Sterile barrier systems
also sustained nicks, cuts and creasing after years of use. Furthermore, data collected during the
Shaffer Study suggest that the duration of use for rigid containers was at least partially accountable for their compromised ability to maintain the sterility of their contents under the defined test conditions compared to sterilisation wraps. This is particularly concerning because all the tested containers were new or identified as clinically acceptable containers. In fact, some of the rigid containers tested, even though identified and deemed ‘acceptable’ and ‘in use’ by the supplying healthcare facility, had loose filter housings, mismatched lids/bottoms or dents/nicks on the lids/bottoms. Perhaps even more concerning is that 72% of the unused containers showed various levels of bacterial ingress.8
Does your SBS perform as expected? All of this highlights the importance of evaluating whether an SBS performs as expected. For sterilisation wrap, the process is quite simple: one only needs to conduct a visual inspection of the wrap after the packaging is opened. However, for sterilisation containers, the process can be a bit more complex. For example, to help end-users properly
evaluate their sterilisation containers, the Association Française de Normalisation (AFNOR) developed a ‘water test’ to determine whether a sterilisation container can be used ‘as is’.9 The test requires one to fill the container with 5mm of water. Once filled, the container is to be closed and placed on its side for a period of 30 seconds, during which time one is to inspect all four sides for signs of a potential leak. The AFNOR test was published after a multicentric survey conducted across seven French hospitals showed that 29% of all tested sterilisation containers leaked10
– leakage that
a paper published by CH Métropole Savoie has linked to a potential risk of bacterial ingress (the “Savoie Study”).11
In the Savoie Study,
researchers used an aerosol with Micrococcus luteus and overpressure (25, 50 or 75 millibar) to simulate atmospheric pressure variations. What they found was that, at 25 millibar, 74% of the containers that leaked during an AFNOR
the evaluation of recycling programmes. While there is no arguing that different
Go Jack
instrument opener made from recycled
sterilisation wrap
(manufactured by Van Straten Medical and
endorsed by GreenCycl.)
water test were also prone to bacterial ingress. This led the authors to conclude that the water test was a valuable tool for evaluating the effectiveness of a sterilisation container.12
When it comes to sustainability, the answer is not clear Aside from patient safety, sustainability and cost are major decision-making factors in the SBS purchasing process. The former is being driven by the EU Green Deal, which aims to make Europe the first climate-neutral continent by 2050. Such sustainability-minded initiatives are having a direct impact on healthcare purchasing. For instance, inspired by the EU Green Deal, the Netherlands launched a voluntary Green Deal in Care initiative. Signed by more than 30013
healthcare-related parties,
the signatories pledge to reduce their carbon footprint and to implement socially responsible and circular procurement practices. While such initiatives are laudable, they will only achieve their intended goals when purchasing decisions are based on facts, local feasibility studies and
Making an informed sterile barrier system purchasing decision starts with knowingall the facts, and the fact is that both sterilisation wrap products and rigid containers have their own pros and cons.
sterile barrier systems have different carbon footprints, the actual size or scale of the difference remains open for debate. For example, one study (the “Friedericy
Study”) claims that the carbon footprint of reusable rigid containers is 85% less than that of single-use tray wraps, with a significantly lower carbon estimate for reusable rigid containers (57g CO2
e per use).14 To reach this conclusion, the Friedericy
Study compares the environmental gain after 5000 cycles for flexible sterilisation wrap versus sterilisation containers and looks at the breakeven point of both packaging systems. However, this choice of benchmark is questionable considering that CEN standard EN 868-815
sets 500 cycles as the minimum service
life for sterilisation containers. If a container is assumed to be used 120 times a year, which is the figure used in a study published in the Health Economics Review (the “Krohn Study”),16 then, when considered against the lifespan of 5000 cycles set out in the Friedericy Study, the result would seem to assume that containers could be used without replacement for approximately 41 years. The Friedericy Study17
cites a waste of 12kg
of plastic per surgical procedure meaning blue wrap would represent 11.5% of that procedure’s total plastic waste. However, our calculations show that H300 sterilisation wrap (101x101cm), the reference wrap in the Friedericy study, would represent 2.43% of the procedural plastic waste (when three instrument trays are unwrapped).18
The Friedericy Study’s Lifecycle Assessment19 includes the washing
and disinfecting of the containers. However, it is unclear whether the wastewater treatment associated with washing the containers is included in this calculation. A recent Green Surgery Report published
by the UK Health Alliance on Climate Change20 helps fill in some of these blanks, particularly
April 2024 I
www.clinicalservicesjournal.com 49
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Image courtesy of Van Straten Medical
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