Infection Control Today

MAY 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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30 ICT May 2019 www.infectioncontroltoday.com your procedures about storage and use of XXXXX. This is important when you require a volume of XXXXX that would be required to come from the end of one bottle and the start of a new bottle for example. When mixing a new batch of X X X X X, from two or more bottles, it is not necessary to have the XXXXX come from the same lot number. It is important to make sure that the bottles being mixed each meet the Minimum Effective Concen- tration, which can be tested by utilizing test strips, that each bottle has not passed its expiration date from manufacture, its XX-day expiration date from opening, or the expiration of already poured from the container XX-day window. All these factors must be met in order to ensure the efficacy of the XXXXX being utilized. It is also critical to ensure proper monitoring of the solution throughout the use period by utilizing test strips to confirm that the minimum effective concentration of XXXXX is available. Do not use the solution if MEC is not met, one of the bottles expires in the timeframe of the intended dates of use of the solution, or if the up to XX-days of use falls outside of the XX-days from opening of the bottle. Due to the multiple factors that impact the use of mixed lots and containers as well as the complexity of ensuring that all the factors are within the acceptable scope it is not always advisable to mix containers and lots. However, it is up to you and your facility to determine best use and tracking methods to ensure that the requirements for maintaining efficacy of XXXXX are met if containers of various lots and expiration dates are mixed as well as how this is tracked and monitored to meet applicable standards and best practices." As you can see, at the end of the day it is the healthcare facility and its many patients that could be at potential risk and will take the liable hit if, as stated above, "However, it is up to you and your facility to determine best use and tracking methods to ensure that the requirements for maintaining efficacy of XXXXX are met if containers of various lots and expiration dates are mixed as well as how this is tracked and monitored to meet applicable standards and best practices." In one sentence, the manufacturer tells healthcare it is OK to mix lots/efficacy dates and in the next dissolves its liability for doing so by stating if healthcare chooses to mix Lots/efficacy dates, healthcare needs to weigh the consequences for creating such a potential for real liability. The manufacturer walks away with neither the consequence nor liability. Healthcare personnel should follow the manufac- turer's IFUs, which do not advocate nor deny that healthcare can or cannot mix lots/solution efficacy dates and the standards of practice which clearly says lot (not lots) and solution (not solutions). Becki Jenkins, PhD, CST, CRCST, CIS, CER, CHL, FCS, is a Maryland-based,35-year healthcare veteran, supervisor/educator, and speaker in sterile processing. " Due to the multiple factors that impact the use of mixed lots and containers as well as the complexity of ensuring that all the factors are within the acceptable scope it is not always advisable to mix containers and lots. Here are two examples of actual standards of practice:

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