Jason Ng, Andy Chung, Bonnie Wong, Becky PY Ho, …...Infusion device incidents Lessons learned and recommendations Jason Ng, Andy Chung, Bonnie Wong, Becky PY Ho, Kate Choi, Anne

Infusion device incidents Lessons learned and recommendations

Jason Ng, Andy Chung, Bonnie Wong, Becky PY Ho, Kate Choi, Anne Kwan, Joseph Lui, Fred Chan, Ella Ma, David Lau, Lilian Lau

HA Convention 8HA Convention 8thth May 2007May 2007

Introduction – Infusion device

• Often employed to infuse fluids, nutrients, or medication into patient’s circulatory system

• Widely used for safe and accurate administration

Safety of the infusion device

• Improper use of the equipment can be potentially dangerous or even life-threatening

Aim of study

• Lack of local data addressing on the safety issue of infusion device

• 1) review the characteristics of the adverse incidents

• 2) recommend appropriate actions to enhance the safe use of infusion device

Method

• Working Group on Safe Use of Infusion Pump

• Risk managers of the clusters reported medical incidents

• Advanced Incident Reporting System(AIRS).

• Electrical and Mechanical Services Department (EMSD) for checking.

2 Stages

• 1st :KCC, NTEC, NTWC• 2nd :All clusters (HKEC, HKWC,

KCC, KEC, KWC, NTEC, NTWC)

Result

• Period: January 2005 to Sept 2006 • 70 incidents • related to the use of infusion device

Types of Infusion device• 59 Infusion pumps • 11 Infusion syringes

RESULTSWhat had been given?

How severe were the incidents? Who were involved?

Which steps were involved?Why did they happen?

Results

RESULTSWhat had been given?

How severe were the incidents? Who were involved?

Which steps were involved?Why did they happen?

Results

What had been given?

• 9 were used for intravenous fluid replacement

• 61 infusion devices were used for administering medication

• Most medications were used for – cardiovascular system

• e.g. thrombolytic agent, vasodilator, vasopressor

RESULTSWhat had been given?

How severe were the incidents?Who were involved?

Which steps were involved?Why did they happen?

Results

Severity IndexSI = 0

Incident occurred but stopped

beforereaching patient.No consequence.

SI = 1Incident occurred

but no injury sustained.

SI = 2Minor injury

SI = 3Temporary

morbidity

SI = 4Significant

Morbidity

SI = 5Major permanent

loss of function / disability

SI = 6 Death

May have required monitoring.

No investigation is required

Required monitoring

&/or investigation

Required monitoring

&/or investigation.

Required transfer to a higher care level.

No change in vital signs.

Some changes in vital signs.

Significant changes in

vital signs.

No treatment required.

Required minor treatment

(e.g. simple wound care, analgesic).

Required simple treatment

(e.g suturing).

Required emergency treatment /

surgical intervention.

Severity Index of the Incidents

05

101520253035404550

0 1 2 3 4 5 6

Severity Index

No. of incidents

RESULTSWhat had been given?

How severe were the incidents?Who were involved?

Which steps were involved?Why did they happen?

Results

WHO were involved?

05

101520253035404550

Nurse MO HO Others

No. ofincidentsinvolved

RESULTSWhat had been given?

How severe were the incidents? Who were involved?

Which steps were involved?Why did they happen?

Results

Infusion steps

Prescription Setting up infusion rate

Device operation

Calculation

Administration Device tampering

23 incidents

11 incidents

RESULTSWhat had been given?

How severe were the incidents? Who were involved?

Which steps were involved?Why did they happen?

Results

WHY did they happen?

Human factorDevice factorUnknown

Factors Human factorsDevice factors

Causes of incidentsHuman factors

0 5 10 15 20 25

Human Factors

Misunderstanding device

Incorrect set up

Device tampering

Calculation errors

Failure to deliver

Wrong consumables

Wrong administration

Wrong set up (23/70)

9

10

Intended setting

99

Actual setting

1

Wrong set up• 3 incidents• Swab between 2

infusion settings

Lack of understanding of device operation (11/70)

• Free flow– administration set had been

removed from an infusion pump– roller was not clamped before

opening door (in some models)• Persons involved

– e.g. nurses, health care assistant, radiographer

• Circumstance• e.g. transferal of patient

Factors Human factorsDevice factors

Causes of the incidentsDevice Factors

0 2 4 6 8

Device factors

Device Design

Device Defect

Device factors (14/70)• Device defect• 7 incidents

– Defective pump– Defective alarm– Damaged electric cord

• Device design• 7 incidents

– Lack of anti-free flow protection

Device design - Free flow

• 7 incidents (7/70)• Models: Drip rate type infusion

– E.g. Dropmat, Dripwatch, Nikkiso• Mechanism: Free flow occurred

when the door was opened without clamping the roller

• Precaution: Not suitable for high risk medications

Device without built in anti-free flow mechanism

Risk Management of Infusion PumpRisk Management of Infusion Pump

Recommendation

Recommendation 1

• Training– To provide adequate education and

training to staff.– Formal demonstration of commonly

used models should be arranged.

Human factors

Recommendation 2

• Safe alert– The awareness of the safety issue on

infusion device should be raised– Ensure 3 checks 5 rights– Periodic assessment on the skill and

knowledge about operating infusion device may be required.

Human factors

Recommendation 3 Device factors

• Include built-in free-flow protectionas standard in the specification in future procurement

• Require timely and appropriate action on high-risk models e.g. removal from service, safety modifications, add safety tags

High-risk models

Recommendation 4

• Standardization of the infusion device to a few models– avoid confusion– promote user training, equipment

maintenance– share equipment library and

consumable supply

Less is more

Significant injury1

69 Mild injury

Near Miss??Mild / Severe event

Limitation 1: Underreporting

Limitation 2 • Simplistic analysis

– Human vs Device factor

• Reality– Multifactorial– Consider other factors

• Staff experience • Ward circumstance• ….

Conclusion

• 70 incidents related to infusion device were captured in 21 months

• Identify – High risk steps – High risk models with no free flow

protection • Error prevention strategy

Conclusion

• Proof of concept• Useful data retrieved from AIRS

– Lessons learned – Make recommendation

Safe Culture

Just culture

Reporting culture

Flexible culture

Sharing and

learning culture

Learning and sharing

It takes a wise man to learn from his mistakes,but an even wiser man to learn from others

Acknowledgement

• Dr Lilian Lau • Mr Andy Chung• Ms Bonnie Wong• Ms Becky PY Ho• Ms Kate Choi• Mr Kennis IP• Dr MY Cheng

• Dr David Lau • Dr Anne Kwan• Dr Joseph Lui• Mr Fred Chan• Ms Jayne Lee• Mr YL Cheung• Ms Ella Ma

Working Group on Safe Use of Infusion Pump

Thank you

Classification Incidents Possible causes

Follow up actions

No. of cases

Incorrect infusion rate setting by users

Wrong infusion rate

Wrong input Staff trainingBuilt-in safety mechanism

5

The use of incompatible consumables

Wrong syringe used for patient controlled analgesia

Use other brand of syringe

Staff trainingStandardize device

4

Lack of understanding of the device operation

Infusion was finished earlier than expectedwith free flow of fluid

Lack of understanding of device operation leading to free flow infusion

Staff trainingReplace high risk modelsBuilt-in safety mechanism

3

Human Factors

Over infusion of IVF to a neonate

Wrong calculation of prescription

Staff trainingStandardize IVF

Over infusion of drug

Wrong calculation of infusion rate

Staff training Standardize drug concentration

Over infusion rate Wrong drug label interpretation

Staff training

3Calculation errors

No. of cases

Follow up actions

Possible causes

Incidents Classification

Human Factors

Battery ran out without power to run the syringe

Staff was not aware of short life duration (4 days)

Reminder staff to use new battery for new set-up or check battery level before use

Syringe driver not in proper position

Staff was not familiar with the set up of infusion pumpLack of monitoring

Staff training

Device tampering Over infusion Tampering Proper placement of infusion device

1

2Failure to deliver drug

No. of cases

Follow up actions

Possible causes

Incidents Classification

Human Factors

Classification Incidents Possible causes

Follow up actions

No. of cases

Drug was not infused

Defective pump syringe

Periodic check by EMSDPump syringe was repaired

Over infusion of the drug

Defective sound blast of pump syringe

Periodic check by EMSDSound blast of pump syringe was repaired

2Infusion device fault

Device Factor

Root cause analysis

Events

System factorsProximate causes

Content

• Introduction• Aim of study• Method • Result• Recommendation• Discussion• Conclusion

Limitation 2

• AIRS version 2 • Infusion device template NOT

AVAILABLE– Free text– Information may be missing

Device tampering (7/70)• Under infusion• 5 incidents• Nurses• Forget to resume

setting after reset

• Over infusion• 2 incidents• Patients• Change setting

accidentally