Mission, Function &

Organizational Structure
of Clinical Engineering Services
Stephen L. Grimes, FACCE
Senior Consultant & Analyst
Strategic Health Care Technology Associates
www.SHCTA.com
 Organization’s (Hospital’s) Mission
• To improve the health of the communities we serve by delivering a
broad range of high quality services with sensitivity to the needs of
our patients and their families
– Hospital’s Goal: To improve the health of the communities
we serve
– What hospital does: delivers a broad range of high quality
services
– How hospital does it: with sensitivity to the needs of our
patients and their families

© SHCTA / slg - 2
 Mission
• Program Mission
– Should be simple
– Should support & be consistent with organization’s
mission statement

Organization’s Mission

Clinical Engineering Medical / Clinical Other Support

Mission Dept Mission Services’ Mission
© SHCTA / slg - 3
 Healthcare Technology
Program Mission
• To support the delivery of healthcare by insuring the availability
of safe and effective medical technology in a cooperative effort
with other members of the healthcare team
– Our Goal: To support delivery of healthcare
– What we do: Provide safe & effective medical
technology
– How we do it: In a cooperative effort with other members
of the healthcare team

© SHCTA / slg - 4
 Mission Statement

• The Office of Engineering Services will

apply engineering, technical, and
managerial expertise to provide safe,
effective, and economical facilities and
equipment as needed by University
Hospital for patient care, teaching,
research, and community service. †

† Slide 10 of Roles of Supervisors & Managers (Miller ~ Peru 2002)

© SHCTA / slg - 5
 Requirements of a Technology
Management Program†
• Program to control & monitor equipment
performance
– Routine performance testing
– Initial inspection
– Preventive maintenance
– Repair
– Action reports on device hazards & recalls

† ECRI
© SHCTA / slg - 6
 Requirements of a Technology
Management Program†
• That accurately and consistently computes
and monitors total equipment maintenance
costs, including:
– In-house costs
– Manufacturer costs
– 3rd party service costs

† ECRI
© SHCTA / slg - 7
 Requirements of a Technology
Management Program†
• Involvement in all aspects of equipment
acquisition and replacement decisions,
development of new services and planning
of new construction and major
renovations:

† ECRI
© SHCTA / slg - 8
 Requirements of a Technology
Management Program†
• Development of training program for all
equipment users of patient care equipment
and for biomedical technicians

† ECRI
© SHCTA / slg - 9
 Requirements of a Technology
Management Program†
• A quality assurance program relating to
technology use

† ECRI
© SHCTA / slg - 10
 Requirements of a Technology
Management Program†
• Risk management as it relates to
technology

† ECRI
© SHCTA / slg - 11
 Traditional Roles & Responsibilities
• Technical services
– Inspection & testing
(functional, safety, performance) Scheduled Maintenance
– Calibration
– Preventive maintenance
– Repair Unscheduled Maintenance
• Technology management services
– Equipment management program (risk analyses, control
elements)
– Evaluation of new technologies prior to acquisition,
including life cycle cost analyses
– Service vendor management
– Compliance (government, accrediting standards)
– Education services (equipment users & biomedical equipment
technicians)
– Device tracking (hazards & recalls)
– Incident reporting & investigation
© SHCTA / slg - 12
 Policies & Procedures

• Policies
Statements of principles and values that
guide organizational activities …
Effective policies are flexible, coordinated,
comprehensive, ethical, and clear
• Procedures
Defined courses of established methods
used to achieve an objective

© SHCTA / slg - 13
 Policies & Procedures
1. Equipment Classification System ~ Criteria for including equipment
categories in program
2. Biomedical equipment inventory management ~ Process for adding, deleting
3. Inspection & PM ~ Determining protocols & frequencies
4. Obtaining Equipment Service/Repair
5. Incoming inspection of all medical devices & systems ~ Installation &
acceptance testing of all purchased, leased, loaned devices
6. Storing & Retiring medical equipment
7. Medical Device Tracking ~ Dealing with hazards and recalls
8. Education/Training ~ Regarding proper use, testing & troubleshooting
9. Evaluating Healthcare Technology Management Program effectiveness
10. Incident reporting & investigation
11. Reporting to Safety Committee

© SHCTA / slg - 14
 C linical En g ine e rin g
Equipment Inventory
0 11 1 7 8

In ven tor y Prin tout

I N VE N T O R Y
- I D o r C o n t ro l #
- D e sc ri p t i o n
- M a n u f a ct u re r
- M o d el #
- S e ri a l #
- L o ca t i o n / C o st C en te r
- A c q u i si t i o n D a te / C o st
- M a i n t e n a n c e r e q ui r em e n t s
( fr eq u e n c y/ s c he d u le )

- IN
I
Do r V
C E
o n
t N
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# O R Y

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IN V E N T O R Y
- I D o r C o n tro l #
- D e sc r ip tio n
- M a n u fa c t u r e r
- M odel #
- S e r ia l #
- L o c a tio n / C o s t C e n te r
- A c q u isitio n D a te/ C o st
- M a in te n a n c e re q u irem e n ts
( freq u en c y /s c h ed u le )

© SHCTA / slg - 15
 Centralized Documentation System
O p era tor ’s &
Servic e Serv ice M a nua ls
Rep o rts

S ervice M an ua l
Operator’s Manual
C linical E n gine e rin g

0 11 1 7 8

In spec tio n Recalls &

Form s Hazard Reports

© SHCTA / slg - 16
 Incoming Inspection of
Biomedical Equipment
Purcha sed,
Lea sed
D em o or
Loa ner
Eq uipm ent

C linica l Bio m ed ic a l Eq uip m e n t

Eng inee r Tec h n ic ia n (BM ET)

C entra lized B io m ed ica l

G EN TECH

0 11 1 7 8
E q uipm e nt Do cum enta tio n

G EN TEC H
D ate: ______ By : _______

Eq u ip m e n t In ve n to ry In spe c tio n
& EM C la ssific a tio n Fo rm

© SHCTA / slg - 17
 Equipment Management Program
“Risk-based Classifications”
Equipm e nt Ca tegorie s

In clu de d in pro gram

GEN TEC H
Da te: ______ By : _______
GEN TEC H

H ig h EM R a ting/S core
Da te: ______ By : _______

E quipm e nt M anagem ent (E M)

Category Cla ssific ation P olicy/Proce dure

A pplication
+ Risk
+ M a in ten ance R equirem en ts
+ History G EN TEC H

G EN TEC H

=Total E M Rating/Score
Low EM Rating/S core

Exe mp t from p rogram

© SHCTA / slg - 18
 Biomedical Inspection/PM Program
Insp e c tio n Sc h e d u le
Insp e c tio n
M a rc h Pro c e du re s
& Fo rm s
Sunda y M o nd a y Tue sd ay We d n esd a y Thursda y Frid ay Sa turd ay
00 00 00 00 00 00 00

Bio m e dic a l 00 00 00 00 00 00 00

G EN TEC H

Equ ip m e n t 00 Feb ru a r y
00 00 00 00 00 00 Date: ______ By : _______

Inv en to r y
Sund a y M o nd ay Tue sd a y W ed n e sda y Thursd a y Frid a y Sa turd a y
00 00 00 00 00 00 00 00 00 00 00 00 00 00

00 00 00 00 00 00 00
00 00 00 00 00 00 00

00
Ja n ua r y
00 00 00 00 00 00
G EN TEC H
S unda y M o nd a y Tue sda y We dn esd a y Thursda y Frid ay Sa turda y Date: ______ By : _______
00 00 00 00 00 00 00
00 00 00 00 00 00 00

00 00 00 00 00 00 00
00 00 00 00 00 00 00

00 00 00 00 00 00 00

00 00 00 00 00 00 00
G EN TEC H
Date: ______ By : _______
00 00 00 00 00 00 00

C e n tra lize d
B iom e d ica l
Eq uip m e nt
D o c u m e n tatio n

© SHCTA / slg - 19
Biomedical Equipment Tagging System
Inve n to r y C lin ic a l E n g in e e r in g

Ta g
0 11 1 78 N O T IC E

Inspe c tion C LIN ICA L E NG IN EE RIN G

S E RVI CE S
O p e ra to r
Ta g D ate: ______ By : _______ W arn in g
D O NO T R EM O V E LA BE L
Tag

Exem pt CL INI CA L E NG IN EE RI NG
S ERV IC ES

Ta g
B ased on crite ria ad op ted by the sa fety
com mitte e, this de vice is e xe mp t fro m the

D EFEC TIVE
org an izatio n’s E qu ip m ent Ma na gm en t
P rogra m. S ervice records a re o n file in
B io me dical En gine ering.

D o N o t U se Red
Sto ra ge C lin ic al E n g in e e r in g
This e quipment has bee n p laced in storage.
C om m ents: __ ____ _____ (Re m o ve
___ ____ ____ ____ ____ __
Ta g C on ta ct Biomed ica /Clinical E ngineering
be fo re using ___ ____ ____ ____ ____ __ fro m Ser vic e )
___ ____ ____ ____ ____ __
D ATE : _______ BY: _______
Tag
C lin ic a l En g ine erin g

© SHCTA / slg - 20
Biomedical Equipment Service/Repair

E q u ip m en t C linica l
U ser Se rvice E ng in e e rin g
DEFEC TIVE
Re que st
Do No t Use

GEN TECH

Biom ed ica l Eq u ip m e nt
Tech n icia n (BM E T)
C e ntra lized Bio m ed ica l
E quip m e nt D o cum entation

- Or -
er
fa c tu r
M a n u S e rv ic e
ir
R ep a

Service
© SHCTARep
/ slgort
- 21
 Biomedical Equipment
Storage/Retirement
C lin ic al E n g in ee r in g - Te m p o ra rily rem ov ed
This equipment h as b een placed in storage.
C on tact Bio me dica/Clinical E ngin eering
fro m se rvic e m ent
E q u ipa g e
b efo re u sing S to r

D EFEC TIVE
D o N o t U se ic e
rv
C om m ents: __ ____ ____ S e_
o m ___
__ ____ ____ ____
e f r ____
v____
__ ____ ____
__ ____
o
m ____
R e____ p o
____ ___
s e____ ___ - O b so le te o r
d is - Re p air no t c o st-e ffe c tive
D ATE : _&___ ___ BY: _______

C lin ic a l En g ine erin g

© SHCTA / slg - 22
 Acquisition of Biomedical Equipment
1. Assess Need ~ Determine Specifications
2. Compare available manufacturers & models. Assess
ease of use, ease of maintenance, operating & life
cycle costs
3. Make selection & prepare purchase order with
specifications including operator & service manuals,
user & service training, warranty, etc.
4. Acceptance/payment conditional on passing
incoming technical inspection, inclusion of manuals,
provision of user & service training, adequate
warranty

© SHCTA / slg - 23
 Equipment Hazard/Recall Program
M an u fa c tu re r F D A E nfo rc e m e n t EC R I/He a lth C e ntra lized B io m ed ica l
Re ca lls & A lerts Re p o rts D e vic e s A le rts E q uip m e nt D o cum enta tion

A c tio n Re po rts

C linic al En g in e e r

Bio m e d ic a l
Eq u ipm e n t
Inv e n to r y
© SHCTA / slg - 24
 Equipment Program Education

• Clinical Staff
– Basic operation & proper use
– Basic Troubleshooting
– Potential hazards
– Equipment management (dealing with obtaining equipment
service, equipment related incidents
• Clinical engineering staff
– Professional (mission, ethics, conduct)
– Codes & standards
– Technical (troubleshooting & use of equipment)
– Clinical equipment operation & inspection procedures
– Policies, procedures & documentation
© SHCTA / slg - 25
 Equipment Related Incident
Investigation
1. Minimize further injury to patients & personnel
2. Minimize any damage to equipment & facilities
3. Impound all equipment, supplies, disposables,
wrappers, etc.
4. Identify witnesses
5. Notify Risk manager, clinical engineering
6. Complete incident report
7. Notify authorities H A ZA R D O U S

E N V IR O N M E N T

© SHCTA / slg - 26
 Equipment Management Program
Benchmarking
• Safety Committee
How to measure program performance &
effectiveness?
• Establish Goal & Compare with Actual
For example:
– User related equipment problems
– Scheduled vs Actual inspections
– Percent of inspections with problems found

© SHCTA / slg - 27
 Typical Organization Chart
Healthcare Technology Program
Dir of Engineering
Dir. Of
Information Technology Safety
Committee

Healthcare Technology Management

Program Manager

Biomedical
Clinical Engineers Administrative Staff
Equipment Technicians

• Technology Consultation • Inspection • Bookkeeping

• Pre-purchase evaluation, life cycle • Preventive Maintenance • Accounts Payable & Receivable
cost analysis • Calibration • Payroll & Benefits Management
• Education of users, technicians • Repair • Correspondence
• Compliance (government, • Filing
accrediting authorities) • Data entry
• Device Tracking (Hazards, Recalls) • Reporting
• Incident Investigation
• Contract/vendor management
© SHCTA / slg - 28
 Organizational Reporting

• Reports directly to
– Director of Engineering (a “traditional” approach)
– Director of Information Technology (the “trend”)
– Other (e.g., Administrator of Support Services)
• Also reports indirectly to
– Safety Committee (interdisciplinary group responsible
for hospital safety … including technology
management elements)

© SHCTA / slg - 29
 Safety Committee
• Purpose
To bring members of the healthcare team together in an non-
adversarial environment to:
♦ identify issues affecting patient & staff safety and formulate an
effective approach toward the resolution of those issues
♦ reviews and approves elements of technology management
program that impact on safety of patients & staff
• Membership must be interdisciplinary to be effective
Typically includes representatives of
• administration • medical staff
• nursing/clinical staffs • education
• personnel • purchasing
• engineering • security
• risk management • clinical engineering

© SHCTA / slg - 30
 Staff Qualifications
• Biomedical Equipment Technicians (BMET)
– Associate Degree in Technology (AA) or higher,
Military or Manufacturer Training
– Certified Biomedical Equipment Technician (CBET)
– Specialties: General Biomedical, Laboratory, Medical Imaging
– Rankings: Level I, II, III … higher level reflects more
experience, education and/or specialization
• Clinical Engineers (CE)
– Batchelor or Masters of Science Degree in Engineering
– Certified Clinical Engineer (CCE)
• Manager
– Clinical Engineer
– Master’s in Business Administration … or business education
© SHCTA / slg - 31
 Organization Chart for
Small Clinical Engineering Program
Typical
BMET
• 300-500 bed hospital Supervisor
• 1500 device inventory

Clerk

BMET BMET BMET

Level I Level I Level II

9 Capable of providing basic service on majority of general

biomedical devices
9 3rd parties provide most sophisticated technical services
9 3rd party provides clinical engineering consultation &
related services
© SHCTA / slg - 32
 Organization Chart for
Medium Clinical Engineering Program
Director,
Clinical
Engineering
Typical
• 500-700 bed hospital Supervisor, Supervisor, Administrative
• 2000 device inventory CE BMET Assistant

Clinical BMET BMET

Engineer Level III Level II

BMET BMET
Level II Level II

9 Capable of providing basic to mid-level services on all but most

sophisticated medical devices (e.g., lab, imaging) in inventory
9 Capable of providing basic clinical engineering services
9 3rd party provides most sophisticated technical services (e.g.,
lab, imaging)
9 3rd party provides high-level clinical engineer services
© SHCTA / slg - 33
 Organization Chart for
Large Clinical Engineering Program
Typical
Director,
• 1000-1500 bed hospital Clinical
Engineering
• 4000 device inventory

Supervisor, Supervisor, Supervisor, Supervisor, Administrative

CE BMET Lab BMET Imaging BMET Assistant

BMET BMET BMET BMET BMET

Senior CE Clerk
Level III Level II Level II Level III Level III

BMET
Clinical BMET
Level II
Engineer Level 1

BMET
Level 1

9 Capable of providing basic to high-level services on almost all medical

devices on inventory (including imaging, lab)
9 Capable of providing basic to high-level clinical engineering services
9 3rd party provides sophisticated technical services on few devices
9 3rd party provides audit of clinical engineer services
© SHCTA / slg - 34
 Clinical Engineering Center 2,200 Sq Ft

Meeting/
Training
Supervisor & Sr Tech
Library
Copy, Fax, Print
Technicians
Test
Equip

Parts Manager

Incoming Admin
Outgoing
Asst
© SHCTA / slg - 35
 Equipment & Other Resources
• Test & Repair equipment • Library
– Oscilloscope – reference books
– Digital multimeter – equipment manuals,
– Electronic thermometer
– Electronic pressure/vacuum – reference guides,
gauge – subscriptions to journals, services
– Spirometer
– Flowmeters • Office furnishings
– ECG analyzer – Workbenches
– Defibrillator analyzer – Desks
– Electrosurgical unit analyzer – Chairs
– Gas analyzer
– Electrical safety analyzer – Stools
– Pacemaker analyzer – Tables
– Hand tools – File cabinets
• Office equipment – Shelving units
– Computers, printers – Storage cabinets
– Photocopiers,
– Facsimile

© SHCTA / slg - 36
 Logistic Models for Service Delivery
• Service Delivery Models
– Centralized (dispatch or depot)
• less duplication, easier management
– Distributed
• Better response time (therefore less downtime)
• Generally less efficient use of resources (more costly)
• Issues affecting decision on which model is
best for situation
– Nature (method) & quality of communications
– Geography of service area (i.e., travel distances)
– Nature (method) & quality of transportation available
– Response time necessary

© SHCTA / slg - 37
Mixed Approach toward Service Delivery

• Use resident or in-house services for

“basics”
• Use centralized or ISO services for more
technically specialized needs

© SHCTA / slg - 38
Centralized Model for Service Delivery
Central Technology
Management
Office and
Service
Center

Client
Hospitals

HH HH HH HH

© SHCTA / slg - 39
Central Dispatch Model for Service Delivery
In this scenario
Cost = 3 hours labor
Downtime = 3 hours
M an
u fa
R e p a c tu r e r
ir S e
rv ic e

1 hour travel
H
1 hour
Technical Service Center labor

1 hour travel

r er
fa c tu
M a n u S e rv ic e
a ir
R ep

Necessary if
• equipment is not portable
• speed to restore is critical © SHCTA / slg - 40
Central Depot Model for Service Delivery
In this scenario:
Cost = 1 hour labor plus shipping
Equipment Downtime = 2-3 days

1 day ship out

H H
1 hour
labor Technical
Service Center
1 day return ship

OK if
• there is redundant capacity &
• equipment is portable © SHCTA / slg - 41
 Distributed (Resident) Model
for Service Delivery
Central Office
for Technology
Management

Hospital-based
Resident
Programs

HH HH HH HH

© SHCTA / slg - 42
 Centralized H

Technician Schedule
Location Beds Mon Tues Wed Thu Fri
Hospital #1 500 2 2 3 2 3
Hospital #2 350 1 2 1 2 2
Hospital #3 200 1 1 1 1 1
Hospital #4 170 1 1 1 1
Hospital #5 150 1 1 1
Hospital #6 100 1 1
Hospital #7 50 1
Depot 2 2 2 2 2
Total 1530 9 9 9 9 9

Important that clients can rely on a firm schedule …

there will be fewer “emergencies”

© SHCTA / slg - 43
 Advantages/Disadvantages
of Sourcing Options
• In-house (e.g., hospital owned & based)
– Less expensive in organizations with larger workload
– Hospital can exercise more control over process
• Independent Service Organization (ISO)
– Less expensive in organizations with smaller workloads
– Usually a more efficient use of resources
– Shared resources with other clients (program
development, management, specialized technical
expertise & equipment)
Access to resources (specialized expertise, equipment)
that couldn’t be afforded on own
© SHCTA / slg - 44
 Questions?

Thank You!
Stephen L. Grimes, FACCE
slgrimes@shcta.com
www.shcta.com

© SHCTA / slg - 45