June 28, 2004Mark Duffett

Leslie Gauthier

The Medley® Pathway to Patient Safety

“If you find a path with no obstacles, it probably doesn’t lead anywhere”

July 2001: Investment in the Medley® Infusion System

• Hamilton first to implement hospital-wide• Implemented a “pump for a pump”• Guardrails were only a promise• Safety features:

– drug calculator– free flow protection– tamper protection– ergonomic design

• Software log—new way of investigating incidents• Beginning of a partnership with Alaris Medical

Initial Issues Identified

• “Air-in-line” alarms• Secondary infusions:

– Different, louder alarm when infusion complete– Alarm if secondary med not “unclamped”– Infusion issues related to high rates (>200mL/hr)

• Keypad noises– awaking patients or a safety feature?

• No graphic display of site pressure • Door Failure• VTBI rate set too low

Canada Day Weekend 2001: Problems

• “System/Communication Errors” appeared on units in the PICU

• There was the perception that the devices powered down and stopped infusing

• Investigation:– Software log confirmed the devices continued to

infuse– Caused by a capacitor problem

First upgrade!

February 2002: Guardrails

• Significant milestone for Hamilton• Consensus building for the dataset• Practice standardization

But…• No bolus feature available• Limited number of drugs supported• Added complexity

July 2002: Disaster Mode

• Multiple incidents the week of July 16th

• “Runaway infusions”, incorrect rates and programming

• Response:– Communication and education for all staff – Mandated use of solusets– Reiterate mandatory use of guardrails– Eliminate bolusing from continuous infusions

July 2002: Investigation

• Joint investigation with HHS, St. Joseph’s and Alaris

• Findings:– “Fluid Ingression” problems – 4 malfunctioning keypads identified– Log analysis showed that after each keypad

malfunction ”START” was selected

• Twofold problem:– Technical malfunction– User/technology interface

June 2002: Results

• Improved processes for incident investigation, including:– Biomedical Support 24 hrs/ 7 days/week– Medley incident form– Segregation of the Medley devices and tubings– Completion of incident reports

• Feedback to Alaris:– Customer Call Centre and the turnaround time for

analyzing the software logs– Why are Guardrails under the “OPTIONS” key?

June 2002: Results

• Provided staff an opportunity to verbalize their concerns regarding their perceptions of the safety of the Medley® system

• Upgrade in August 2002 to replace keypads• Practice issues

– Guardrails underused– Bolusing from continuous infusions

• Competency checklists

October 2002: Upgrade

Hardware:• APM seals

Software:• Guardrails for bolus doses of infusions• Increased capacity of Guardrails system• CQI software installed

May 2003: Upgrade

Hardware:• Correct “System/Communication Errors”

Software:• revisions to the Guardrails • 1st download of CQI data:

– 10% of all devices in the city over 6 months

Dobutamine Incident

RN description of event:• The pump “all of a sudden” increased the rate to 905

mL/h following the hanging of a new 250 mL bag of dobutamine

Software log showed:• The pump alarmed for the VTBI absorbed• Door opened• 75 seconds later new VTBI selected• 245 entered in the dose field instead of the VTBI field• “START” selected • Guardrails were not being used

Overinfusions

• A number of incidents where the RN identified that the pump “ran away”

• Software log showed no problems• Most likely caused by improper set loading

resulting in free flow

Solution to be implemented soon!

December 2004: Upgrade

Hardware:• Capacity for syringe platform (NICU, PICU, OR)• Corrective actions for fluid ingression

Software:• Guardrails are not under “OPTIONS”• Updates to the Guardrails

– to deal with issues identified in the CQI download in May 2003 Direct access to the Guardrail Software

• Easier access to the CQI data • 2nd CQI download

June 2004: Audit

Software:• Download of CQI data• Are channel labels used appropriately?• Guardrails audit

– Use of guardrails– Overrides of alerts– Appropriate patient profile used

• Can we gain insight into the overrides?

Hardware:• Are we using this expensive technology

appropriately?

June 2004: Device Use Audit

Hend General MUMC NICU

# pumps 149 235 211 55

# pumps with a pt 90 118 95 35

# LVP not used with a pt 30 56 32 38

No clear indication (%) 20% 20 % 14% 0%

Not plugged in (%) 27% 27% 22% 2%

June 2004: Guardrails Audit

Hend General MUMC NICU

Guardrails not used 27% (3)

15% (9)

20% (2)

30% (3)

Channel labeled (%) 43% 56% 54 % 97%

Wrong patient profile 8 18 7 0

Current guardrail alert 0 1 2 1

System Improvement Using CQI Data

• Does the system prevent errors?• Can we increase Guardrail use? • Can we reduce nuisance alerts?• Can we improve the response to alerts?

What Do With CQI Data?

CQI Data

Adverse Events

Prevented

Guardrail Changes

Opportunities to improve practice!

Improving Guardrails: Then

Guardrails Changes

Practice Changes

Clinical Practice

Staff Feedback

Improving Guardrails: Now

Guardrails Changes

CQI Data

Practice Changes

Clinical Practice

Staff Feedback

Response to Guardrail Alerts(837 events)

Overrides - Nuisance

18%

Overrides - Bolusing

16%

Overrides - Other30%

Programming Changes

23%

Overrides - Inotropes

13%

Summary of Downloaded Data(analyzed by event)

Total Changes

Alerts 2675 250 9.3 %

Events 837 196 23 %

69 potentially clinically significant events

= 576 events/year prevented at

Hamilton Health Sciences

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Can We Improve the Response to Alerts?

Work in Progress: Hardware

• Issues with secondary medication infusions:– Alarms, clamps etc.

• Correction for the free flow problem• Fluid Ingression• Batteries• Keypad Failure related to an electronic

circuit• Disposables, e.g. blood filters for NICU• Allocation of this expensive resource

Work in Progress: Software

• Improve Guardrails dataset• Guardrails for secondary infusions• Improvements to Guardrails software• Improvement in CQI data downloading and

analysis.

Work in Progress: Practice

• Better incident reporting• Improve front line staff’s knowledge, skill

and understanding of the safety platform• Standardization of practice• Improve decision making skills related to

alerts and overrides• Improve understanding of over-rides• Disseminate audit/download results.

What Have We Learned?

• This is a process, not a project. • This is a complex process.

• Buying technology to improve patient safety isn’t an easy fix. It requires continuous investment in staff and infrastructure to support it at make it successful.

It took Thomas Edison 2000 experiments to invent the light bulb.

He said, “I never failed once. It just happened to be a 2000 step process”