1. High voltage testing of laparoscopic accessories
Bruce Morrison
Hunter Area Health Service
John Hunter Hospital
Newcastle, NSW

2. Outline Particular Issues arising with laparoscopic instruments
Background to the NSW DOH guidelines on testing laparoscopic instruments
Development of the guideline
Application of the guideline
Where to next ?

3. Minimally invasive surgery - introduced in early 60’s
Advantages
less blood loss
low complication rate
minimal post op pain and discomfort
early discharge
reduced recovery time due to minimal tissue damage
Disadvantages
can be more expensive
electrosurgical burns can be a complication
Surgeons take longer to master the technique

4. The ESU Provides cut and coagulation power
Should be functional and appropriately adjusted
Output power and waveform should be in accord with manufacturers’ specifications
Return electrode should be appropriately connected to the patient
Lead integrity to the instruments in essential

5. The laparoscope Types of instruments Leads Forceps Hooks Scissors
Monopolar and bipolar
Leads
single
double

6. Parts of the instrument
Parts which make contact with the patient
conductive parts
non-conductive parts
Parts which do not make contact with the patient
handles
terminations

7. Laparoscopic Instruments
A selection filmed
(somewhat poorly) in the CSSD
at John Hunter Hospital
- after cleaning and washing and
prior to testing before
packaging and sterilising

16. Risks to the patient Burns Limited field of view operator induced
insulation breakdown
direct
capacitive coupled
Limited field of view
large sections of the leads and instruments are not in the surgeon’s field of view (90%)

17. Background to the NSW guideline
Patient incident - electrosurgical burns?
Reference to the NSW Healthcare Complaints Commission
NSW HCCC asks BEAG (NSW) for advice
BEAG gives preliminary advice
preliminary advice published as 97/20
considered advice published as 98/17

18. Development of the guideline
Preliminary discussions lead to publication of Information Bulletin 97/20
Bulletin widely distributed
reference to further work by BEAG
hospitals begin to expect testing will be done
NPCE working party develops a document aimed at providing good guidance for testing
Revision 2 sent to DOH and becomes Information Bulletin 98/17

19. Application of the guideline
Guideline recommended testing by BME
Original high voltage testers “dangerous”
BME had done what testing was previously done
Problems with tagging and tracking
How often should instruments and leads be tested

20. Older style high voltage tester

21. A newer “safe” HV tester

22. Testing in the CSSD Newer “safe” testers allow testing in the CSSD
OK for use by CSSD?
Training
Industrial issues
Why test in CSSD?
no problems with tagging
no requirement to track instruments and leads
nothing is missed
safe instrument is presented to the patient every time

23. Where to now? Development of Ver 3 of the guideline
Publication by NSW DOH
Version 3 contains …
information on “safe” testers
recommendations for testing in CSSD
voltages and currents for testing
Version 3d is almost ready to go!

24. Need to assure the insulation integrity
of the non-conductive parts
which make contact with the patient
Visual inspection is not adequate
High voltage testing is required to
detect insulation breakdown

26. Testing laparoscopic instruments
Practical experience from NSW
Testing statistics
Test jigs & all that jazz . . .

27. Testing protocols From the NSW Guideline 3.0 kV rms 50Hz or 4.2 kV dc
0.5 mA current limit
Compromise between
safety
voltages found in laparoscopic surgery
recommendations in AS

28. Why 3 kV rms?
All reinsulated instruments can withstand this test voltage.
Newly manufactured or reinsulated instruments typically withstand voltages greater than 8kV rms.
3kV is probably a higher voltage than needed, but leaves some margin for deterioration of insulating properties during the use of the instrument.

29. Who is testing? BME departments Outside contractors CSSD staff
in almost all Area Health Services
Outside contractors
very few
CSSD staff
Hunter Area Health Service
Politics of testing
use of the guideline for industrial purposes

30. How often are they testing?
Every use - HAHS
Monthly - many city hospitals
Quarterly - some city and many country hospitals
Never - one city Area Health Service
Mostly in theatre
all in one sweep

31. Equipment? All respondents using the Hi-Pot 140 high voltage tester
4 kV dc
Very high output impedance
Audible and visual breakdown indicators
Very few using test jigs

32. Test methods Some more less than perfect home snaps in the CSSD at
John Hunter Hospital

44. Testing results Hunter Area Health Service
Western & South-Western Sydney
Area Health Services

48. Final thoughts on testing . . .
Manufacturers’ test methods
8 kV in saline bath
What parts of an instrument should we test?
Should leads be tested?
Packaging after testing - care required!
What of Electroshield type devices?
Who should test - BME or CSSD?
The future of tracking?

49. Questions and discussion