Medical Device Interoperability: From Abstract Concepts to Clinical Improvement

Collaborative Innovation at the Bedside: Collaborative Innovation at the Bedside: A Case StudyA Case Study

May 31, 2008

Yadin DavidYadin David Ed.D., P.E., C.C.E.Ed.D., P.E., C.C.E.

Biomedical Engineering Consultants, LLC

Asst. Professor, Pediatrics, Baylor College of Medicine

Project Overview

Create an environment where technology is a workflow enabler not a driver through adoption of interoperability and standardization at the point of care.• Integration – require that vendors (e.g., nurse call,

monitors, communication systems) speak “nursing” instead of nursing speaking each vendor’s dialect

• Collaboration – multi-disciplinary participation of Nursing, Biomed, and IT to determine solutions

• Objective data – direct improvements in patient safety, staff satisfaction, & clinical workflows based on historical patient event data collected from bedside technologies

Why?• Many visual/auditory alerts• Communication barriers• Burden on caregiver to

learn and adapt to each system

• Duplicate data entry• Lack of audit trails

Decades of medical device technology evolution, without examination of the cumulative impact on patient care workflow, has made the workplace more difficult for nurses and potentially less safe for patients.

How? Focus on point of care• Build internal collaboration & multi-disciplinary team• Understand bedside workflow & processesCommit to integration• Develop short-, mid-, and long-term vision• Drive vendors towards standards & interoperabilityIncremental adoption• Bridge “concept” to “reality” of technology via small cycles• Fund low cost proof of concept projects with governance

decision points prior to major capital expenditures

Medical Device Interoperability: From Abstract Concepts to Clinical

ImprovementEd.D., Ed.D., Professor, Pediatrics, Baylor

College of Medicine

Nursing, the human interface

Vendor driven technology

•Many proprietary solutions•Significant overlap in functionBurden on caregiver to learn & adapt to each system

What?

Centralize• Caregiver to patient assignments• Alarms from disparate systems• Message patient’s caregiversManage clinical alarms• Rules based distribution of alarms• Closed loop communication of alarms Historical patient data (“black box”)• Record of patient transactions (e.g., alarms, caregiver

responses, medical device to patient association) • Objective black box data to support root cause analysis

and development of best practice models

It’s not about technology, but . . .It’s not about technology, but . . .

PnPService Oriented Architecture

PnP

Service Oriented Architecture

Centralized assignments

Whiteboard

Spectralink phone directory

Event Recorder OverviewProblem: High frequency of clinical alarms generated at point of care

Action plan: Address operational & technological solutions• Involve unit staff in focus groups in work process & human

factors discussions• Keep leadership actively engaged – focus on quality of care• Review number of clinical alarms on 36-bed unit• Assess if monitoring clinically necessary & parameters are

patient/age specific• Assess need for and develop training program• Determine appropriate filters for non-critical alarms

Centralize event processingEvent occurs

Match event rule?

Message recipient?

Select output device(s)

Message delivery result(s)?

Monitor alarm, room 11005

Send to RN assigned to room 11005

Message acknowledged?

Yes, send all monitor alarms

Select comm device assigned to RN

Event

Management

Message successfully delivered to comm device

RN acknowledges message

Event history - patient “black box”

Level 1 – alarm not escalated to level 2 or 3

RN & patient name

Spectralink phone

Detailed transaction log

Root cause analysis and investigations• Objective history for individual patient or unit profile • Can produce a comprehensive report of:

- All alarms, alerts, messages, and staff/equipment location

- For a patient, room, unit, or other selected parameters

Quality improvement tools

• Proactively - Collect data

- Analyze and measure trends- Anticipate and correct gaps- Share information with all stakeholders

• Knowledge gained can direct improvements in - Patient safety- Staff satisfaction- Clinical workflows

• Patient black box is the cornerstone

RCA historical transaction

Preliminary Findings• Alarm frequency & distribution graph generated for 36-bed

surgical/orthopedic unit• Initial data quantified anecdotal reports that nurses are

barraged by alarms and messages

Dashboards

ResultsFirst deployment (36-bed unit)• Created governance structure & project roadmap• Clinical workflow and process maps developed • Used surveys & observation to evaluate incremental

deployment and drive improvements• Training program materials & training completed • Validated full system deployment in patient care areaLong-term project• Continue deployment to acute-care units• Implemented a high-availability infrastructure• Drive integration at the point of care by forcing vendor

conformance to standards

Detailed Findings

Reviewing trending data• 2 to 5 patients (in 36-bed unit) account for >80% of monitor

alarms• On 5/18/07, 2 patients generated 435 alarms out of a 508

totalConducted lab simulation of cardiac and pulse oximeter

monitor alarms• ~33% of monitor alarms reset within 10-seconds • Critical alarms required a manual reset

What Worked

• Multidisciplinary team – nursing, biomedical engineering, information services and vendors partnerships (select vendors carefully)

• Bedside nursing focus group – drove identification & rapid resolution of issues and adoption of changes

• Incremental approach – facilitated new workflow model, process evolution/validation, and major funding for proven proof of concept models

• Improve communication - centralized assignments and communication of alarms/messages

• Historical data – black box transaction capture, reporting, quality analysis (trends and patterns)

Lessons Learned

What worked?• Continuous review of impact of bedside technology• Leadership, focus group, and tech team participation• Multi-disciplinary (Nursing, Biomed, IT) tech team• Simultaneous operational and technical improvementsWhat’s next?• Expansion of initiatives to “smart” bedside alarms• Expanded deployment to additional units

Lessons Learned

It’s not about technology

… it’s about patients & people

… it’s about the bedside

… it’s about collaboration

… it’s about integration

… it’s about workflow & process

Technology

Contact Information

Yadin David, Ed.D., P.E., C.C.E.

Biomedical Engineering Consultants, LLCdavid@biomedeng.com

(713) 522-6666

Melita Howell

Texas Children’s HospitalSr. Project Manager

mjhowell@TexasChildrensHospital.org(832) 824-4434