2. Thorough Cleaning: The device should be thoroughly cleaned after the point-ofuse processing. Generally, thorough cleaning is done in a dedicated cleaning area. Devices that will likely not become contaminated with pathogens during use (e.g., room vital signs monitor) may not require disinfection, and therefore may be suitable for use after cleaning only. 3. Disinfection or Sterilization: Depending on the intended use of the device, the device should be disinfected or sterilized, and routed back into use. A simple overview of reprocessing is presented in Figure 1. A more detailed overview of each reprocessing step is provided in Appendix B. Use Point-of-Use Processing (prompt, initial treatment to remove and/or prevent drying of soil and contaminants) Thorough Cleaning (and return to use, or) Disinfection (Low, Intermediate, or High Level) FIGURE 1. PROCESS OVERVIEW SterilizationContains Nonbinding Recommendations It is important to note that cleaning, disinfection, and sterilization are distinctly different processes. Cleaning is the physical removal of soil and contaminants; the methods and agents used for cleaning should be designed to remove such soil and contamination effectively. Effective cleaning should: § minimize the soil transfer from one patient to another or between uses in a single patient; § prevent accumulation of residual soil throughout the product’s use life; and § allow for successful, subsequent disinfection/sterilization steps. In comparison, disinfection and sterilization processes are intended to kill microorganisms; the methods and agents employed for disinfection and sterilization should be designed to achieve appropriate microbicidal effects. Please see Appendix A for the definitions of disinfection and sterilization, and Section VI. Criterion 3 for specific information on appropriate microbicidal processes. Accordingly, cleaning steps should be validated separately and independently from disinfection or sterilization steps. An overview of reusable medical device processing is found in Appendix B of this document. B. Resources for Developing Reprocessing Instructions The following are resources to consider when developing reprocessing instructions for reusable medical devices. 1. You should follow the labeling recommendations in device-specific guidance, when available. Device guidance may be found by searching FDA’s Guidance Document Database available


6 2. The following Technical Information Reports (TIRs) developed by the Association for the Advancement of Medical Instrumentation (AAMI) provide technical information for manufacturers and users and may be helpful when developing labeling instructions for reusable medical device: a. AAMI TIR12, Designing, testing and labeling reusable medical devices for reprocessing in health care settings: A guide for medical device manufacturers. 2. AAMI TIR30, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. 3. We recommend you refer to the current FDA-recognized version of AAMI/ANSI ST81, Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices. 4. We recommend you use current FDA-recognized test methods available from standards developing organizations (SDO). A searchable database of FDA-Contains Nonbinding Recommendations recognized consensus standards is available

7 5. You should also consult any relevant clinical practice guidelines and recommendations for infection control published by professional societies and associations, standards developing organizations, and government agencies (for example, the “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” from the Centers for Disease Control (CDC), available


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