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Medical device incident investigations, November 2008

11 November 2008

Reprocessing phaco-emulsifying handpieces

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).

Recommendation

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.

Statistics report

Device incident reports 01/07/2008 to 30/09/2008

Number received: 397

Cause of problem1
Component failure 16
Contamination 4
Design 14
Electrical 41
Inadequate Instructions 6
Labelling 6
Maintenance 4
Manufacture 12
Material/Formulation Deficiency 20
Mechanical 169
Not Device Related 59
Other 13
Packaging/Sterility 2
Quality Assurance 10
Unknown 40
Wear/Deterioration 8
Effect
Death 8
Serious Injury 123
Temporary Injury 90
No Injury 176
Source category
Medical Administrator 15
Specialist 7
General Practitioner 1
Nurse 27
Blood Bank 1
Hospital Supply Service 10
Other 6
Sponsor 306
Overseas Advice 2
Biomed Engineer 12
Para Medical 5
Patient/User 4
Dentist 1
Coroner 0
Result of investigation
Bulletin article 1
Company warned 2
No Further Action 89
Not Investigated2 271
Other 42
Problem Not Confirmed 6
Product Improvement 22
Recall/Hazard Alert 5
Safety Alert 4
User Education 11

Notes

  1. The problem causes are not mutually exclusive. For example, a material deficiency may have led to a mechanical malfunction or a biocompatibility problem.
  2. 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.

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