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A presentation given at the Welch Allyn Educational Symposiums in 2011. The presentation offers methods of reducing risk, exchanging data and a warning of 'Safety creep'
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Reduce Risk, Save Money and Live Happily Ever After?
Paul A Blackett
Medical Engineering Operations Manager
Lancashire Teaching Hospitals NHS Foundation Trust
Paul A Blackett: Completing the Picture 2011
Warnings…
• This presentation is suitable for all ages
• Does not contain nuts or nut products
• Contains no flash photography
• Is low in salt and fat content
• Has no sharp edges or high voltages
• However may contain unsettling thoughts!
Paul A Blackett: Completing the Picture 2011
Scope
• Risk definition
• 4 Risk models briefly explained
• Limitations and how we could overcome them
• Promising developments
• Does it save us money?
• Warnings from other industries
• Summary
Paul A Blackett: Completing the Picture 2011
What is “Risk” anyway?
A situation involving
exposure to danger
“
”Oxford English Dictionary
Combination of the probability of
occurrence of harm and the
severity of that harm
“
”ISO 14971:2007Medical devices -- Application of risk management to medical devices
Paul A Blackett: Completing the Picture 2011
Paul A Blackett: Completing the Picture 2011
Paul A Blackett: Completing the Picture 2011
Say cheese ☺
• James Reason - University of Manchester
HAZARD
PATIENT
HARMBARRIERS
Paul A Blackett: Completing the Picture 2011
Risks ‘R’ UsBut what sort of risk(s) are we talking about?
•Risk of devices not being available when needed?
•Risk of device failing outright in use?
•Risk of unknown inaccuracy, calibration error?•Risk induced by maintenance itself?
•Risk of incorrect operation or use?•Risk to the patient, service or indeed organisation?
Where do we start?
Keep it simple,
Make a start,
But we do something!
Paul A Blackett: Completing the Picture 2011
But we do Something…
We are the experts in equipment management -
So we look at risk assessing equipment from our point of view
We have an Inventory, a starting point
Name, Rank and Number!
We risk assess our equipment with
the data we have…
And there a few ways of doing this…
KEEP
CALM AND
RISK
ASSESS
Paul A Blackett: Completing the Picture 2011
Some tools of the Risk trade
•ECRI categories
•Ottawa model
•IPEM model
•Swedish model
•Australian/NZ Risk calculation method [1]
A widely used method for calculation of many
types of risk widely adopted.
Risk = Probability (1-5) x Consequence (1-5)
Simple but subjective
Paul A Blackett: Completing the Picture 2011
ECRI categories [2]
•Well respected organisation, over 40 years experience in
healthcare safety
•Non-profit, independent, US based but worldwide in
influence.
•3 categories suggested:
•High Risk– “Life support, key resuscitation, critical
monitoring and other devices whose failure or misuse is
reasonably likely to seriously injure patients or staff.”(Ventilators, Anaesthetic m/c, Defibs, Hoists etc)
Paul A Blackett: Completing the Picture 2011
ECRI categories [2]
•Medium Risk– “Devices, including many diagnostic instruments, whose misuse, failure or absence would
have a significant impact on patient care but wouldnot be likely to cause direct serious injury”.
(ECG Recorders, U/s Scanners)
•Low Risk– “Devices whose failure or misuse is unlikely to result in serious consequences”.
(Ophthalmoscopes, Thermometers)
Paul A Blackett: Completing the Picture 2011
Ottawa model [3]
Suggested by Leo de Kryger, Health Science Technology,
Biomedical Engineering, The Ottawa Hospital
Developed a questionnaire for each device model.
Inputs are:•Function (Life support, diagnostic, no contact etc.)•Consequence (Death, delayed treatment, discomfort etc.)•Maintenance (Moving parts to adjust, calibration, part replacement)•Protection (Alarms, Failsafes, Self tests etc.)•Failure (Average failures per annum)•Usage (Daily…infrequent)
Calculated numerical output dictates PM at :•Once per 24 months, 12 months, 6 months
or greater!
Paul A Blackett: Completing the Picture 2011
IPEM model [4]
Contained within The Institute of Physics and Engineering in Medicine Report 95, Chapter 4, author Paul Robbins.
The IPEM proposes a risk model which considers the following inputs:•Technical Complexity•Invasive or Non-invasive•Diagnostic or Therapeutic•Statutory Instrument compliance•User type and location•General reliability•Organisational importance
•The output is calculated and ranges given for infrequent PM, increased PM frequency, or maintaining the status quo.
This model brings in the consideration of organisational requirements!
Paul A Blackett: Completing the Picture 2011
Swedish model [5]
Project team revised existing models and produced a national model
•Based on a variation of the NZ method of Risk = Likelihood x Severity Risk calculated between 1 and 5 (greatest)
•Includes the maintenance needs of the equipment Maintenance needs between 1 and 5 (greatest)
•Includes “mission critical” functions.Mission Critical function between 1 and 10 (most severe)
Score = 2*Risk + 2*Maintenance + Mission Critical
Serves as a method of prioritising maintenance.
If used to depart from the manufacturers recommendations then any further risk assessment should take into account historical data.
Paul A Blackett: Completing the Picture 2011
Not precise enough for you?
• As Engineers, we would love to have an numerical answer that would tell us what its risk rating was and
how often we should PM something.
• But - because our inputs are subjective, the risk output
cannot be objective no matter which method we use
• The risk number is for guidance, a way
of prioritising risk…
…if applied consistently!
Paul A Blackett: Completing the Picture 2011
Next Steps• Propose a Risk Model through Management/Risk
channels and get the use of it agreed.
• Apply it to your inventory
• Whichever system used - you now have a list of equipment prioritised in risk order
• What next?
– Pick a point on your list, maintain everything above a certain point?
– It’s a simple approach, but…
Paul A Blackett: Completing the Picture 2011
Add value to your risk rating• The Ottawa and IPEM model both include an input of
“reliability”
A general ‘Good’ or ‘Fair’ or No. of failures per annum
• Are all Work Orders/Jobs created equal?
• Start using your data to make decisions…
• Add a little History!
Paul A Blackett: Completing the Picture 2011
The value of Historical data• Equipment databases usually contain a vast amount of
data
• Mine the database for information
But…
– Time consuming!
– Not recorded systematically?
– Data not easily understood?
– Wouldn’t it be better if we shared?
Data shared is a risk assessed more accurately!
What are the obstacles to sharing data???
Paul A Blackett: Completing the Picture 2011
Obstacles to sharing
The amount of data available
• Individually we have (comparatively) little information
• We need good reliability data from manufacturers
• We need data from MHRA, FDA etc
Paul A Blackett: Completing the Picture 2011
Obstacles to sharing
Pavement or Sidewalk?
• ECG Monitor, Cardiac monitor, vital signs monitor, multiparameter monitor?
• We should be reducing risk by using a common naming convention
– GMDN [6] (Global Medical Device Nomenclature) From ISO 15225:2010
– Used by Manufacturers and EUDAMED (European Database on Medical Devices)
– Term: Centrifuge , general-purpose laboratory
(Code: 36465)
Paul A Blackett: Completing the Picture 2011
More Obstacles…
Corrective Maintenance, repair, PM, PVP, Maintained, Serviced, inspection , inspection , inspection , inspection , TestedTestedTestedTested, , , , PPM, PPM, PPM, PPM, checked ok! FixedFixedFixedFixed
• We need to speak the same language!
• ECRI Publication:
– “Clear Talk About Service” [7] ECRI publication for
unifying and defining terms we use in our profession –Universal Medical Technical Service Nomenclature
(UMTSN).
Paul A Blackett: Completing the Picture 2011
More Obstacles…
No fault found, component replaced, new battery new battery new battery new battery fittedfittedfittedfitted, calibratedcalibrated…
• We should be using common codes to classify work!
• Standardised failure Codes [8]
– Journal of Clinical Engineering: Measuring
Maintenance Effectiveness with Failure Codes.
Range of codes suggested to make comparing
failures easier between organisations
Paul A Blackett: Completing the Picture 2011
Some light at the end of the tunnel• Common data structures - Coding for Success [11]
– GS1 coding of labels for patient… and equipment
(300 trusts reg’d)
– Recommended by the NAO [12] and Lord Hunt [13]
– Choose your data carrier
• Unique Device Identification [14]
– A global number for each device type/model by 2013
– Traceable, containing: GMDN Name, manufacturer, model, and much more, but not serial number.
Paul A Blackett: Completing the Picture 2011
So how is all this saving us money?
• Managing your risk = reducing risk = less potential liability
• Prioritise maintenance
– Do you really need to exert as much effort in planning
a PM on an Ophthalmoscope as an ECG Recorder?
– Risk assessing can prove you right or wrong about
your gut feelings!
– If you can’t afford to do PMs on everything then this is
your documented evidence for why you are making changes.
• What are the consequences of
not risk assessing?
Paul A Blackett: Completing the Picture 2011
But Beware• Risk assessment prioritises your equipment
maintenance so that your medical devices get the most appropriate amount of time and money.
• It must not be used as a method to reduce the amount of time or money spent on maintenance. Safety should be the driver, not finance.
• The amount of funding required
may go up or down!
Paul A Blackett: Completing the Picture 2011
Space Shuttle Safety• We must not become complacent about risk
NASA “repeatedly observed the problem with no
consequence to the point where flying with a known flaw was normal and acceptable” [9]
“If a system is doing something that it says in the
handbook that it shouldn’t be doing,
then consider yourself warned…
…and fix it…”
Paul A Blackett: Completing the Picture 2011
Space Shuttle Safety
• Safety creep
…Many managers come onto the scene years after a
system has been designed and long after the organisation has forgotten why certain rules were
set in place to start with”. Dennis Gilliam Avionics Engineer [10]
“ As time goes by, new managers see a record of
zero accidents and assume they can formulate their own rules about safety. And then the truth comes
home to roost and the deviances from the original specifications lead towards catastrophe” [10]
This is why documenting your decisions is so important!
Paul A Blackett: Completing the Picture 2011
Summary – It’s a Balancing Act
• Pick and stick with your risk model rating and advise
those that need to know
• Look at your history and document changes of PM
frequency
• Do not become complacent.
• Manage the Risks, review your data, and…
Paul A Blackett: Completing the Picture 2011
and… Live Happily ever after!
Paul A Blackett: Completing the Picture 2011
References and suggestions for further study
[1] Australian/New Zealand Standard. Risk Management: AS/NZS 4360 1999 ISO 31000:2009 Risk management --principles and guidelines
[2] Tim Ritter, 2008 Assessing Scheduled Support of Medical Equipment. North Central Biomedical AssociationSeminar. (PPT Presentation)
http://www.ncbiomed.org/pp/Assessing_Scheduled_Support_of_Medical_Equipment-NCBA_website_.ppt
[3] Leo de Kryger, Risk Management of Medical Devices in Hospitals. Ottawa. Undated. (PPT presentation), link broken (will send copy on request)
[4] Paul Robbins et al, 2007 IPEM Report 95:Risk Management and its Application to Medical Device Management.[5] Christian Sand et al, 2009 Priority Model for Preventative Maintenance, Sveriges Kommuner och Landsting,
http://www.skl.se/vi_arbetar_med/halsaochvard/ehalsa/lfmt/lfmt_pmfu credit to Google Chrome translator.
[6] http://www.gmdnagency.com/
[7] Clear Talk about Service. 2009 ECRI Health Devices, April https://www.ecri.org/umtsn
[8] Wang B. et al. 2010 Evidence Based Maintenance pt 1 Journal of Clinical Engineering Vol 35, No. 3 July/Sep[9] Diane Vaughan, 1996 The Challenger Launch Decision: Risky technology, culture, and deviance at Nasa”
[10] http://eandt.theiet.org/magazine/2010/13/challenging-establishment.cfm
[11] DH 2007 Coding for Success. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_066082
[12] GS1-uk 2010 http://www.gs1uk.org/news/Pages/GS1UKNewsDetails.aspx?NewsID=445[13] http://www.connectingforhealth.nhs.uk/systemsandservices/aidc/background
[14] GHTF 2010 Unique Device Information for Medical Devices
http://www.ghtf.org/documents/ahwg/AHWG-PD2-N2R2.pdf
Thank you for your attention [email protected]