More than a third of medical device incidents are attributed to use error . Alistair Fleming and Kay Sinclair at Sagentia explain in this article from Operating Theatre Journal how device design, specifically human factors engineering, can help reduce use errors and improve clinical outcomes.
Regulators have introduced a number of human factors standards, demanding a more evidential approach to improving device usability and reducing the risk of human errors. These standards apply to all medical devices and are equally pertinent for devices designed for use in the high-pressured environment of the operating theatre. Device manufacturers must demonstrate that their products are not only functionally safe and fit for purpose, but also that they have eliminated all reasonable risk of adverse events caused by unintended errors arising from the use of the device.
The benefits of usability analysis in surgical device design should not be underestimated because medical specialists are highly trained: a number of factors affect the way surgeons and their teams interact with devices. Anything that diverts their attention away from the patient presents a risk. As surgical procedures become more complex and devices more feature-rich, the potential for use error in the operating theatre grows. This presents a challenge and opportunity for device manufacturers to design products that are easier, more comfortable and more efficient to use.Read the full article from Operating Theatre Journal online (free registration required).
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