Technology Assesment Technology Assesment (TA)(TA)

bybyMohd Yusof BaharuddinMohd Yusof Baharuddin

IntroductionIntroduction

As medical technology continues to evolve, As medical technology continues to evolve, the impact is on:the impact is on: patient outcome, patient outcome, hospital operations, andhospital operations, and financial resources financial resources

The deployment of medical technologies is The deployment of medical technologies is now on a relatively fast track. New now on a relatively fast track. New devices, diagnostic procedures, equipment, devices, diagnostic procedures, equipment, and systems of health-care delivery are and systems of health-care delivery are continually being produced and flow rapidly continually being produced and flow rapidly to the mainstream hospitals.to the mainstream hospitals.

DefinitionDefinition

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

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

Pre-requisite for TAPre-requisite for TA

Medical technology is a major strategic Medical technology is a major strategic factor in positioning and creating a factor in positioning and creating a positive community perception of the positive community perception of the hospital.hospital.

Exciting new biomedical devices and Exciting new biomedical devices and systems are continually being introduced - systems are continually being introduced - expenditure is mountingexpenditure is mounting

For hospitals to remain cost-effective and For hospitals to remain cost-effective and competitive, it is essential that any competitive, it is essential that any medical technology chosen or selected medical technology chosen or selected based on the “knowledge” gathered about based on the “knowledge” gathered about it’s performance, value and availability.it’s performance, value and availability.

Without TA analysis, hospital may Without TA analysis, hospital may purchase sophisticated biomedical purchase sophisticated biomedical equipment only to discover that equipment only to discover that some needs or features were not some needs or features were not included or not yet approved for included or not yet approved for delivery, or that the installation delivery, or that the installation has not been adequately planned.has not been adequately planned.

Hospitals perform TA activities to Hospitals perform TA activities to project needs for new assets and project needs for new assets and to better manage existing assets.to better manage existing assets.

Medical equipment has a life-cycle Medical equipment has a life-cycle that can be defined as :that can be defined as : the innovation phase, which includes the innovation phase, which includes

the concept, basic and applied research the concept, basic and applied research and development, and and development, and

the adoption phase, which begins with the adoption phase, which begins with the clinical studies, through diffusion, the clinical studies, through diffusion, and wide-spread use.and wide-spread use.

TA ProcessTA Process

More and more hospitals are faced with the More and more hospitals are faced with the difficult phenomena of a capital equipment difficult phenomena of a capital equipment requests list that is much larger than a capital requests list that is much larger than a capital budget allocation.budget allocation.

The most difficult decision is the one that The most difficult decision is the one that matches clinical decision with financial matches clinical decision with financial capability.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 how to avoid medical staff conflicts as they relate to

technology;technology; how to control equipment-related risks; andhow to control equipment-related risks; and how to maximize the useful life of the equipment or how to maximize the useful life of the equipment or

systems while minimizing the cost of ownership.systems while minimizing the cost of ownership.

To aid the TA process, the following To aid the TA process, the following tools need to be utilized:tools need to be utilized: access to national database services, access to national database services,

directories and libraries;directories and libraries; visits to scientific and clinical exhibits;visits to scientific and clinical exhibits; a network of key industry contacts; a network of key industry contacts;

andand a relationship with peers in the a relationship with peers in the

country and internationally.country and internationally.

Problems without TAProblems without TA

Recently purchased equipment or its Recently purchased equipment or its functions are underutilized.functions are underutilized.

Ongoing user problems with Ongoing user problems with equipment.equipment.

Excessive maintenance costs.Excessive maintenance costs. Inability to comply with standards or Inability to comply with standards or

guidelines for equipment guidelines for equipment management.management.

High percentage of equipment High percentage of equipment awaiting repair.awaiting repair.

Equipment operator training Equipment operator training inefficiency due to shortage of allied inefficiency due to shortage of allied health professionals.health professionals.

A closer look at the symptoms behind A closer look at the symptoms behind these problems may reveal the followingthese problems may reveal the following:: A lack of central clearinghouse to collect, A lack of central clearinghouse to collect,

indexes, and monitors all technology-related indexes, and monitors all technology-related information for future planning purposes.information for future planning purposes.

The absence of procedures for identifying The absence of procedures for identifying emerging technologies for potential acquisition.emerging technologies for potential acquisition.

The lack of systematic plan for conducting TA The lack of systematic plan for conducting TA resulting in the inability to maximize the benefits resulting in the inability to maximize the benefits from deployment of available technology from deployment of available technology

The inability to benefit from the The inability to benefit from the organization’s own previous organization’s own previous experience with a particular type of experience with a particular type of technology.technology.

The random replacement of medical The random replacement of medical technologies, rather than systematic technologies, rather than systematic plan based on a set of well developed plan based on a set of well developed criteria.criteria.

The lack of integration of technology The lack of integration of technology acquisition into the strategic and acquisition into the strategic and capital planning of the hospital.capital planning of the hospital.

Objectives of TA ProcessObjectives of TA Process

accumulate information on medical accumulate information on medical equipment,equipment,

facilitate systematic planning,facilitate systematic planning, create an administrative structure create an administrative structure

supporting assessment process and supporting assessment process and its methodology,its methodology,

monitor the replacement of outdated monitor the replacement of outdated technology,technology,

improve the capital budget process improve the capital budget process by focusing on long-term needs by focusing on long-term needs relative to the acquisition of medical relative to the acquisition of medical equipment.equipment.

TA & Clinical EngineerTA & Clinical Engineer

Clinical engineers and other technology Clinical engineers and other technology managers are qualified to participate in managers are qualified to participate in every phase of equipment life cycle from its every phase of equipment life cycle from its introduction into clinical investigation to its introduction into clinical investigation to its final retirement.final retirement.

Clinical engineers match the skills with their Clinical engineers match the skills with their knowledge of their hospital’s technology knowledge of their hospital’s technology deployment phases ranging from capital deployment phases ranging from capital budget planning, equipment evaluation, and budget planning, equipment evaluation, and performance validation, to user training, performance validation, to user training, inventory control, repair, and maintenance inventory control, repair, and maintenance services, and incident investigation.services, and incident investigation.

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

Technology Planning & Technology Planning & management programmanagement program

StrategicPlanning

Long-TermBudget

CapitalBudget

OperatingBudget

Technology Assessment

EquipmentPlanning

Equipment Procurement

AssetsManagement

TA ProcessTA Process

1. Interest in Technology Acquisition2. Initial Planning, Evaluation & Assessment3. Capital Budget Committee

Construction and Renovation Committee Medical Technology Advisory Committee Computer Standards Committee

4. Product Standards Committee5. Administrative Approval6. Material Management7. Technology Management

Equipment Asset Equipment Asset ManagementManagement

Mohd Yusof BaharuddinMohd Yusof Baharuddin

IntroductionIntroduction

Initially called “equipment management” Initially called “equipment management” and “technology management” by ECRI.and “technology management” by ECRI.

An accountable, systematic approach An accountable, systematic approach will ensure that cost-effective, will ensure that cost-effective, efficacious, safe and appropriate efficacious, safe and appropriate equipment is available to meet the equipment is available to meet the demands of quality patient care.demands of quality patient care.

Requires managing medical equipment Requires managing medical equipment resources that result in measurable resources that result in measurable outputs that are monitored and outputs that are monitored and measured.measured.

Equipment Asset Equipment Asset ManagementManagement

involvement in equipment acquisition involvement in equipment acquisition and other life-cycle issues,and other life-cycle issues,

technical support for equipment,technical support for equipment, supplying equipment information and supplying equipment information and

training,training, monitoring and evaluating equipment, monitoring and evaluating equipment,

andand documenting equipmentdocumenting equipment analysis of specific financial and analysis of specific financial and

clinical indicatorsclinical indicators compliance with regulatory and compliance with regulatory and

accreditation requirements.accreditation requirements.

Equipment Management Equipment Management ProcessProcess

AcquisitionAcquisition Involvement in the process of Involvement in the process of

determining the need of equipment.determining the need of equipment. Prepare bid specification and support Prepare bid specification and support

negotiation.negotiation. Resolve all facility planning issues.Resolve all facility planning issues. Careful and detailed pre-purchase Careful and detailed pre-purchase

evaluation and selection.evaluation and selection. Develop and perform acceptance Develop and perform acceptance

testing.testing.

Technical SupportTechnical Support Establish a complete equipment inventory – Establish a complete equipment inventory –

control records, operating and service manuals list, control records, operating and service manuals list, testing and QA indicators.testing and QA indicators.

Incoming equipment acceptance testing and Incoming equipment acceptance testing and application of control number tagging, assist in application of control number tagging, assist in incident investigation (and handling system along incident investigation (and handling system along with a medical device reporting system).with a medical device reporting system).

Supervise corrective as well as preventive Supervise corrective as well as preventive maintenance of all equipment – in house or outside maintenance of all equipment – in house or outside vendors.vendors.

Equipment repair – including management and Equipment repair – including management and integration of outside service vendor activities.integration of outside service vendor activities.

Day- to-day assistance to equipment users, Day- to-day assistance to equipment users, promoting improvement in clinical use of promoting improvement in clinical use of equipment.equipment.

Information and TrainingInformation and Training Disseminate user’s manuals and other Disseminate user’s manuals and other

information.information. Process and track hazard, recall and Process and track hazard, recall and

regulatory data.regulatory data. Initial and ongoing training on safe and Initial and ongoing training on safe and

effective use of annual patient care effective use of annual patient care equipment.equipment.

Investigate equipment-related Investigate equipment-related incidents, hazards, and problems. incidents, hazards, and problems. Discovered errors incorporated into Discovered errors incorporated into staff training.staff training.

Monitoring and EvaluationMonitoring and Evaluation Develop, implement, and participate Develop, implement, and participate

in QA and RM activities.in QA and RM activities. Periodically assess equipment Periodically assess equipment

management program’s effectiveness management program’s effectiveness with combination of objective and with combination of objective and subjective data.subjective data.

Develop effective communication and Develop effective communication and feedback between relevant personnel feedback between relevant personnel in the hospital.in the hospital.

DocumentationDocumentation Activities above must be documented Activities above must be documented

to meet regulatory, accreditation, and to meet regulatory, accreditation, and problem-solving requirements to problem-solving requirements to minimize liability.minimize liability.

DispositionDisposition Recommendations for assistance in Recommendations for assistance in

disposition of equipment by disposition of equipment by replacement, refurbishment, replacement, refurbishment, upgrading, or declared obsolescence. upgrading, or declared obsolescence.

Case Study: Privatized Biomedical Case Study: Privatized Biomedical Engineering Maintenance Service in Engineering Maintenance Service in

Ministry of Health HospitalsMinistry of Health Hospitals

Scope of ServicesScope of Services

1.1. To carryout a comprehensive To carryout a comprehensive program of planned and scheduled program of planned and scheduled maintenance for all medical and maintenance for all medical and laboratory equipment. laboratory equipment.

To provide effective and responsive repair on To provide effective and responsive repair on all medical equipment and provision of on-all medical equipment and provision of on-call and emergency services. call and emergency services.

To carry out Acceptance Testing as well as To carry out Acceptance Testing as well as safety and performance characteristics on all safety and performance characteristics on all incoming new equipmentincoming new equipment

2.2. To provide mechanisms to avoid To provide mechanisms to avoid failure or breakdown during failure or breakdown during diagnosis or therapy.diagnosis or therapy.

3.3. To carryout all works necessary to To carryout all works necessary to provide uptime guarantee on provide uptime guarantee on maintenance uptime. maintenance uptime.

4.4. To implement the Hospital To implement the Hospital Engineering Quality Assurance Engineering Quality Assurance plan. plan.

5.5. To establish a computerized To establish a computerized documentation system which documentation system which include equipment control record include equipment control record (KEW 312) (KEW 312)

To provide quarterly reports on To provide quarterly reports on maintenance activities to MOH and Hospital maintenance activities to MOH and Hospital AdministrationAdministration

To notify departments of warranty To notify departments of warranty expirations.expirations.

6.6. To dispose / remove unwanted To dispose / remove unwanted medical equipment.medical equipment.

7.7. To implement procedures for dealing with To implement procedures for dealing with hazardous matter and handling hazardous matter and handling contaminated equipment. contaminated equipment.

8.8. To co-operate in the investigation of To co-operate in the investigation of related incidents.related incidents.

9.9. To train users on daily user maintenance To train users on daily user maintenance procedure (excludes clinical procedure procedure (excludes clinical procedure related to the equipment)related to the equipment)

10.10. To maintain a stock of genuine sparesTo maintain a stock of genuine spares

11.11. Establish a library of user and service Establish a library of user and service manualsmanuals

Master Agreed Procedure Master Agreed Procedure (MAP) (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]

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

SummarySummary

1.1. Technology Assessment (TA)Technology Assessment (TA) IntroductionIntroduction Prerequisite for TAPrerequisite for TA TA ProcessTA Process TA and Clinical Engineering (CE)TA and Clinical Engineering (CE)

2.2. Equipment Assets ManagementEquipment Assets Management IntroductionIntroduction Equipment Management ProcessEquipment Management Process Case studyCase study