1. Technology Assesment (TA) by Mohd Yusof Baharuddin

2. Introduction As medical technology continues to evolve, the impact is on: As medical technology continues to evolve, the impact is on: patient outcome, patient outcome, hospital operations, and hospital operations, and financial resources financial resources The deployment of medical technologies is now on a relatively fast track. New devices, diagnostic procedures, equipment, and systems of health-care delivery are continually being produced and flow rapidly to the mainstream hospitals. The deployment of medical technologies is now on a relatively fast track. New devices, diagnostic procedures, equipment, and systems of health-care delivery are continually being produced and flow rapidly to the mainstream hospitals.

3. Definition An integral part of an ongoing technology planning and management program at the hospital, addressing the needs of the patient, the user, and the support team.

4. In the TA process, the CE/TM professional wears two hats: manager and that of the engineer that allows one to be a key leader and contributor in to the decision making process of the Medical Technology Advisory Committee (MTAC). In the TA process, the CE/TM professional wears two hats: manager and that of the engineer that allows one to be a key leader and contributor in to the decision making process of the Medical Technology Advisory Committee (MTAC).

5. Pre-requisite for TA Medical technology is a major strategic factor in positioning and creating a positive community perception of the hospital. Medical technology is a major strategic factor in positioning and creating a positive community perception of the hospital. Exciting new biomedical devices and systems are continually being introduced - expenditure is mounting Exciting new biomedical devices and systems are continually being introduced - expenditure is mounting For hospitals to remain cost-effective and competitive, it is essential that any medical technology chosen or selected based on the “knowledge” gathered about it’s performance, value and availability. For hospitals to remain cost-effective and competitive, it is essential that any medical technology chosen or selected based on the “knowledge” gathered about it’s performance, value and availability.

6. Without TA analysis, hospital may purchase sophisticated biomedical equipment only to discover that some needs or features were not included or not yet approved for delivery, or that the installation has not been adequately planned. Without TA analysis, hospital may purchase sophisticated biomedical equipment only to discover that some needs or features were not included or not yet approved for delivery, or that the installation has not been adequately planned. Hospitals perform TA activities to project needs for new assets and to better manage existing assets. Hospitals perform TA activities to project needs for new assets and to better manage existing assets.

7. Medical equipment has a life-cycle that can be defined as : the innovation phase, which includes the concept, basic and applied research and development, and the innovation phase, which includes the concept, basic and applied research and development, and the adoption phase, which begins with the clinical studies, through diffusion, and wide- spread use. the adoption phase, which begins with the clinical studies, through diffusion, and wide- spread use.

8. TA Process More and more hospitals are faced with the difficult phenomena of a capital equipment requests list that is much larger than a capital budget allocation. More and more hospitals are faced with the difficult phenomena of a capital equipment requests list that is much larger than a capital budget allocation. The most difficult decision is the one that matches clinical decision with financial capability. The most difficult decision is the one that matches clinical decision with financial capability. Following issues are often raised: Following issues are often raised: how to avoid costly technology mistakes; how to avoid costly technology mistakes; how to wisely target capital money for technology; how to wisely target capital money for technology; how to avoid medical staff conflicts as they relate to technology; how to avoid medical staff conflicts as they relate to technology; how to control equipment-related risks; and how to control equipment-related risks; and how to maximize the useful life of the equipment or systems while minimizing the cost of ownership. how to maximize the useful life of the equipment or systems while minimizing the cost of ownership.

9. To aid the TA process, the following tools need to be utilized: To aid the TA process, the following tools need to be utilized: access to national database services, directories and libraries; access to national database services, directories and libraries; visits to scientific and clinical exhibits; visits to scientific and clinical exhibits; a network of key industry contacts; and a network of key industry contacts; and a relationship with peers in the country and internationally. a relationship with peers in the country and internationally.

10. Problems without TA Recently purchased equipment or its functions are underutilized. Recently purchased equipment or its functions are underutilized. Ongoing user problems with equipment. Ongoing user problems with equipment. Excessive maintenance costs. Excessive maintenance costs. Inability to comply with standards or guidelines for equipment management. Inability to comply with standards or guidelines for equipment management. High percentage of equipment awaiting repair. High percentage of equipment awaiting repair. Equipment operator training inefficiency due to shortage of allied health professionals. Equipment operator training inefficiency due to shortage of allied health professionals.

11. A closer look at the symptoms behind these problems may reveal the following : A lack of central clearinghouse to collect, indexes, and monitors all technology-related information for future planning purposes. A lack of central clearinghouse to collect, indexes, and monitors all technology-related information for future planning purposes. The absence of procedures for identifying emerging technologies for potential acquisition. The absence of procedures for identifying emerging technologies for potential acquisition. The lack of systematic plan for conducting TA resulting in the inability to maximize the benefits from deployment of available technology The lack of systematic plan for conducting TA resulting in the inability to maximize the benefits from deployment of available technology

12. The inability to benefit from the organization’s own previous experience with a particular type of technology. The inability to benefit from the organization’s own previous experience with a particular type of technology. The random replacement of medical technologies, rather than systematic plan based on a set of well developed criteria. The random replacement of medical technologies, rather than systematic plan based on a set of well developed criteria. The lack of integration of technology acquisition into the strategic and capital planning of the hospital. The lack of integration of technology acquisition into the strategic and capital planning of the hospital.

13. Objectives of TA Process accumulate information on medical equipment, accumulate information on medical equipment, facilitate systematic planning, facilitate systematic planning, create an administrative structure supporting assessment process and its methodology, create an administrative structure supporting assessment process and its methodology, monitor the replacement of outdated technology, monitor the replacement of outdated technology, improve the capital budget process by focusing on long-term needs relative to the acquisition of medical equipment. improve the capital budget process by focusing on long-term needs relative to the acquisition of medical equipment.

14. TA & Clinical Engineer Clinical engineers and other technology managers are qualified to participate in every phase of equipment life cycle from its introduction into clinical investigation to its final retirement. Clinical engineers and other technology managers are qualified to participate in every phase of equipment life cycle from its introduction into clinical investigation to its final retirement. Clinical engineers match the skills with their knowledge of their hospital’s technology deployment phases ranging from capital budget planning, equipment evaluation, and performance validation, to user training, inventory control, repair, and maintenance services, and incident investigation. Clinical engineers match the skills with their knowledge of their hospital’s technology deployment phases ranging from capital budget planning, equipment evaluation, and performance validation, to user training, inventory control, repair, and maintenance services, and incident investigation.

15. The clinical engineers involvement improves planning for new equipment and the management of the existing equipment inventory, thus impacting quality of care, financial management or cost-effectiveness, and risk management. The clinical engineers involvement improves planning for new equipment and the management of the existing equipment inventory, thus impacting quality of care, financial management or cost-effectiveness, and risk management.

16. Technology Planning & management program Strategic Planning Long-Term Budget Capital Budget Operating Budget Technology Assessment Equipment Planning Equipment Procurement Assets Management

17. TA Process 1. 1. Interest in Technology Acquisition 2. 2. Initial Planning, Evaluation & Assessment 3. 3. Capital Budget Committee Construction and Renovation Committee Medical Technology Advisory Committee Computer Standards Committee 4. 4. Product Standards Committee 5. 5. Administrative Approval 6. 6. Material Management 7. 7. Technology Management

18. Equipment Asset Management Mohd Yusof Baharuddin

19. Introduction Initially called “equipment management” and “technology management” by ECRI. Initially called “equipment management” and “technology management” by ECRI. An accountable, systematic approach will ensure that cost-effective, efficacious, safe and appropriate equipment is available to meet the demands of quality patient care. An accountable, systematic approach will ensure that cost-effective, efficacious, safe and appropriate equipment is available to meet the demands of quality patient care. Requires managing medical equipment resources that result in measurable outputs that are monitored and measured. Requires managing medical equipment resources that result in measurable outputs that are monitored and measured.

20. Equipment Asset Management involvement in equipment acquisition and other life-cycle issues, involvement in equipment acquisition and other life-cycle issues, technical support for equipment, technical support for equipment, supplying equipment information and training, supplying equipment information and training, monitoring and evaluating equipment, and monitoring and evaluating equipment, and documenting equipment documenting equipment analysis of specific financial and clinical indicators analysis of specific financial and clinical indicators compliance with regulatory and accreditation requirements. compliance with regulatory and accreditation requirements.

21. Equipment Management Process Acquisition Involvement in the process of determining the need of equipment. Involvement in the process of determining the need of equipment. Prepare bid specification and support negotiation. Prepare bid specification and support negotiation. Resolve all facility planning issues. Resolve all facility planning issues. Careful and detailed pre-purchase evaluation and selection. Careful and detailed pre-purchase evaluation and selection. Develop and perform acceptance testing. Develop and perform acceptance testing.

22. Technical Support Establish a complete equipment inventory – control records, operating and service manuals list, testing and QA indicators. Establish a complete equipment inventory – control records, operating and service manuals list, testing and QA indicators. Incoming equipment acceptance testing and application of control number tagging, assist in incident investigation (and handling system along with a medical device reporting system). Incoming equipment acceptance testing and application of control number tagging, assist in incident investigation (and handling system along with a medical device reporting system). Supervise corrective as well as preventive maintenance of all equipment – in house or outside vendors. Supervise corrective as well as preventive maintenance of all equipment – in house or outside vendors. Equipment repair – including management and integration of outside service vendor activities. Equipment repair – including management and integration of outside service vendor activities. Day- to-day assistance to equipment users, promoting improvement in clinical use of equipment. Day- to-day assistance to equipment users, promoting improvement in clinical use of equipment.

23. Information and Training Disseminate user’s manuals and other information. Disseminate user’s manuals and other information. Process and track hazard, recall and regulatory data. Process and track hazard, recall and regulatory data. Initial and ongoing training on safe and effective use of annual patient care equipment. Initial and ongoing training on safe and effective use of annual patient care equipment. Investigate equipment-related incidents, hazards, and problems. Discovered errors incorporated into staff training. Investigate equipment-related incidents, hazards, and problems. Discovered errors incorporated into staff training.

24. Monitoring and Evaluation Develop, implement, and participate in QA and RM activities. Develop, implement, and participate in QA and RM activities. Periodically assess equipment management program’s effectiveness with combination of objective and subjective data. Periodically assess equipment management program’s effectiveness with combination of objective and subjective data. Develop effective communication and feedback between relevant personnel in the hospital. Develop effective communication and feedback between relevant personnel in the hospital.

25. Documentation Activities above must be documented to meet regulatory, accreditation, and problem-solving requirements to minimize liability. Activities above must be documented to meet regulatory, accreditation, and problem-solving requirements to minimize liability.Disposition Recommendations for assistance in disposition of equipment by replacement, refurbishment, upgrading, or declared obsolescence. Recommendations for assistance in disposition of equipment by replacement, refurbishment, upgrading, or declared obsolescence.

26. Case Study: Privatized Biomedical Engineering Maintenance Service in Ministry of Health Hospitals Scope of Services 1. To carryout a comprehensive program of planned and scheduled maintenance for all medical and laboratory equipment. To provide effective and responsive repair on all medical equipment and provision of on-call and emergency services. To provide effective and responsive repair on all medical equipment and provision of on-call and emergency services. To carry out Acceptance Testing as well as safety and performance characteristics on all incoming new equipment To carry out Acceptance Testing as well as safety and performance characteristics on all incoming new equipment

27. 2. To provide mechanisms to avoid failure or breakdown during diagnosis or therapy. 3. To carryout all works necessary to provide uptime guarantee on maintenance uptime. 4. To implement the Hospital Engineering Quality Assurance plan.

28. 5. To establish a computerized documentation system which include equipment control record (KEW 312) To provide quarterly reports on maintenance activities to MOH and Hospital Administration To provide quarterly reports on maintenance activities to MOH and Hospital Administration To notify departments of warranty expirations. To notify departments of warranty expirations. 6. To dispose / remove unwanted medical equipment.

29. 7. To implement procedures for dealing with hazardous matter and handling contaminated equipment. 8. To co-operate in the investigation of related incidents. 9. To train users on daily user maintenance procedure (excludes clinical procedure related to the equipment) 10. To maintain a stock of genuine spares 11. Establish a library of user and service manuals

30. Master Agreed Procedure (MAP) BEMS/001 Planned Preventative Maintenance [5.1] BEMS/0002 Corrective Maintenance including Routine Corrective, Breakdown and Emergency Maintenance [5.1] BEMS/0003 Acceptance Testing [5.1] BEMS/0004 Mechanisms to Avoid Failure or Breakdown During Use [5.2] BEMS/005 Uptime Guarantee [5.3] BEMS/006 Quality Assurance Program (QAP) [5.4] BEMS/0007 Maintenance Management Information System (MMIS) [5.5] BEMS/0008 Management of Warranties [5.1]

31. BEMS/0009 Decommissioned Medical Equipment [5.6] BEMS/0010 Process for Handling hazardous / Contaminated Equipment[5.7] BEMS/0011 Incidents and Hazards [5.8] BEMS/0012 User Training [5.9] BEMS/0013 Stock of Genuine Spares [5.10] BEMS/0014 On-Site Library [5.11] BEMS/0015 Workshop Set-up BEMS/0016 Utilities/Services BEMS/0017 Advisory Service BEMS/0018 Biomedical Minor Works BEMS/0019 Procurement of Medical Equipment

32. Summary 1. Technology Assessment (TA) Introduction Introduction Prerequisite for TA Prerequisite for TA TA Process TA Process TA and Clinical Engineering (CE) TA and Clinical Engineering (CE) 2. Equipment Assets Management Introduction Introduction Equipment Management Process Equipment Management Process Case study Case study