of the devices. A borescopy involves a small camera being inserted into the bore or the hole of the device, which allows one to visually inspect the channels inside the scope. Interestingly, there were no breaches in technique, precleaning, or high-level disinfection failures. There was, however, a defect in the device which,“ despite compliance with manufacturer’ s recommended reprocessing procedures, [ allowed ] accumulation of proteinaceous debris... that may have contributed to the establishment of a biofilm and subsequent contamination...”
To be clear, the hospital was following all the convoluted steps mandated by the manufacturer and could not detect a defect significant enough to be seen in an unmagnified image during a borescopy. That defect allowed the innocuously named“ proteins” to build up sufficiently to harbor and transmit an
36 The Trial Lawyer