Choosing a detergent will depend on a combination of three considerations: the device materials, the users, and the cleaning procedure.
Reprocessing instructions
When selecting a detergent, it is important that the label claim of the cleaning agent you wish to use specifies that the product can in fact be used as a cleaning agent for the reprocessing of medical devices. Unfortunately, there is no list of approved detergents, so finding a suitable detergent can be challenging.
Additionally, the detergent’s IFU should be checked to make sure that the intended use of the cleaning agent is compatible with the intended reprocessing instructions of the medical device. For example, not all detergents suitable for manual cleaning are suitable for automated cleaning. Manual cleaning agents may generate too much foam during automated cleaning, thereby hindering the proper functioning of automated washer-disinfectors. But even detergents intended for manual cleaning may not be suited for your specific manual cleaning procedure. For example, you may wish to wipe or spray the device even though the detergent’s IFU indicates that submerging the device is required for proper functioning of the detergent. A final consideration is the compatibility of the detergent with the rest of your reprocessing instructions, more specifically if your instructions include high-level disinfection. Not all high-level disinfectants are compatible with all cleaning agents. Hence, the IFU of the disinfectant should be checked to see which detergents can be used in the cleaning phase. If compatibility issues exist with the intended detergent either another detergent should be selected or a rigorous rinsing step after cleaning should be introduced.
Location of the users
Selecting a detergent will not only depend on your reprocessing instructions, but also on where the users of your device are located. Several detergent classes exist such as alkaline, neutral pH, enzymatic, etc. and based on the location of your users they may have access to different detergent classes. Historically, it has been noted that the majority of healthcare facilities in the US will rely on enzymatic detergents, whereas European healthcare facilities will mostly use alkaline detergents. ISO17664:2017[1] mentions that, “at least one validated method shall be specified for each applicable stage of processing of the medical device. The method shall be relevant to the market in which the medical device is to be supplied.” This means that you may need to specify and validate multiple detergents or detergent classes depending on the markets in which your medical device is to be marketed. To aid in the selection of one or multiple detergents it may be useful to reach out to your users to determine which detergent types or specific detergents they can access. It is pertinent to note that enzymatic alkaline detergents do exist which can be used to cover both the EU and US markets.
Device materials
Keeping the reprocessing instructions and the location of the users in mind, a final consideration is whether the selected detergent is compatible with the materials used in the construction of the device. For example, devices containing aluminum can sustain surface damage when exposed to some alkaline cleaning chemicals[2]. The detergent selected should not affect the biocompatibility or functionality of the device.
In conclusion
Selecting the proper detergent will depend on the reprocessing instructions, the location of your users, and the materials used to construct the device. The IFU of the detergent you wish to use should always be checked to make sure that it is appropriate for the intended reprocessing instructions and that it is compatible with your device’s materials. The absence of a list of suitable detergents can make the selection process challenging but reaching out to your users to see what is available to them may be a good place to start.
[1] ANSI/AAMI/ISO17664-2017 Processing of health care products – information to be provided by the medical device manufacturer for the processing of medical devices
[2] AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.
