Initial rinse
The first step in the cleaning process is often a rinse with cool utility water to remove any remaining gross (large) debris from the medical devices[1]. This is an important step given that many organic soils, including proteinaceous blood components, are water-soluble and can easily be washed away with water alone1. One important factor to consider is that the water used at this stage should be cool water, as warm water (> 45°C) may denature proteins, thereby making them harder to remove1. Depending on the nature and amount of contamination that is expected to be present on a medical device, the initial rinsing step may not be deemed necessary. For semi-critical and critical devices, we do recommend the addition of an initial rinsing step to the cleaning procedure whether the cleaning procedure is manual or automated. It is also important to note that gross soil can inhibit the cleaning action of ultrasonic cleaners. Therefore, devices that are cleaned by sonication should, at the minimum, be rinsed prior to ultrasonic cleaning to remove soil that could interfere with proper cleaning1.
Rinse after cleaning
Not all detergent manufacturers will specify that rinsing is required following cleaning. However, improper removal of detergent residues after cleaning may affect subsequent processing steps such as disinfection and/or sterilization1, [2], [3];therefore, a rinsing step following cleaning should always be included[4]. Rinse type, duration, and water quality used during the rinse should all be specified in the medical device manufacturer’s instructions for use document. Rinsing instructions should be validated to show that residual cleaning agents are reduced to levels that will not interfere with subsequent reprocessing steps and that are non-toxic4. Not having a thorough rinsing step in place following cleaning is, in fact, a common cause for cleaning validation failures when it comes to residual analysis. To ensure rinsing is thorough enough for semi-critical and critical devices, it is recommended that a sufficient volume of water is used to completely immerse the device, and that the water is changed two to three times[5].
[1] AAMI TIR12: 2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.
[2] ISO17664: 2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.
[3] ISO 17664-2: 2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: non-critical medical devices.
[4] FDA Guidance for Industry and Food and Drug Administration Staff: 2015 Reprocessing Medical Devices in Health Care Settings: Validation methods and Labeling
[5] AAMI TIR34: 2014/(R)2017 Water for the reprocessing of medical devices.
