Reprocessing of Reusable Medical Devices (RMD) – Is this a Governance Issue?

Sue Greig 1

Senior Project Officer, Australian Commission On Safety And Quality In Health Care (acsqhc), Sydney, NSW, Australia

 

Any organisation large or small that requires reusable medical devices (RMDs) as part of its scope of service has the responsibility to insure that the reprocessing of RMDs is in a manner consistent with relevant national or international guidelines. This is designed to minimise risk of infection transmission or injury to patients and the workforce. The responsibility applies regardless of whether the reprocessing is related to large numbers of complex items, endoscopes, or a small number of items for clinic or session use.

Sterilising services are often placed under management oversight of operating theatre managers who are also responsible for the major customer of the sterilising service. One of the key factors impacting upon the efficiency in sterilising services in-addition to appropriately trained staff is ongoing maintenance and upgrade of equipment and consumables used in this area. Providing these resources requires engagement by governance, vision and forward planning as cost and logistics are key risks for any organisation when undertaking reprocessing of RMDs.

As part of an organisation’s quality and safety program it will need to demonstrate how it has responded to the requirements of NSQHS Standard 3. The quality management system of the organisation should demonstrate:
• What is the current level of compliance with the recommendations in the relevant national or international standards?
• How is this demonstrated in the organisations quality management system?
• How is the organisation responding to any gaps in compliance?
• What is the plan for the organisation to progress towards compliance?

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