PERSONAL P ROT ECT ION EQUI PMENT
good material compatibility. The responsible German authorities
Federal Ministry of Labour and Social Affairs and Federal Ministry for Health issued a document on 31 March recommending the dry heat disinfection of FFP2 masks at temperatures of 65°-70°C / 150°-160°F for 30 minutes, to overcome shortage situations. The letter recommended masks to be reused by the same person (“individualised reuse”) in line with the described fact that the decontamination method while assumed to be effective against SARS-CoV-2 viruses, does not provide sufficient safety against other pathogens. However, the German Society of Sterile Supply (DGSV) issued a statement a few days afterwards, questioning the dry heat disinfection approach for various reasons. These included lack of availability of suitable equipment, limited microbicidal efficacy, logistic challenges of individualised reuse and difficulty to implement dry heat disinfection as a quality assured process. The DGSV statement went on to
suggest the steam sterilisation approach at 121°C / 250°F as potentially preferable option (as implemented in Austria and the Netherlands). After the adequacy of the dry heat process was questioned also in public media the Federal Ministry of Labour and Social Affairs and Federal Ministry for Health stated on their website on 29 April that the recommendation of 30 minutes of 65°-70°C / 150°-160°F dry heat decontamination protocol is taken back until further notice. The ministry continued that the protocol is currently under validation and left open if it might be reintroduced with possible modifications. After the recommendation had been taken back by the ministry German hospitals that had started to implement the dry heat disinfection switched to steam sterilisation as contingency method instead or considered a longer dry heat process with much higher microbicidal impact as described in the following.
During the time the recommendation
was in force various German customers requested Belimed to implement the dry heat process within a WD 290 washer disinfector by using only a drying cycle. This was seen as beneficial for a relatively smooth implementation and decontamination workflow as many CSSDs in Germany do not have access to drying cabinets. In addition, all CSSDs have workflow and quality assurance for this process (ensuring that all items passing are actually processed in a clearly defined way). It is important to note that after the discontinuation of the recommendation of the German ministry the 30 min dry heat process alone cannot be considered as sufficient – but it may be used as a first step in a longer decontamination protocol as described in the next section.
Symbolic depiction of the first thermal decontamination step in the washer disinfector. Depiction of the 8 step workflow as developed by Helios Group Germany 68 l
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Under normal circumstances Belimed would have refused to implement such a solution because it is outside the intended use of a washer disinfector to disinfect only with dry heat. However, it must be remembered that this is generally also outside of the intended use of a drying cabinet or an oven. The emergency regulation in force gave the regulatory permission implement new processes (that may normally be considered off-label use) for a limited time during the crisis and to solve the problems of PPE shortages. Because the intended use of a WD does not include dry heat disinfection a concern was raised for potential infection risk for CSSD staff, because potentially infectious masks are first treated with cold air before the heating temperature is reached. It was argued that cold air with airborne virus particles, could be exhausted from the WD into the immediate working environment of the CSSD. This argument was discussed between hospital infection control teams and washer disinfector manufacturers and they came to the following conclusion which was also accepted by the DGSV. This should not be considered a critical risk, as long as the washer disinfector type used is connected to an active exhaust ventilation system and is not discharging drying air into the room (e.g. as small washer disinfectors do). If aerosols going into the exhaust system would be a problem, then the same concern would be there for all process stages in a washer disinfector before thermal disinfection, since during all these stages aerosols of non- disinfected and potentially highly infectious medical devices can exit from the washer into the hospital exhaust system. Therefore, with an active exhaust ventilation system, the process in WDs is considered safe in terms of aerosol spread and the question is only the technical feasibility of implementing the required decontamination conditions in a reliable and repeatable manner. On the request of
OCTOBER 2020
©Helios
©Helios
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