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Medical device incident investigations, November 2008
The TGA Incident Report Investigation Scheme (IRIS) has received several reports in recent times about concerns with cleaning and sterilising reusable phacoemulsion handpieces used in eye surgeries.
Concerns from theatre staff and sterilising managers relate more specifically to the perceived lack of manufacturers' instructions on how to reprocess these devices if used on patients suspected of having Creutzfekdt-Jakob Disease (CJD) or when used in high risk infectivity sites such as specific parts of the eye. (See Department of Health and Ageing 2004, Infection control guidelines for the prevention of transmission of infectious diseases in the health care setting).
The TGA recommends that if hospital staff suspect that a patient may be infected with a prion-type disease, those responsible for ensuring the safe reprocessing of such devices should firstly contact the sponsor of the device to obtain appropriate manufacturer's reprocessing instructions.
If these instructions are not sufficient to meet the requirements of the healthcare facility's policy and procedures, it is recommended that the healthcare facility then follow local or national guidelines on how to manage these instruments.
Device incident reports 01/07/2008 to 30/09/2008
Number received: 397
|Not Device Related||59|
|Hospital Supply Service||10|
|No Further Action||89|
|Problem Not Confirmed||6|
- The problem causes are not mutually exclusive. For example, a material deficiency may have led to a mechanical malfunction or a biocompatibility problem.
- Every report received by IRIS receives a risk analysis by the Scheme Coordinator and is discussed by a panel of technical and clinical professionals. In the case of reports that are "Not Investigated" the panel has made a decision that further investigation of the particular event is not necessary at that time. However, these reports are logged into the database for future reference and the trend of reports is monitored. In making their decision, the panel considers whether any similar reports have been received previously.