Creating a system to ensure 27/4 access to all Medical Equipment Manufacturer supplied instructions via your hospitals intranet
http://bioclinicalservices.com.au/
http://www.epsmabec2010.org/abstract/116.asp
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Australian Biomedical Engineering Conference 2010
1. User Errors and No Fault Found ?
There are Well , not this
There are
also one , that's my
known
unknown contribution
knowns
unknowns
There are
known Then there
unknowns are Users
Users = (√ Unknown Unknowns ) ¾ + known unknowns ͯ⁄ known knowns * ß
2. The Definition of a Medical Device
• Officially – regulating agencies around the
world refer to devices as items which vary
from :
• Cardiac output Monitors to Condoms
• Tongue Depressors' to Tourniquet's
3. 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
4. In the 2006 – 2008
reporting period the MHRA (
UK ) apportioned causes of
Errors into 3 categories -
“Hospitals & Users”
5.
6. Lets take the equipment out
of the devices – say call it:
“Clinical Equipment”
12. Direct Costs of No Fault Found
• Time : Medical Staff
• Nursing Staff
• Biomedical Staff
• 3rd Party Service Time ( $90 to $300/ hr)
• Other: Cancelled Procedures / Operations
• Unplanned over time due to delays
• Accessories / Consumables and other
associated items
13.
14. Fire Safety Training
• Mandatory in all Australian Hospitals for all
members of staff including clinicians
• Medical Equipment User Training for all
clinicians including Drs , Surgeons and Nursing
Staff ??
15. • How many patient deaths can be related to Fires
or anything associated with a fire in Australian
Hospital – extensive Google search lists nothing –
Not even a topic for discussion !
• Yet every hospital in Australia has a robust and
functional hospital wide fire training program and
accreditation with all the boxes ticketed
• What about Medical Device User Accreditation ?
Zero
16. Nursing Staff
User Manuals , Unit Managers
Operators Guides , Nurse Educators
Manufacturers , Instructions for Use Surgeons
Multi Nationals – 1000s of them Clinicians
& Distributors of
Allied Services
Medical
etc etc ......
Equipment -
Users @!!&##@
100s of them
17. The Biomeds touch these devices once a
year
Theatre ,
GE , Coviden
ICU, Surgical
,CareFusion,ABBOTT,ACCOSON,Ae
rogen,Akola,Alcon,Alpine Ward ,
Biomed,APC
Medical,Bbraun,Bard,B&L,Baxter, Physio,
Beckman,Bedfont,Beigler,BHM
Medical,Biometrics,Bio-RAD,BK
Medical,BrainZ,BURKE,Caesarea The Hospital Ophthalmic
Medical , Cardiac
Science,CardinalHealth,,Care Biomed Department
Essentials,Caridian
BCT,CASMED,Chattanooga,CHF
Department , Gynie ,
Soultions,Clements,CME
McKinley,Coltene Peads ,
Whaledent,Compumedics,COMW
ELD,ConvaTech,COOK
Inc,CooperSurgical,CSI,CSO
Neonatal ICI
Ophthalmic,CSZ,Datascope,Delfi
Medical,deSoutter,DeVilbiss,Drag
,ED,CathLab,
er,DWL Medical,EASTWOOD,
Edwards Lifescience,ELMO,EMS Rehab,EEG
Physio,ENRAF,Envitec,ERBE,esaot
e,ESCHMANN,Exergen,Fiocchetti,F Dept
&P,Fresenius,Fujinon,Ganbro,GAY
MAR,Geratherm,GN
Otometrics,Gyrus,ACMI,HAAG-
STREIT,Hadeco,Haemonetics,Hem
oCue,Hill-Rom,Hills Health and so
etc etc etc etc
19. So what can the Biomedical
Engineering Department do to
address some of these User
Issues ?
AS/NZS 3551 :2004
Technical management programs for medical
devices
20. 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 ....”
21. This this not Rocket Science
ECRI Chem Alert
Intranet Accessible Product Specific Information
22. Nobody Reads the User Manual
User “ Reference” Manual
Operators “Reference” Manual
Instruction “Reference” Manual
Owners “Reference” Manual
23.
24. Current Subscribers
New South Wales Government - Health Support Services ( CiAP Web Portal )
Accessible by 220 NSW Hospitals including:
Royal Prince Alfred Hospital
Royal North Shore Hospital
John Hunter Hospital
St Vincent’s Hospital
Prince of Wales Hospital
Liverpool Hospital Gosford Hospital
Western Australia
Royal Perth Hospital www.bioclinicalservice.com.au
Victoria george@bioclinicalservices.com
Burnside Hospital
Gouldburn Valley Healthcare
South West Healthcare
United Kingdom
Aintree University Hospital NHS Foundation Trust
Walton Centre NHS Foundation Trust
Editor's Notes
This is a talk about something we all knowWe know its happens in ever hospital – ever dayIts happens to medical staff , nursing staff and biomedsIts happens with devices at all levels along the technology complexity scale About me very quickly – I’ve been in the medical equipment industry since 1986I have worked in various state intuitions , companies with + 200 employees and one which 2 in the end The last 2 were Allergan Pharmaceuticals – Ophthalmic’s – Phaco Machines 3 x models – 8 years _ knew them backwards – 95% were related to Users Royal Hobart Hospital ( Honeywell ) average size hospital + 250 beds , about 3000 staff – User Errors around 15 to 20 % I can count One noticeable issue about User errors in Tasmania is that its essentially a remote location with less than average supplier representation so the cost associated with User Errors is relatively high 3Rd party repair costs involve fights and accommodationThere is a culture of buying “one more as backup” or extra leads etc Time – staff time , patient time
In this presentation the high lighted issue refers to how many investigations result in User Education – think about it , some sees happen and or occur , they might talk to a few people – clearly of the same view , opinion and come to the conclusions they need to submit a incident report – so from a User competence point of view we could double that number ie at least 2 people involved in each incident !
Lets differentiate our devices ( technical ) from their devices ( users )They tend to throw most of theirs away once they finished with theirs Ours tend to last longer than they were designed to – 7 to 10 yrsOne way of doing this is focus on the what we deal with – come to some consensus about what it is and what we call it and start tracking issues related it so we can come up with useful informationOne idea would be reporting by GMDNS codes for example
This particularly incident happened over a long period of days – involved many people – drs , nurses and of course its an extreme case but it highlights some issues
What I would like to demonstrate here is that even though many people at all levels were involved in this case over a significant period of time – some how individuals ability to understand and use a particularly medical device slipped under the radar – who's responsibility is it ? Medical staff – nursing staff = does it really matter . What about the rest of the devices they use or the other units . Is this not indicative of the “ No Fault Founds” or “User Related problems” logged on service and job sheets as a result of breakdowns reported to them .What about the rest of the devices The rest of the hospital Now I don’t know if the User Manuals were available or not – but surely this factor which need to eliminated ???
Conclusions from this investigation speak for themself
If you took historical data into account – Fire Hazards would not feature
On – Line training Annual accreditation Fire Drills Fire Wardens Posters Its consistent
Yet every year we have plus 10 deaths related to medical devices We have a lot of consensus that incidents related to devices are largely under reported And going forward the technology is become more complex , there is more of it and the nature of the commercial world is such that things like industry wide standardization is less likely to be on anyone's agenda
and this makes perfect sense - This is the basic process as how equipment gets into our hospitals
Companies tend to supply soft cover , low cost documentation or CDs – both have issues – Books never last and “somebody” never puts it back and as for the CD – how many people really get access it after 6 , 12 ,24 , 48 months I have noticed 2 basic types of User Manual management systems at ward / unit level – the good ones - those under lock & key and then there's the rest However not allowing those technical members of staff to readily access these docs ( a user un-education strategy ) has a significant cost in terms of time , efficient use of devices and the Total Cost of Ownership of the device . I have no doubt there are many similarities when it comes to the use and roll out of IT services and products – User Education , User Competence , Staff ( Medical , Nursing , Admin ) embracing change etc
Lets look at AS 3551
We are the custodians of Users Manuals and Operating Instructions amongst other things
MIMS in the Pharm industry and many more
Manufacturers and suppliers who call there product guides by any other name than a “Reference Manual” have got it wrong – nobody reads a User Manual from cover – to cover any more – there is no time – however staff may attend 1 or 2 in-service training sessions over a period of months or years – but when you need to clarify something – you look for the Reference ManualWe need to create a culture of Referring to the Reference Manual Your GP does it with MIMS
These are the hospitals currently using the User manual Library The library currently has more than 5000 user manuals uploaded
