The FDA announced earlier this year it was investigating the cause of 450 infections in patients who had undergone procedures involving urological endoscopes. The cases, which took place from January 2017 to February 2021, are chronicled in Medical Device Reports submitted to the FDA.
Inadequate reprocessing of the scopes involved in the procedures is one of the potential causes of the infections, says the FDA, which recommended high-level disinfection or low-temperature sterilization to minimize infection risks in its April letter announcing the investigations. The incidents and subsequent probes have sparked debate among experts as to which method of reprocessing the delicate instruments is best to ensure safe patient care.
Cori Ofstead, MSPH, founder and CEO of the medical research firm Ofstead & Associates, says the choice is simple. “In my view, endoscopes should be sterilized with low-temperature sterilization systems,” she says. “Urology scopes should be considered critical devices requiring sterilization because they come in contact with sterile tissue during procedures involving the bladder, ureter and kidneys.”
Urological endoscopes must be thoroughly dried before they’re sterilized, so microbial proliferation is reduced and is less than what is commonly seen in scopes that are stored after high-level disinfection. Also, sterilized scopes are packaged in ways that prevent contamination during transport and storage.“The sterilization process is more rigorous than high-level disinfection and provides a much larger margin of safety,” says Ms. Ofstead.
She believes the transition from high-level disinfection to low-temperature sterilization wouldn’t be an expensive one for facilities with low-temperature sterilization systems that employ hydrogen peroxide gas plasma, vaporized hydrogen peroxide gas, liquid chemical sterilization with peracetic acid or ethylene oxide gas.