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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.

In 2015, the Food and Drug Administration (FDA) updated its guidance on test methods for cleaning validations for reusable medical devices. The changes include the condition and contamination of devices, test samples and controls, cleaning process performed during validation, extraction methods, and endpoints. This article reviews the FDA's changes to cleaning validations. Examples are presented using flexible endoscopes in order to provide a practical guide to performing cleaning validations.

Flexible endoscopes are implicated in deaths from healthcare-associated infections (HAIs), in particular antibiotic-resistant infections. This article analyzes whether terminal sterilization should be required as part of endoscope reprocessing to reduce or eliminate HAIs and thus improve patient safety. Reusable flexible endoscopes are processed to make them ready for clinical use by the processing department of the healthcare facility. Unlike most critical and semicritical medical devices, the final step of processing an endoscope is high-level disinfection and not terminal sterilization. This is because most flexible endoscopes come in contact with mucosal membranes (versus contact with direct blood stream) and cannot withstand sterilization. However, sterilization currently is performed by a small number of U.S. healthcare facilities on reusable flexible endoscopes with the belief that they are safer for use compared to flexible endoscopes that are high-level disinfected. Based on the analysis in this article, terminal sterilization is not a required or necessary step to eliminate HAIs.

As technology advances, so does the complexity of reusable medical devices. This creates greater challenges for cleaning, disinfecting, and sterilizing devices between patient uses. There is increasing concern from the U.S. Food and Drug Administration (FDA) and the reusable device industry that inadequately reprocessed devices are contributing to infections acquired in hospitals and other healthcare facilities. This concern has led to a recently published draft guidance document for reusable device manufacturers, as well as meetings held by the FDA and AAMI in 2011, to address perspectives on these industry issues. The FDA has encouraged reusable device manufacturers to consider design features that allow for simple and more effective reprocessing procedures. This is a challenge for engineers whose primary focus is to design devices that can meet demands for increased sophistication and functionality. However, intensified regulatory scrutiny of reprocessing validations requires design innovation.