This module will cover the theoretical and practical aspects of using low temperature sterilisation for medical devices
Thermal and non thermal methods of sterilisation
Moist heat, dry heat, radiological, chemical and low-temperature gas plasma sterilisation methods will be discussed and compared in terms of the anti-microbial effects, and the different practices that prevail in using these sterilisation methods. The advantages and disadvantages of each methodology of sterilisation will be summarised as a prelude to a detailed review of Low-Temperature Sterilisation Technologies.
Low-Temperature Sterilisation Using Hydrogen Peroxide Gas Plasma: Theo
A detailed description of low-temperature sterilisation and a review of the chemistry of low temperature sterilisation technology using hydrogen peroxide gas plasma and its effects on materials, microorganisms and prions will be presented. The micro-biocidal mode of action of the gas plasma will be a significant element of the learning and the oxidative and denaturant effects of the technology on molecules within microorganisms will be discussed. Issues of material compatibility, contact time, temperature and residual organic matter and residual moisture content effects will be discussed. The concept of medical device compatibility and “type testing” of medical devices to ensure suitability for Low-Temperature Sterilisation will be introduced. These are key elements in understanding the operation and appropriate use of the technology. The preparatory steps required to prepare compatible instruments for low-temperature sterilisation will be described.
Equipment used for Low Temperature Sterilisation
A review of the common equipment used in the production of sterilising plasma involving hydrogen peroxide will be presented. The consumables required to routinely conduct the low-temperature sterilisation of compatible medical devices will be described and discussed. A discussion of the operational merits of bench-top and large volume low-temperature sterilisation technologies will be presented. Safety features and hazards associated with the equipment will be highlighted as well as load configurations and packing medical instruments for loading into Low-Temperature Sterilisers. Key elements of low-temperature sterilisation processes to be mindful of at the procurement stage will be emphasised.
Optimal Facility Design for placement of Low-Temperature Sterilisation
The facility requirements for placement of a low temperature sterilisation unit into a hospital, clinic or primary care facility will be discussed. The signage requirements, spatial requirements, utilities, and safe segregation of work areas in the vicinity of the sterilisation unit and the control of aseptic work flow and practice in an optimally designed facility will be presented. Contrasts will be made with actual work site situations to illustrate where improvements in facility design to accommodate placement of low-temperature sterilisation units may be situated for optimal aseptic workflow and safe operation.
Staff training operational requirements Low-Temperature Sterilisation
Operational Safety features of low-temperature sterilisers, PPE and work practices including the storage of consumables and disposal of spent consumable packaging will be discussed. The aim of this element of the module is to ensure that environmental awareness and safety are foremost in the minds of those operating the low-temperature steriliser and that the potential for accidents and incidents are minimised and negated.
Validation and and routine Quality Assurance of the operation of a Low
The IQ, OQ, PQ requirements for Low-Temperature Sterilisation will be discussed including validation frequency, the parameters measured and the specifications required to assure valid instrument placement, operation and performance. Explanation of monitoring and measurement of the chemical composition of the atmosphere within the sterilisation chamber including moisture content will be explained. Discussion on the structure of validation reports for low-temperature sterilisers and the interpretation of data from the validation of a low-temperature steriliser will be discussed. The inclusion of rapid biological and chemical indicators to assure load sterility will also be explained and the principles of their operation will be described. Appropriate document requirements for validation and routine monitoring of loads will be described and the safe secure archiving of these documentary records will be discussed.
Preventative Maintenance of a Low-Temperature Steriliser
Typical preventative maintenance schedules for low-temperature sterilisers will be described with an emphasis on the components of the steriliser that are subject to regular replacement. The use of correct safety and aseptic practices when conducting preventative maintenance will be emphasised as well as documentation requirements for the completion of operational and performance checks after maintenance has been performed.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |