This module will provide an outline of a number of key re-usable medical devices that are classified as non critical semi critical and critical (as defined by the Spaulding system of classification for medical devices)and are in routine use in the health services. It will also focus on the medical devices used in the decontamination of medical instruments. It will include reference to necessary compliance requirements from manufacturers and guidance offered by the HSE & HPRA.
Spaulding classification of medical devices
Spaulding classification of non-critical (non-invasive), semi-critical (semi-invasive) and critical (invasive medical devices) with examples.
Decontamination Risk Assessment
Risks associated with the use of re-useable medical devices with examples.
Risk Reduction
Risk reduction through effective decontamination of re-usable medical devices
National Standards
Introduction to national standards for the effective decontaminaton of re-usable medical devices.
Device Design Constraints
Medical Device Design Constraints and manufacturers recommendations influencing the choice of decontamination process used in their decontamination: device compatibility for the decontamination processes, hinged and lumen instruments, multi-component electro-mechanical instruments, thermo-labile, chemo-labile and UV labile instruments and their coatings.
Device Design Operation and Manitenance
Design, operation and maintenance of decontamination equipment (medical devices) used in the cleaning, disinfection, high-level disinfection and sterilisation of re-useable medical devices
Decontamination Device Installation Requirements
Installation requirements for facilities introducing medical devices used in decontamination; ultra-sonic washers, washer disinfectors, automated endoscope re-processors, drying cabinets, autoclaves, low-temperature sterilisers
Post Processing Inspection and Release of Medical Devices
Assessing the effectiveness of medical device decontamination via visual inspection, residue assessment, parametric release, indicator monitors and rinse water analysis
Reporting Quality
Reporting conformance and non-conformance in the decontamination of medical devices, including the required reporting practice and follow-up corrective action deployment, monitoring and reporting.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |