ISMP
ISMP
Home Support ISMP Newsletters Webinars Report Errors Educational Store Consulting FAQ Tools About Us Contact Us
ISMP
ISMP
ISMP Facebook

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 they occur.

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 orders.

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!.

Survey on practice site distribution of the ISMP Medication Safety Alert!

References

  • 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 Pharm 1994;29:331-7.
  • 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.
  • Resources
    Acute Care Main Page
    Current Issue
    Past Issues
    Highlighted articles
    Action Agendas - Free CEs
    Special Error Alerts
    Subscribe
    Newsletter Editions
    Acute Care
    Community/Ambulatory
    Nursing
    Long Term Care
    Consumer
    ISMP 17th Annual Cheers Awards
    Home | Contact UsEmployment  | Legal Notices | Privacy Policy | Help Support ISMP
    Med-ERRS Med-ERRS | MSOMedication Safety Officers Society | Consumer Medication SafetyFor consumers
     ISMP Canada ISMP Canada | ISMP Spain ISMP Spain | ISMP Brasil ISMP Brasil | International Group | Pennsylvania Patient Safety Authority

    200 Lakeside Drive, Suite 200, Horsham, PA 19044, Phone: (215) 947-7797,  Fax: (215) 914-1492
    © 2014 Institute for Safe Medication Practices. All rights reserved

     
    ISMP
    ISMP