By Allyson Doan, Verica Saveski, Jere

Sims, and Dallisa Williams

April 27,2010
Understand what Healthcare Failure Mode and
Effect Analysis Method is.
Know the history of the Failure Mode and
Effect Analysis Method.
Know FMEA terms.
Know how to use the FMEA method.
Know when this method is used and by whom.
Know the steps to use the method.

The process of
evaluation to identify
where and how a design
inadequacy might fail by
assessing the impact of
difference failures, and
identifying the parts of
the process that are in
most need of change.
Developed in the U.S. Military 11/9/1949.

Titled Procedures for Performing a Failure
Mode, Effects, and Critical Analysis
Failures were classified according to their impact on
mission success and personnel/equipment safety

Cayman Business Systems, 2004
Failure Mode
The way in which a process can fail
Effect
The impact on the process or customer requirements as a
result of the failure
Severity
The impact of the effect on the customer or process
Root Cause
The initiating source of the failure mode
Occurrence (or frequency)
How often the failure is likely to occur
Detection
The likelihood that the failure will be discovered in a
timely manner, or before it can reach the customer

iSix Sigma, 2010
Steps in the process
Failure Modes
What could go wrong?
Failure causes
Why would failure happen?
Failure effects
What would be the consequences of each failure?

Institute for Healthcare Improvement, 2010
Analyze and evaluate processes for potential
impact of considered changes
Discuss and analyze steps of a process
Consider changes
Calculate Risk Priority Number (RPN)
Obtained by multiplying values assigned to severity,
occurrence, and detection.
Track improvement over time
calculate the total RPN for a process
track the RPN over time to see if changes have lead
to improvement

Institute for Healthcare Improvement, 2010
All health facilities that are accredited by
JCAHO use the FMEA method. A FMEA is
performed at least once a year for all accredited
health facilities.
The JCAHO standards are used by hospitals,
physicians, nurses, pharmacists and other health
care organizations, as a means to improve
quality of care in the organization. The JCAHO
is used to accredit and certify medical
organizations.
http://medicalhealthcarefmea.com/
Standard MM.2.20 Medications are
properly and safely stored.
Standard MM.2.30 Emergency
medications and/or supplies are
consistently available, controlled, and
secured.
Under the Code Documentation and
Quality Review of Codes, there are
standards like:

Standard PI.1.10 The hospital collects data to
monitor the performance of potentially high-
risk processes, e.g. resuscitation and its
outcomes.
Standard PI.2.10 Data are systematically
aggregated and analyzed.

Data are analyzed and compared internally
over time and externally with other sources of
information when available.
Comparative data are used to determine if
there is excessive variability or unacceptable
levels of performance when available.

Standard PI.2.20 Undesirable patterns or
trends in performance are analyzed.
Standard PI.3.10 Information from data
analysis is used to make changes that improve
performance and patient safety and reduce the
risk of sentinel events.
JCAHO standards are also used for medical
restraints, administering medication and
conscious sedation.

Leads to improved patient care
Demonstrates the organization's commitment to
safety and quality
Offers a consultative and educational experience
Supports and enhances safety and quality
improvement efforts
May substitute for federal certification surveys for
Medicare and Medicaid
Provides a competitive advantage
Fulfills licensure requirements in many states
Recognized by insurers and other third parties
Strengthens community confidence

Step 1. Define the Scope of the HFMEA along with a
clear definition of the process to be studied:

FMEA is focused on ICU Monitors and response time.

Step 2. Assemble the team and define goals:

Team Members: Management, Physicians, Nursing
Staff, Respiratory Therapists, Biomedical Engineer
Goal: To reduce response time to ICU Monitor
Alarms

Healthcare FMEA Process
Teaching Example 1
Step 3a. Graphically describe process:




Patient transferred
to
ICU
Patient connected
to monitor
and equipment
Provide care
and monitor
alarms
Respond as
appropriate
Sub-Process Steps 1
a. Determine type
of isolation &
post
b. Determine
parameters to be
monitored
c. Gather and
calibrate monitor
and accessories
Sub-Process Steps 2
a. Connect to
ventilator if
required
b. Connect
monitoring
devices to patient
c. Set alarm
parameters
d. Test alarm
broadcast
Sub-Process Steps 3
a. Periodically
check monitor
status
b. Respond to
alarms
Sub-Process Steps 4
a. Verify validity of
alarms
b. Reconnect
equipment as
needed
c. Medically
intervene as
needed
d. Silence alarm
e. Readjust alarm
parameters as
needed
(Dunn, n.d)
Healthcare FMEA Process
Teaching Example 1
Step 3b. List failure modes:




Patient transferred
to
ICU
Patient connected
to monitor
and equipment
Provide care
and monitor
alarms
Respond as
appropriate
Failure Mode 1
a. Determined
wrong
parameters to be
monitored

Failure Mode 2
a. Incorrectly
connected
monitoring
devices
b. Did not set alarm
parameters
c. Did not test
alarm broadcast
Failure Mode 3
a. Failed to check
status
b. Misread or
misinterpret
c. Partially check
d. Did not respond
e. Respond slowly
or late
Failure Mode 4
a. Did not verify
alarm
b. Did not adjust
parameters
Identified
area of
failure
(Dunn, n.d)
Step 4. Analyze each identified failure mode:
Determine probability, severity and detectability
using rating scale.

Step 5. List causes, interventions and outcome:
Redesign process by assigning action to eliminate
or control failure mode.

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16 N N Y
3B1a Ignored alarm
(desensitized)
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16 N N Y C
Reduce unwanted alarms by:
changing alarm parameter to fit
patient physiological condition
and replace electrodes with
better quality that do not become
detached
Unwanted alarms on
floor are reduced by
75% within 30 days of
implementation.
N
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3B1b Didn't hear; care
giver left immediate
area
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12 N N Y C
Alarms will be broadcast to
Central Station with
retransmission to pagers
provided to care staff.
Alarms will be
broadcast to the
central station within 4
months; complete by
mm/dd/yyyy B
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3B1c Didn't hear; alarm
volume too low
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12 N N Y E
Set alarm volume on isolation
room equipment such that the
lowest volume threshold that can
be adjusted by staff is always
audible outside the room.
Immediate; within 2
working days;
complete by
mm/dd/yyyy
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3B1d Didn't hear alarm;
remote location
(doors closed to
isolation room)
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16 N N Y C
See 3B1b See 3B1b
3B1e Caregiver busy;
alarm does not
broadcast to
backup
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12 N N Y C
Enable equipment feature that
will alarm in adjacent room(s) to
notify caregiver or partner(s).
Immediate; within 2
working days;
complete by
mm/dd/yyyy
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Yes
Actions or Rationale for
Stopping
Outcome
Measure
3B1 Don't
respond to
alarm
HFMEA Subprocess Step: 3B1 - Respond to Alarms
Scoring Decision Tree Analysis
HFMEA Step 5 - Identify Actions and Outcomes HFMEA Step 4 - Hazard Analysis
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Failure
Mode: First
Evaluate failure
mode before
determining
potential
causes
Potential
Causes
A
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T
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(
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,

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,

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)
(Dunn, n.d)
Healthcare FMEA Process
Teaching Example 1
Step 1.
FMEA is focused on Bar Code Medication
Administration and accurate documentation of
medications.

Step 2.
Team Members: Management, Nursing Staff,
Pharmacy staff, Information Resource
Management

Goal: To accurately record dispensation of
medication.

Healthcare FMEA Process
Teaching Example 2
Step 3a. Graphically describe process:




Medication ordered
Auto electronic
Transfer to
Pharmacy package
Pharmacy fills
script & sends
to unit
Nurse administers
Sub-Process Steps 1
a. Order sent to
pharmacy

Sub-Process Steps 2
a. Check drug
allergies &
interations
b. Check proper
dosages
c. Send order to
auto dispensing

Sub-Process Steps 3
a. Fills verified
orders
b. Loads med-cart
and sends to unit

Sub-Process Steps 4
a. Logs on to laptop
b. Retrieves meds
from med-cart
c. Scans meds and
patiends ID band
d. Administers
medication to
patient
e. Patient medical
records updated
(VA National Center for Patient Safety, n.d)
Healthcare FMEA Process
Teaching Example 2
Step 3b. List failure modes:




Medication ordered
Auto electronic
Transfer to
Pharmacy package
Pharmacy fills
script & sends
to unit

Nurse administers
Failure Mode 1
a. Order is not sent to
pharmacy

Failure Mode 2
a. Allergies and
interactions are not
verified
b. Incorrect dosages
Failure Mode 3
a. Verification not
complete
Failure Mode 4
a. Laptop not working
or unavailable
b. Med-cart stocked
incorrectly
c. Scanner missing
d. Barcode unreadable
or missing
e. ID Band missing or
unreadable Identified
area of
failure
(VA National Center for Patient Safety, n.d)
Healthcare FMEA Process
Teaching Example 2
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6 Y N N Y
4A(2)a Battery failure
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6 Y N N Y
Control Backup battery Total down time is less than or
equal to 15 minutes
Chief
IRM
Y
4A(2)b Battery not charged up
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6 Y N N Y
Control Add 120v reseptacles Power available Chief
ENG
Y
Actions or Rationale for
Stopping
Outcome Measure
Scoring Decision Tree Analysis
HFMEA Step 5 - Identify Actions and Outcomes HFMEA Step 4 - Hazard Analysis
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Failure Mode: First
Evaluate failure mode
before determining
potential causes
Potential Causes
Action
Type
(Control,
Accept,
Eliminate)
(VA National Center for Patient Safety, n.d)
The Failure Mode and Effect Analysis method is a effective way to
prevent medical error. The method focuses on observing an error,
how it occurs, acknowledging the failure effect, followed by
creating a solution to the failure. This method should be
performed before techniques are put to use to prevent negative
safety outcomes and negative performance outcomes. By defining
the topic, assembling a team, understanding the process, and
conducting a hazard analysis, medical errors can be prevented.
This method insures patients and employees that health providers
are highly qualified to deliver quality care and safety. The
commitment that health care providers deliver is highlighted by
the pre assessments taken in order to prevent any negative
outcomes.
Cayman Business Systems.
(2004,January 28). Potential Failure Mode and Effects Analysis. Retrieved April 23, 2010.
http://elsmar.com/FMEA/sld011.htm

Dunn, Edward J.. (n.d) Healthcare Failure Mode and Effect Analysis. Retrieved April 24, 2010 from
VA National Center for Patient Safety website
http://www.fmeainfocentre.com/presentations/HFMEA_FacDev.ppt#3

Institute for Healthcare Improvement. (2010) Failure Modes and Analysis Tool. Retrieved April 24,
2010. http://www.ihi.org/ihi/workspace/tools/fmea/.

iSix Sigma. (2010). FMEA Can Add Value in Various Project Stages. Retrieved April 23,
2010.http://www.isixsigma.com/index.php?option=com_k2&view=item&id=1520:fmea-can-
add-value-in-arious-project-stages&Itemid=203.

JCAHO AND RESUSCITATION. (2010). Retrieved April 21, 2010, from Resuscitation Central :
http://www.resuscitationcentral.com/documentation/jcaho-health-care-hospital-
accreditation/

VA National Center for Patient Safety. (n.d). The Basics of Healthcare Failure Mode and Effect
Analysis. Retrieved April 24, 2010 from
http://www.patientsafety.gov/SafetyTopics/HFMEA/FMEA2.pdf

http://medicalhealthcarefmea.com/