Perspectives on Use Error Harm Estimation

Estimating the severity of harms

Accurately estimating the severity of harms resulting from use errors is an essential component of use-related risk analysis in medical device development. Yet, the conventional method for estimating potential harm is arguably primitive and unreliable. As a result, two assessment teams can arrive at different harm severity estimates based on the same inputs. For example, one team assessing an insulin pen-injector might rate a needlestick injury as catastrophic, while another might rate it as minor or even negligible.

Approaches to assessing harm severity

In this webinar, presenters will discuss approaches to assessing harm severity based on multiple contributing factors. Consistent with regulatory guidance on use-related risk analysis, they will set the probability of the use error as 100%. 

They will also address how to fully consider use error preconditions and ensuing events, including:

• User vulnerability
• Failure interdependency
• Use error and harm detectability
• Medical intervention efficacy

The presenters will explain the advantages of using harm estimation rules to balance severity ratings and avoid both under- and over-estimates. They will also highlight why overestimating harm severity does not necessarily result in a safer medical device and could ultimately block access to devices patients need.