Can Collaborative Efforts to Improve Device Design Improve Safety?

During World War II, the U.S. Army Air Corps depended on its B-17 bombers to inflict incredible damage against the Axis powers in Europe. These “Flying Fortresses” were deemed essential to winning the war in the European theater, but they had one big problem. Despite the plane’s technically advanced design and the provision of effective training for the young pilots responsible for steering them through war zones, too many crashed on landing, destroying the machines and often killing the pilots and crew.

Initial investigations into B-17 crashes concluded that the accidents resulted from pilot error, and the Army invested in training and retraining pilots. Yet, the crashes continued. Then Alphonse Chapanis, a young psychologist who joined the Army Air Corps’ aeromedical lab in 1942, noticed that the switches for the plane’s flaps and the landing gear were adjacent on the dash and identical in appearance — but radically different in function.

It was far too easy for pilots — stressed and weary after hours of combat flying — to flip the wrong switch when trying to land the B-17. The plane’s design had failed to account for the likelihood of normal human error. Chapanis suggested changing the knobs so that one was triangular and the other was spherical, making it easy for pilots to differentiate. This small change in design led to an immediate and substantial decrease in the number of B-17 crashes. (Read more about Chapanis and his influence on device design).

While most health care isn’t delivered in war zones, health care and device company leaders recognize that care is often delivered in high-stress, high-risk situations. Despite elegant efforts to design for safe use, rigorous standards and regulatory requirements from the Food and Drug Administration and standards bodies, and lots of training of health care professionals, many acknowledge that there is still room to ensure clinicians are “flipping the right switch” when using medical devices.

AHA and AAMI Meeting

Earlier this year, the American Hospital Association (AHA) and the Association for Advancement of Medical Instrumentation (AAMI) brought together a small group composed of hospital and health system leaders, device manufacturers and policy leaders to explore how to make devices safer by design. Their energy and commitment were palpable. Participants were invigorated and challenged by the shared goal of creating devices that could be used more easily, effectively and safely.

The meeting began with table-setting presentations to make sure all attendees understood each other’s perspectives. Clinical leaders described the stresses and distractions of the busy hospital environment that make it difficult for staff to use devices as the designers had envisioned, including their personal experiences of devices being implicated in near misses or safety events. Manufacturers discussed their rigorous processes for designing, testing and providing instructions to ensure safe use. An AAMI leader described the role of standards in promoting safety, and a former FDA official spoke about the role of regulation, oversight and post-market surveillance in promoting safety. The group then broke into multidisciplinary groups with direction to identify practical, actionable pathways that augment or replace current activities and lead to better safety by design.

3 Key Takeaways from the Conversations

• Users and manufacturers need better information. Engineers and users need to be able to exchange the right information to make design improvements that address usability issues. Right now, they are not connecting well. Health care providers often discover a design challenge with a piece of equipment when conducting a root cause analysis and then report that information to their patient safety organization, but that information is not readily available to manufacturers. Manufacturers get information from FDA databases, but these may not have sufficient information to understand exactly how the device design may have contributed to the occurrence of patient harm or inform design alterations that could prevent it in the future. Finally, post market surveillance reporting is often slow to reach the manufacturer, limiting their ability to alter design in a timely fashion.
• Work as imagined differs from work as done. In designing each particular product, engineers imagine the clinical environment in which it will be placed, plan for a rigorous training of the health care professionals who will be operating it and create comprehensive instruction manuals. Health care professionals use an expanding and rotating panoply of devices every day, and their ability to be trained on each and every one of those, remember that training and use it in a moment of emergent patient need is radically different from what the designer imagined. Better communication between users and designers is the only way to help designers anticipate how their devices will actually be used.
• There is a natural tension between innovation and the experience that promotes safe use of a device. In a busy clinical environment, it is challenging for clinicians to keep up with all they must learn, but device makers may want to make routine improvements to the software or user interface of their devices to refresh perceptions of the device. Honest discussions about the kind of innovation device manufacturers intend and how the alteration will work in a busy clinical environment are needed to ensure innovation better contributes to safety and ideally decreases the draw on clinicians’ already-stretched mental capacity. Further, the regulatory framework needs to support this balance between innovation and safety by recognizing and creating safe tables and sandboxes within which to drive progress.

One actionable item that drew keen interest was creating an opportunity for the manufacturers’ engineers to participate in a hospital’s response to a patient safety event. Stakeholders across the spectrum agreed that open sharing of how design may have contributed to an event is vital to generating changes needed to promote safer use and reduce patient harm. AHA and AAMI are committed to working to make these conversations a reality as part of our ongoing efforts to make care safer.

Nancy Foster is the AHA’s vice president of quality and safety policy.