Medical Technology

Management

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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 ?