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Medical device incident investigations, April 2008

9 April 2008

Cleaning and disinfecting intra-cavitary transducers

The TGA has received several incident reports to the Incident Reporting and Investigation Scheme (IRIS) of the difficulties clinicians are having in determining how to clean and disinfect intra-cavitary transducer medical devices between patients.

The TGA has investigated these reported difficulties. Findings suggest that some manufacturers are providing comprehensive cleaning and disinfecting instructions (for example, on their website) while some manufacturers' instructions are brief, confusing and inconsistent. Improvements can be made by ensuring the instructions are comprehensive and consistent across the different forms of media used to inform users (such as, instructions provided with the product and instructions provided on the website be consistent).

Because many of the manufacturers are catering to the international market, their Instructions For Use (IFU) for different medical devices are not written specifically to meet local standards and guidelines. In these instances some local interpretation may be required. It should be pointed out that manufacturers and sponsors are not required to meet particular standards and guidelines for their product to be included on the Australian Register of Therapeutic Goods (ARTG). Also, a manufacturer will state that a particular disinfectant suitable for high level disinfection be used on its product. If the end user is unfamiliar with the recommended disinfectant they may need to access the ARTG (accessed through the TGA website) to find out if this product is available for use in the Australian market. If not, the user will need to seek information from the manufacturer about what chemicals that are available in Australia can be used with their product.

As part of the information sought from the manufacturer. the user should ascertain:

  • whether the product is compatible with the particular medical device, and
  • how to use the chemical to achieve the required level of disinfection for this particular product

Manufacturers and sponsors of medical devices have an obligation to provide up-to-date instructions to end users on how to reprocess the reusable medical devices. Those who use the medical devices must be satisfied that the manufacturer and/or the sponsor meet these obligations and continue to provide such assistance as required. Any discrepancies in these obligations can be reported to the TGA through the IRIS scheme.

The TGA also recommends that end users consider all manufacturer's instructions and their health facility's ability to adequately reprocess reusable medical devices at the time of making the decision to purchase the devices.

Warning! MRI compatible monitors can still be drawn into the core of the scanner

Issue

The Incident Report Investigation Scheme (IRIS) has received reports about MRI compatible monitors and other equipment being drawn into the core of the scanner because they have been placed too close to the scanner or the brakes on trolleys supporting this equipment have not been applied.

In the report about the monitor, the audible alarms were switched off as well as the trolley not having its brakes applied, therefore the user did not notice that the monitor was too close. The patient was not injured in this case but there have been other reports from overseas describing serious injuries and deaths associated with this problem.

All MRI compatible equipment has limitations associated with the proximity of the device to the core of the MRI scanner. Some MRI equipment can be placed relatively close to the scanner on trolleys but they must have brakes on the wheels.

Recommendation

The TGA recommends that if MRI compatible equipment can not be secured to the wall of the MRI scanner's room, great care must be taken to ensure that the brakes are applied to trolleys.

It is also recommended that audible alarms are not turned off. A visual aid, such as a line on the floor indicating the minimum range for equipment, will also assist in determining how close equipment is to the core. If the equipment crosses this line, the MRI scanner can be shut down to prevent potential serious injury to the patient.

Statistics report

Device incident reports 01/10/2007 to 31/12/2007

Number received: 303

Cause of problem1
Component failure 7
Contamination 1
Design 18
Electrical 10
Inadequate Instructions 1
Labelling 3
Maintenance 2
Manufacture 12
Material/Formulation Deficiency 5
Mechanical 31
Not Device Related 41
Other 51
Packaging/Sterility 2
Quality Assurance 5
Unknown 105
Wear/Deterioration 13
Effect
Death 10
Serious Injury 87
Temporary Injury 79
No Injury 127
Source category
Medical Administrator 6
Specialist 10
Nurse 18
Blood Bank 3
Hospital Supply Service 10
Other 22
Overseas Advice 1
Sponsor 209
Biomed Engineer 7
Para Medical 1
Patient/User 2
Coroner 1
Dentist 1
Result of investigation
Bulletin article 1
Company warned 0
Compliance testing 3
No Further Action 41
Not Investigated2 204
Other 21
Problem Not Confirmed 9
Product Improvement 10
Recall/Hazard Alert 5
Safety Alert 4
User Education 14

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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