Presentation on theme: "High voltage testing of laparoscopic accessories"— Presentation transcript:
1High voltage testing of laparoscopic accessories Bruce MorrisonHunter Area Health ServiceJohn Hunter HospitalNewcastle, NSW
2Outline Particular Issues arising with laparoscopic instruments Background to the NSW DOH guidelines on testing laparoscopic instrumentsDevelopment of the guidelineApplication of the guidelineWhere to next ?
3Minimally invasive surgery - introduced in early 60’s Advantagesless blood losslow complication rateminimal post op pain and discomfortearly dischargereduced recovery time due to minimal tissue damageDisadvantagescan be more expensiveelectrosurgical burns can be a complicationSurgeons take longer to master the technique
4The ESU Provides cut and coagulation power Should be functional and appropriately adjustedOutput power and waveform should be in accord with manufacturers’ specificationsReturn electrode should be appropriately connected to the patientLead integrity to the instruments in essential
5The laparoscope Types of instruments Leads Forceps Hooks Scissors Monopolar and bipolarLeadssingledouble
6Parts of the instrument Parts which make contact with the patientconductive partsnon-conductive partsParts which do not make contact with the patienthandlesterminations
7Laparoscopic Instruments A selection filmed(somewhat poorly) in the CSSDat John Hunter Hospital- after cleaning and washing andprior to testing beforepackaging and sterilising
16Risks to the patient Burns Limited field of view operator induced insulation breakdowndirectcapacitive coupledLimited field of viewlarge sections of the leads and instruments are not in the surgeon’s field of view (90%)
17Background to the NSW guideline Patient incident - electrosurgical burns?Reference to the NSW Healthcare Complaints CommissionNSW HCCC asks BEAG (NSW) for adviceBEAG gives preliminary advicepreliminary advice published as 97/20considered advice published as 98/17
18Development of the guideline Preliminary discussions lead to publication of Information Bulletin 97/20Bulletin widely distributedreference to further work by BEAGhospitals begin to expect testing will be doneNPCE working party develops a document aimed at providing good guidance for testingRevision 2 sent to DOH and becomes Information Bulletin 98/17
19Application of the guideline Guideline recommended testing by BMEOriginal high voltage testers “dangerous”BME had done what testing was previously doneProblems with tagging and trackingHow often should instruments and leads be tested
22Testing in the CSSD Newer “safe” testers allow testing in the CSSD OK for use by CSSD?TrainingIndustrial issuesWhy test in CSSD?no problems with taggingno requirement to track instruments and leadsnothing is missedsafe instrument is presented to the patient every time
23Where to now? Development of Ver 3 of the guideline Publication by NSW DOHVersion 3 contains …information on “safe” testersrecommendations for testing in CSSDvoltages and currents for testingVersion 3d is almost ready to go!
24Need to assure the insulation integrity of the non-conductive partswhich make contact with the patientVisual inspection is not adequateHigh voltage testing is required todetect insulation breakdown
26Testing laparoscopic instruments Practical experience from NSWTesting statisticsTest jigs & all that jazz . . .
27Testing protocols From the NSW Guideline 3.0 kV rms 50Hz or 4.2 kV dc 0.5 mA current limitCompromise betweensafetyvoltages found in laparoscopic surgeryrecommendations in AS
28Why 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.
29Who is testing? BME departments Outside contractors CSSD staff in almost all Area Health ServicesOutside contractorsvery fewCSSD staffHunter Area Health ServicePolitics of testinguse of the guideline for industrial purposes
30How often are they testing? Every use - HAHSMonthly - many city hospitalsQuarterly - some city and many country hospitalsNever - one city Area Health ServiceMostly in theatreall in one sweep
31Equipment? All respondents using the Hi-Pot 140 high voltage tester 4 kV dcVery high output impedanceAudible and visual breakdown indicatorsVery few using test jigs
32Test methods Some more less than perfect home snaps in the CSSD at John Hunter Hospital
48Final thoughts on testing . . . Manufacturers’ test methods8 kV in saline bathWhat 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?