Breigh Ridley & Jeanie Misko

Pharmacy Department, FSH

Smart Infusion Pumps –

from commissioning to real world use:

the Fiona Stanley Hospital experience

Introduction - what is a smart pump?

• Infusion device

utilising smart

technology for central

programming of drug

protocol libraries

(‘profiles’)

• 659 PC units

• Updated via Wi-Fi

Background: Pre commissioning

Clinical Readiness:

Training

Identification of required profile areas

Data entry – 10 weeks

Clinical Review x 2 weeks

Dataset sign off

Weekly project team meetings and ongoing

stakeholder engagement

Technical Readiness:

Parallel program to ensure data sets can

be uploaded and are operational on

the devices

Project completed on Friday 26th

September 2014

14 weeks

Guardrails Editor

• Guardrails® Editor Software allows:

• development of intravenous fluid and

medication dosing and delivery guidelines

• programming of device configuration

Soft limit: can be overridden by the user by accepting an alert message

Hard limit: cannot be overridden by the user but may be bypassed by restarting the infusion pump in basic infusion mode

Continuous infusion +/- Bolus Dose

Adult General Profile

Infusion type

Continuous infusion +/- Bolus Dose 2 x Therapies

Weight based vs non-weight based

Continuous Infusion:

dosing units and infusion rate ranges

Bolus dose (disabled)

Select concentration and delivery method

Concentration limits if

variable dose option

enabled

Intermittent Infusion

Dosing range

Concentration limits enabled

Infusion rate ranges

FSH Hub

Guardrails feedback form

Background: FSH commissioning

Phases III & IV February 2015 Haematology /

Oncology Paediatric General

Paediatric Critical Care

Training Profiles

Phase II November 2014

No major changes

Phase I October 2014 Adult

General Adult Critical

Care Obstetrics Neonates

Training Profiles

What happens in the real world

• New datasets released approx. monthly

– On average 5-10 updates per dataset

release. All updates DTC approved.

– Common changes:

• alignment with updated or new guidelines

• modifying limits to match clinical practice based

on CQI data

• new evidence

• addition of newly released drugs.

Updating the Dataset

Implementation by Wi-Fi using Alaris Systems Manager

Dataset review using Continuous Quality

Improvement (CQI) tool

Dataset updates

Test updates

Nursing review

HOS review and approval

DTC approval IPA

applications and drug formulary

submissions to the DTC

Feedback from medical, nursing and

pharmacy staff

CQI Reporter Tool

• Manual process, data doesn’t come

through in real time

• Run monthly

• Uses

– track compliance with Guardrails

– review recorded alerts

– review near miss events

Top Drugs Causing Alerts May 2015

Noradrenaline – May 2015

• 2232 alerts

• 92.4% overrides of soft limits

Noradrenaline – May 2015

• Soft max is 25microg/min for all noradrenaline inf.

• Minimise alerts by increasing the soft maximum

of each concentrations: – Single strength (4mg/50mL, 8mg/100mL) – increase the soft

maximum to 28mcg/min

– Double strength (8mg/50mL, 16mg/100mL) – increase the soft

maximum to 56mcg/min

– Quad strength(16mg/50mL, 32mg/100mL) – increase the soft

maximum to 112mcg/min

Noradrenaline – August 2015

• 312 alerts

• 86.5% overrides of soft limits

• Reduction of unnecessary alerts

minimising user alert fatigue

Blood product Includes all blood products – from albumin to tetanus IG

(most common: PRBC, platelets)

• 1794 alerts

• 72.7% overrides of soft limits (1-2.499 times limit)

• Mainly in Haem/Onc profile

• Consult with Cancer Centre nurses – run

at maximum rate while priming, then

slow down (usually to soft maximum)

• On discussion, left at same limits

Piperacillin/tazobactam

• 1624 alerts

• 69.9% partial dose infusion alert

– When VTBI is 60% less or 125% more than diluent

volume

• e.g. an alert is generated when VTBI:

– <30mL or >62.5mL for 4.5g/50mL

• ‘Deep-diving’ into more reports indicated

practice on floor is to program VTBI of 80mL

for 4.5g/50mL (50mL minibag + 30mL

dissolved drug)

Piperacillin/tazobactam

• To ensure patient receives the prescribed and

programmed dose a recommendation was made

to the DTC, approved in January 2015 &

communicated to nursing staff

Is the message getting through?

For intermittent & continuous infusions the drug diluent volume must be removed from the infusion bag

before drug is added to bag

Compliance with Guardrails by Profile

– July 2015

Lessons learnt

• Wi-Fi is a must for updating!

• Reliable, real time pump tracking preferred

• Significant stakeholder engagement including

medical input for dataset review

• Strong governance structure & change control

pre and post implementation

• Have guidelines in place before developing

dataset

• Clear delineation of expectations of pharmacy

Conclusion

• Limitations:

– Paediatric dose banding

– Maximum of 1 PCA module

– IT overload in a new environment

– Doesn’t replace a brain/common sense!

• Positive effect on medication safety

• Raised the profile of pharmacy

• Successful implementation & post go-

live

Questions?

Near Miss Events

• Benzylpenicillin 3.6g: exceeds hard max

– Infusion not given, dosing discussed with pharmacist and

then medical staff reduced to 2.4g

• Multiple reports of insulin infusions being run outside

of Guardrails in a 50mL minibag outside of hospital

guidelines. All reports indicated the remaining VTBI

did not match the actual volume remaining in the

bag. Use of Guardrails encourages compliance with

hospital guidelines of 50 units Actrapid® in a 50mL

syringe driver and ensure infusion rates remain

within the expected range

Near Miss Events: 10 & 100 x dose errors July 2015

283

1327

2298

1118

651 612

205

11 56 1 0

0

500

1000

1500

2000

2500

0 - 0.499 0.5 -0.999

1 - 1.499 1.5 -1.999

2 - 2.499 2.5 -4.999

5 - 9.999 10 10 -99.999

100 100+

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f F

req

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