1. Medical Technology Management
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2. 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.

3. 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.

4. 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

5. Outline Scope of Management Implementation Training
Acceptance / Inspection Testing PM
Staff
Working Space

6. Outline Finance Resources Tools / Test Equipment
Assessment and Planning
Equipment Selection
Utilization
Removal From Service
Communications

7. Outline Incident investigation and Failure analysis
Safe Medical Devices Act
Benchmarking

8. Scope of Management Equipment inventory inclusion criteria Function
Risk
Maintenance Requirements
Incident History
Supporting Documents

9. Scope of Management Equipment inventory inclusion criteria (cont.)
Traditional JC Method By Larry Fennigkoh & Smith B.
Algorithm-based Systems
Risk-based Systems

10. 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 :
UMDNS : Universal Medical Device Nomenclature System
Risk
IPM : Health Devices Inspection and Preventive Maintenance System
Health Devices Alerts

11. Scope of Management Sources of criteria GMDN Agency
The Global Medical Device Nomenclature (GMDN)

12. Scope of Management Scope of Management Procurement
Preventive Maintenance
Corrective Maintenance
Training
Replacement program
KPI
CMMS
Environment Audit

13. 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.

14. Implementation Equipment Inventory List Hospital-owned Equipment
Leased Equipment
Rented Equipment
Loaned/Demo Equipment
Employee-owned Equipment
Research Equipment
Patient-owned Equipment

15. Implementation Equipment Inventory Information of Inventory
A unique identification number
Manufacturer
Model
Serial Number
Type of Equipment
Location
Purchasing Information
Equipment History
Etc.

16. Implementation Equipment Inventory Updating List Process Record Format
Software

17. Training Training Program Law / Statute Management Knowledge Risk
Safety
Maintenance
Operating
Metrology
Ethics
Etc.

18. Training Training Participate Training Documents Management Level
Operation Level
Training Documents
Training need Assessment
Training Record
Training Evaluate

19. Training
Training Responsibilities
Training Hours
Training Courses

20. Acceptance / Inspection Testing
Acceptance Test for New Equipment before Using
Specification Check
Inspection Test
Function Test
Safety Test

21. Acceptance / Inspection Testing
Routine Inspection Test
By User
Alarm Test
Check List

22. PM What is your definition of PM ? Preventive Maintenance
Predictive Maintenance
Planned Maintenance
Proactive Maintenance

23. PM Preventive Maintenance Calibration PM/Cal Report or Certificate
Metrology Knowledge

24. 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.)

25. Staff Staff Qualification Knowledge Competence Technical Skill
Leadership
Service Mind
Communication Skill

26. Staff
Staff Level
Manager / Leader
Engineer
Technician
Administrator

27. Working Space Engineering Areas Documentation Parts Inventory
Repair Zone
PM Zone
Cleaning Zone
Documentation
Parts Inventory
Equipment Awaiting Zone
Supporting Facilities
Safety & Environment

28. Finance Resources Budget Planning Staff Replacement Parts PM Kits
Out-source Services
Etc.

29. Finance Resources Information for Budget Planning Equipment Value
Equipment History
KPI

30. Tools / Test Equipment Hand Tools Test Equipments
Personnel Protective Equipments
Office Equipments

31. Tools / Test Equipment Management of Tools and Test Equipment
Investment
Utilization
Human Resources
Calibration Master Plan
Traceability

32. Assessment and Planning
KPI Report
% PM Completion
Average Repair Time
Uptime
Etc.
Goal
Balanced Score Card
Quality Report
Monthly
Quarter
Semi-Annually
Annually

33. Assessment and Planning
Improvement Planning
Training Plan
Replacement Plan
Investment Plan
Etc.

34. Equipment Selection Procurement Method Sources of Information
ECRI : HPCS
Medical Equipment Website
Selection Criteria
Investment Plan

35. Utilization Equipment List Usage Log Technology Assistance
Human Resource
Equipment Investment
Equipment Community

36. Removal From Service Unsafe Equipment No Longer Support Equipment
Technology
Cost of Ownership
Back-up Equipment

37. Removal From Service
Replacement Plan
Disposal Plan

38. Communications Medical Equipment Team Meeting Department Meeting
Management Meeting
Operations Report
Problems Report
KPI Report
Improvement Plan
Training Plan
Supporting Software
Etc.

39. Incident investigation and Failure analysis
Type of Incidents
Malfunction
Misuse
Repeat Repair
Etc.
Failure Analysis
Repair Database
PM Database

40. Incident investigation and Failure analysis
Hazard Alerts
Law / Statute
Safety Committee
Quality Record
Preventive Plan

41. 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

42. 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)

43. Benchmarking
Benchmarking means measuring and comparing, which is at the heart of almost all of our publications and research.

44. 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.

45. 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.

46. Benchmarking Basics (cont.) Typical areas to benchmark Financial
Staffing
Safety
Performance
Quality

47. 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

48. Benchmarking Process Determine and define the activity to measure
Develop effective indicators
Validation of the measures
Collect and share data
Review and Improve

49. Benchmarking Summary Value of Benchmarking Comparison
A good “Blunt Instrument”
Help Operations
“Positive or Negative” Impact

50. References ANSI/AAMI EQ56:1999/(R)2004
Joseph Dyro, The Clinical Engineering Handbook
JCI :
ECRI Institute :
US FDA :
AAMI :

51. Question ?