Cleaning, Disinfection and Sterilization of Reusable Instruments

The FDA’s overview of reusable-device reprocessing describes initial care at the point of use, thorough cleaning in the processing area, and subsequent disinfection or sterilization as appropriate to the device. It is not a universal instruction to disinfect every instrument before cleaning. Follow the complete approved sequence for the actual device and equipment.

Cleaning removes organic and inorganic material through the specified manual or mechanical method. Thorough cleaning is needed before high-level disinfection and sterilization; remaining material can interfere with those processes. CDC guidance on cleaning also distinguishes cleaning agents from disinfectants. An enzymatic detergent is not automatically a disinfectant.

Prepare and use the selected chemistry according to its instructions. Use only cleaning methods compatible with the instruments. The required disassembly, access to internal surfaces, rinsing and drying must be drawn from the relevant instructions, not from a generic article.

Select the appropriate observation within the cleaning validation and monitoring range: removal of applied test soil and detection of residue on an instrument require different evidence.

Disinfection addresses microorganisms to the level required by the chosen process; it must not be described as sterilization. Sterilization is a process intended to eliminate all forms of microbial life, including bacterial spores. The CDC’s definitions explain this distinction and the importance of prior cleaning.

Choose a compatible process based on the device’s intended use and instructions. Do not substitute ultraviolet exposure, boiling or an arbitrary heat programme for the required validated process. A temperature-and-time list detached from the sterilizer, load, packaging and instrument instructions is not an operating procedure. See the CDC recommendations on processing selection and equipment use.

Where permitted by the instrument and equipment instructions, ultrasonic cleaning is a mechanical cleaning method. Its settings and loading conditions belong to the applicable procedure. It does not establish sterility simply because the cycle has finished or an indicator has cleared.

MEDIWISH Universal Strip REF 647913 monitors removal of its applied test soil in the documented configuration, with holder 12-5814. It does not directly measure cavitation energy or determine an exact detergent concentration. A result at one position also cannot demonstrate removal of all contamination throughout a load.

The comparison of ultrasonic cleaning indicators explains why vials, strips, foil and residue tests are not interchangeable. For preparation and documentation of a bath check, use the ultrasonic cleaner testing guide alongside the applicable instructions.

Record cleaning-indicator observations separately from instrument inspection, required residual testing, disinfection records and sterilization monitoring. Investigate unacceptable or invalid observations using the facility’s procedure. No single soil-removal indicator authorizes release of instruments for patient use.