Presentation
HE3 - Bidirectional Feedback Loop Between Product/User Research and Patient Safety
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. Usability testing is a critical step in the design of safe medical devices; however, usability analysis is traditionally performed in optimal environments. It is impossible for manufactures to replicate every scenario and every unique mix of other devices and products within which their device may be used. This can create unique, unknown areas of risk that can lead to patient harm. The opportunity for harm is further compounded by technology that is increasingly complex to use and many complex medical devices are now being used by patients themselves in their home settings.
Unfortunately, medical device use errors continue to contribute to adverse patient events, with end-users often not reporting device-related concerns. This has led to the chronic under-reporting of medical device malfunctions (Tase et al., 2022; Vicente & Kern 2005). In turn, the lack of feedback from end-users creates a delay in enhancing the design of medical devices and products to ensure higher standards of safety. Easty (2018) recognized there are three unique applications of human factors in the clinical environment related to medical devices and products. One area he highlighted was investigating use errors associated with medical devices. Easty highlighted how human factors can be used both proactively, through predictive techniques such as Failure Mode and Effect Analysis, and retroactively is response to an adverse event involving a medical device or product.
This panel will highlight how a Product Development/User Research team and a Patient Safety team, each containing human factors and usability expertise, have established a bi-directional feedback reporting loop regarding medical devices and products to enhance patient safety. Other areas of potential cross-collaboration will be discussed along with how patient safety teams can work to report end-use errors back to manufacturers.
Agenda:
Panelist Stories (10 minutes each)
Audience Q&A (20 minutes)
Panelists:
Brittany Anderson-Montoya: Despite decades of focused investigations into patient safety events, typically though Root Cause Analysis, medical device malfunctions remain under-reported (Vicente & Kern 2005; Tase et al., 2022). Further, even when device malfunctions or usability concerns are identified, there is lack of a clear pathway for end-users of medical devices to report these concerns back to the manufacturers of the products. I will discuss how Patient Safety teams can identify usability concerns and medical device malfunctions through adverse event investigation. Further, I will discuss the unique collaborative environment, consisting of bi-directional feedback between Patient Safety and the User Research team, that has been established in our company to create faster, more real-time opportunities to improve the medical devices and products our clinicians and patients interact with.
Jennifer Teves: Patient Safety should always be at the top of considerations when making decisions about products that would impact patients’ lives. Ensuring Patient Safety should not just be the responsibility of those who work in Patient Safety organizations or departments but also of teams who are involved in designing and developing products, be it physical or digital products. My discussion will focus on the value of a human factors perspective in the early stages of product design and development. I will also discuss the importance of collaborative environments and research-driven culture in ensuring Patient Safety.
Yin-Juei Chang: While the term “Patient Safety” emphasizes “patients”, patients receive care through their interaction with physicians and other members of their care team. Products used by care providers should always consider the implications of design faults and complexity not only to its intended users but also to the people who are at the receiving end of the users’ care. I will discuss the importance of research in all phases of the product development process for products that physicians and care team members use when they deliver care for their patients.
Felix Chang: In Telemedicine, while there are digital visits where patients interact with providers (physicians, mental health professionals, care team members) in real-time, there are points in their care journey when patients are expected to navigate within the digital environment in their pursuit of achieving their desired health outcomes. I will speak about the importance of research from discovery and exploration phases and throughout the entire process of product design and development. I will be touching on the unique role of researchers to ensure that the products being built are not only easy-to-use but also safe to use for patients.
Unfortunately, medical device use errors continue to contribute to adverse patient events, with end-users often not reporting device-related concerns. This has led to the chronic under-reporting of medical device malfunctions (Tase et al., 2022; Vicente & Kern 2005). In turn, the lack of feedback from end-users creates a delay in enhancing the design of medical devices and products to ensure higher standards of safety. Easty (2018) recognized there are three unique applications of human factors in the clinical environment related to medical devices and products. One area he highlighted was investigating use errors associated with medical devices. Easty highlighted how human factors can be used both proactively, through predictive techniques such as Failure Mode and Effect Analysis, and retroactively is response to an adverse event involving a medical device or product.
This panel will highlight how a Product Development/User Research team and a Patient Safety team, each containing human factors and usability expertise, have established a bi-directional feedback reporting loop regarding medical devices and products to enhance patient safety. Other areas of potential cross-collaboration will be discussed along with how patient safety teams can work to report end-use errors back to manufacturers.
Agenda:
Panelist Stories (10 minutes each)
Audience Q&A (20 minutes)
Panelists:
Brittany Anderson-Montoya: Despite decades of focused investigations into patient safety events, typically though Root Cause Analysis, medical device malfunctions remain under-reported (Vicente & Kern 2005; Tase et al., 2022). Further, even when device malfunctions or usability concerns are identified, there is lack of a clear pathway for end-users of medical devices to report these concerns back to the manufacturers of the products. I will discuss how Patient Safety teams can identify usability concerns and medical device malfunctions through adverse event investigation. Further, I will discuss the unique collaborative environment, consisting of bi-directional feedback between Patient Safety and the User Research team, that has been established in our company to create faster, more real-time opportunities to improve the medical devices and products our clinicians and patients interact with.
Jennifer Teves: Patient Safety should always be at the top of considerations when making decisions about products that would impact patients’ lives. Ensuring Patient Safety should not just be the responsibility of those who work in Patient Safety organizations or departments but also of teams who are involved in designing and developing products, be it physical or digital products. My discussion will focus on the value of a human factors perspective in the early stages of product design and development. I will also discuss the importance of collaborative environments and research-driven culture in ensuring Patient Safety.
Yin-Juei Chang: While the term “Patient Safety” emphasizes “patients”, patients receive care through their interaction with physicians and other members of their care team. Products used by care providers should always consider the implications of design faults and complexity not only to its intended users but also to the people who are at the receiving end of the users’ care. I will discuss the importance of research in all phases of the product development process for products that physicians and care team members use when they deliver care for their patients.
Felix Chang: In Telemedicine, while there are digital visits where patients interact with providers (physicians, mental health professionals, care team members) in real-time, there are points in their care journey when patients are expected to navigate within the digital environment in their pursuit of achieving their desired health outcomes. I will speak about the importance of research from discovery and exploration phases and throughout the entire process of product design and development. I will be touching on the unique role of researchers to ensure that the products being built are not only easy-to-use but also safe to use for patients.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives