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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8 www.infectioncontroltoday.com ICT November 2018 By Nancy Chobin SPD dialogue RN, AAS, ACSP, CSPM, CFER Q Q: Q r department was recently cited for Q Our department was recently cited for Q manufacturer's written instructions Q not having manufacturer's written instructions Q ll the devices we clean and sterilize. Q (IFUs) for all the devices we clean and sterilize. Q o we ever comply with this? We have Q How do we ever comply with this? We have Q y i ems to process. Q so many items to process. Q A: Your concern is one I hear often. Long gone are the days of processing just basic instruments. In the past, maybe 10 percent of the devices were "special," thereby requiring some special cleaning or sterilization. Today, it is the reverse; approximately 80 percent of the devices we process require special cleaning and/or sterilization instructions. The sophistication of today's medical devices makes it critical that IFUs be obtained and available for all devices being reprocessed, regardless of how long a device has been in use. Many manufacturers regularly update their IFUs; therefore, to ensure the safety of the device, it is essential that SPD technicians have the most current information. he best approach is to obtain the IFU before a device is purchased so that it can be verifi ed that the processing equipment and cycle parameters recommended by the device manufacturer are available at the facility. If the device is new (meaning it has never been used in your facility before), it is important to ensure that the staff is in-serviced in the cleaning, disinfection, or sterilization of the device according to the IFU. Thereafter, the IFU should be required each time the device is purchased. When the device is received, the IFU should be reviewed and compared to the information on fi le. If the IFU has been updated, SPD personnel should be in-serviced in the changes and the new IFU dated and placed in the reference binders. If the IFU is the same, no action need be taken. However, you fi rst, you need to start with a very strong policy and procedure that states your department will not process any device or instrument without specifi c written IFUs. As a matter of fact, no reusable instrument or device should even be brought into your facility unless the IFUs have been obtained and reviewed by you. Why would any facility bring in a device only to fi nd they do have the equipment or chemicals to clean, high level disinfect and/or sterilize pp y d y sterilize the device? This happens every day and then the problem becomes one for SPD. What to do? While some of the surgeons may not be happy with this change, once they understand the patient safety and legal liability associated with improperly processed devices, they agree. While the policy is being approved you can start to obtain IFUs from your vendors. If you are a larger facility, there is an online IFU site that you can subscribe to. However, you still need to review the IFU to make sure you can comply with it. The cleaning information must be readily available to the staff for reference in the decon- tamination area. You can install a computer monitor in the area, so that staff members can access the IFUs. However, surveying agencies are asking for a back-up system in the event the online service goes down or if your computer system goes down. So, it is recommended to download and copy the cleaning instructions and place them in plastic page protectors and place in the decontamination area. Provide the date when they were downloaded. The same goes for the prep and packaging/ sterilization area; have the IFUs available on a computer or hard copy for easy staff access. Some individuals think that the fact that the IFUs are now in the department means their responsibility is over. Not true. You need to monitor that your staff is complying with the IFUs every time. This can be diffi cult to do. I like to practice "management by walking around" (MBWA). It permits you to see what the staff is doing and ask questions — similar to surveyors — about how they are processing a specifi c device, where they obtained the information, etc. pt At the time of receipt, the written IFU should be reviewed to ensure the following: • The decontamination recommendations provide for thorough cleaning and defi ned microbial lethality. • The procedures can be performed in the healthcare facilit y using commonly available chemicals, supplies, and equipment. • The procedures can be duplicated by healthcare personnel. • T h e p ro ce d u re s c a n b e e a s il y u n d e r s to o d b y t h e u s e r. ( F o r example, diagrams and step-by-step instructions are helpful to personnel.) • The procedures are in alignment w it h t h e re co mm e ndat i o ns of professional organizations and with OSHA regulations for minimizing occupational exposure to bloodborne pathogens (21 CFR 1910.1030). • T h e i n s t r u c t i o n s i n c l u d e a method by which users can verify effective decontamination. • The instructions for use for the cleaning agent include the dilution/ concentration that should be used, the temperature, the water quality (e.g., pH, hardness), and the exposure time (soaking or contact). • The type and necessary quality of the water are specifi ed (e.g., distilled water, deionized water, water treated by reverse osmosis, fi ltered water, hard or softened tap water). 'Management by Walking Around': A Strategy to Ensure A Strategy to Ensure IFUs are Followed in the S are Followed in the SPD Q are Followed in the SPD Q

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