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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, [email protected]
(713) 522-6666
Melita Howell
Texas Children’s HospitalSr. Project Manager
[email protected](832) 824-4434