Infection Control Today

NOV 2018

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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• The type and quality of cleaning agents and cleaning accessories that should be used are specifi ed. • T here are ins truc ti o ns fo r the handling and preparation of the device for cleaning. • Instructions are provided for the manual or mechanical method that should be used for cleaning, rinsing, and drying. • The time-at-temperature and water pressure parameters for mechanical cleaning equipment are specifi ed. • Instructions are provided for any necessary testing of function and cleanliness that should be performed after the decontamination process. • Any necessary additives (e.g., lubricants) that should be used in reassembly are specifi ed. • The compatibility of packaging with device materials is described. • Instructions are provided on the use of packaging materials commercially available to healthcare facilities. • The compatibility of the packaging technique with existing packaging practices is described. • The compatibility of the wrapped device with the planned sterilization process When you review the IFUs make sure you understand them. If you have questions, call the manufacturer and ask for the product manager or technician who can answer technical questions. If the device manufacturer provides cycle times/temperatures not validated for SPD by your sterilizer manufacturers, or if the high-level disinfection instructions dif fer from national standards or the high-level disinfec tant / liquid chemical sterilant instruc tions, do not process the device. Contact the manufacturer to resolve the discrepancies. I f t h e c o m p a n y f a i l s t o p r o v i d e instructions or resolve the discrepancy, do not process the device. Notify the operating room (OR_ — or other end user — to report the problem. Although the device manufacturer is responsible for qualifying the sterilization process for the device, healthcare personnel are responsible for demonstrating that they can replicate that process exactly and consistently. Any device manufacturer which fails to provide users with specific written instructions should be reported to the Food and Drug Administration (FDA) at: www.fda.gov/medwatch/report /hcp/htm. This is for voluntary reporting of problems; however, this the only way the FDA can correct these problems. In summary, there is a legal liability and patient safety risk when processing reusable devices. Ever y device should be processed in strict compliance with the IFU. This is your responsibility as the person who is processing the device. The patient expects a safe device. The surgeon has the right to expect that any devices or instruments brought into the OR are safe to use. When you release a device or instrument set, you are, in fact, telling the end user it is safe. Don't take short cuts and do the right thing for the patient every time. Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant and educator. References: ANSI/AAMI: ST79:2017. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. AAMI TIR 12 -Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers, 2010 Basics of Sterile Processing 6th Edition. Sterile Processing University, LLC. Lebanon, N.J. Proven, Quantifi ed Hygienically Clean Linens, Gowns and Scrubs Infection prevention to minimize HAIs requires your laundry service to be Hygienically Clean certifi ed to ensure healthcare textiles (HCTs) are safe from microbes, molds and fungus: • Proven best laundry practices detailed in quality assurance (QA) manuals • Multiple third-party inspections that follow consistent, proven protocols • Quarterly testing of clean laundry to internationally recognized standards Managed by an advisory board of laundry, epidemiology, infection control, nursing and other healthcare professionals, Hygienically Clean is the right certifi cation to include in your RFP for linen and uniform service. YOUR LAUNDRY VISIT PLAN—Know what to look for when you observe a healthcare laundry's washing, fi nishing (drying, folding, ironing), staging and storage. Download this guide to visible indications of a laundry's thoroughness, based on Hygienically Clean certifi cation inspection protocols: www.hygienicallyclean.org/laundryvisit

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