C

U
R
S
O

E

O
F
I
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I
N
A

D
E

T
R
A
B
A
L
H
O

S
O
B
R
E

G
E
R
E
N
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I
A
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O

D
E

R
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S
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O

E

S
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G
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S
O

E

O
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I
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I
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A

D
E

T
R
A
B
A
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H
O

S
O
B
R
E

G
E
R
E
N
C
I
A
M
E
N
T
O

D
E

R
I
S
C
O

E

S
E
G
U
R
A
N
A
N

A

E
M

S
A
A

E
M

S
A

D
E
D
E
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Management in Healthcare
Risk Management in Healthcare
Frank R. Painter, MS, CCE Frank R. Painter, MS, CCE
Clinical Engineering I nternship Clinical Engineering I nternship
Program Director Program Director
University of Connecticut University of Connecticut
Healthcare Technology Consultant Healthcare Technology Consultant
2 2
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S
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o

P
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-
S
P
,

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r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
ACCE
ACCE

American College of Clinical

American College of Clinical
Engineering
Engineering

Professional society of Clinical

Professional society of Clinical
Engineers
Engineers
3 3
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C
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E
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a
o

P
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-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Versus Safety
Risk Versus Safety
Safety & Risk; opposite sides of the
Safety & Risk; opposite sides of the
same coin
same coin

If risk goes up, safety goes down

If risk goes up, safety goes down

If risk goes down, safety goes up

If risk goes down, safety goes up

Everyone likes safety; no one likes

Everyone likes safety; no one likes
risk
risk
4 4
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d

C
l
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c
a
l

E
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a
o

P
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o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Versus Safety
Risk Versus Safety

Risk management identifies risks,

Risk management identifies risks,
analyzes risk data and mitigates risk
analyzes risk data and mitigates risk

Safety programs manage that risk

Safety programs manage that risk
through education, maintenance,
through education, maintenance,
design, and personal protective
design, and personal protective
equipment
equipment
5 5
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c
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a
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E
n
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M
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a
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S
a
o

P
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l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Understanding Safety
Understanding Safety

Safety = The level of risk you are

Safety = The level of risk you are
willing to accept
willing to accept

Safety
Safety
is freedom from danger,
is freedom from danger,
risk or injury
risk or injury

Safety is subjective
Safety is subjective
6 6
A
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n
c
e
d

C
l
i
n
i
c
a
l

E
n
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i
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r
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p

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R
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M
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S
a
o

P
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-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Understanding Risk
Understanding Risk

Risk
Risk
is the possibility of suffering
is the possibility of suffering
harm or loss
harm or loss

Probability of an event
Probability of an event

Severity of an event
Severity of an event

Risk = Probability x Severity

Risk = Probability x Severity

Risk is measured in numbers

Risk is measured in numbers
7 7
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d

C
l
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c
a
l

E
n
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a
o

P
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u
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o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Acceptance
Risk Acceptance
Acceptable
considering
the benefit
Probability
S
e
v
e
r
i
t
y
Generally
unacceptable
Generally
acceptable
8 8
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d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
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S
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r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Managing Risk
Managing Risk

Reduce the probability

Reduce the probability

Reduce the severity

Reduce the severity
9 9
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C
l
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E
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5

7
,

2
0
0
7
10 10
A
d
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c
e
d

C
l
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c
a
l

E
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s
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M
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a
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S
a
o

P
a
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o

-
S
P
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B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
11 11
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
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r
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g

W
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s
h
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a
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M
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m
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t

a
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S
a
o

P
a
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-
S
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,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
12 12
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
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M
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m
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a
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y
S
a
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P
a
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o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Healthcare Risks
Healthcare Risks

Medication Errors
Medication Errors

Wrong Site Surgery
Wrong Site Surgery

Hospital Acquired Infections
Hospital Acquired Infections

Managing Multiple Alarms
Managing Multiple Alarms

Patient Restraints
Patient Restraints

Electromagnetic Interference
Electromagnetic Interference

Patient Falls
Patient Falls

Surgical & ICU Fires
Surgical & ICU Fires

Electrosurgical Burns
Electrosurgical Burns
13 13
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d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
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r
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g

W
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s
h
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H
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a
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m
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t

a
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S
a
o

P
a
u
l
o

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S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
14 14
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
e
r
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n
g

W
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k
s
h
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p

-
H
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a
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a
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R
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M
a
n
a
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m
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t

a
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d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Managing Risk
Managing Risk
CONTROL
take actions to
avoid/minimize
risks
EVALUATE
compute risk exposures and
determine which risks pose
the greatest threat, and how
they might be averted
ANALYZE
estimate the likelihood
and loss of each
outcome, under all
alternative choices or
decisions
PLAN ACTION
avoid/minimize risks
MONITOR
monitor risk prevention
activities and modify as
needed
ASSESS
RISK
identify, name and
categorize risks
15 15
A
d
v
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c
e
d

C
l
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c
a
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E
n
g
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e
e
r
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g

W
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k
s
h
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p

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H
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a
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t
h
c
a
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R
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s
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M
a
n
a
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e
m
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n
t

a
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d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Unusual Conditions in
Unusual Conditions in
Hospitals Increase Risk
Hospitals Increase Risk

Functions 24 x 7
Functions 24 x 7

Multiple functions; patient care, cafeteria, clinical

Multiple functions; patient care, cafeteria, clinical
lab, laundry, etc
lab, laundry, etc

Hospital equipment varied and complex

Hospital equipment varied and complex

Hazards affect healthy staff as well as severely ill

Hazards affect healthy staff as well as severely ill
& immobile patients
& immobile patients

Hazards
Hazards

mean fires, infections, security issues,

mean fires, infections, security issues,
chemicals and the like
chemicals and the like

Hazards vary with equipment and applications

Hazards vary with equipment and applications

Hazards constantly changing

Hazards constantly changing
16 16
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
e
r
i
n
g

W
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k
s
h
o
p

-
H
e
a
l
t
h
c
a
r
e
R
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s
k

M
a
n
a
g
e
m
e
n
t

a
n
d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Integrated Safety
Integrated Safety
Program
Program
(Tobey Clark)
(Tobey Clark)
Environmental Safety
Employee Safety
Risk Management
Patient Safety
17 17
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
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r
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g

W
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k
s
h
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p

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H
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a
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R
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s
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M
a
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a
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m
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t

a
n
d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Hospital Risk Management
Hospital Risk Management
Programs
Programs

One component of an overall quality

One component of an overall quality
control program
control program

Historically, treated as separate process

Historically, treated as separate process

Recently integrated into quality

Recently integrated into quality
assurance and patient safety activities
assurance and patient safety activities

Risk managers, safety officers, quality

Risk managers, safety officers, quality
assurance, & patient safety
assurance, & patient safety

All integrated at some level

All integrated at some level
18 18
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
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e
r
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g

W
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s
h
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H
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a
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t
h
c
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M
a
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m
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t

a
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a
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y
S
a
o

P
a
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l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Hospital Risk Management
Hospital Risk Management
(continued)
(continued)

Risk is an exposure to the chance of

Risk is an exposure to the chance of
injury or financial loss
injury or financial loss

Risk Managers reduce liability & costs

Risk Managers reduce liability & costs
by managing risks
by managing risks

Accident data analysis

Accident data analysis

Constant systems improvements to

Constant systems improvements to
reduce risk
reduce risk
19 19
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
e
r
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g

W
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k
s
h
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p

-
H
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a
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t
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c
a
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M
a
n
a
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e
m
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t

a
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S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Management
Risk Management

Insurance policies
Insurance policies

Malpractice
Malpractice

Liability
Liability

Errors & Omissions

Errors & Omissions

Claims management
Claims management

Risk reduction strategies

Risk reduction strategies

Incident investigation
Incident investigation
20 20
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
e
r
i
n
g

W
o
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k
s
h
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p

-
H
e
a
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t
h
c
a
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R
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k

M
a
n
a
g
e
m
e
n
t

a
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d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Management Tools
Risk Management Tools

Administrative support
Administrative support

Hazard identification
Hazard identification

Hazard evaluation
Hazard evaluation

Training
Training

Controls
Controls

Communications
Communications

Record keeping
Record keeping

Program review & improvement
Program review & improvement

Total involvement
Total involvement
21 21
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
e
r
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g

W
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k
s
h
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H
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a
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c
a
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M
a
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a
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m
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t

a
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S
a
f
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t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
J CAHO
J CAHO

Environment of Care Standards
Environment of Care Standards

Safety Management
Safety Management

Security Management
Security Management

Hazardous Materials & Waste Management

Hazardous Materials & Waste Management

Emergency Management
Emergency Management

Life Safety (Fire Safety) Management

Life Safety (Fire Safety) Management

Medical Equipment Management

Medical Equipment Management

Utility Systems Management

Utility Systems Management

Safety Committee & Safety Officer

Safety Committee & Safety Officer
22 22
A
d
v
a
n
c
e
d

C
l
i
n
i
c
a
l

E
n
g
i
n
e
e
r
i
n
g

W
o
r
k
s
h
o
p

-
H
e
a
l
t
h
c
a
r
e
R
i
s
k

M
a
n
a
g
e
m
e
n
t

a
n
d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
J CAHO
J CAHO

Patient Safety Standards

Patient Safety Standards

Annual FMEA (Failure Mode

Annual FMEA (Failure Mode
and Effect Analysis)
and Effect Analysis)

Sentinel Events
Sentinel Events

RCA (Root
RCA (Root
Cause Analysis)
Cause Analysis)

National Patient Safety Goals

National Patient Safety Goals
23 23
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W
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a
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R
i
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M
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e
m
e
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t

a
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S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
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7
Clinical Engineers as Risk
Clinical Engineers as Risk
Managers
Managers

By definition, clinical engineers

By definition, clinical engineers

apply
apply
engineering and managerial skills to
engineering and managerial skills to
the advancement of health care.
the advancement of health care.

Engineering education
Engineering education

Scientific method (cause and effect)

Scientific method (cause and effect)

Analysis of systems and processes

Analysis of systems and processes
(identify root causes)
(identify root causes)
24 24
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C
l
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E
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W
o
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h
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p

-
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a
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h
c
a
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R
i
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M
a
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e
m
e
n
t

a
n
d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Clinical Engineers as Risk
Clinical Engineers as Risk
Managers
Managers

Knowledge:
Knowledge:

How technology works

How technology works

How hospitals work

How hospitals work

How the human body works

How the human body works

How the human mind works

How the human mind works

How to investigate an accident

How to investigate an accident

How to work with people

How to work with people

How to write technical reports

How to write technical reports
25 25
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R
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M
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t

a
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S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Engineering & Risk
Engineering & Risk
Reduction
Reduction

Contributions to risk reduction and

Contributions to risk reduction and
patient safety:
patient safety:

Medical equipment planning

Medical equipment planning

Medical equipment inspection

Medical equipment inspection

Medical equipment maintenance

Medical equipment maintenance

Training medical equipment users

Training medical equipment users
26 26
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a
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R
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M
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m
e
n
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a
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a
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e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Engineering & Risk
Engineering & Risk
Reduction
Reduction

Management of recalls & hazard alerts

Management of recalls & hazard alerts

Analysis of maintenance records

Analysis of maintenance records

Review of
Review of

near miss
near miss

events
events

Incident investigation
Incident investigation

User Training
User Training

Quality Improvement
Quality Improvement
27 27
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R
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M
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m
e
n
t

a
n
d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Systems Approach to
Systems Approach to
Reducing Medical Device Risk
Reducing Medical Device Risk

Assure safety of systems & processes

Assure safety of systems & processes

Modify systems & processes as

Modify systems & processes as
recommended by the team
recommended by the team

Investigate failures
Investigate failures

Identify root causes

Identify root causes

Modify the
Modify the
systems
systems
to prevent future
to prevent future
failures
failures

Benefit from past failures

Benefit from past failures
28 28
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e
m
e
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t

a
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d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Manufacturers
Manufacturers

Know their devices

Know their devices

Use FMEA in design

Use FMEA in design

Use human factors

Use human factors
engineering and usability
engineering and usability
testing in design
testing in design

Keep a complaint file

Keep a complaint file

Listen to feedback and

Listen to feedback and
improve the design
improve the design
29 29
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M
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a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
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2
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7
Healthcare Workers
Healthcare Workers

Device training
Device training

How it works
How it works

What can go wrong

What can go wrong

What happens when it goes wrong

What happens when it goes wrong

Report problems without fear of

Report problems without fear of
punishment or ridicule.
punishment or ridicule.

Competency assessment
Competency assessment
30 30
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S
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.

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2
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Patients and Family
Patients and Family

Device Training
Device Training
31 31
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B
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N
o
v
.

5

7
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2
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7
Clinical Engineers
Clinical Engineers

Device Training
Device Training

Service and inspection

Service and inspection

Investigate problems
Investigate problems

Provide feedback to healthcare

Provide feedback to healthcare
workers
workers

Advise administration
Advise administration
32 32
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N
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v
.

5

7
,

2
0
0
7
Administration
Administration

Know devices in general

Know devices in general

Costs, risks, supplies, maintenance

Costs, risks, supplies, maintenance

Support training and improvement

Support training and improvement

Support non
Support non
-
-
punitive problem
punitive problem
reporting
reporting

Provide record keeping

Provide record keeping

Share information
Share information

Have a plan
Have a plan
33 33
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a
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a
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e
t
y
S
a
o

P
a
u
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o

-
S
P
,

B
r
a
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i
l

N
o
v
.

5

7
,

2
0
0
7
Government
Government

Regulate medical device quality

Regulate medical device quality

Create systems to share information

Create systems to share information

Facilitate open communications

Facilitate open communications

Publicize trends
Publicize trends

Encourage quality healthcare systems

Encourage quality healthcare systems

Acknowledge good performance

Acknowledge good performance
34 34
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a
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a
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e
t
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a
o

P
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u
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o

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S
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B
r
a
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i
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N
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v
.

5

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2
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Risk Management
Risk Management
Summary
Summary

Safety must begin at the top

Safety must begin at the top
---
---
Ministry
Ministry
of Health, Local Health Authorities
of Health, Local Health Authorities
,
,
and hospital administrators
and hospital administrators
---
---
but must
but must
be implemented by motivated staff
be implemented by motivated staff
members
members

Risk management must be fully

Risk management must be fully
integrated into our health care culture,
integrated into our health care culture,
systems and processes
systems and processes
35 35
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M
a
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e
m
e
n
t

a
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d

S
a
f
e
t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

7
,

2
0
0
7
Risk Management
Risk Management
Summary
Summary
(continued)
(continued)

Investigation of accidents, incidents and
Investigation of accidents, incidents and

near hits
near hits

can provide information that will

can provide information that will
allow improvements in systems and
allow improvements in systems and
processes
processes

Clinical Engineers are valuable team
Clinical Engineers are valuable team
members
members

Educated, trained and experienced in accident

Educated, trained and experienced in accident
investigation, they can provide the identification
investigation, they can provide the identification
of the root causes of failed systems
of the root causes of failed systems
36 36
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a
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R
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M
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m
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t

a
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S
a
f
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t
y
S
a
o

P
a
u
l
o

-
S
P
,

B
r
a
z
i
l

N
o
v
.

5

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2
0
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7
perguntas
comentrios
&