Mrs. Sue Greig1
1Ramsay Health Care, St Leonards, Australia
Biography:
Sue Greig is currently the National Manager, Infection Prevention and Control for Ramsay Health Care, Australia. She is a Life Member of ACIPC. She has worked in infection prevention and control in a variety of settings in Australia and internationally.
Abstract:
Medical technology in Australia is less than 2% of the global medical technology market. The ability for Australia to influence the world market is limited and risk management systems play an important role when responding to risks.
To highlight this, last year a cluster of defects were identified in a reusable medical device (RMD) used in joint replacement surgery.
The issues included loose or missing screws from a complex device used in robotic joint replacement surgery.
The defect was identified initially by the sterilising service staff completing the RMD inspections during reprocessing and the corporate product specialist was informed. As part of the risk management process, the affected devices were withdrawn from use, replaced, the incident was reported. The risk was assessed by infection control, governance and clinicians to determine if further investigation was required to confirm safe use of this device.
Questions investigated.
Was it a problem of which we were not aware?
In which facilities was this device used?
How likely was this defect related to the device, reprocessing or use?
Had this defect been previously identified, and if so, what action had been taken?
Our investigation included the supplier, manufacturer, and Therapeutic Goods Administration (TGA) and our facilities and surgeons.
Outcomes of this investigation included the importance of notifying risks identified; being aware that there is a difference between a corporate and clinical risk; identifying a way to manage the continued use of this device as part of the set up and the importance of ongoing education.