High voltage testing of laparoscopic accessories
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High voltage testing of laparoscopic accessories. Bruce Morrison Hunter Area Health Service John Hunter Hospital Newcastle, NSW. Outline. Particular Issues arising with laparoscopic instruments Background to the NSW DOH guidelines on testing laparoscopic instruments

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High voltage testing of laparoscopic accessories

High voltage testing of laparoscopic accessories

Bruce Morrison

Hunter Area Health Service

John Hunter Hospital

Newcastle, NSW


Outline

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 ?


Minimally invasive surgery introduced in early 60 s

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


The esu

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


The laparoscope

The laparoscope

  • Types of instruments

    • Forceps

    • Hooks

    • Scissors

    • Monopolar and bipolar

  • Leads

    • single

    • double


Parts of the instrument

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


Laparoscopic instruments

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


Risks to the patient

Risks to the patient

  • Burns

    • 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%)


Background to the nsw guideline

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


Development of the guideline

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


Application of the guideline

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


Older style high voltage tester

Older style high voltage tester


A newer safe hv tester

A newer “safe” HV tester


Testing in the cssd

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


Where to now

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!


High voltage testing of laparoscopic accessories

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


Testing laparoscopic instruments

Testing laparoscopic instruments

Practical experience from NSW

Testing statistics

Test jigs & all that jazz . . .


Testing protocols

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-3894.1 1991


Why 3 kv rms

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.


Who is testing

Who is testing?

  • BME departments

    • 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


How often are they testing

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


Equipment

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


Test methods

Test methods

Some more less than perfect

home snaps in the CSSD at

John Hunter Hospital


Testing results

Testing results

Hunter Area Health Service

Western & South-Western Sydney

Area Health Services


Final thoughts on testing

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?


Questions and discussion

Questions and discussion


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