AS 5369 Compliance

AS 5369 Compliance

Ecosafe International recognises and understands the challenges associated with achieving and maintaining compliance with AS/NZS 5369:2023 within the Central Sterile Services Department (CSSD) and Endoscopy Department.

Our Team of specialists are able to assist you with understanding, planning and implementing all aspects of AS 5369 compliance, with our approach typically including the following stepwise approach:

Step 1 : System Assessment

Ecosafe International will inspect and sample key points from point of entry through filtration, reverse osmosis, storage and delivery, to determine the location/s with water quality concerns or challenges.

Step 2: Investigation

Ecosafe International will conduct a detailed inspection of the entire system from entry to delivery, to determine possible causes of measured results and any potential for existing or future challenges or infrastructural deficiencies.

Step 3: Remediation

Ecosafe International will work with existing suppliers and advise on required corrective actions (such as removal of deadlegs, replacement, removal or addition of filters, disinfection procedures, maintenance and / or servicing frequencies, changes to the distribution network and other applicable corrective actions).

Step 4: Validation

Ecosafe International will conduct validation testing to confirm the effectiveness of remediation works, advise on further action/s if applicable and provide status of compliance with Tables 7.2, 7.3 and 7.4 of AS 5369.

Step 5: Implement Compliance Tool

Ecosafe International will implement our Compliance Tool to facilitate continued compliance with the overall AS 5369 compliance requirements, allowing complete transparency of records and audit readiness at all times. The Compliance Tool can also be utilised to manage workflows, maintenance and servicing requirements for other Reusable Medical Device Reprocessing related equipment and systems.

Step 6: Review & Improve

Ecosafe International will review and revise the AS 5369 Compliance Program on a regular basis or in response to any significant system change.

Step 1: System Assessment

Ecosafe International will inspect and sample key points from point of entry through filtration, reverse osmosis, storage and delivery, to determine the location/s with water quality concerns or challenges.

Step 2: Investigation

Ecosafe International will conduct a detailed inspection of the entire system from entry to delivery, to determine possible causes of measured results and any potential for existing or future challenges or infrastructural deficiencies.

Step 3: Remediation

Ecosafe International will work with existing suppliers and advise on required corrective actions (such as removal of deadlegs, replacement, removal or addition of filters, disinfection procedures, maintenance and / or servicing frequencies, changes to the distribution network and other applicable corrective actions).

Step 4: Validation

Ecosafe International will conduct validation testing to confirm the effectiveness of remediation works, advise on further action/s if applicable and provide status of compliance with Tables 7.2, 7.3 and 7.4 of AS 5369.

Step 5: Implement CSSD Compliance Tool

Ecosafe International will implement our Compliance Tool to facilitate continued compliance with the overall AS 5369 compliance requirements, allowing complete transparency of records and audit readiness at all times. The Compliance Tool can also be utilised to manage workflows, maintenance and servicing requirements for other Reusable Medical Device Reprocessing related equipment and systems.

Step 6: Review & Improve

Ecosafe International will review and revise the AS 5369 Compliance Program on a regular basis or in response to any significant system change.

We look forward to discussing your CSSD Compliance needs in further detail.

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