reduce risk, save money, and live happily ever after?

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!


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


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


Say cheese ☺

• James Reason - University of Manchester

HAZARD

PATIENT

HARMBARRIERS


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!


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


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


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)


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)


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!


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!


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.


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!


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…


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!


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???


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


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)


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).


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


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.


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?


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!


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…”


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!


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…


and… Live Happily ever after!


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]