Deciding which disinfection level applies to your non-critical device can be tricky. Non-critical devices are defined as devices that will either only contact intact skin but do not penetrate it, or which have no direct patient contact but may become cross contaminated in a clinical setting[1],[2]. AAMI TIR12:2020 provides some guidance as to how the appropriate disinfection level should be selected. It states, non-critical devices that come in direct contact with patients or healthcare personnel and that are soiled with blood or other potentially infectious materials should be intermediate-level disinfected after cleaning2. On the other hand, non-critical devices that do not come in direct contact with patients or healthcare personnel and are soiled with blood or other potentially infectious materials should be at a minimum low-level disinfected after cleaning2. Finally, non-critical devices that are not expected to be soiled by blood or other potentially infectious materials should be, at a minimum, visibly clean2.
So how to interpret this guidance with the tremendous variety in non-critical devices that exists, some of which may fall in between the categories outlined in AAMI TIR12? At Nelson Labs, we propose the following interpretation:
Devices with direct patient contact
For non-critical devices that directly contact the patients’ skin, we would advise to perform an intermediate-level disinfection when the devices have a potential to be soiled with blood, bodily fluids, or both. For devices that directly contact the patients’ skin, but which are not soiled with blood or bodily fluids, low-level disinfection is generally appropriate. An example of a device that would fall into this category would be a blood pressure cuff.
Devices without direct patient contact that are soiled with blood, bodily fluids, or both
Non-critical devices that are soiled with blood or bodily fluids but do not directly contact the patient can be especially challenging when it comes to determining the proper disinfection level. Here, a determining factor will be the risk the device poses for cross contamination. We would advise any devices that are soiled with blood or bodily fluids should be intermediate-level disinfected if they pose a high risk for cross contamination. For example, devices that could be considered a high risk for cross contamination are devices that have direct contact with healthcare personnel or are located at close proximity to the patient during surgery. When the risk for cross contamination is not very high, for example when there is no healthcare personnel contact, non-critical devices that are lightly soiled with blood and bodily fluids can be low-level disinfected.
Devices without direct patient contact that are not soiled with blood or bodily fluids
Non patient-contacting, non-critical devices that are not soiled with blood or bodily fluids but present a high risk of cross-contamination (e.g. through contact with healthcare personnel), should be low-level disinfected. For devices that are not expected to be soiled with blood or bodily fluids and do not present a high risk for cross contamination, AAMI TIR12 states that at a minimum these devices should be visibly clean. We would advise medical devices that fall into this category to be low-level disinfected. A notable exception to this may be hospital equipment, for which only cleaning may suffice.
In conclusion
To determine the appropriate disinfection level for non-critical devices, the guidance given in AAMI TIR12:2020 provides a useful starting point. When devices fall in between the categories outlined in AAMI TIR12:2020, a risk-based approach should be applied considering the clinical use and the type of soil.
[1] Food and Drug Administration, 2015 “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
[2] AAMI TIR12:2020 “Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers”
