Medical

Technology
Management

เฉลิมพล
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
• Scope of Management
• Implementation
• Training
• Acceptance / Inspection Testing
• PM
• Staff
• Working Space
Outline
• 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
• Procurement
• Preventive Maintenance
• Corrective Maintenance
• Training
• Replacement program
• KPI
• CMMS
• Environment Audit
Implementation
Procedure
• 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
• 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
• 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
• 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
• Technical Skill
• Leadership
• Service Mind
• Communication Skill
Staff
• Staff Level
• Manager / Leader
• Engineer
• Technician
• Administrator
Working Space
• Engineering Areas
• Repair Zone
• PM Zone
• Cleaning Zone
• Documentation
• Parts Inventory
• Equipment Awaiting Zone
• Supporting Facilities
• Safety & Environment
Finance Resources
• Budget Planning
• Staff
• Replacement Parts
• PM Kits
• Out-source Services
• Etc.
Finance Resources
• Information for Budget Planning
• Equipment Value
• Equipment History
• KPI
Tools / Test Equipment
• Hand Tools
• Test Equipments
• Personnel Protective Equipments
• Office Equipments
Tools / Test Equipment
• Management of Tools and Test Equipment
• Investment
• Utilization
• Human Resources
• Calibration Master Plan
• Traceability
Assessment and Planning
• KPI Report
• % PM Completion
• Average Repair Time
• Uptime
• Etc.
• Goal
• Balanced Score Card
• Quality Report
• Monthly
• Quarter
• Semi-Annually
• Annually
Assessment and Planning
• Improvement Planning
• Training Plan
• Replacement Plan
• Investment Plan
• Etc.
Equipment Selection
• Procurement Method
• Sources of Information
• ECRI : HPCS
• Medical Equipment Website
• Selection Criteria
• Investment Plan
Utilization
• Equipment List
• Usage Log
• Technology Assistance
• Human Resource
• Equipment Investment
• Equipment Community
Removal From Service
• 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
– Operations Report
– Problems Report
– KPI Report
– Improvement Plan
– Training Plan
– Supporting Software
– Etc.
Incident investigation and
Failure analysis
• Type of Incidents
• Malfunction
• Misuse
• Repeat Repair
• Etc.
• Failure Analysis
• Repair Database
• PM Database
Incident investigation and
Failure analysis
• 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
» Operational Beds
» Technical Staff
» Number of Equipment
» Etc.
Benchmarking
• Basics (cont.)
• Typical areas to benchmark
» Financial
» Staffing
» Safety
» Performance
» Quality
Benchmarking
• Basics (cont.)
• Used to demonstrate compliance with Joint
Commission Requirements
» PM Completion Rate for Life Support Equipment
• 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
• Determine and define the activity to measure
• Develop effective indicators
• Validation of the measures
• Collect and share data
• Review and Improve
Benchmarking
• Summary
• 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 ?