These sterilants do not irritate the eyes and nasal passages as much as glutaraldehyde. Liquid chemical sterilants (also known as germicides) such as ortho-phthalaldehyde (OPA) are now in use in Europe and the USA and have been shown to have superior mycobactericidal activity compared with glutaraldehyde (New Disinfection and Sterilization Method: Ortho-phthalaldehyde: a New Chemical Sterilant 9). Such large scale recalls can make manufacturers nervous about adopting new technologies, even when the systems have had FDA clearance to market. One very popular peracetic acid sterilisation system for endoscopes and devices that are sensitive to moisture and radiation, Steris 1, is now under mandatory recall by the FDA (Steris 1 peracetic acid sterilisation system recall 8). Chemical sterilants such as ozone, nitrogen dioxide and supercritical carbon dioxide may encounter constraints for validation of sterility because the commercial sterilisation indicators are not as widely available, and fewer laboratories are trained in their use ( Lambert, 2010). Numerous other chemical sterilisation systems that create penetrating vapours currently have limited availability or are still under development and qualification. To date, these constraints have retarded the widespread use of the VHP sterilisation method, but the process and chemistry are relatively more compatible with the materials, making this a suitable alternative for implantable sensor systems.
However, when used in an industrial setting, the sterilisation equipment and support systems must undergo installation, operations and sterilisation validation which can be time-consuming and costly. The FDA has granted 510(k) clearance for the use of various models of vapour sterilisation systems to terminally sterilise medical devices (K083097 6 K071385 7). Because hydrogen peroxide breaks down to water and oxygen, aeration time is greatly reduced and any concern for toxicity is very low risk.
Compared to EO gas, VHP typically cannot penetrate large, dense packaging, but it can offer an alternative where material compatibility with EO is a problem. Vaporised hydrogen peroxide (VHP) sterilisation is a low-temperature gaseous method of sterilisation. When protecting the performance of the implantable sensor is critical, neither extra time nor cost will prevent these alternative sterilisation processes from being the method of choice. Other less conventional, less frequently used methods may be considered as suitable alternatives for implantable sensor systems, because these systems have different performance and risk priorities compared with large volume, low cost disposable medical devices. Duncan, in Implantable Sensor Systems for Medical Applications, 2013 8.3.5 Alternative sterilisation methods: considerations for implantable sensor systems
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