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The FDA wants providers to know about “contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes—devices used to view and access the urinary tract.”
The United States Food and Drug Administration (FDA) wants health care providers to know that some medical devices have caused serious infections in patients. The information comes from numerous medical device reports (MDRs) focusing mainly on endoscope malfunctions. MDRs can be filed by providers, manufacturers, importers, or anybody else who sees a problem.
In a press release,1 the FDA said that the MDRs describe “patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes—devices used to view and access the urinary tract. Reprocessing these types of medical devices involves both cleaning and high-level disinfection or sterilization so the devices can be reused.”
The FDA received 450 MDRs from January 1, 2017, through February 20, 2021, that describe how patients were infected through devices post procedure, with the cause likely to be faulty decontamination. Olympus Corporation, a manufacturer of endoscopes, filed 3 MDRs concerning cases in which patients died from bacterial infections outside the United States (the FDA said MDRs are not evidence that an infection was caused by a device malfunction).
“Two of those reports were associated with a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope,” the FDA press release stated. “Lab tests confirmed the same infectious bacteria [were] present in both the forceps/irrigation plug and in the patient with the infection. The third patient death report involved a cystoscope that did not pass a leak test, indicating possible damage to the device, which could have been an underlying factor in the infection.” (For more about the sterile processing of endoscopes and all surgical devices, see our interview with Tanya Lewis, CRCST, of the International Association of Healthcare Central Service Materiel Management on page 30.)
Jeffrey E. Shuren, MD, JD, the director of the FDA’s Center for Devices and Radiological Health, said in the press release that “while some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling. Although we believe that the risk of infection is low based on available data, we’re reminding health care providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.”
Linda Spaulding, RN, BC, CIC, CHEC, CHOP, a member of Infection Control Today®’s Editorial Advisory Board, warned in an interview in last month’s issue of ICT® that much can go wrong in sterile processing. She told of a time when she was working for a hospital accreditation company and inspected hospitals “where they didn’t even track their scopes. They didn’t know what scope was used on what patient or…that a particular scope kept breaking down. And that’s the same one they kept sending out, because their tracking programs just aren’t there.”2
There’s a solution, though, Spaulding said. The Healthcare Infection Control Practices Advisory Committee, which is under the Centers for Disease Control and Prevention, published a document called “Essential Elements of a Reprocessing Program for Flexible Endoscopes—Recommendations of the Healthcare Infection Control Practices Advisory Committee.”3
“Not only does it give you good information related to scopes and processing, but if you don’t have a strong program setup, it gives you everything to put that program in place,” Spaulding said. “It gives you a policy format [and] audit tools. It gives you a competency verification tool so you can make sure your people are competent, [and]…an inventory repair and maintenance log, so you can log every single time a scope breaks and when it goes out.”
The letter the FDA sent to providers offers “recommendations for reprocessing and using these devices, including following the reprocessing instructions, not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urological endoscopes with patients,” according to the FDA press release.