medical technology management เฉลิมพล สืบ แสงอินทร์
TRANSCRIPT
Medical Technology
Management
เฉลิ�มพลิ สืบแสืงอิ�นทร์�
Medical Technology Management
The organization plans and implements a program for inspecting, testing, and maintaining medical equipment and documenting the results.
JCI : FMS.8 (3rd Edition)
Medical Technology Management
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.
ANSI/AAMI EQ56:1999/R2004
Medical Technology Management
Key ObjectiveTo reduce the risk of injury or adverse impact on
patient careTo decrease equipment life cycle costsTo 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.
Risk-based Systems
Algorithm-based Systems
Scope of Management
Sources of criteriaUS 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 criteriaGMDN 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
ImplementationProcedure
• 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.
ImplementationEquipment Inventory
List Hospital-owned Equipment Leased Equipment Rented Equipment Loaned/Demo Equipment Employee-owned Equipment Research Equipment Patient-owned Equipment
ImplementationEquipment Inventory
Information of Inventory A unique identification number Manufacturer Model Serial Number Type of Equipment Location Purchasing Information Equipment History Etc.
Implementation
Equipment InventoryUpdating List ProcessRecord
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
PMWhat 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 : IPMACEManufacturer RecommendationJCAHO : 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
• 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)
JCI 3rd Edition
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)2004Joseph Dyro, The Clinical Engineering
HandbookJCI : www.jointcommissioninternational.org
ECRI Institute : www.ecri.org
US FDA : www.fda.org
AAMI : www.aami.org
Question ?