Sterile barrier systems
Choosing sterile barrier systems: a holistic approach
As the healthcare sector faces increasing pressure to reduce its environmental impact, sterile services departments are debating the relative advantages of flexible sterile wrap versus reusable rigid containers. Choosing a sterile barrier system is a major decision and can only be made after weighing all the relevant factors. Karina Engels provides an insight into the key considerations.
While sustainability is important and should be part of the design of any sterile barrier system, it cannot be the only factor considered when choosing sterile packaging systems. One must also consider such factors as usability, space, costs and, above all else, patient safety. When it comes to choosing the right sterile
packaging system, patient safety must be the primary determining factor. The European Centre for Disease and Control (ECDC) estimated that in the period from 2016 to 2017, 3.1 to 4.6 million people acquired a healthcare-associated infection (HCAI) during that period, in acute care hospitals, in EU/EEA countries.1
HCAIs can lead
to increases in patient morbidity and mortality, with more than 90,000 people dying every year in the EU/EEA due to the six most common infections in healthcare settings.2
HCAIs account for a significant cost to the healthcare sector, representing up to 6% of public hospital budgets.3
Comparing the risk for a barrier breach Maintaining a sterile environment starts with sterile barrier systems (SBS). Various methods are used for sterilising surgical instruments. SBSs are used to enclose and maintain the sterility of instruments until the point of use and to allow for aseptic presentation.4
SBSs include
heat sealable pouches, synthetic disposable wraps and rigid containers. Unfortunately, SBSs aren’t a bulletproof solution. For example, with wrapped trays, stacking, sliding, transporting or using improper folding techniques can result in barrier breaches – breaches through which bacteria could enter. For rigid containers, bacteria could enter
Furthermore,
via breaches caused by poorly joined, oxidised, cut or compressed gaskets; gaps caused by mismatched lids and bases; loose filter retainers; loose rivets or fasteners; or due to misuse,
damage or age-related fatigue. Furthermore, the aluminium body of most rigid containers can become degraded from the use of incompatible detergents, incorrect pH or repeated metal-on- metal rubbing during cleaning.5 A HALYARD-sponsored study conducted
by Applied Research Associates (ARA), an independent international research laboratory (the “Shaffer Study”), used a dynamic biological aerosol test to evaluate the ability of an SBS to maintain the sterility of surgical instruments, devices and implants.6
Using a custom aerosol
chamber, the Shaffer Study challenged 111 rigid containers of various durations of use (unused, used <5 years, used 5-9 years) and 161 wrapped trays using three grades of sterilisation wrap with ~102 colony-forming units per litre of air containing aerosolised Micrococcus luteus with a count median particle size of 1 µm. The SBS simultaneously experienced air volume exchanges caused by vacuum cycles that simulated air exchange events occurring during the sterilisation, transportation and storage of sterilised instrument trays in healthcare facilities. The Shaffer Study, which was published
in the American Journal of Infection Control (AJIC) in 2015, found that sterilised wrapped trays demonstrated significantly greater protection than sterilised rigid containers against the ingress of airborne bacteria. Of the 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container. By comparison, none of the 161 wrapped trays demonstrated bacteria ingress into the tray.7
The Shaffer Study further showed
that contamination rates of rigid containers increased significantly with increasing duration of use. Specifically, the study found that the seals of the rigid containers aged and lost some elasticity compared to new seal material. They
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www.clinicalservicesjournal.com I April 2024
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