Scope Problems

An Update On The Problems Caused By Non-Validated Endoscopes The ongoing problem of patient harm caused by endoscopes whose cleaning IFUs have not been validated continues to make the news. As readers of this blog know, this is a major, national problem that has harmed hundreds of patients and caused the death of dozens more over the past decade. “As many as 350 patients at 41 medical facilities in the United States and worldwide were infected or exposed to contaminated scopes from Jan. 1, 2010, to Oct. 31, 2015, according to a U.S. Food and Drug Administration document obtained by the House Committee on Oversight and Government Reform and made public in mid-April 2016.”¹ A July 2017 Novo blog  addressed the fact that a scope manufacturer had just issued an Urgent Medical Device Correction and Removal Notification informing customers of its voluntary recall of certain duodenoscopes due to the inability to thoroughly decontaminate and clean the scopes. The FDA’s Safety Communication issued earlier this year pointed out that “The FDA has been working with several duodenoscope manufacturers as they modify and attempt to validate their cleaning and reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.”² On March 9th of this year, the FDA  issued warning letters to some duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.³ In announcing the warning letters the FDA pointed out that the manufacturers were to study scopes in clinical use to learn about contamination issues and human factors including staff training.⁴ The magnitude of the problem with non-validated, contaminated endoscopes was further documented in a new study published in the March 2018 issue of the American Journal of Infection Control. The data from three major hospitals was used to document 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 the study.⁵ The study highlights that more progress must be made by manufacturers, reprocessing personnel and regulators in reducing patient risk caused by non-validated scopes that remain contaminated after reprocessing. This new study is especially troubling given the history of so many news reports documenting superbug outbreaks and patient deaths from contaminated scopes whose cleaning IFUs have never been validated. News reports on these patient tragedies can be found going all the way back to 2013.⁶ Non-validated endoscopes are not the only reusable medical devices that are causing patient harm, suffering and even death. Many surgical instrument manufacturers, including those who make take-apart and modular instruments, have not validated their cleaning IFUs. The first step that you and your staff can take to reduce your patients’ risk of harm from a contaminated instrument is to only use instruments whose cleaning IFUs have been validated. In the absence of validated cleaning IFUs, you and your staff can be doing everything right according to the manufacturer’s IFUs and you will still be returning contaminated instruments to the O.R. 1. The Morning Call, November 6, 2018 by Jon Harris 2. Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA Safety Communication, FDA Safety Communication Issued July 21, 2017. 3. FDA News Release March 9, 2018 4. Op. Cite. 5. “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. 6. Op. Cite.