Medical Health Care FMEA

Failure Mode and Effect Analysis and Risk Analysis for Medical Applications
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Medical Heath Care FMEA - Failure Mode and Effects Analysis is :

FMEA (Failure Mode Effects Analysis) is a tool that when performed adequately, can reduce the risk of preventable medical errors. Hospitals in the US that are accredited by JCAHO are required to perform at least one FMEA each year.

The main output of FMEA is a series of mitigations, each of which is some process change implemented to reduce the risk of error. Because resources are limited, implementing all mitigations are not possible so the challenge is to find the set of mitigations that provides the highest reduction in risk for the least cost.

Hence, preventability may be viewed in terms of the cost and effectiveness of a mitigation. A low cost and effective mitigation is associated with a highly preventable medical error, whereas a high cost and or less effective mitigation is associated with a less preventable medical error.

The origins of the inclusion of risk analysis are real incidents of harm to the patients receiving treatment by medical devices, such as electric shocks, over-infusion by infusion pumps, and over doses of radiation by radiotherapy devices. Too many of these incidents resulted in the deaths of patients. For example, between June, 1985 and January, 1987, a computer controlled radiation therapy machine called the Therac 25 massively overdosed six people. The results were deadly. (See: Nancy Leveson, Safeware: System Safety and Computers, Addison-Wesley, 1995.)

Failure mode effects analysis (FMEA) is a "bottom up" approach which assumes a basic defect at the component level, assesses the effect, and identifies potential solutions. It should be conducted before the application of medical procedures and as part of each new step in a procedure to identify potential weaknesses. Failure mode effects criticality analysis (FMECA) adds probability of occurrence and severity of failure to the FMEA process. 

The primary purpose of FMEA is the early identification of potential design inadequacies that may adversely affect safety and performance. Identified inadequacies can then be eliminated or their effect minimized through design correction or other means before they reach the patient.

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Where to find what you need on this site:

FMEA in short the place to start if you're a newbie to FMEA
Community we have a large member list of FMEA users that can help to solve your FMEA questions
Examples Example FMEA sheets
Guides Guides, primers and Introductions about Failure Mode and Effects Analysis
Some Foreign language FMEA docs are also available
Handbooks Various handbooks about using and introducing FMEA
Books all kind books about FMEA and Risk Analysis
Papers FMEA related (research) papers
Presentations Mainly Powerpoint presentations that can inspire you
Services FMEA is a major topic in engineering consultancy, here you'll find information about services, training, ...
Standards links to the major FMEA standards
Tools in the past few years a number of powerful software tools have been developed to support FMEA, also some FREE tools by our community members
Add a link use this link to propose a new contribution or link to the site
Recommend site here you'll an easy form to inform your colleagues about this site
Link to site this page provide all the info you need to link your site to the FMEA Info Centre
About this site the story behind this site, how it all began, ...
Status provides the latest news about the site

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Medical Health Care FMEA

Failure Mode and Effect Analysis and Risk Analysis for Medical Applications
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