1. User Errors and No Fault Found ?There are Well , not thisThere are also one , thats my knownunknown contribution knownsunknowns There areknown Then there unknownsare UsersUsers = ( Unknown Unknowns ) + known unknowns known knowns *

2. The Definition of a Medical Device Officially regulating agencies around theworld refer to devices as items which varyfrom : Cardiac output Monitors to Condoms Tongue Depressors to Tourniquets 3. In 2008 the TGA identified UserEducation as the 2nd on the list of recommendations as a result oftheir investigations into incidentsDr Larry Kelly TGA - Office of Device -Sydney, March 26 2009 4. In the 2006 2008reporting period the MHRA ( UK ) apportioned causes of Errors into 3 categories -Hospitals & Users 5. Lets take the equipment out of the devices say call it:Clinical Equipment 6. So why is itimportant ? 7. Not all registrars appearedto understand the ventilators and their appropriate applications 8. variable levels of understanding of theworkings, limitations andappropriate application 9. Prolongedhospital stayPermanentHarmLifesustainingIntervention 27 % of eventshad at least onecascade eventwherein multiple, related events occurred in succession 10. Direct Costs of No Fault Found Time : Medical StaffNursing StaffBiomedical Staff3rd Party Service Time ( $90 to $300/ hr) Other: Cancelled Procedures / OperationsUnplanned over time due to delaysAccessories / Consumables and other associated items 11. Fire Safety Training Mandatory in all Australian Hospitals for allmembers of staff including clinicians Medical Equipment User Training for allclinicians including Drs , Surgeons and NursingStaff ?? 12. How many patient deaths can be related to Firesor anything associated with a fire in AustralianHospital extensive Google search lists nothing Not even a topic for discussion ! Yet every hospital in Australia has a robust andfunctional hospital wide fire training program andaccreditation with all the boxes ticketed What about Medical Device User Accreditation ?Zero 13. Nursing Staff User Manuals ,Unit Managers Operators Guides ,Nurse EducatorsManufacturers , Instructions for Use SurgeonsMulti Nationals 1000s of themClinicians& Distributors ofAllied ServicesMedicaletc etc ...... Equipment - Users @!!#@ 100s of them 14. The Biomeds touch these devices once ayearTheatre ,GE , CovidenICU, Surgical,CareFusion,ABBOTT,ACCOSON,Ae rogen,Akola,Alcon,AlpineWard ,Biomed,APC Medical,Bbraun,Bard,B&L,Baxter, Physio,Beckman,Bedfont,Beigler,BHMMedical,Biometrics,Bio-RAD,BKMedical,BrainZ,BURKE,CaesareaThe HospitalOphthalmicMedical , Cardiac Science,CardinalHealth,,CareBiomed Department Essentials,CaridianBCT,CASMED,Chattanooga,CHF Department , Gynie ,Soultions,Clements,CME McKinley,ColtenePeads ,Whaledent,Compumedics,COMW ELD,ConvaTech,COOKInc,CooperSurgical,CSI,CSONeonatal ICIOphthalmic,CSZ,Datascope,Delfi Medical,deSoutter,DeVilbiss,Drag,ED,CathLab, er,DWL Medical,EASTWOOD,Edwards Lifescience,ELMO,EMS Rehab,EEG Physio,ENRAF,Envitec,ERBE,esaote,ESCHMANN,Exergen,Fiocchetti,F Dept&P,Fresenius,Fujinon,Ganbro,GAYMAR,Geratherm,GNOtometrics,Gyrus,ACMI,HAAG-STREIT,Hadeco,Haemonetics,Hem oCue,Hill-Rom,Hills Health and so etc etc etc etc 15. Theres no other way to express this ! 16. So what can the BiomedicalEngineering Department do to address some of these User Issues ?AS/NZS 3551 :2004Technical management programs for medical devices 17. 2.3.4.4 Device-specific documentsDocuments such as technical and user manuals shall beidentified and their location recorded in the database3.2.4 Tenders and quotations (c) Technical documentation shall be supplied , including.......operating instructions ....4.2.3 General acceptance inspection (b).....appropriate documentation has been provided . Thiswill normally include ......., operating instructions .... 18. This this not Rocket ScienceECRI Chem Alert Intranet Accessible Product Specific Information 19. Nobody Reads the User ManualUser Reference ManualOperators Reference ManualInstruction Reference ManualOwners Reference Manual 20. Current SubscribersNew South Wales Government - Health Support Services ( CiAP Web Portal )Accessible by 220 NSW Hospitals including:Royal Prince Alfred HospitalRoyal North Shore HospitalJohn Hunter HospitalSt Vincents HospitalPrince of Wales HospitalLiverpool Hospital Gosford HospitalWestern AustraliaRoyal Perth Hospital www.bioclinicalservice.com.auVictoria george@bioclinicalservices.comBurnside HospitalGouldburn Valley HealthcareSouth West HealthcareUnited KingdomAintree University Hospital NHS Foundation TrustWalton Centre NHS Foundation Trust