CLINICAL ENGINEERING

Definitions
Biomedical Engineering
Solving problems in biology and medicine using engineering methods and technology (e.g., research, design and development of biomedical instrumentation.)
Clinical Engineering
Application of engineering methods and technology to the safe and effective provision of health care.

Definitions
Technology
Broad class of related procedures and systems used to perform a common function. (e.g., Computer technology performs the function of data processing.)
Equipment
Specific device within a class of technology. (e.g., Macintosh or IBM PC)

Clinical Engineering
Mission:
Ensure the safe and effective application of technology to patient care.
Customers:
Clinical staff and patients.

Functions of Clinical Engineering
Technology Planning (project management)
Technology Assessment
Acquisition and Application of Technology
Equipment Control
Preventive and Corrective Maintenance
Service Contract Management

Functions of Clinical Engineering
Development of New Technology
Facility Planning and Development
Safety and Risk Management
Continuous Quality Improvement
Education
Clinical Equipment Application

Technology Planning
What types of technology are best suited to satisfy the program needs of this facility?
What are the future technology requirements?
What technologies are under development? How will they impact patient care?
How can technology be better utilized to improve patient outcome, control costs and improve productivity?

Technology Planning
Continuing Education
Professional Journals and Newsletters
Professional Societies
Internet
Seminars and Conferences
Awareness of Program Needs
Frequent communication with users
Involvement with technology related committees
Awareness of Technology Resources
Equipment Control Program

Technology Assessment
Definition:
Assessment of medical technology (devices, drugs, procedures, & systems)
Safety
Clinical effectiveness
Cost effectiveness
Ethical (e.g., reproductive technologies)
Legal

Technology Assessment
Given one or more competing technologies, which is the most appropriate and cost effective for a particular clinical application?

Technology Assessment
Clinical Engineering Role:
Information gathering
Information dissemination
Facilitation

Acquisition and Application of Technology
What equipment do we need to do the job?
Is it commercially available?
Which of the available models is best?
How much will it cost to buy? To operate?
Where will it go? Will we need to renovate?
Who will use it? Will they need training?
Who will service it?
How often will it need to be serviced?
When will we need to replace it?

Acquisition and Application of Technology
Needs Assessment
Environmental Assessment
Translation of Clinical Requirements into Technical Specifications
Research
Technical & Functional Evaluations

Acquisition and Application of Technology
Recommendation and Purchase
Incoming Inspection
Add to Equipment Control Program
Installation
User Education

Equipment Control
What equipment is in the hospital? (make, model, serial#)
Where is it?
Who does it belong to?
Is it safe?
Is it reliable?
Is it effective?
How is it utilized?

Equipment Control
Is it easy to use?
How frequently is it utilized?
Is it time for replacement?
What service procedures have been performed, when, what parts were used, how much did it cost?
How frequently is preventive maintenance and performance assurance performed? What P.M. procedures are performed?

Preventive and Corrective Maintenance
In-house or external service?
Warranty management
Level of in-house service (board level, component level)
Corrective-maintenance service process
Service facility (size, location, etc.)
Size of technical staff

Preventive and Corrective Maintenance
Staff training
Staff organization
Parts inventory
Test equipment
Equipment manuals & documentation
Diagnostic software

Preventive and Corrective Maintenance
Vendor support
Frequency of PMs
Scheduling
PM procedures
Service reports
Billing rate

Service Contract Management
In-house, vendor, third-party, maintenance insurance?
Provisions of service contracts
Service contract negotiation
Monitoring and documentation service contracts
Cost analysis

Development of New Technology
Needs assessment
Research
Design and specification
Prototype construction, testing and evaluation

Development of New Technology
Construction, testing and documentation of final assembly
Regulatory approvals
User education
Clinical trials, modification, documentation and reporting
Add to equipment control program

Facility Planning and Development
Specifying equipment requirements
Liaison between contractor and hospital
Project planning and management
Ensure conformance to relevant codes & regulations

Safety and Risk Management
Remain current on all pertinent codes & regulations
Interpretation of codes & regulations
Implementation and enforcement of codes & regulations
Maintain system for responding to published equipment hazard reports

Safety and Risk Management
Reviewing requests for new technology as to safety and effectiveness
Identification of potential hazards
Assessing degree of hazard protection required in relation to size of risk
Preventing technological change when risk unwarranted or effectiveness not demonstrated

Safety and Risk Management
Incident investigation and reporting
Maintain incident database.
Safety policy development
Development of safety education programs
Representation on hospital safety committee
Liaison with manufacturers
Liaison with hazard reporting agencies (ECRI, Government)

Continuous Quality Improvement
Identify customers
Identify and measure improvement needs
Identify critical processes
Identify quality indicators
Examine problems and analyze the causes
Decide on solutions and action plans to achieve them
Implement proposed solutions, measure and evaluate
Adopt and standardize improved processes

Education
Education of Clinical Engineering
Education of Clinical Staff
Education of Patients
Partnership with local Clinical Engineering Technology Programs

Education of Clinical Engineering
Attend relevant conferences and seminars
Attend vendor service courses
Participate in Clinical Engineering professional associations (Alberta Clinical Engineering Society)
Read clinical engineering magazines and journals
Remain current on developments in medical technology (vendor contacts)

Education of Clinical Staff
Development of in-service education programs
User training on new equipment
Annual refresher courses for clinical staff
Informal user assistance and training
Documentation of user training
Education of clinical staff on new developments in medical technology

Education of Patients
Provide in-service education to patients responsible for the operation of medical devices

Training Partnerships
Advise local Clinical Engineering Technology programs on curriculum content
Assist with training
Provide hospital internship program

Clinical Equipment Application
Provide assistance with set-up and operation of technically complex medical devices
Assist clinicians with application of medical technology in tertiary care areas (ICUs, Diagnostic areas, and ORs)
Dialysis
Intraaortic Balloon Pump
Lasers & Electrosurgery

Evolution of Clinical Engineering
Level 1 (1970-1978)
Associated with Physical Plant
Electrical safety
Corrective maintenance of basic electromedical equipment
Initiation of PM program
Equipment Control Program initiated
Initial involvement in equipment acquisition process

Evolution of Clinical Engineering
Level 2 (1978-1984)
Center for hazard and recall network
Incident investigation
Significant involvement in acquisition process
Initial involvement in outside service contracts

Evolution of Clinical Engineering
Level 3 (1984-1989)
Reports directly to administration
Computerized equipment control program with productivity and cost analysis capability
Maintenance of more sophisticated technology including medical imaging and clinical lab.

Evolution of Clinical Engineering
Level 4 (1989-1993)
Integration of CQI/RM into technology management
Comprehensive service contract management
Computerized ECP with extensive analysis capability
Active participation in equipment planning and facilities development

Evolution of Clinical Engineering
Level 5 (Future Projection)
Technology Assessment
Strategic Technology Planning
Integration of Clinical and Information Technologies
Home Care technology management
Increasing clinical involvement

Clinical Engineering Program Structure
Historically a function of Physical Plant
A modern CE program should
report directly to administration
have autonomy (i.e., own personnel, capital equipment and operating budgets)
Political strength with administration and medical staff is essential to accomplish program goals

Clinical Engineering Program Subdivisions
Risk management/CQI
Technology Planning and Assessment
Technology Development
Technical Support Services
Clinical Laboratory
Diagnostic Imaging
Medical Instrumentation Group 1
Medical Instrumentation Group 2
etc.

Clinical Engineering Program Structure
President
Vice President
Director of Technology
Manager
Equipment Services
Clinical Engineer.
Service
Group
Service
Group
Service
Group
Service
Group
Governing Board
Clinical Engineer.

Engineer vs. Technologist vs. Technician
Administrative
Model
Engineer
Technologist
Technician
Functional
Model
Educational
Model
Broad
Narrow
Engineer
Technologist
Technician
Engineer
Technologist
Technician

Centralized vs. Distributed Service
Centralized Service Advantages
Lower cost
Increased efficiency
Prevents duplication of function and personnel
Common resource and knowledge base
Centralized Service Disadvantages
Lack of individual department control

Equipment Specialist vs. Generalist
Specialist Advantages
Staff are more capable
More efficient
Job gets done faster
Specialist Disadvantages
Staff are less flexible
No cross-training
Department is vulnerable
Uneven workload distribution

Single Team vs. Multiple Team (Area Specialization)
Multiple Team Advantages
More efficient
Improved familiarity with equipment and users
Clear identification of responsibility by clinical staff and CE staff
Ownership (pride in work)
Accountability
Improved communication between clinical staff and CE staff

Single Team vs. Multiple Team (Area Specialization)
Multiple Team Disadvantage
More vulnerable
Technologist may become bored with same range of equipment
Uneven workload distribution