This week, FDA released a set of human factors-related guidance documents, intended to reduce the risk of potential user mistakes and serious harm. As part of this, the agency published draft guidance, “List of Highest Priority Devices for Human Factors Review,” and listed over a dozen device types it wants to see human factors data for when sponsors file premarket submissions.
These device categories were chosen because the agency thinks user error could potentially lead to serious injury, as reflected in information from recalls and medical device reporting. FDA wants to use human factors data to inform decisions on safety, effectiveness, and substantial equivalence, according to the draft document.
Many of the devices on the list have been associated with recalls or adverse event reports recently. Infusion pumps from various manufacturers have been recalled in the last few years and there were enough adverse event reports associated with the devices—approximately 56,000 between 2005 and 2009, according to FDA—that the agency undertook the Infusion Pump Improvement Initiative in 2010.
Reprocessed duodenoscopes with elevator channels have been under close scrutiny for the past couple years, since news of infectious bacterial outbreaks at hospitals had been linked to the contaminated scopes. In October, FDA requested that duodenoscope manufacturers selling in the United States provide plans for postmarket surveillance studies on reprocessing practices and results, so it follows that the agency would have interest in human factors data around scope reprocessing.
Other devices, like artificial pancreas systems, hemodialysis and peritoneal dialysis systems, and ventricular assist devices (VADs) carry the burden of supporting a major organ function, making the motive behind FDA's interest in human factors data apparent. There have also been recent Class I recalls of some VADs.
- Ablation generators (associated with ablation systems)
- Anesthesia machines
- Artificial pancreas systems
- Auto injectors (when CDRH is lead Center)
- Automated external defibrillators
- Duodenoscopes (on the reprocessing) with elevator channels
- Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing) with elevator channels
- Hemodialysis and peritoneal dialysis systems
- Implanted infusion pumps
- Infusion pumps
- Insulin delivery systems
- Negative-pressure wound therapy intended for use in the home
- Robotic catheter manipulation systems
- Robotic surgery devices
- Ventricular assist devices
Sponsors of these listed devices should include a report and data from its human factors validation testing in premarket submissions. If the sponsor feels human factors data isn't warranted, they should submit a detailed analysis showing that user mistakes do not lead to serious potential harm. According to the final guidance released this week, "Applying Human Factors and Usability Engineering to Medical Devices," the human factors engineering report should include numerous details, including a description of the device user interface, users, use environments, training, known use problems, risks, validation testing details, critical tasks, and findings.
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