A large, multi-national medical device company sells single-use chest drains used by healthcare providers in a variety of use environments, including the OR, the ICU, and the ER. They sought to evaluate changes they had made to the user interfaces of three of their products. These changes consisted of 1) a redesigned sterile barrier system (SBS) and 2) updated labeling and documentation that complied with the new EU Medical Device Regulation (MDR). 
 
The EU’s MDR specifies certain requirements for labeling, and medical device manufacturers now need to become compliant with the updated requirements. Thus, our client sought to validate the usability of their updated packaging and labeling. In addition, they wanted to ensure they adhered to their own internal SOPs and quality system requirements, which had been revised to align with the latest global regulations.  
 
LHF provided services to support our client in accomplishing these goals. We started by first developing a comprehensive strategy for evaluating the three chest drains in a way that aligned with regulatory expectations and internal SOPs. Once the scope and strategy were refined, our team developed a usability engineering (UE) plan to document the planned execution of the strategy.  
 
We then worked closely with our client, following an iterative and cross-functional process, to develop a use-related risk analysis (URRA) that captured the critical risks associated with use of their chest drains and accompanying documentation. The URRA was the necessary foundation for any further device user interface validation as it allowed our client and team to collaboratively assess the severity and thus, the criticality of any use-related risks.  
 
With the completion of the URRA, our team turned its focus on executing three studies to evaluate the redesigned SBS of the chest drains and assess the comprehensibility and layout of the updated labeling.  
 
To evaluate the redesigned SBS of the chest drains, LHF designed an aseptic presentation validation study and executed it with a variety of healthcare providers to obtain diverse and representative feedback. The study involved participants demonstrating two different aseptic presentation techniques (picking and tossing), which later informed a poster created by LHF team members, Jan and Laurie, at the 2024 Annual Healthcare Symposium.