Transcript Medical Technology Management and Medical Equipment

Medical
Technology
Management
เฉลิมพล สื บแสงอินทร์
Medical Technology
Management
JCI : FMS.8 (3rd Edition)
The organization plans and implements a
program for inspecting, testing, and
maintaining medical equipment and
documenting the results.
Medical Technology
Management
ANSI/AAMI EQ56:1999/R2004
Medical equipment is an essential part of health
care. Appropriate management of equipment
maintenance is vital for ensuring that medical
equipment remains safe for its intended use,
that equipment life is maximized, and that total
lifetime costs are minimized.
Medical Technology
Management
Key Objective
To reduce the risk of injury or adverse impact on patient
care
To decrease equipment life cycle costs
To comply with codes, standards, and regulations
Outline
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Scope of Management
Implementation
Training
Acceptance / Inspection Testing
PM
Staff
Working Space
Outline
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Finance Resources
Tools / Test Equipment
Assessment and Planning
Equipment Selection
Utilization
Removal From Service
Communications
Outline
• Incident investigation and Failure analysis
• Safe Medical Devices Act
• Benchmarking
Scope of Management
Equipment inventory inclusion criteria
• Function
• Risk
• Maintenance Requirements
• Incident History
• Supporting Documents
Scope of Management
Equipment inventory inclusion criteria
(cont.)
 Traditional JC Method By Larry Fennigkoh & Smith B.
Algorithm-based Systems
Risk-based Systems
Scope of Management
Sources of criteria
 US FDA : www.fda.gov/cdrh
 Classify Your Medical Device
 Device Classes
 Device Classification Panels
 Medical Device Recalls
 ECRI Institute : www.ecri.org
 UMDNS : Universal Medical Device Nomenclature System
 Risk
 IPM : Health Devices Inspection and Preventive Maintenance System
 Health Devices Alerts
Scope of Management
Sources of criteria
GMDN Agency
 The Global Medical Device Nomenclature (GMDN)
Scope of Management
Scope of Management
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Procurement
Preventive Maintenance
Corrective Maintenance
Training
Replacement program
KPI
CMMS
Environment Audit
Implementation
Procedure
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Procurement Procedure
Inventory Assessment Procedure
Acceptance / Inspection Procedure
Preventive Maintenance Procedure
Corrective Maintenance Procedure
Retirement / Remove From Service Procedure
Medical Equipment Incident Procedure
Hazard Alert Procedure
Emergency Procedure
Records
Etc.
Implementation
Equipment Inventory
List
 Hospital-owned Equipment
 Leased Equipment
 Rented Equipment
 Loaned/Demo Equipment
 Employee-owned Equipment
 Research Equipment
 Patient-owned Equipment
Implementation
Equipment Inventory
Information of Inventory
 A unique identification number
 Manufacturer
 Model
 Serial Number
 Type of Equipment
 Location
 Purchasing Information
 Equipment History
 Etc.
Implementation
Equipment Inventory
Updating List Process
Record
 Format
 Software
Training
• Training Program
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Law / Statute
Management Knowledge
Risk
Safety
Maintenance
Operating
Metrology
Ethics
Etc.
Training
• Training Participate
• Management Level
• Operation Level
• Training Documents
• Training need Assessment
• Training Record
• Training Evaluate
Training
• Training Responsibilities
• Training Hours
• Training Courses
Acceptance / Inspection
Testing
• Acceptance Test for New Equipment
before Using
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Specification Check
Inspection Test
Function Test
Safety Test
Acceptance / Inspection
Testing
• Routine Inspection Test
• By User
• Alarm Test
• Check List
PM
What is your definition of PM ?
• Preventive Maintenance
• Predictive Maintenance
• Planned Maintenance
• Proactive Maintenance
PM
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Preventive Maintenance
Calibration
PM/Cal Report or Certificate
Metrology Knowledge
PM
• PM Intervals and Master Plan
ECRI : IPM
ACE
Manufacturer Recommendation
JCAHO : EC.1.6 , EC.2.10 / NFPA Standard 99
(Larry Fennigkoh & Smith B.)
Staff
• Staff Qualification
• Knowledge
• Competence
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Technical Skill
Leadership
Service Mind
Communication Skill
Staff
• Staff Level
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Manager / Leader
Engineer
Technician
Administrator
Working Space
• Engineering Areas
• Repair Zone
• PM Zone
• Cleaning Zone
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Documentation
Parts Inventory
Equipment Awaiting Zone
Supporting Facilities
Safety & Environment
Finance Resources
• Budget Planning
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Staff
Replacement Parts
PM Kits
Out-source Services
Etc.
Finance Resources
• Information for Budget Planning
• Equipment Value
• Equipment History
• KPI
Tools / Test Equipment
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Hand Tools
Test Equipments
Personnel Protective Equipments
Office Equipments
Tools / Test Equipment
• Management of Tools and Test Equipment
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Investment
Utilization
Human Resources
Calibration Master Plan
Traceability
Assessment and Planning
• KPI Report
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% PM Completion
Average Repair Time
Uptime
Etc.
• Goal
• Balanced Score Card
• Quality Report
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Monthly
Quarter
Semi-Annually
Annually
Assessment and Planning
• Improvement Planning
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Training Plan
Replacement Plan
Investment Plan
Etc.
Equipment Selection
• Procurement Method
• Sources of Information
• ECRI : HPCS
• Medical Equipment Website
• Selection Criteria
• Investment Plan
Utilization
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Equipment List
Usage Log
Technology Assistance
Human Resource
Equipment Investment
Equipment Community
Removal From Service
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Unsafe Equipment
No Longer Support Equipment
Technology
Cost of Ownership
Back-up Equipment
Removal From Service
• Replacement Plan
• Disposal Plan
Communications
• Medical Equipment Team Meeting
• Department Meeting
• Management Meeting
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Operations Report
Problems Report
KPI Report
Improvement Plan
Training Plan
Supporting Software
Etc.
Incident investigation and
Failure analysis
• Type of Incidents
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Malfunction
Misuse
Repeat Repair
Etc.
• Failure Analysis
• Repair Database
• PM Database
Incident investigation and
Failure analysis
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Hazard Alerts
Law / Statute
Safety Committee
Quality Record
Preventive Plan
Safe Medical Devices Act
• Report to FDA when…..
incident in which a medical device may
have caused or contributed” to the death,
serious illness or serious injury to a patient
Benchmarking
JCI 3rd Edition
• The analysis process includes
comparisons internally, with other
organizations when available, and with
scientific standards and desirable
practices. (QPS.4.2)
• The organization compares its
performance using external reference
databases. (MCI.20.3)
Benchmarking
Benchmarking means measuring and
comparing, which is at the heart of
almost all of our publications and
research.
Benchmarking
A tool designed specifically to help clinical
engineering departments measure their
practices, policies, and procedures against
similar departments at other facilities;
monitor their progress throughout the year;
and share best practices.
Benchmarking
• Basics
• Measuring activities and comparing the result to a
reference value
» % of Service Cost/Acquisition Cost
» PM Completion Rate
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Operational Beds
Technical Staff
Number of Equipment
Etc.
Benchmarking
• Basics (cont.)
• Typical areas to benchmark
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Financial
Staffing
Safety
Performance
Quality
Benchmarking
• Basics (cont.)
• Used to demonstrate compliance with Joint
Commission Requirements
» PM Completion Rate for Life Support Equipment
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Internal Benchmarking (Compare yourself to yourself)
External Benchmarking (Compare yourself to others) *
Definitions and standards impact measurements
A great blunt instrument to focus management
attention
* The measurement is well understood and defined
Benchmarking
• Process
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Determine and define the activity to measure
Develop effective indicators
Validation of the measures
Collect and share data
Review and Improve
Benchmarking
• Summary
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Value of Benchmarking
Comparison
A good “Blunt Instrument”
Help Operations
“Positive or Negative” Impact
References
ANSI/AAMI EQ56:1999/(R)2004
Joseph Dyro, The Clinical Engineering
Handbook
JCI : www.jointcommissioninternational.org
ECRI Institute : www.ecri.org
US FDA : www.fda.org
AAMI : www.aami.org
Question ?