ABSTRACT
Background: Cleaning is essential to ensuring the safe processing of reusable medical devices, and most manufacturers' instructions for use (IFUs) specify that clinical soil should not be allowed to dry on devices. If soil is allowed to dry, the cleaning challenge could be increased due to change in soil solubility. As a result, an additional step could be needed to reverse the chemical changes and return a device to a state where cleaning instructions are appropriate. Methods: Using a solubility test method and surrogate medical devices, the experiment described in this article challenged eight remediation conditions to which a reusable medical device might be exposed if soil is dried on a device. These conditions included soaking with water or neutral pH, enzymatic, or alkaline detergent cleaning agents, as well as conditioning with an enzymatic humectant foam spray. Results: The results demonstrated that only the alkaline cleaning agent was able to solubilize the extensively dried soil as effectively as the control, with a 15-minute soak being as effective as a 60-minute soak. Discussion: Although opinions vary, the overall data demonstrating the risk and chemical changes that occur when soil dries on medical devices are limited. Further, in cases in which soil is allowed to dry on devices for an extended time outside of the guidance from leading practices and manufacturers' IFUs, what additional steps or processes may be necessary to ensure that cleaning can be effective? Conclusion: This experiment demonstrated the effectiveness of a soaking step with an alkaline cleaning agent as an additional step if soil is dried on reusable medical devices, thus reversing the effect of an extended soil dry time.
Subject(s)
Disinfection , Equipment Reuse , Equipment and SuppliesABSTRACT
Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.
