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Failure Mode and Effects Analysis (FMEA):

A Tool to Help Guide Error Prevention Efforts

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). FMEA is an ongoing quality improvement process that is carried out in healthcare organizations by a multidisciplinary team. It can be employed 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 they occur.

How can FMEA be used to reduce the risk of medication errors? To cite one example, a multidisciplinary 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 a mistake occurring 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 or at the wrong time?

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 orders.

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! ® newsletters.

Adapted from: ISMP Medication Safety Alert! ® October 17, 2001. (6)21.

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