An Engineer’s Perspective

It can be novel to take a look at the complex process behind the design of medical devices we use in transfer every day. This can end up being a years-long and time-consuming process before a new device is ready to market for the end-user…

• The design of medical devices is always done with the reduction of human error in mind. Most incidents in transfer medicine reported to the FDA involve equipment user errors, which are frequently due to poor usability. Modern devices have been made much safer to use.
• You will become a better user if you understand the design and the long process of device development, which is safety-focused and tailored to enable an efficient and satisfying user experience.

Design In Practice

• When designing a medical device, hazardous situations are analysed to understand why and how the system or the existing security layers have failed and how to improve them in future to minimise risk and error.
• As an example of this, the on/off button is frequently now placed at the back of the machine to avoid accidental switch off of the device during use.

The post-production information and the handling of complaints plays a crucial role in the development of devices. It is helpful if you report incidents and failures back to the manufacturers to help continuously improve design.

• As explained in the video, this is highly regulated in various norms like the ISO 80601-2-84.
• In emergency situations and under stress, fatigue or lack of experience, usability becomes a critical factor in the process of care. This is regulated in the ISO 62366–1.
• Usability Engineering therefore includes the analysis of human factors. The ISO 14971 norm aims to identify and minimise user associated errors.

In the next step we are moving on to a new topic. We will discuss issues around documentation and data collection in tranfser medicine with experts in the field. You have the opportunity to design your own chart and listen into a fascinating interview about digital transformation of services.