Role of CLINICAL ENGINEER

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the role of cilinical engineer in health care facilities - hospitals

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Slide 1:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering


1 . Definition of Clinical Engineer and Evolution:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations.


2. range of interactions of a clinical engineer.:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices.


Slide 4:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer


3. Clinical engineering practices :Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management


4. Hospital Organization:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2


Slide 7:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital


Slide 8:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board


Slide 9:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3


6. CE- Department [5] :Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006


6 .1 Mission & Purpose of Clinical Engineering:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment


6.2 Major Functions of a CE - Department:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management


Slide 13:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies


7 .The CE Role & Responsibilities :Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies 7 .The CE Role & Responsibilities 7.1 Main Responsibilities To ensure that the medical equipment within the hospital is used safely and effectively. To ensure that all medical and laboratory equipment is operating according to strict manufacturers ,national and international guidelines and standards. To provides technical support for the maintenance and repair of medical, clinical laboratory and audio-visual equipment . To provide the hospital administration with an objective option of equipment function, purchase, application, overall system analysis, and preventive maintenance policies.


Slide 15:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies 7 .The CE Role & Responsibilities 7.1 Main Responsibilities To ensure that the medical equipment within the hospital is used safely and effectively. To ensure that all medical and laboratory equipment is operating according to strict manufacturers ,national and international guidelines and standards. To provides technical support for the maintenance and repair of medical, clinical laboratory and audio-visual equipment . To provide the hospital administration with an objective option of equipment function, purchase, application, overall system analysis, and preventive maintenance policies. 7.2 CE roles / services Management & Consulting Services associated with medical devices & systems - Inventory & asset management - Strategic planning ... considering technology's ability to improve healthcare quality, safety and availability while reducing costs - Quality & safety ... insuring the application of industry best practices - Regulatory & standards compliance - Clinical information system integration & infrastructure support - Service Vendor management (e.g., medical device manufactures & service providers) 2. Support Services - Training users in operation, potential hazards, basic troubleshooting and the care and handling of medical devices & systems - Help desk .. providing operation & technical support for medical devices Equipment management including procurement, commissioning, acceptance testing and maintenance of medical equipment


Slide 16:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies 7 .The CE Role & Responsibilities 7.1 Main Responsibilities To ensure that the medical equipment within the hospital is used safely and effectively. To ensure that all medical and laboratory equipment is operating according to strict manufacturers ,national and international guidelines and standards. To provides technical support for the maintenance and repair of medical, clinical laboratory and audio-visual equipment . To provide the hospital administration with an objective option of equipment function, purchase, application, overall system analysis, and preventive maintenance policies. 7.2 CE roles / services Management & Consulting Services associated with medical devices & systems - Inventory & asset management - Strategic planning ... considering technology's ability to improve healthcare quality, safety and availability while reducing costs - Quality & safety ... insuring the application of industry best practices - Regulatory & standards compliance - Clinical information system integration & infrastructure support - Service Vendor management (e.g., medical device manufactures & service providers) 2. Support Services - Training users in operation, potential hazards, basic troubleshooting and the care and handling of medical devices & systems - Help desk .. providing operation & technical support for medical devices Equipment management including procurement, commissioning, acceptance testing and maintenance of medical equipment 3. Technical Services - Installation & integration of medical devices & systems - Upgrades (hardware & software) - Testing, inspection (functional, safety, performance) - Calibration - Preventive maintenance - Corrective maintenance& repair 4. Additional Technology management services - Equipment management program (risk analyses, control elements) - Evaluation of new technologies prior to acquisition, including life cycle cost analyses - Education services (equipment users ,biomedical equipment technicians, CE , BMETs & students of BME – specialty) - Device tracking (hazards & recalls) - Incident reporting & investigation Scheduled Maintenance Unscheduled Maintenance Discrete Equipment Management Technology Management Safety inspection & maintenance Clinical engineering & IT- TECHNOLOGY CE Model has changed[6] 1970 2010 [6] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006


8. Diversity of Clinical Engineering:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies 7 .The CE Role & Responsibilities 7.1 Main Responsibilities To ensure that the medical equipment within the hospital is used safely and effectively. To ensure that all medical and laboratory equipment is operating according to strict manufacturers ,national and international guidelines and standards. To provides technical support for the maintenance and repair of medical, clinical laboratory and audio-visual equipment . To provide the hospital administration with an objective option of equipment function, purchase, application, overall system analysis, and preventive maintenance policies. 7.2 CE roles / services Management & Consulting Services associated with medical devices & systems - Inventory & asset management - Strategic planning ... considering technology's ability to improve healthcare quality, safety and availability while reducing costs - Quality & safety ... insuring the application of industry best practices - Regulatory & standards compliance - Clinical information system integration & infrastructure support - Service Vendor management (e.g., medical device manufactures & service providers) 2. Support Services - Training users in operation, potential hazards, basic troubleshooting and the care and handling of medical devices & systems - Help desk .. providing operation & technical support for medical devices Equipment management including procurement, commissioning, acceptance testing and maintenance of medical equipment 3. Technical Services - Installation & integration of medical devices & systems - Upgrades (hardware & software) - Testing, inspection (functional, safety, performance) - Calibration - Preventive maintenance - Corrective maintenance& repair 4. Additional Technology management services - Equipment management program (risk analyses, control elements) - Evaluation of new technologies prior to acquisition, including life cycle cost analyses - Education services (equipment users ,biomedical equipment technicians, CE , BMETs & students of BME – specialty) - Device tracking (hazards & recalls) - Incident reporting & investigation Scheduled Maintenance Unscheduled Maintenance Discrete Equipment Management Technology Management Safety inspection & maintenance Clinical engineering & IT- TECHNOLOGY CE Model has changed[6] 1970 2010 [6] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 8. Diversity of Clinical Engineering Beside hospital, and clinics CE may works in :


9 Areas of Competence of the Clinical Engineer [7]:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies 7 .The CE Role & Responsibilities 7.1 Main Responsibilities To ensure that the medical equipment within the hospital is used safely and effectively. To ensure that all medical and laboratory equipment is operating according to strict manufacturers ,national and international guidelines and standards. To provides technical support for the maintenance and repair of medical, clinical laboratory and audio-visual equipment . To provide the hospital administration with an objective option of equipment function, purchase, application, overall system analysis, and preventive maintenance policies. 7.2 CE roles / services Management & Consulting Services associated with medical devices & systems - Inventory & asset management - Strategic planning ... considering technology's ability to improve healthcare quality, safety and availability while reducing costs - Quality & safety ... insuring the application of industry best practices - Regulatory & standards compliance - Clinical information system integration & infrastructure support - Service Vendor management (e.g., medical device manufactures & service providers) 2. Support Services - Training users in operation, potential hazards, basic troubleshooting and the care and handling of medical devices & systems - Help desk .. providing operation & technical support for medical devices Equipment management including procurement, commissioning, acceptance testing and maintenance of medical equipment 3. Technical Services - Installation & integration of medical devices & systems - Upgrades (hardware & software) - Testing, inspection (functional, safety, performance) - Calibration - Preventive maintenance - Corrective maintenance& repair 4. Additional Technology management services - Equipment management program (risk analyses, control elements) - Evaluation of new technologies prior to acquisition, including life cycle cost analyses - Education services (equipment users ,biomedical equipment technicians, CE , BMETs & students of BME – specialty) - Device tracking (hazards & recalls) - Incident reporting & investigation Scheduled Maintenance Unscheduled Maintenance Discrete Equipment Management Technology Management Safety inspection & maintenance Clinical engineering & IT- TECHNOLOGY CE Model has changed[6] 1970 2010 [6] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 8. Diversity of Clinical Engineering Beside hospital, and clinics CE may works in : 9 Areas of Competence of the Clinical Engineer [7] (a) Advice on available technology; (b) Evaluation and purchase of equipment; (c) Maintenance; (d) Hazard prevention and reporting; (e) Clinical measurement; (f) General technical support and facilities; (g) Education and training; (h) Research and development, [ 7]P. Inchingolo CLINICAL ENGINEERING TOWARD THE THIRD MILLENIUM ,IFMBE Proceedings Part I,MEDICON 2001, 12-15 June 2001, Pula, Croatia


Slide 19:Prepared By Dr.Eng. Walid Tarawneh Hospital organization and The role of clinical engineer Clinical Engineering 1 . Definition of Clinical Engineer and Evolution When Biomedical Engineers work within a hospital or clinic, they are called Clinical Engineers ( CE ) “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and management skills to healthcare technology” CE entered the hospital environment to inspect electrical safety . It was found during the CE inspection program within the hospital that :  electrical safety failures represented only a small part of the overall problem facing medical equipment in the clinical environment.  medical equipment is not properly maintained  the use of medical equipment not totally understood by the medical staff  many devices did not perform in accordance with manufacturers’ specifications  many equipment were not maintained in accordance with manufacturers’ recommendations. 2. range of interactions of a clinical engineer. Most of CE could be function in hospitals or similar organizations Clinical Engineers usually work with : Physicians , Nurses , Respiratory therapists, Radiology technicians, Clinical laboratory technologists, Venders of medical equipment , Hospital administrations, Others hospital engineers ( mechanical ,electrical ,software …etc ), Contractors that service medical equipment , Regulation agencies, Patients, and other health care professionals in the function and use of medical devices. Fig .1 Range of interactions of a clinical engineer 3. Clinical engineering practices Includes : Health Technology Management, Safety and Quality Assurance & Control Medical Device Service Technology Application Information Technology Education and Training, Research , Development and Design Clinical Facilities & Planning Standards and Regulations. Risk Management 4. Hospital Organization 4.1 hospital mission Hospital’s Mission is to improve the health of the communities by delivering a broad range of high quality services with sensitivity to the needs of the patients and their families 4.2 The primary components of the hospital organization (Fig .2) Fig .2 4.3 Administrative Board of hospitals The Administrative board are involved in the following functions: - Establishing the mission statement and defining the specific goals and objectives that the hospital (health care organization) must satisfy. - Establishing the policies of the institution - Providing equipment and facilities to conduct patient care - Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance) - Coordinating professional interests with administrative, financial, and community needs - Providing adequate financing by securing sufficient income and managing the control of expenditures - Providing a safe environment - Selecting qualified administrators, medical staff, and other professionals to manage the hospital 4.4 Hospital Administration The Hospital Administration, the Chief Executive Officer (CEO) represents the Governing Board in carrying out the day-to-day operations to reflect the broad policy The duties of the Administrator are summarized as follows: - Preparing a plan for accomplishing the institutional objectives, as approved by the board - Selecting medical chiefs and department directors to set standards in their respective fields - Submitting for board approval an annual budget reflecting both expenditures and income projections - Maintaining all physical properties (plant and equipment) in safe operating condition - Representing the hospital in its relationships with the community and health agencies - Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board 4.5 Organization Charts (fig 3) fig 3 6. CE- Department [5] 1-Technology Consultation, Project Management & System Planning 2-Emerging Technology Review, Pre- Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost Analyses 3-Education & training 4-Compliance (government, accrediting authorities) 5-Device Tracking (Hazards, Recalls) 6-Incident Investigation 7-Contract/vendor management 1-Installation & configuration 2-Inspection 3-Preventive Maintenance 4-Calibration 5-Repair 1-Communications (client interface) Bookkeeping Accounts Payable & Receivable Payroll & Benefits Management 2-Correspondence 3-Filing 4-Data entry 5-Reporting Administrative Staff Biomedical (BMETs) Equipment Technicians Clinical Engineers (CE) Healthcare Technology Management (Clinical Engineering) Program Manager (Dir of Clinical Engineering) Safety Committee Typical Clinical Engineering Program Organization by Function / Roles [ 5 ] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 6 .1 Mission & Purpose of Clinical Engineering To apply engineering, technical, and management expertise to the identification, acquisition and support of safe, effective, and economical healthcare technology as needed for patient care, education, research and community service To Improve the Quality of Patient Care through Technical Support of the Medical Services To Provide Technical Assistance on Procurement and Evaluation of Instrumentation To Implement an Effective Safety and Maintenance Program to Provide a Return on Investment 6.2 Major Functions of a CE - Department 1. Technology Management. Developing, implementing, and directing equipment management programs. Accepting and installing new equipment Establishing preventive maintenance and repair programs Managing the inventory of medical instrumentation. Ensure the implementation of cost effective and quality assurance plan . Advises the administrator of the budgetary, personnel, space, and test equipment requirements Provide necessary support to organization for equipment management program. 2. Risk Management. Evaluating and taking appropriate action on incidents related to equipment malfunctions or misuse. Reporting to the hospital authority for any unsafe ,risky Medical Devices Sharing the hospital administration in preparing and implementing hospital policy for risk management 3. Technology Assessment. Evaluating and selecting new equipment. Evaluation of new requests for capital equipment expenditures, Providing hospital administrators and clinical staff with an in depth assessment of the benefits/ advantages of new equipment. Monitoring and reporting the utilization of medical equipment within the organization. 4. Facilities Design and Project Management. Assisting and sharing in the design of new or renovated clinical facilities that house specific medical technologies like operating rooms, imaging facilities, and radiology treatment centers. 5. Training. Establish and deliver instructional modules for clinical engineering staff as well as clinical staff and other medical staff on the operation , safety , effective and best use of medical equipment 6. Accreditation Development and implementation of documentation protocols required by external accreditation and licensing agencies 7 .The CE Role & Responsibilities 7.1 Main Responsibilities To ensure that the medical equipment within the hospital is used safely and effectively. To ensure that all medical and laboratory equipment is operating according to strict manufacturers ,national and international guidelines and standards. To provides technical support for the maintenance and repair of medical, clinical laboratory and audio-visual equipment . To provide the hospital administration with an objective option of equipment function, purchase, application, overall system analysis, and preventive maintenance policies. 7.2 CE roles / services Management & Consulting Services associated with medical devices & systems - Inventory & asset management - Strategic planning ... considering technology's ability to improve healthcare quality, safety and availability while reducing costs - Quality & safety ... insuring the application of industry best practices - Regulatory & standards compliance - Clinical information system integration & infrastructure support - Service Vendor management (e.g., medical device manufactures & service providers) 2. Support Services - Training users in operation, potential hazards, basic troubleshooting and the care and handling of medical devices & systems - Help desk .. providing operation & technical support for medical devices Equipment management including procurement, commissioning, acceptance testing and maintenance of medical equipment 3. Technical Services - Installation & integration of medical devices & systems - Upgrades (hardware & software) - Testing, inspection (functional, safety, performance) - Calibration - Preventive maintenance - Corrective maintenance& repair 4. Additional Technology management services - Equipment management program (risk analyses, control elements) - Evaluation of new technologies prior to acquisition, including life cycle cost analyses - Education services (equipment users ,biomedical equipment technicians, CE , BMETs & students of BME – specialty) - Device tracking (hazards & recalls) - Incident reporting & investigation Scheduled Maintenance Unscheduled Maintenance Discrete Equipment Management Technology Management Safety inspection & maintenance Clinical engineering & IT- TECHNOLOGY CE Model has changed[6] 1970 2010 [6] Stephen L. Grimes, Convergence of Clinical Engineering and Information Technology August 24, 2006 8. Diversity of Clinical Engineering Beside hospital, and clinics CE may works in : 9 Areas of Competence of the Clinical Engineer [7] (a) Advice on available technology; (b) Evaluation and purchase of equipment; (c) Maintenance; (d) Hazard prevention and reporting; (e) Clinical measurement; (f) General technical support and facilities; (g) Education and training; (h) Research and development, [ 7]P. Inchingolo CLINICAL ENGINEERING TOWARD THE THIRD MILLENIUM ,IFMBE Proceedings Part I,MEDICON 2001, 12-15 June 2001, Pula, Croatia As a result the CE is involved in Safety Committee Product Evaluation Staff Education Technology Assessment Quality Improvement Technology Planning Installation CMMS Management Software Development Incident Investigation