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“To err is human”

“To err is human” according to the old adage. People make mistakes that have no cause other than human imperfection. But when it comes to mistakes made by medical device users, the consequences can literally be fatal. In 2013, 13,642 ‘adverse incidents’ were reported to the MHRA, the regulatory agency for the industry; investigations reveal that only 20% of errors are due to mechanical failure – 80% are caused by human error (Institute of Medicines 2000 & Perrow, 1984).

Written by Paul Brown on 20th November 2015

"To err is human” according to the old adage. People make mistakes that have no cause other than human imperfection. But when it comes to mistakes made by medical device users, the consequences can literally be fatal. In 2013, 13,642 ‘adverse incidents’ were reported to the MHRA, the regulatory agency for the industry; investigations reveal that only 20% of errors are due to mechanical failure – 80% are caused by human error (Institute of Medicines 2000 & Perrow, 1984).

With this in mind, a recent seminar organised by Medilink for members in the Midlands, brought together experts in medical device design and commercialisation, intellectual property and regulatory affairs to help map the route from product idea to market launch. It is quite startling, but strangely understandable that you and I, as well as trained medics, are capable of making mistakes. How did we manage to press the wrong button, attach the wrong lead and insert the wrong needle?

It’s most probably because the designers failed to take human factors into account. They simply didn’t build the product from scratch around the intended user’s behaviours, conscious or sub-conscious. In the medtech industry, Human Factors is the science that focuses on understanding and supporting how people interact with technology. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the
design of the device’s controls, displays, software, labels, and instructions—anything the user may need to operate and maintain the product.

According to the Alzheimer’s Society, medication packaging can be confusing for people with dementia. So, simple modifications, such as indicating the days of the week on the blister packs or making the font clearer to read, are due to be introduced by the manufactures from June 2016.

Poor design can trigger other use errors. If a port allows the insertion of the wrong tube, you have a use error waiting to happen. If an alarm signal frequency is too high and the tone too quiet, someone will fail to detect it. If a drug-delivery rate should be in the 0–100 mL/h range, but a device accepts an entry of 1000 mL/h (10 times the intended maximum), there is a good chance someone will overdose a patient.

Matthew Theobald of Three Circles, a Founder Member of the Medical Devices Alliance, advises anyone in the process of designing a new medical device to avoid "group think” – the assumption that we all think alike. We don’t. So amongst other things, good design should include a mode of operation that is intuitive, with easy-to-read displays, easy-to-use controls, appropriate connections of device-to-device and device-to-outlet for safe use, effective alarms, and easy repair and maintenance.

Take Human Factors into consideration and log all your development and testing procedures. This way, any insurances you take out to protect against user miss-use should remain valid. 

Finally, we’d like you to nominate the medical device you feel deserves merit, especially from a Human Factors design perspective. What is the device and why is it so effective? Just 100 words please to biotech@franklands.co.uk and we’ll publish the Franklands’ favourite.

See other blogs related to: Lifescience

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