Presentation
The Use Error Lab: Did We Err in Our Error?
DescriptionIn medical device development, the accurate identification and evaluation of use errors is vital for compliance with regulatory standards and for ensuring use/user/patient safety. Misidentification or improper categorization of potential use errors can lead to inadequate risk control strategies, poor user experience, post-market safety concerns, and challenges during a regulatory submission. In addition, improper identification of use errors has the potential to create unnecessary overhead in product development without increasing use safety.
Despite the centrality of identifying and assessing use error in medical device human factors, professionals often face challenges in identifying and defining use errors. These challenges emerge from a complex web of human-device interactions, a lack of consensus amongst internal stakeholders of what constitutes a use error, and from a lack of clear industry-wide agreement on the details of our definitions of use error. This panel addresses these challenges by providing a platform for knowledge sharing and collective problem-solving. The panel will adopt a case study approach to delve into the complexities of identifying, categorizing, and evaluating use errors. By examining real-world scenarios, we aim to foster an interactive discussion relevant to attendees that leads to actionable insights that can be implemented into use related risk management by professionals in the field.
To make this session uniquely engaging, we will incorporate audience participation in an innovative way. First, the panelists will present and analyze each of five case studies individually, and ask for audience participation on how they would manage the situation/handle the use error to get a sense of the different ideas out there. After discussing the prepared case studies, we will invite attendees to share their own case studies or challenges they face in their work. This interactive element not only enriches the discussion but also provides immediate, expert feedback on issues directly relevant to the audience. By utilizing interactive technology, participants can submit their questions and thoughts anonymously if they prefer, or they can choose to speak directly into the microphone.
This novel approach transforms the traditional panel format into a dynamic, collaborative learning experience akin to a participatory “mini-workshop” in which the audience becomes part of the extended panel, thus leveraging the expertise of both panelists and attendees.
The panelists are experienced, director-level experts in the field of human factors engineering, each bringing over 10 years of industry experience. They have played pivotal roles in developing and obtaining market clearance for multiple medical devices and will leverage their deep understanding of both practical application and regulatory compliance during the panel discussion. The panelists feature a diverse mix of professional backgrounds, including those with extensive internal human factors experience at leading healthcare organizations and those with rich backgrounds in consulting. Several of the panelists also contribute to academia by teaching human factors courses, including those specific to use-related risk analysis, at the university level.
Case Study 1: A dialysis technician opens a case of dialysate and accidentally punctures the sterile bag. The technician proceeds to use the bag of dialysate during treatment. Is the use error that the technician used a sharp object to open the box, that they punctured the bag, or that they used a compromised bag? Should this be recorded as one use error or multiple sequential errors?
Case Study 2: An individual drops an injection device, damages it, but proceeds to use it. Is the use error the act of dropping the device, using a damaged device, or both?
Case Study 3: An app user forgets their password and is unable to login to their app to obtain a medication calculation. As such, the user manually calculates a dose and takes it. The manual calculation is not as precise as the app would provide, but is still suitable to provide some therapeutic benefit. Is there a use error in this sequence? What is the use error, if there is one?
Case Study 4: A physician uses a device for a medical procedure, the use of which also requires clinical judgment. If the physician makes poor clinical judgment, is the use error the lapse in judgment, the resulting impact it has on the use of the device for the medical procedure, or both? When is it appropriate to assume good clinical judgment and keep it out of the use-related equation?
Case Study 5: During a surgical procedure, a surgeon uses a wrong-sized implant that was incorrectly placed by the hospital staff in the wrong bin (i.e., size X was placed in the bin with size Y) . Is the use error the incorrect binning of the implant, selecting the implant without confirming the size, the action of using it, or some mix? When does the use error “take effect” — at the time of binning, selection or when the implant is used in surgery?
Case Study 6: A respiratory therapist sets up a ventilator for a patient. While adjusting the settings, they misread the patient’s height and weight from the patient chart, resulting in incorrect volume and pressure settings. Is the use error the misreading of the patient chart, the incorrect settings being input, or both? Does it only become a use error if the patient receives improper ventilation after being connected?
Case Study 7: A nurse prepares to insert a catheter. During preparation, she opens a sterile package but accidentally touches the inside of the packaging, potentially contaminating the catheter when she removes it from the package as it passes over the area she touched. Is the use error the act of touching the interior of a sterile package, the failure to maintain sterility in general, or it is a use error only if the catheter is inserted after potential contamination? Should this be recorded as one use error or multiple? Also, what if there was no contamination? Notice that we said “potential contamination”? Does it matter if contamination occurred or not for this to be defined as a use error?
Despite the centrality of identifying and assessing use error in medical device human factors, professionals often face challenges in identifying and defining use errors. These challenges emerge from a complex web of human-device interactions, a lack of consensus amongst internal stakeholders of what constitutes a use error, and from a lack of clear industry-wide agreement on the details of our definitions of use error. This panel addresses these challenges by providing a platform for knowledge sharing and collective problem-solving. The panel will adopt a case study approach to delve into the complexities of identifying, categorizing, and evaluating use errors. By examining real-world scenarios, we aim to foster an interactive discussion relevant to attendees that leads to actionable insights that can be implemented into use related risk management by professionals in the field.
To make this session uniquely engaging, we will incorporate audience participation in an innovative way. First, the panelists will present and analyze each of five case studies individually, and ask for audience participation on how they would manage the situation/handle the use error to get a sense of the different ideas out there. After discussing the prepared case studies, we will invite attendees to share their own case studies or challenges they face in their work. This interactive element not only enriches the discussion but also provides immediate, expert feedback on issues directly relevant to the audience. By utilizing interactive technology, participants can submit their questions and thoughts anonymously if they prefer, or they can choose to speak directly into the microphone.
This novel approach transforms the traditional panel format into a dynamic, collaborative learning experience akin to a participatory “mini-workshop” in which the audience becomes part of the extended panel, thus leveraging the expertise of both panelists and attendees.
The panelists are experienced, director-level experts in the field of human factors engineering, each bringing over 10 years of industry experience. They have played pivotal roles in developing and obtaining market clearance for multiple medical devices and will leverage their deep understanding of both practical application and regulatory compliance during the panel discussion. The panelists feature a diverse mix of professional backgrounds, including those with extensive internal human factors experience at leading healthcare organizations and those with rich backgrounds in consulting. Several of the panelists also contribute to academia by teaching human factors courses, including those specific to use-related risk analysis, at the university level.
Case Study 1: A dialysis technician opens a case of dialysate and accidentally punctures the sterile bag. The technician proceeds to use the bag of dialysate during treatment. Is the use error that the technician used a sharp object to open the box, that they punctured the bag, or that they used a compromised bag? Should this be recorded as one use error or multiple sequential errors?
Case Study 2: An individual drops an injection device, damages it, but proceeds to use it. Is the use error the act of dropping the device, using a damaged device, or both?
Case Study 3: An app user forgets their password and is unable to login to their app to obtain a medication calculation. As such, the user manually calculates a dose and takes it. The manual calculation is not as precise as the app would provide, but is still suitable to provide some therapeutic benefit. Is there a use error in this sequence? What is the use error, if there is one?
Case Study 4: A physician uses a device for a medical procedure, the use of which also requires clinical judgment. If the physician makes poor clinical judgment, is the use error the lapse in judgment, the resulting impact it has on the use of the device for the medical procedure, or both? When is it appropriate to assume good clinical judgment and keep it out of the use-related equation?
Case Study 5: During a surgical procedure, a surgeon uses a wrong-sized implant that was incorrectly placed by the hospital staff in the wrong bin (i.e., size X was placed in the bin with size Y) . Is the use error the incorrect binning of the implant, selecting the implant without confirming the size, the action of using it, or some mix? When does the use error “take effect” — at the time of binning, selection or when the implant is used in surgery?
Case Study 6: A respiratory therapist sets up a ventilator for a patient. While adjusting the settings, they misread the patient’s height and weight from the patient chart, resulting in incorrect volume and pressure settings. Is the use error the misreading of the patient chart, the incorrect settings being input, or both? Does it only become a use error if the patient receives improper ventilation after being connected?
Case Study 7: A nurse prepares to insert a catheter. During preparation, she opens a sterile package but accidentally touches the inside of the packaging, potentially contaminating the catheter when she removes it from the package as it passes over the area she touched. Is the use error the act of touching the interior of a sterile package, the failure to maintain sterility in general, or it is a use error only if the catheter is inserted after potential contamination? Should this be recorded as one use error or multiple? Also, what if there was no contamination? Notice that we said “potential contamination”? Does it matter if contamination occurred or not for this to be defined as a use error?
Event Type
Discussion Panel
TimeTuesday, April 110:30am - 12:00pm EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)