new south wales ( biomed ) smbe 2011 user errors final b

User Errors – User Manuals

And

Clinical Information Access Program (CIAP)

Clinical Equipment User Manual Library

“Not all registrars

appeared to understand the ventilators and

their appropriate

applications”

“ 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 ?

How often does this occur ?

At least once a day in Australia

TGA 2004 to 2009 Incidents

2470 or 494/year

1670 or 67%

245 or 10%

In the 2006 – 2008 reporting period the MHRA ( UK )

apportioned causes of Errors into 3 categories - “Hospitals

& Users”

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

Under Reporting

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

So what can the Biomedical Engineering Department do to

address some of these User Issues ?

AS/NZS 3551 :2004Technical management programs for

medical devices

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 ....”

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

And User Manuals

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

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

User “ Reference” ManualOperators “Reference” ManualInstruction “Reference” ManualOwners “Reference” Manual

Nobody Reads the User Manual

Experience – every single one of us have been there !

Service Manual vs User Manual

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 !

Instructions For Use

PDF Copy 24/7 – 365

From any NSW Health PC

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 :

george.koning@bioclinicalservices.com.au

www.bioclinicalservices.com.au Video Introduction - 4 min