Clinically Embedded Human Factors for Medical Devices
Event Type
Discussion Panel
TimeFriday, April 1611:00am - 12:00pm EDT
LocationHospital Environments
DescriptionWhile significant advancement has been made by the FDA and medical device manufacturers to develop safer medical products, opportunity remains to mitigate risk associated with medical devices. Healthcare organizations who purchase devices for use within their system can play a more active role in this process by developing a human factors product framework for medical devices. Easty (2018) suggested there are three primary roles for human factors in the clinical environment related to medical devices and products and further suggested the role clinical engineering can play in this process. The first area involves executing human factors usability testing for evaluating products that are being considered for procurement into the healthcare setting. While devices are subject to higher levels of usability assessment, the reality is that often these assessments are performed under ideal scenarios in sterile conditions. It is impossible to replicate the infinite mix of different medical devices and products that are unique to each healthcare organization. Product procurement testing allows end users to use the medical device in conjunction with the other products already in their organization, allowing for deeper understanding of the merits and limitations of that device.

The second role for human factors suggested by Easty (2018) is for predicting and investigating errors associated with medical devices. Even when a device or product is carefully selected, malfunctions and errors do still occur. Human factors can be used both proactively, through predictive techniques such as Failure Mode and Effect Analysis, and retroactively, in response to an adverse event involving a medical device or product.

The third role Easty (2018) suggested is for identifying potential usability issues from clinical engineering “no fault found” reports. These reports are generated when a clinical engineering department receives a product marked as “broken” or “defective” only to discover there is nothing wrong with the device. If a trend develops for a particular device, a human factors assessment, including ethnographic observation, can be conducted to identify if there are usability concerns that can be addressed to reduce the number of these incidences.

This panel will highlight different organizations’ experience and approaches to incorporating human factors for medical devices and products into their organizations. Further, we will discuss how healthcare organizations can provide feedback to manufacturers regarding usability concerns of medical devices, thus providing valuable end user usability data for future device iterations.