71% of Scopes Tainted

Nearly Three-Quarters Of Commonly Used Medical Scopes Tainted By Bacteria! Data from three major hospitals documented the fact that seventy-one percent (71%) of their reusable medical scopes deemed ready for use on patients after reprocessing tested positive for bacteria according to a new study.¹ The study was published in March of this year in the American Journal of Infection Control and it underscores the infection risk posed by a wide range of endoscopes. The study documents a critical lack of progress by manufacturers, reprocessing personnel and regulators in reducing patient risk caused by scopes that remain contaminated after reprocessing. Sadly, this is after major news reports of superbug outbreaks and patient deaths from contaminated scopes going all the way back to 2013. A major part of the problem is the scope manufacturers’ not having validated (or not being able to validate) their cleaning IFUs to ensure that their IFUs actually work to remove all organic debris from their scopes. As readers of this blog know, in the absence of cleaning IFUs that have been validated by independent laboratory testing using AAMI and FDA testing protocols, you are putting your patients at risk of an infection. This is because in the absence of validated IFUs, you have no way of ensuring that you are returning clean, sterile, moisture-free devices for use on the next patient. The new study found bacteria and other organic debris in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine procedures. Researchers said the findings confirm earlier work showing that these issues aren’t simply confined to duodenoscopes. Gastrointestinal devices have been linked to at least 35 deaths in the U.S. since 2013. Scope-related infections and patient deaths have been reported at Cedars-Sinai Medical Center in Los Angeles, UCLA’s Ronald Reagan Medical Center, Huntington Hospital in Pasadena, Virginia Mason Hospital in Seattle and Lutheran General Hospital in Park Ridge, Illinois.² The study’s authors said that the complex and intricate design of many endoscopes continues to hinder effective cleaning and those problems are compounded when health care workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient. The study identified reprocessing challenges and assorted issues with colonoscopes, bronchoscopes, ureteroscopes and gastroscopes.³ “Sadly, in the 10 years since we’ve been looking into the quality of endoscope reprocessing, we haven’t seen improvement in the field,” says Cori Ofstead, the study’s lead author and an epidemiologist in St. Paul, Minnesota, referring to how the devices are prepared for reuse. “If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated procedures with endoscopes that, frankly, are not even clean,” Ofstead said.⁴ On March 9, 2018, the FDA issued warning letters (see Novo blog dated March 16, 2018) to three scope makers for failing to conduct real-world studies on whether health care facilities can effectively clean and thoroughly disinfect their duodenoscopes. The FDA had originally ordered the manufacturers to conduct similar reviews in 2015 after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines. Last year, the study researchers visited three hospitals, which weren’t named, and performed visual examinations and tests to detect fluid and contamination on reusable endoscopes marked ready for use on patients. One hospital met the current guidelines for cleaning and disinfecting scopes, while the other two committed numerous breaches in protocol. Nevertheless, 62 percent of the disinfected scopes at the top-performing hospital tested positive for bacteria, including potential pathogens. It was even worse at the other two — 85 and 92 percent. Clearly, this study proves that meeting the current guidelines for cleaning and disinfecting scopes that have not been validated is no assurance that you’re not putting your patients at risk of an infection from a contaminated device. In addition to cleaning issues, the study identified other issues as well. Among the safety issues: hospital technicians wore the same gloves for handling soiled scopes fresh after a procedure and later, when they were disinfected and employees wiped down scopes with reused towels. Storage cabinets for scopes were visibly dirty and dripping wet scopes were hung up to dry, which is a known risk because bacteria thrive on the moisture left inside. The two hospitals also turned off a cleaning cycle on a commonly used “washing machine,” known as an automated endoscope reprocessor, to save time.⁵ Photo of a common automatic scope washer/reprocessor “It was very disturbing to find such improper practices in big health systems, especially since these institutions were accredited and we assumed that meant everything would have been done properly,” said Ofstead, chief executive of the medical research firm Ofstead & Associates. Ofstead and her co-authors recommended moving faster toward sterilization of all medical scopes using gas or chemicals. That would be a step above the current requirements for high-level disinfection, which involves manual scrubbing and automated washing. A shift to sterilization would likely require significant changes in equipment design and major investments by hospitals and clinics.⁶ 1. “Residual moisture and waterborne pathogens inside flexible endoscopes: Evidence from a multisite study of endoscope drying effectiveness” Cori L. Ofstead, MSPH, Otis L. Heymann, BA, Mariah R. Quick, MPH, John E. Eiland, RN, MS, Harry P. Wetzler, MD, MSPH. American Journal of Infection Control, March, 2018. 2. Op Cite 3. Op Cite 4. Op Cite 5. Op Cite 6. Op Cite