A critical standard focusing on the reprocessing of reusable medical devices in both health and non-health-related facilities. This standard provides guidelines to help ensure reusable medical devices are cleaned, disinfected, and sterilised properly to prevent infections and improve patient safety.
Separate rooms are required for clean & contaminated reprocesing and ensure unidirectional workflow & airflow to reduce the risk of cross-contamination.
RMDs are grouped according to their material, intended use, design characteristics, physical mass & thermal conductivity. You are required to understand & document the product family for each individual device used and correctly reprocess each device.
Washer Disinfector (WD) compliant with ISO 15883, Sterilizer compliant with EN 285 or ISO 13060, Water Supply as in Table 7.2 & 7.3 of AS 5369 and undergo documented IQ, OQ & PQ.
All instruments are required to be traceable to the patient. The system needs to identify the cleaning process applied to each RMD including an ability to track a device to a patient & allow a recall if required.
Water quality is a critical consideration in all stages of RMDs. The key Water Quality parameters to be considered are shown below;
High mineral content can affect sterilization efficiency and equipment lifespan. Water must be softened or treated to meet specified hardness levels.
The pH of the water should be controlled to prevent damage to medical devices and ensure effective sterilization.
Water must be free from harmful ionic contaminants, including heavy metals, halides, chlorides, phosphates, and silicates, as these can corrode equipment and compromise sterilization.
Water must be treated to reduce microbial presence, ensuring that no microorganisms survive the sterilization process.
Levels of bacterial endotoxin in the water must be controlled to prevent contamination of sterilized devices.
Capable of delivering water that meets the quality parameters specified in tables 7.2 , 7.3 and 7.4 of AS 5369.
| Analyte | Maximum Concentration Levels Supply water | Final Rinse | AST Limit of reporting |
|---|---|---|---|
| Total Hardness (CaCO3) | 150 mg/L | 1 mg/L CaCO3 | |
| Chloride (Cl) | 120 mg/L | 0.05 mg/L | |
| Conductivity 20°C | As recommended by system manufacturer | 1 µS/cm | |
| Total Viable Count (cfu/100 mL)* | 10 cfu/100 mL | 1 cfu/mL | |
| Pseudomonas aeruginosa | Not detected/100 mL | N/A | |
| (Atypical) Mycobacterium sp. | Not detected/100 mL | N/A | |
| Chemical purity^ as Electrical Conductivity | In accordance with WD manufacturer's recommendations | 1 µS/cm | |
| Endotoxin EU/mL | 30 EU/mL | 0.1 EU/mL |