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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29 May 2019 ICT HLD Solution: • Date opened • Expiration date once HLD solution is opened • HLD solution lot number (batch) and manufacturer's solution efficacy expiration date associated with the HLD lot number (batch) • Temperature of the solution in the AER unit • Initials of the processor • Adenosine triphosphate protein surveillance testing results can also be recorded on the same document actual and potential risk, and work toward a standard of practice that eradicates or reduces any actual or potential risk to patients. Mixing Lot/Batch Numbers The potential danger in mixing Lot / batch numbers is real. Manufacturers and distributors will tell healthcare that they cannot guarantee matching Lot / batch numbers. In addition, they will also tell healthcare that if the choice is made to mix lot/batch numbers, the manufacturer nor the distributor will stand behind that decision when it comes down to verification of the solution efficacy once multiple lot/batch numbers with multiple solution-efficacy expiration dates have been mixed thus creating a different solution efficacy that cannot be verified or tracked if there is a failure. The liability would rest solely with the healthcare facility that chose to mix the lot/batch numbers. Here are the critical questions to ask the manufacturer's medical affairs department: Introduction: Each Lot number has its own expiration date or solution efficacy date. Healthcare is asked to document the Lot number with the corresponding solution efficacy date along with the when opened date and its respective expiration date after opening. We are also asked to test MEC/MRC, using a solution specific test strip to verify solution efficacy prior to each use. Everyone can agree on that. Here are the issues: 1. Manufacturers/distributors do not guarantee to deliver same lot numbers/ efficacy dates. 2. Issue No. 1 above forces healthcare professionals to potentially choose to mix lot numbers and respectively solution efficacy dates. 3. While healthcare will test the MEC/MRC before each use, if we are using multiple Lot numbers with multiple solution efficacy dates we are not really able to verify the efficacy of any "one" of the solutions used. In fact by mixing Lots and solution efficacy dates we have in effect: a. Negated any company/ distributor liability b. Opened healthcare up to serious p o t e n t i a l l i a b i l i t y b e c a u s e healthcare is not able to verify the solution efficacy of all the potential lot(s) used (together) nor is it able to track the efficacy (of the newly formed solution) in the potential that healthcare might be in a litigation case. Thereby creating enough doubt to lose a case. Healthcare personnel record the lot/batch number and manufacturer solution efficacy expiration date of the corresponding lot/batch number for tracking when there is a potential/ actual failure with either the HLD or the AER unit. If there is a MEC/MRC failure, before the manufacturer's recommended use date after opening, healthcare professionals need to know which lot/batch number to recall. We can't just change the HLD and call it a day; we must report the failure so that other healthcare facilities do not have potential failures and other patients are not potentially put at risk because a manufacturer did not know there was a potential problem with a lot/batch number in circulation. Healthcare facilities report this infor- mation to infection prevention and control departments and leadership in the event that a patient must be notified; depending on the type of failure and the extent it reaches, manufacturers/FDA MedWatch or state/local healthcare regulatory bodies that pertain to patient-care delivery failures. Everything we do hinges upon the "what if" and "what are." Our role as healthcare providers is to identify c. By using multiple lot s with multiple solution efficacy dates, healthcare personnel in essence have created a new solution (lot) with an efficacy date they cannot verify because they cannot test or validate its efficacy. This is something the manufacturer does which is why it is listed on the packaging. Manufacturers certainly do not stand behind the use of multiple lots/solution expiration dates but will not put it in writing, either. d. Healthcare personnel would have to repor t all lot s used in a recall. Companies could potentially have to recall multiple Lots rather than just one. The expense would be exponential. The real-world expectation would be that healthcare would discard the affected solution (lot) and buy more without reporting any efficacy issues. e. Healthcare facilities often must report recalls that may affect a patient, to internal infection control departments, state, local and federal governing bodies. f. Joint Commission asks healthcare to show verification of lot and solution efficacy. 4. While we understand why companies and distributors are telling us that there can be no lot/solution efficacy date delivery guarantee, companies/ distributors of medical devices/supplies operate much like healthcare in that we employ the "first in, first out" rule. In addition, the standards of practice recommend healthcare record lot number not numbers of solution used not solutions. Here are the questions: 1. Is there any documentation available that states that the use of multiple Lots with multiple efficacy dates is recommended from manufacturer XYZ? 2. My vendor's representative stated that he/she always teaches his/her customers to use same Lots/efficacy expiration dates and not to mix them. Can manufacturers at least make sure they are sending distributors the same Lot and solution efficacy dates using the "first in, first out" rule? Here is a real manufacturer response: "It is important to follow both the storage and use instructions from the IFU as well as

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