QMED - An interdisciplinary strategy to identify medical devices as a source of allergic or pyrogenic reactions

Healthcare demands in terms of quality and accessibility are higher than ever, leading to an increased usage of medical devices (MD) to improve the quality of life. Unfortunately, these devices have been associated with serious adverse events leading to a new regulation being introduced in 2017, emphasizing on the safety and performance of MD through risk management, clinical investigations and post-market surveillance. 

Adverse events

Since MD are healthcare products that draw upon multiple disciplines to be established, they require an interdisciplinary approach to evaluate them. Therefore, we focus on potential chemical and biological risks associated with their use to generate an overview of the emerging health risks.

These risks include Allergic Contact Dermatitis (ACD — an allergic reaction caused by direct contact), a chronic disease associated with high attributable healthcare costs. Although various MD have been associated with ACD, the substances causing these adverse events require further investigation to be able to mitigate the associated risk. Moreover, device-associated pyrogenic reactions, e.g. fever, can also occur after using a reprocessed MD. Hence, the question arises if the reprocessing methods, like cleaning and disinfecting, adequately remove pyrogens. 

Safer Devices

By developing the analytical tools to evaluate the substances that cause allergic reactions or fevers  present in MD, and by providing valuable insights on the origin of adverse events caused by MD, this project will lead to:

• new scientific knowledge
• societal and political impact by improving the market surveillance of MD
• safer devices for the patients.