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User Errors – User Manuals
And
Clinical Information Access Program (CIAP)
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Clinical Equipment User Manual Library
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“Not all registrars
appeared to understand the ventilators and
their appropriate
applications”
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“ variable levels of understanding of the workings, limitations
and appropriate application”
What about the other devices in the unit ?
What about the other units in the hospital ?
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How often does this occur ?
At least once a day in Australia
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TGA 2004 to 2009 Incidents
2470 or 494/year
1670 or 67%
245 or 10%
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In the 2006 – 2008 reporting period the MHRA ( UK )
apportioned causes of Errors into 3 categories - “Hospitals
& Users”
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In 2008 the TGA identified User Education as the 2nd on the list of recommendations as a result of
their investigations into incidents
Dr Larry Kelly – TGA - Office of Device -Sydney, March 26 2009
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Under Reporting
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Direct Costs of User Error TIME
• Biomedical Staff• Nursing Staff• Medical Staff• Unnecessary 3rd Party Service
Time • Cancelled Procedures / Operations• Unplanned over time due to delays
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So what can the Biomedical Engineering Department do to
address some of these User Issues ?
AS/NZS 3551 :2004Technical management programs for
medical devices
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2.3.4.4 Device-specific documents
“Documents such as technical and user manuals shall be identified and their location recorded in the database”
3.2.4 Tenders and quotations (c)
“ Technical documentation shall be supplied , including .......operating instructions ....”
4.2.3 General acceptance inspection (b)
.....appropriate documentation has been provided . This will normally include ......., operating instructions ....”
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Where would a Clinician expect to find a Clinical Resource
• Patient Information• Clinical Forms• Pharmacy Information / Tests / Results • Clinical guides and protocols • Pathology Results / Tests – etc
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And User Manuals
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Manufacturers , Multi Nationals
& Distributors of Medical
Equipment - 100s of them
Nursing StaffUnit Managers
Nurse Educators SurgeonsClinicians
Allied Services etc etc ......
Users @!!&##@
User Manuals , Operators Guides , Instructions for Use
– 1000s of them
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The Biomeds touch these devices once a year
The Hospital Biomed
Department
GE , Coviden ,CareFusion,ABBOTT,ACCOSON,Aerogen,Akola,Alcon,Alpine
Biomed,APC Medical,Bbraun,Bard,B&L,Baxter,B
eckman,Bedfont,Beigler,BHM Medical,Biometrics,Bio-RAD,BK Medical,BrainZ,BURKE,Caesarea
Medical , Cardiac Science,CardinalHealth,,Care
Essentials,Caridian BCT,CASMED,Chattanooga,CHF
Soultions,Clements,CME McKinley,Coltene
Whaledent,Compumedics,COMWELD,ConvaTech,COOK
Inc,CooperSurgical,CSI,CSO Ophthalmic,CSZ,Datascope,Delfi
Medical,deSoutter,DeVilbiss,Drager,DWL Medical,EASTWOOD,
Edwards Lifescience,ELMO,EMS Physio,ENRAF,Envitec,ERBE,esaote,ESCHMANN,Exergen,Fiocchetti,F&P,Fresenius,Fujinon,Ganbro,GAY
MAR,Geratherm,GN Otometrics,Gyrus,ACMI,HAAG-
STREIT,Hadeco,Haemonetics,HemoCue,Hill-Rom,Hills Health and so
etc etc etc etc
Theatre , ICU, Surgical
Ward , Physio,
Ophthalmic Department,
Gynie , Peads ,
Neonatal ICI ,ED,CathL
ab, Rehab,EEG
Dept
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User “ Reference” ManualOperators “Reference” ManualInstruction “Reference” ManualOwners “Reference” Manual
Nobody Reads the User Manual
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Experience – every single one of us have been there !
Service Manual vs User Manual
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After having done the “course” using the device and dealing
with issues is a key step which enables one to move from
generalist to specialist
We’ve all been there !
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Instructions For Use
PDF Copy 24/7 – 365
From any NSW Health PC
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These User Manuals belong to NSW Health Support Services
Marie Pryor A/Knowledge Manager, Content Manager
Communications & Knowledge ServicesHealth Support Services
To have manuals uploaded please e-mail them to :
www.bioclinicalservices.com.au Video Introduction - 4 min