Instructions for use (IFU) documents can come in many different shapes and sizes and looking at these documents, the term “pre-cleaning” may pop up several times at different stages of the reprocessing instructions. Instructions are sometimes termed pre-cleaning when explaining the treatment at the point of use. Additionally, the “preparation before cleaning” section of the IFU or the cleaning instructions themselves can refer to pre-cleaning instructions. However, it is important to realize that treatment at point of use is not the same as pre-cleaning and that this distinction will also be made when performing cleaning validations.
What is the difference between treatment at point of use and pre-cleaning instructions?
AAMI TIR12:2020[1] defines point of use as “physical location and interface where the medical device is used according to its intended use, or proximal location to where the device is used”. The FDA guidance document for reprocessing medical devices[2] further states that “reprocessing begins with processing at the point of use (i.e., close proximity to the point of use of the device), to facilitate subsequent cleaning steps”. Hence, treatment at point of use will occur at or near the actual site where the device was used in the healthcare setting. These treatment instructions can be as simple as covering the devices with a wet towel, or can be a bit more elaborate such as wiping the devices with a wet towel or submerging the devices in water or cleaning agent while transporting the devices to the central processing departments (CPD) where the rest of the processing is carried out. The goal of treatment at point of use is to prevent the drying of soil and contaminants in and/or on the device.1,2 This may be required to ensure effective processing of the device[3].
Pre-cleaning is considered to be part of the preparation before cleaning instructions of the IFU3, although some IFUs will mention pre-cleaning instructions as part of the cleaning procedure rather than in a designated preparation before cleaning section. Either way, pre-cleaning will occur at the dedicated cleaning area of healthcare facilities1. Preparation before cleaning instructions can, for example, include disassembly instructions that are necessary to ensure proper cleaning of the device. Additionally, it is recommended to include a rinsing step at this stage, either by rinsing off the devices with cool water or by wiping the devices with a wet cloth. This is recommended to remove gross soil because many organic soils are water-soluble and can be easily washed away with water alone1. It is important to use cool water at this stage to prevent the fixation of proteins, which makes their removal more difficult1. Depending on the nature and complexity of the medical device, the pre-cleaning instructions may be more comprehensive; including for example, a step where devices are submerged and brushed in a bath of water or cleaning agent, or even adding a sonication step.
Should your IFU contain treatment at point of use or pre-cleaning instructions, or both?
ISO 17664:20173 indicates both for initial treatment at the point of use as well as for preparation before cleaning. These steps should be described in the IFU when this treatment or preparation is required to ensure effective processing of the medical device. Hence, this should be evaluated for each device individually and is going to depend on the overall cleaning procedure, complexity, and criticality of the device. For non-critical devices, treatment at point of use may not be necessary. With regards to the preparation before cleaning instructions it is important to consider that, whatever the device, AAMI TIR12:20201 does recommend adding a rinsing step as previously mentioned.
Should the treatment at point of use and preparation before cleaning instructions be included in the cleaning validation?
The FDA guidance document2 indicates that reprocessing validations should be performed according to worst-case conditions. It mentions that “if after clinical use of the device, drying of soil might occur and cleaning might not be performed immediately after use (…), the validation methods should allow soils to dry for a length of time that simulates worst-case (longest duration)”. Given that treatment at the point of use may not always happen in the healthcare facility, this step will be omitted from the cleaning validation and instead the soil will be allowed to dry completely on the device to simulate worst-case conditions. Preparation for cleaning instructions on the other hand are considered part of the cleaning procedure and will therefore be included in the cleaning validation.
In conclusion
Treatment at point of use is not the same as preparation before cleaning. Point of use treatment will occur at or near the site of clinical use and is intended to prevent the drying of soil. Including these instructions in your IFU may not always be necessary and given that this step may not always be performed in a healthcare setting it is omitted from the cleaning validation, to simulate worst-case conditions. Preparation before cleaning instructions may be required to ensure proper processing and will be carried out at the cleaning area of healthcare facilities. As such, these instructions are considered part of the cleaning procedure of the medical device and will therefore be included in the cleaning validation. It is recommended to include at minimum a pre-cleaning rinse step.
[1] AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.
[2] FDA Guidance for Industry and Food and Drug Administration staff 2015: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
[3] ISO 17664:2017: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.
