One of the first step in redressing the clinical underreporting data gap has already been implemented by the standards community by replacing the term User Error with Use Error. FDA defines use error as An act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. It takes the onus off the user by providing only the identification of what happened, not why it happened. It is no longer the users fault if the device causes the user to commit an error.
Usability, and the consequences of how people interact with medical devices, are important in device design and testing, and malpractice and product liability litigation.Usability and human factors are used by FDA more often for :
Why should you Attend?
FDA constantly strives to approve devices which are designed so that it is almost impossible for accidental usage harm to people. Still there is loads of evidence that doctors, nurses and patients make user error while using medical devices that result in patient harm. FDA and other international regulatory agencies identified that manufacturers must pay more attention to human factors at the earliest stages of product design and development, when user input can make a difference.
Due to clinical under-reporting, the number and nature of close calls is unknown. Undefined close calls make it difficult for product design and development team to analyze and potentially correct the issue. International Electrotechnical Commission (IEC) standards call these under reported close calls Slips, Lapses, and Mistakes and most of these are device-use errors that have the potential to result in serious hazards.
Who will Benefit?
This webcast will be of a valuable assistance to the below audience.
ISO 62366, FDA Guidance, Validation Studies, Human Factors, FDA, Medical Device, Device Validation, Risk and Validation Activities, Sample Size Requirements, Engineers, QA, QC
Ed Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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