The Business Operations of Clinical Engineers
Sunday, June 7, 2015 | 10am-11pm

Thomas Judd, MS, PE, CCE

The Differences between Japanese CEs andAmerican CEs
Kaiser Permanente Clinical Technology
ACCE (American College of Clinical Engineering)© 2015 Association for the Advancement of Medical Instrumentation www.aami.org

Who are US Clinical Engineers• Profession by the title of Clinical Engineer (CE)– Coined in mid 1960s by Cesar Caceres, MD, later AAMI Board member• American College of Clinical Engineering began in 1990
– "A Clinical Engineer is a professional who supports and advances
patient care by applying engineering managerial skills to healthcaretechnology." - ACCE Definition, 1992, see http://accenet.org/• Education– Typically has at least a baccalaureate (4-year) degree in engineering orengineering technology from an accredited college or university– Of ACCE Individual members*, 60% have masters or doctoral degrees• Certification & Licensing– CE Certification desirable after 3 years of experience; 31%* have CCE– Licensing as a professional engineer (PE) not requiredUS Clinical Engineers
Number*• US CEs est. 20,000• ACCE members ~800••••Work Place**
Hospitals 70%Consultant 15%Industry
10%
Academia 5%*Sources: PayScale.com, Bureau of Labor StaHsHcs, and CNNMoney research, 2012**ACCE Body of Knowledge (BOK) 2010 Survey re Health Technology (HT) DeﬁniHons & PracHces

US CEs: Activities & Knowledge BaseIn the US, by many other health professionals operate clinical equipment: e.g.,
Nurses; Cardiovascular, Respiratory, Dialysis, Lab, and Radiologic Technologists, etc.
Categories of CE Work% Time

1. HTM

32.2

1.

Physiological Monitoring

2. Service Delivery Management 16.8

2.

General Med./Nursing Equipment

3. General Management

10.7

3.

Surgical Equipment

4. EducaHon of Others

10.6

4.

Computers, Networking, IT

5. Risk Management / Safety

10.6

5.

PresentaHon Skills

6. CE-IT (InformaHon Technology) 8.0

6.

Anesthesia

7.

Medical Imaging

8.

Respiratory Therapy

9.

Management Theory

7. TesHng, EvaluaHon, ModiﬁcaHon 4.9
8. FaciliHes Management

4.7

9. Other

1.2

CE Knowledge Category

10. Medicial Terminology, Anatomy/Physiology
Source: ACCE Body of Knowledge (BOK) 2010 Survey

US CE BOK Categories of Work Deﬁned
Health Technology Management (HTM)

Technology, Usability/CompaHbility assessment; Product & vendor selecHon
Device integraHon planning, Life cycle analysis, Device / system upgrade planning
Return on investment (ROI) analysis, HT strategic planning, Capital planning
CoordinaHng device interoperability / interfacing, Clinical systems networking,Project management, InterpretaHon of codes and standards
Clinical trials management (non-invesHgaHonal), EMI / RF (wireless) management
Clinical devices use and / or applicaHon, Pre-Clinical procedure set-up / tesHng,
ParHcipaHon in clinical procedures (e.g. surgery)• Water quality management, lab, dialysis, pharmacy•••••••Service Delivery Management (SDM)
••
•
•
•
•
•

Technician/ service supervision
Service contract management
Equipment repair and maintenance, Equipment acceptance & performance tesHng
Develop test/calibraHon/maintenance proceduresComputerized maintenance management system (CMMS) AdministraHon
Parts/supplies purchase and/or inventory management
Technical library/service manuals management

US CE BOK Categories of Work, cont.
Product Development, TesRng, EvaluaRon, & ModiﬁcaRon
••••
•
•

Medical device concept development / invenHon
Human factors engineering, Medical device design
New product tesHng and evaluaHon, Device modiﬁcaHons,
Research and development, Product sales / sales support,
Product / systems quality management, Regulatory compliance
DocumentaHon development / management

InformaRon Technology (IT) / TelecommunicaRons (aka CE-IT)•••

Help Desk / dispatching / call tracking
IT management, TelecommunicaHons management
IntegraHon of medical device data

EducaRon of Others
•
•
•
•
•

Technician educaHon
Engineering educaHon
Device user / nurse training
Develop / manage staﬀ training plan,InternaHonal HTM educaHon

US CE BOK Categories of Work, cont.
FaciliRes Management•••••Building design, Building plan review
Medical gas system tesHng
Supervise / manage / direct faciliHes management operaHons
Facility / uHlity remediaHon planning, Emergency electrical power
Facility emergency preparedness acHviHes

Risk Management/Safety
••
•
•
••
•
•

PaHent safety, Expert witness, Risk Management
Forensic invesHgaHons, Medical device incident reporHng
Root cause analysis, Failure mode eﬀects analysis
Product safety / hazard alerts / recalls, Incident /untoward event invesHgaHons
InvesHgaHonal Research (Human Use), RadiaHon safety
Fire protecHon and safety planning,, InfecHon control, Industrial hygieneWork place safety pracHces, Hazardous materials
Engineering assessment of medical device failureGeneral Management••••••

Staﬃng, Staﬀ skills / competency assessment
Budget development / execuHon, Revenue producing acHviHes
Personnel management / supervision
Performance improvement / CQI, Policy/procedure management/development
Commikee management
Business / operaHon plan development / management

Funding Mechanisms for CE Programs• Japan– Largely based on national Medical Insurance Fundreimbursement for clinical equipment operation;– and to a lesser extent on service delivery management(SDM) activities• US– Largely based on service contract elimination throughuse of in-house CE / SDM services, as well as wise useof HTM activities leading to efficiencies in care delivery,
value additions to hospital budgets and cost reductions

Typical activities of ACCE(American College of Clinical Engineering)& ExpoAAMI2015 Conference
June 5-8, Denver, COACCE: Certification System• The Certification in Clinical Engineering (CCE) systembegun in the 1970s today is under ACCE oversight.
• The CCE process – for applicants with the right mix ofeducation and experience – involves written & oral exams
on the CE BOK topics introduced earlier, of a clinical,technical, and managerial nature.
• A key purpose of certification is to demonstrate the CEsclinical competence - e.g., ability to partner with physician
and nursing leaders to improve patient care quality andsafety - as well as to enhance the CEs ability to manage
complex technologies through their lifecycle alongsidehospital business leaders, at best possible cost.

ACCE http://accenet.org
Addresses naHonal health technology (HT) & health IT (CE-IT) concerns
Partners with other health leaders to improve paHent safety
Over 700 individual leaders as well as 20 organizaHons, including over 150
internaHonals from nearly 40 countries• 60% of our membership is 40 years old and younger as we conHnue to growand to akract younger members• Historical strong US educaHonal role; olen for leading edge topics and venues• Created Advanced CE/HT workshops in 1991, with WHO-PAHO, now provided
over 50 week-long seminars to developing country leaders from > 70 countries•••Typical ACCE HTM Seminar• HT Policy & RegulaRons (HTR)
ACCE International
CE Seminars•

HT Assessment (HTA)•HT Management (HTM)• Service Delivery Management (SDM)• Computerized SDM (aka CMMS)• Managing Donated Equipment•

PaRent Safety, Risk Management, Use Error•

Healthcare FaciliRes & Medical Devices•

Human Resources Development (HRD)• EducaRon• Professional SocieRes & CerRﬁcaRon•Emerging eHealth and CE-IT Issues