Failure Mode and Effects Analysis
can help guide error prevention efforts
From the October 17, 2001 issue
Too often, marketing efforts, contractual agreements with
purchasing groups or vendors, and cost serve as primary sources
of information when making decisions about which medical products
to purchase and use. Evaluation and input from those who would
be using the products may not be sought and error potential
may not be considered ahead of time. Later, this may lead
to unforeseen problems in the hands of clinical users.
These pitfalls can be avoided by using a process known as
Failure Mode and Effects Analysis (FMEA) to examine the use
of new products and the design of new services and processes
to determine points of potential failure and what their effect
would be - before any error actually happens. In this regard,
FMEA differs from Root Cause Analysis (RCA). RCA is a reactive
process, employed after an error occurs, to identify its underlying
causes. In contrast, FMEA is a proactive process used to look
more carefully and systematically at vulnerable areas or processes.
FMEA can be employed before purchase and implementation of
new services, processes or products to identify potential
failure modes so that steps can be taken to avoid errors before
How can FMEA be used to reduce the risk of medication errors?
To cite just one example, an interdisciplinary committee could
use FMEA to assess new drugs being considered for the formulary.
Here's how the process would work.
Step 1: The committee would explore how the intended
product would be procured and used, from acquisition through
administration. Who would prescribe the drug and for what
type of patient? Where would the drug be stored? Who would
prepare and dispense it? How would it be administered?
Step 2: Potential failure modes (how and where systems
and processes may fail) would be identified while considering
how the product would be used. Could the drug be mistaken
for another similarly packaged product? Does the label clearly
express the strength or concentration? Does the name sound
or look like another drug on the formulary? Are dosing parameters
complex? Is the administration process error prone?
Step 3: Once failure modes have been identified,
staff would determine the likelihood of making a mistake and
the potential consequences of an error. What would happen
to the patient if the drug were given in the wrong dose, at
the wrong time, to the wrong patient, by the wrong route,
at the wrong rate?
Step 4: Staff would identify any
preexisting processes in place that could help detect the
error before it reaches the patient, and evaluate their effectiveness
based upon knowledge of human factors.
Step 5: If failure modes could cause errors with
significant consequences, actions would be taken to prevent
the error, detect it before it reaches the patient, or minimize
its consequences. A few examples include using an alternative
product; preparing the drug in the pharmacy; standardizing
drug concentrations, order communication and dosing methods;
using auxiliary warning labels or computer alerts; and requiring
entry of specific data into computer systems before processing
JC's new patient safety standards now require hospitals
to engage in proactive risk management activities, including
FMEA. Although industries outside of medicine have developed
elaborate FMEA scoring systems to rank items for action, the
simplified FMEA process as described above can be an efficient
proactive risk management tool, especially when organizations
consider what is already known about error potential from
past experiences or information available in the media such
as the ISMP Medication Safety Alert!.
on practice site distribution of the ISMP Medication Safety Alert!
Cohen MR, Davis NM, Senders J. Failure mode and effects
analysis: a novel approach to avoiding dangerous medication
errors and accidents, Hosp Pharm 1994;29:319-24.
Williams E, Talley R. The use of failure mode effect and
criticality analysis in a medication error subcommittee. Hosp
Senders JW, Senders SJ. Failure mode and effects analysis
in medicine. In Cohen MR ed. Medication Errors: Causes, Prevention
and Risk Management. Am Pharm Assoc. Washington, DC 1999.
JC: Sentinel Event Alert. No. 16. Feb, 2001.