Lecture 01

Part II - Background
 Content
– Background
• Clinical Engineering Services
• History - The Patient’s Safety & Early Issues
• History - The Begin
• History - Important Events
– Profession
• AAMI – Technicians
• AAMI – Engineers & Managers
– Engineering
• Clinical Engineer
• Hospital (Maintenance) Engineer
• Typical Engineering Responsibilities
• Engineering or Maintenance ?
– Healthcare Technology
• Definitions & Concepts
Background
 Clinical Engineering Services
Definition
The clinical engineering service is typically responsible for medical
equipment and systems –
– support of assessment,
– replacement,
– acquisition,
– patient safety,
– compliance and education with a major responsibility for quality assurance
and maintenance.

• The primary organization representing clinical engineering is

the American College of Clinical Engineering (ACCE).

• Depending upon the hospital, the group may also be called

biomedical engineering, biomed, or technical services.
Healthcare Technology Life Cycle
 History - The Patient’s Safety
The field of clinical engineering grew out of a concern with medical
device safety focusing on electrical safety in the late 1960's.

Article in New York Post - 1969

 History - Early Issues
The early issues were
– Testing grounding
– Device electrical leakage current
– Patient isolation for directly connected devices,
and how often this testing should occur
– Isolated power systems in patient care areas and
critical care outlets and grounding - at this time
large green ground cables were used to
redundantly ground equipment in the intensive
care unit
 History - The Begin
The Begin
In the early 1970's, clinical engineering departments
started to rapidly appear in hospitals.

Reasons
• The need was defined by the previously mentioned
issues,
• the growth of medical devices role and number in
hospitals,
• the need for technical expertise on-site,
• and regulatory and standards developed by NFPA and
Joint Commission.
 History - Important Events
Kellogg Foundation

The Kellogg Foundation, the corporation most known for cereals, was a major
player in the development of clinical engineering programs.

• They funded clinical engineering shared services, i.e. multi-hospitals, programs

in the early 1970’s.

• These programs eventually developed into moderate sized private firms such
as:
– Master Plan,
– Technology in Medicine, and
– Aramark.

IBM PC
An advance was the introduction of the IBM PC in 1981 and related database
software.
 History - Important Events
Business-like fashion
The clinical engineering department began to operate in a more
business-like fashion due to

• cost pressures when the diagnostic related groups (DRG's)

caused a cost crunch in healthcare in the mid-1980’s.

• Other changes caused:

– a quality assurance and improvement focus, 
– an expansion of services to cover a more comprehensive inventory
including imaging and clinical lab,
– a shifting focus to help hospitals with the patient safety, and
implementing the "cradle-to-grave",
– healthcare technology management system - the theme of this
course.
 History - Important Events
Biomedical Equipment Technician (BMET)

– After the WW II, the biomedical equipment

technician (BMET) profession started in the
military.

– In the late 1960’s, entering into the private sector

with the formation of the Technical Education
Research Center, which developed the first
curriculum for biomedical equipment technology
in community colleges.
 History - Important Events
Clinical Engineer (CE) - First CE
• In 1971, Dr. Cesar Caceres first coined the
term Clinical Engineer
• He started the first Clinical Engineering
newsletter while president of the Association
for the Advancement of Medical
Instrumentation (AAMI).
 Profession
Managers, Engineers & Technicians
 Association for the Advancement of Medical
Instrumentation (AAMI)
• Clinical engineering (CE) and biomedical equipment
technology are recently developed professions.
• In 1971, AAMI was the first group to embrace these fields
through the development of the AAMI Board of
Examiners.

1971
Profession
Technicians
 Association for the Advancement of Medical
Instrumentation (AAMI)
AAMI - BMET Certification Program
– 1971, AAMI developed and offered the first certification exam the
same year for
– 1971 : Certified Biomedical Equipment Technician (CBET) -
General
– 1979 : Certified Radiology Equipment Specialist (CRES) - Radiology
– 1981 : Certified Laboratory Equipment Specialist (CLES) - Clinical
Laboratory
– 1983: the AAMI certification merged with ABCE to form the
International Certification Commission (ICC).
– Today, there are more than 7000 certified biomedical equipment
technicians.
Association for the Advancement of Medical
Instrumentation (AAMI)

Certified Biomedical Equipment Technician (CBET)

 Profession
Engineers & Managers
 Association for the Advancement of Medical
Instrumentation (AAMI)
AAMI - CCE & CHTM Certification Program
– 1974: Clinical engineering certification (CCE) - was also started by
AAMI in.

– 1999: AAMI dropped the program, and the CCE program was
revamped and placed under the Healthcare Technology
Foundation (HTF).

– 2014: the CCE program transferred to the American College of

Clinical Engineering (ACCE).

– Recently: Certified Healthcare Technology Manager (CHTM) -

AAMI began offering for technical services managers.
Association for the Advancement of Medical
Instrumentation (AAMI)

Certified Healthcare Technology Manager (CHTM)

Ethics
 Clinical Engineering - Ethics
Ethics are a part of all fields and everyone's personhood.

The statement on ethics for the clinical engineering from the American
College of Clinical Engineering is below:

1. Strive to prevent a person from being placed at risk of injury due to

dangerous or defective devices or procedures.
2. Accurately represent my level of responsibility, authority, experience,
knowledge and education.
3. Reveal any conflicts of interest that may affect information provided or
received.
4. Protect the confidentiality of information from any source.
5. Work toward improving the delivery of health care to all who need it.
6. Work toward the containment of costs by the better utilization of technology.
7. Promote the profession of clinical engineering.
Engineering Concepts
 Engineering Concepts
• Clinical Engineering
 “A Clinical Engineer is a professional who supports
and advances patient care by applying
engineering and managerial skills to healthcare
technology." - ACCE Definition, 1992
• Other terms used to specify this professional
are:
 Healthcare engineer, hospital engineer, biomedical
equipment technician, equipment managers,
technology manager, biomedical engineer,
maintenance engineer, healthcare technologist.
 Clinical & Hospital Engineering
Definition
• Clinical Engineering equipment
responsibilities
 Infusion pumps, defibrillators, monitors, x-ray
machines, cath scan, MRI, ultrasound, ventilators,
surgical table and lights, electrosurgical units,
pulse oxymeters, CT scan, etc.
• Hospital Engineering equipment
responsibilities
 HVAC, medical gases, electrical systems, medical
compressed air, vacuum systems, elevators,
construction support, communication systems,
vehicles, steam, hot water, etc.
 Typical Engineering Responsibilities
Definition
1. Supervision, coordination and technical orientation
2. Studies, planning, projects and specifications
3. Technical and economic feasibility studies
4. Counseling and advisory services
5. Manpower and resource management
6. Inspections, audits, evaluation, survey, technical
reports
7. Technical functions
8. Teaching, research, analysis, experimentation, tests
9. Budget preparation
 Typical Engineering Responsibilities
Definition
10. Standardization, measurements, quality control
11. Constructions
12. Fiscalization of service execution
13. Specialized technical production
14. Technical evaluation of work conductions
15. Management of installation, mounting, operation, repair or
maintenance team
16. Execution of installation, mounting, repair and remodeling
17. Installations and equipment operations and maintenance
18. Technical drawing
 Engineering or Maintenance ?
Definition
GENERAL
ADMINISTRATION

MAINTENANCE
SERVICE X SERVICE Y
SERVICE

PREVENTIVE CORRECTIVE
MAINTENANCE MAINTENANCE
 Engineering !!!
Definition
GENERAL
Engineering includes
ADMINISTRATION

SERVICE X SERVICE Y ENGINEERING

CLINICAL HOSPITAL
ENGINEERING ENGINEERING

TECHNOLOGY PATIENT QUALITY MAINTENANCE OTHER

PLANNING SAFETY ASSURANCE PROGRAM PROGRAMS

Preventive Corrective
Maintenance Maintenance
Healthcare Technology
 Healthcare Technology Definitions

• Healthcare Technology. What is it?

 Healthcare technology includes the devices,
equipment, systems, software, supplies,
pharmaceuticals, biotechnologies, medical and
surgical procedures, organizational structures
used in the prevention, diagnosis, and treatment of
disease in humans; for rehabilitation; and for
assistive purposes.
 Here we will focus on medical equipment and
hospital installations and facilities.
 Healthcare Technology Concepts

• Technology Efficacy
 A benefit from a given medical technology under
ideal conditions of use.
• Technology Effectiveness
 A benefit from a given medical technology under
average (real) conditions of use.
• Technology Efficiency
 Lowest price when different technologies have
same efficacy and effectiveness.