PERSONAL P ROT ECT ION EQUI PMENT
(SF2S) recommends not to use these masks for healthcare workers with direct patient contact, but for administrative and logistic hospital staff as well as for COVID-19 patients in public environments. Although the masks do not replace medical face masks according to EN 14683 Type I in all cases they can significantly support the shortage of medical face masks. The SF2S has published an instruction on how to manufacture medical face masks out of sterilisation wrap in times of shortage. It is important to emphasise the indications for use. These masks are to be manufactured according to the templates and instructions linked in the reference section. This can take place in the sterile processing department, in other units of the hospital or even at home. It is not strictly necessary to sterilise masks if they have been manufactured in a hygienically safe environment; however a final sterilisation stage and delivery to the end user in sterilised pouches, will ensure the hygienic safety of the masks. (Note. This was reported to contribute to the acceptance of the mask by end users.)
Masks can be packed individually or e.g. in packs of ten and sterilised in standard steam sterilisation processes. In the French context, Belimed has supported customers to implement this process with existing French standard sterilisation programs (pre- vacuum, 134˚C / 273˚F for 18 minutes).
Automated cleaning and disinfection of reusable PPE equipment Reusable PPE, such as goggles and face shields, under normal circumstances are typically cleaned and disinfected manually (e.g. by using a disinfectant wipe in the department of their use). Face shields and goggles may be recommended to be used in combination with FFP2 / N95 respirators to reduce the contamination of these respirators – especially when their extended use is being implemented as a measure to manage supply shortages. Goggles can reduce the risk of airborne infection entering via the eyes of HCWs when working with infectious COVID-19 patients. In the context of the current pandemic, some hospitals have expressed interest in automated cleaning and disinfection processes, to ensure a more stringent decontamination and quality assured method as opposed to a manual approach. This should increase safety for both the next user of the equipment and the person responsible for manual cleaning. These items typically do not require additional sterilisation and can be reused after cleaning, disinfection and drying according to their Spaulding classification. According to Kampf et al (2020), a one-minute thermal disinfection at 80˚C / 176˚F is enough to disinfect SARS-
Steriliser batch with FFP2 masks for decontamination
CoV-2 with at least a 4 log reduction factor. Moreover, since SARS-CoV-2 is an enveloped virus, the cleaning step involving surfactants at elevated temperatures around 50˚C / 122˚F will bring a significant reduction of infectivity. To be on the safe side, Belimed recommends the use of a thermal disinfection step of A0 600 whenever material compatibility allows to do that in an acceptable cycle time. When implementing automated cleaning and disinfection processes for these items, there are a few things to consider: l High safety of decontamination of SARS- CoV-2 virus and other potentially harmful infectious agents on the whole surface of the item
l Satisfactory cleaning efficacy l The PPE equipment must have sufficient material compatibility to allow for an acceptable number of reuses. Material damage can typically arise from high temperatures and cleaning chemicals that are not compatible with the materials used, especially if they are not rinsed off sufficiently
l These PPE products are typically not passed through automated washer disinfectors, so there are no dedicated load carriers (washer disinfector racks) available. However, it is generally possible to find a convenient way to position and fix these items such that all surfaces are cleaned by the water jets (even if the capacity utilisation might not be optimised)
l Plastics are more difficult to dry than steel, therefore dedicated washer disinfector cycles may need an extended drying time (at moderate temperatures) or a manual drying step added after the wash cycle is completed.
l It is highly recommended that customers perform durability tests of the items to be reprocessed at each site (typically 5 or 10 consecutive cycles with visual evaluation
70 l
WWW.CLINICALSERVICESJOURNAL.COM of material changes).
lWash cycles will typically use neutral enzymatic cleaning agents at moderate temperatures (rather than alkaline agents and higher temperatures) in the cleaning phase. After that they may feature long/ repeated rinse phases to ensure sufficient removal of the cleaning chemicals which could otherwise potentially harm the plastic materials.
l Whenever possible, thermal disinfection is recommended because of its generally higher reliability. The wash program ends with a thermal disinfection step of A0 600 with moderate maximum temperatures of 80˚C / 176˚F or less, depending on the heat stability of the products.
l If 70˚C / 158˚F is seen to cause material damage, then chemical disinfection instead of thermal disinfection could be considered.
Steam disinfection at 105˚C/221˚F as backup option for FFP2 masks The Austrian society for sterile supply (ÖGSV) has proposed a 105˚C steam disinfection with 5 minutes holding time as an alternative to the 121˚C / 250˚F steam sterilisation cycle for decontamination of suitable FFP2 masks. This option was also mentioned as a viable option by the German society for sterile supply (DGSV) in their last statement (5 April 2020). Rationale for this practice is again that SARS-CoV-2 virus is relatively easily inactivated by dry and moist heat. A 105˚C / 221˚F steam disinfection was common for thermal mattress disinfection and is still available in a number of hospitals in Central Europe. Moreover, this process can also be implemented in many standard medical sterilisers and can therefore easily be implemented into the workflow of a CSSD department. 105˚C / 221˚F thermal disinfection can be seen as
OCTOBER 2020
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