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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27 April 2019 ICT Going forward, the FDA says it will carefully track cases of infection with multidrug-resistant bacteria and the use of duodenoscopes through medical device adverse event reports submitted to the FDA, literature and stakeholders' feedback. The agency also will work with healthcare facilities and reprocessing personnel to understand their experiences implementing repro- cessing protocols. In addition, the FDA will work with manufacturers to modify the reprocessing instructions to enhance the safety margin of methods used to clean, disinfect and sterilize duodenoscopes, as well as encourage the development of new technology and design features, such as disposable components, to enhance patient safety. Regarding a more defnitive solution to endoscope contamination following reprocessing, Kotz says, "We are waiting for the fnal results of the 522 studies before making any determinations. We have been consulting with the Centers for Disease Control and Prevention and other federal health partners to provide their input and guidance on the issue of infection control and reprocessing of these diffcult to clean scopes. We are considering whether additional recommendations will be necessary to help healthcare facilities with properly cleaning and high-level disinfection of duodenoscopes to lower contamination rates to less than 1 percent." What Hospitals Should Do "There has never been more attention and action being taken regarding the reprocessing of fexible endoscopes so that the people reprocessing these complex devices have not only the training to do the job, but also the tools to do it safety and effectively," says Damien Berg, CRCST, president of the International Association of Healthcare Central Service Materiel Management (IAHCSMM). "It is essential that we attract, hire and retain the best technicians to do the job and provide the best outcome for the patient, adds Berg, who is manager of the sterile processing department at St. Anthony Hospital in Lakewood, Colo. "We must train them properly and ensure that the skills are maintained and that the staff can perform the steps consistently and without error. We must also recognize that it takes time to reprocess instruments correctly and diligently, and this is certainly the case with fexible endoscopes. With all the advancements in this feld, the one area that infuences all others is providing the staff enough time to properly reprocess these devices." Hospitals and any other healthcare facilities that use duodenoscopes should meticulously follow manufacturer reprocessing instructions. In addition, healthcare facilities should consider implementing supplemental reprocessing measures to reduce the risk of infection transmission, such as microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. The FDA previously issued a safety communication recommending these additional reprocessing steps to further reduce the risk of infection and increase the safety of these medical devices. Healthcare facilities "should follow the recommendations outlined in our latest Safety Communication," Kotz says. This alert can be accessed at: https://www.fda.gov/MedicalDevices/ Safety/alertsandnotices/ucm628020.htm The FDA also recommends that in addition to supplemental reprocessing measures, hospital staff carefully inspect a component of the duodenoscope that is diffcult to clean, called the elevator recess, and to repeat cleaning if any soil or debris is visible. The FDA also urges users to follow the manufacturer's recommendations for inspection, leak testing and maintenance of the duodenoscope and return the duodenoscope to the manufacturer, at least once a year, for inspection, servicing and maintenance. The FDA also strongly encourages healthcare providers to participate in the manufacturers' sampling and culturing studies and consider initiating their own duodenoscope surveillance sampling and culturing to reduce the risks of infection. However, Shuren warned, "It has become clear that following the manufacturer's reprocessing and maintenance instructions, while critical, is not suffcient to avoid all infections associated with the use of duodenoscopes. That is why the FDA has also been working with developers on new product designs, including disposable components. Technological advances in product design hold promise to reduce the risk of contamination and enhance patient safety." Shuren emphasized that a patient's risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use: "We have seen a steady decline in medical device reports associated with patient infections after the FDA implemented safety measures to improve reprocessing techniques including issuing recommendations to health care providers to enhance their cleaning and high-level disinfection of these devices, working with duodenoscope manufacturers as they reviewed and modifed their instructions for manual reprocessing and reviewing validated instructions for manufacturers of automated endoscope reprocessors that are used to reprocess duodenoscopes. A recent analysis of medical device reports indicates that the number of reports associated with patient infections peaked in 2015 at 250 reports and has declined 62 percent to fewer than 100 reports per year in 2017 and 2018. We are hopeful that this decline is the result of a successful effort on the part of healthcare facilities to implement our enhanced safety measures." "Reducing patient exposure to infections in healthcare settings remains a national priority involving multiple stakeholders with overlapping responsibilities," Shuren added. "The FDA's foremost concern is patient safety and we are committed to enhancing the safety margin of procedures with reprocessed medical devices, which include duodenoscopes and other endoscopes. As part of our larger efforts outlined in our Medical Device Safety Action Plan, our goal is to protect patients and spur innovation of new products that are safer, more effective, and address unmet medical needs." Reference: Food and Drug Administration (FDA). Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication. Dec. 10, 2018. Ò Tere has never been more attention and action being taken regarding the reprocessing of fexible endoscopes so that the people reprocessing these complex devices have not only the training to do the job, but also the tools to do it safety and efectively.

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