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Abstract

Concerned about the high incidence of medical errors, The US Food and Drug Administration's Human Factors Engineering Group of the Center for Devices and Radiological Health (CDRH) has begun an aggressive approach to consider the impact of Human Factors (HF) in medical device design and labelling. In Australia and Europe, government activities also include HF in the labelling of pharmaceuticals. The CDRH is encouraging manufacturers to apply HF during design and development. The agency also verifies that HF is being considered when the manufacturer's design validation documentation is reviewed as required by the Quality System Regulation. Including Human Factors throughout the product life-cycle will increase product acceptance, prevent costly post-market ‘upgrades’ and offer a new competitive advantage. Examples from one HF provider and a medical device developer are provided.

Keywords

human factors performance-based customer-centric use-related medical errors

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References

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(2000) To Err is Human: Building a Safer Health System, Committee on Quality of Health Care in America, Institute of Medicine, National Academy Press, Washington, DC.

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Ibid..

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Human Factors: A Vital Component in Product Development and Launch

Abstract

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References