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Medical device usability as a factor in reducing error and improving outcomes

Human factors are key inputs in the design of medical devices, especially with the increasing number aimed at patient use in the home. Kay Sinclair & Natalie Scott of Sagentia outline the issues involved and the implications of new standards aimed at usability in this MTB Europe article.

The new set of human factors standards that were introduced in 2010 (HE75, the new ANSI/AAMI standard and the IEC62366) aim to address the high number of medical device incidents that involve usability issues.

By requiring companies to track user feedback and justify proposed use error mitigation approaches, regulators are emphasising the important role that usability plays in product safety.

These new regulations also recognise the fact that, as some therapies transition away from clinical environments, medical devices are increasingly being used by a patient population that has less experience and training.

In addition to promoting safety, integrating usability into a product development programme is quite simply good design practice. In fact, a good way of adhering to the new standards is to:
  • take a holistic view of usability and incorporate it as a key component of every product development programme
  • make sure that the specific market demands for each new product are understood from the outset
Read the full article on the MTB Europe website.

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