Infection Control Today

APR 2019

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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25 April 2019 ICT associated with the use of duodenoscopes, the FDA re-emphasized recommendations regarding steps that healthcare providers can take to enhance duodenoscope reprocessing. In October 2015, the FDA ordered all three manufac- turers (Fujifi lm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America), who make duodenoscopes sold in the U.S. to conduct post-market surveillance studies so that the FDA could better understand how duodenoscopes are reprocessed in real-world settings. As of November 2018, the initial Human Factors Study testing has been completed and at least 10 percent of the samples have been collected for the Sampling and Culturing Study. For the human factors study, manufacturers were tasked with answering the question, "Are the user materials included in your duodenoscope labeling and instructions for use suffi cient to ensure user adherence to your reprocessing instructions?" Human factors study results indicate that reprocessing instructions in current user manuals are diffi cult for reprocessing staff to comprehend and follow. For example, some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly. The study revealed that the descriptions of some of the processing steps in the user manuals were unclear. As a result, the FDA is working with the duodenoscope manufacturers to revise and clarify the user materials to improve comprehension and adherence to reprocessing instructions. For the sampling and culturing study, manufacturers were tasked with answering the question, "After use of your labeled reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms? For devices that remain contaminated after use of your labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?" The objectives of the sampling and culturing study were to identify clinical sites to collect duodenoscope samples and identify laboratories for culturing those samples; train staff on sampling and culturing protocols; and pilot the sampling and culturing protocols to identify errors and ineffi ciencies in the pilot protocols which will allow for streamlining of the sampling and culturing protocols during the pivotal phase of the study. Let's examine each of the manufacturer's preliminary results. Olympus The study population consisted of Olympus duode- noscope models PJF-160, JF-140F, TJF-160F, TJF-160VF, and TJF- Q180V. After clinical use, each duodenoscope under study was cleaned and reprocessed according to approved Olympus instructions before being sampled. Duodenoscopes were either reprocessed manually or with the aid of the Olympus OER-Pro AER. If the OER-Pro was used to reprocess the duodenoscopes, detailed information was collected to document the specifi cs of the procedure (including germicide used, concentration, expiration date, cycle setting, number of cycles, etc.). Currently, Olympus reports that at least 10 percent of the samples have been collected for the sampling and culturing studies. The studies were designed assuming less than a 0.4 percent contamination rate. As of the interim report dated Nov. 15, 2018, of the 1,736 total samples required for the study, 498 samples have been collected and 319 samples have been analyzed: • number of samples positive for low-concern organisms >100 CFU: 0/33 (0%) • number of samples positive for high-concern organisms: 1/33 (3.0%) • number of samples positive for low-concern organisms >100 CFU: 1/319 (0.3%) ** • number of samples positive for high-concern organisms: 22/319 (6.9%) ** ** Olympus culturing results for all samples collected (including protocol violations collected using non-sterile methods). Because many of these samples were collected using non-sterile methods, FDA does not believe these data refl ect real-world contamination rates. Regarding the data collection, Olympus noted, "The primary endpoint of the pilot phase is successful completion of duodenoscope sampling and culturing, where the duodenoscope samples were collected from clinically used duodenoscopes from the identifi ed healthcare facilities. Although the expectation is that none of the duodenoscope samples should be positive for high-concern organisms or have >100 CFU of low/ moderate-concern organisms, a thorough investigation to identify the root causes of positive samples will be conducted for any positive sample." Pentax The study population consisted of Pentax duode- noscope model ED-3490TK. After clinical use, each duodenoscope under study was cleaned and reprocessed according to approved instructions before being sampled. Duodenoscopes were either reprocessed manually or with the aid of an automated endoscope reprocessor (AER). If an AER was used, specifi c details regarding the AER use were documented in the study records (including germicide used, concentration, expiration date, cycle setting, number of cycles etc.). As of the interim report dated Nov. 1, 2018, of the 850 total samples required for the study,205 samples have been analyzed: • number of samples positive for low/moder- ate-concern organisms >100 CFU: 3/107 (2.8%) • number of samples positive for high-concern organisms: 3/107 (2.8%) • number of samples positive for low/moder- ate-concern organisms >100 CFU: 5/205 (2.4%) ** • number of samples positive for high-concern organisms: 21/205 (10.2%) ** ** Pentax culturing results for all samples collected (including protocol violations collected using non-sterile methods). Because many of these samples were collected using non-sterile methods, FDA does not believe these data refl ect real-world contamination rates. Ò In October 2015, the FDA ordered all three manufacturers (Fujif lm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America), who make duodenoscopes sold in the U.S. to conduct post-market surveillance studies so that the FDA could better understand how duodenoscopes are reprocessed in real-world settings.

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