PERSONAL P ROT ECT ION EQUI PMENT
the German Hospital Group Helios, Belimed performed tests proving that it is possible to generate the conditions defined by the German ministry recommendation (65- 70°C / 150°-160°F for 30 minutes) in a Belimed WD 290 washer disinfector, by implementing a carefully designed drying program.
The temperature band of the masks was
verified on all levels of a four level instrument rack, similar to the way temperature bands of cleaning and thermal disinfection stages are verified during yearly on site qualification with temperature loggers. The loggers used had a significant thermal mass and temperature sensors placed inside the logger housing for additional safety. This method reflects possible delayed heating kinetics (due to the less efficient heat transfer of air compared to water).
Helios Process: from individualised to non-individualised reuse The Helios Group, currently operating 42 CSSDs in Germany, had researched dry-air disinfection and other methods already before the Ministry had published their recommendations. They had set themselves the challenging goal of implementing a process with highest possible safety standards to ensure uncompromised health protection of their employees, while maintaining a work-flow that: a) Is manageable on a large scale b) Can be transferred to different Helios hospital sites
With this ambitious goal, Helios dedicated an interdisciplinary team to work on the challenge of FFP2 mask contingency reprocessing. Their solution was in line with the temporary emergency recommendation by the ministry, while highly increasing the microbicidal efficacy and thus overcoming limitations of individualised reuse, greatly simplifying logistics and process complexity. The Helios process is based on a two-step thermal decontamination with dry heat. The first thermal disinfection step takes place in the normal CSSD inside the washer disinfector at 65-70° for 35 minutes. Here it is made sure that the drying phase before the “dry heat decontamination plateau” is long enough to for the masks to be completely dry. Subsequent to this first treatment step the masks are packed into sterilisation wrap for transport to a specialised CSSD with additional infrastructure for further dry heat decontamination (convection ovens). There the masks undergo another treatment of 9 hours dry heat at 70°C / 160°F, resulting in a total thermal disinfection dose that mathematically corresponds to A0 3000 but with dry heat and not with moist heat as described in the ISO 15883 WD standard. In this way, according to the
OCTOBER 2020
Many hospitals have decided to install the steam sterilisation process for reprocessing FFP2 masks as a risk-reduction procedure (for potential out of stock situations within the next 4-6 weeks). The reprocessed masks are kept in stock in the event that no new masks are available.
infection control specialists that were involved into the process design and its quality control a level of disinfection is reached that can be expected to provide safety from SARS-CoV-2 and other pathogens that may present a risk during mask reuse. With this method, Helios can decontaminate any type of CE marked mask, the only limiting factor for reuse would be potential wear or damage due to repeated use by HCWs. Helios has implemented a stringent quality management system in this decontamination process including microbiological and technical quality control of samples of every batch of reprocessed masks.
Helios report a capacity of 8,000 masks per day in the 36 CSSDs where this process was introduced. Due to the fact that enough new masks could be sourced Helios – similar to most hospitals who have tested or introduced steam sterilization for FFP masks – is collecting the reprocessed masks in a separate stock for the time being and will only use them when no other options are available.
Similar as described for steam sterilisation in the Netherlands, there are considerations made that reuse of decontaminated high quality masks could actually be safer for HCWs than use of new low quality masks due to better filtration properties. Helios has an extensive press release on their process and will make all relevant data available to healthcare providers, to benefit from their experience and to provide full transparency to stakeholders.
Steam sterilisation of single-use OR gowns in France
Since OR gowns are frequently used as PPE for HCWs in contact with potential or confirmed COVID-19 patients, a much higher number of these gowns is needed than usual. The French Association for hospital infection Control (SF2H) has published a statement concerning the exceptional-case reprocessing (cleaning and sterilisation) reuse of surgical gowns. Recommended process by the SF2H:
l Cleaning and disinfection process in a laundry machine at 60˚C (140°F) for 30 minutes
l Drying process (attention: some gowns materials can catch fire when dried at too high temperatures
l Sterilisation with steam sterilisation at 125˚C (257˚F) and 20 minutes holding time.
In close cooperation with the French Society of Sterilisation Sciences (SF2S), Belimed has defined the standard parameters following the recommendation by the SF2S (fractionated pre-vacuum steam sterilisation process with a plateau at 125˚C / 257˚F for 20 minutes) and implemented this process for various interested hospitals.
Whenever possible, the pre-phase of the steam sterilisation process should be kept identical to existing validated programs so that the daily Bowie-Dick test results are valid for this special program as well.
Steam sterilisation of face masks from sterilisation wrap in France During the COVID-19 pandemic many countries have encouraged more extensive use of medical face masks (often referred to as ‘surgical masks’) in healthcare and also in everyday life.
As a consequence, a massive increase in consumption of single-use medical face masks has depleted stocks in many countries. In the absence of appropriate masks or lack of knowledge, HCWs and others also may misuse and overconsume FFP / N95 respirator masks when medical face masks (type 1/2/3) would be appropriate, thereby further increasing the scarcity of FFP / N95 masks. A simple workaround method to overcome out of stock situations for medical face masks is therefore highly beneficial for safety and public health. Both France and China have started systematic approaches to manufacturing medical face masks from sterilisation wrap (similar to type 1 EN 14683) in CSSDs. Sterilisation wrap materials (SMS or SMMS) that comply with the standards ISO11607 and EN 868 have a proven impermeable for airborne infectious particles and can therefore be considered as appropriate material for the purpose of medical face masks for contingency use. The resulting manufactured masks do not strictly comply with EN 14683 but can have very similar properties as type I masks, as defined in this standard. Because of the lack of strict compliance with the standard, the French Society of Sterilisation Sciences
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