EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA reviewers emphasized the need for “usable” human factors documentation in premarket submissions at recent Human Factors and Ergonomics Society symposium;
  • Thorough utilization of use-related risk analysis becoming more important, according to FDA.
  • FDA officials recommend that manufacturers reduce use-related risks in their devices and stay current with post-market surveillance requirements.

Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual Human Factors and Ergonomics Society Health Care Symposium. After taking in dozens of oral presentations and hundreds of posters, attendees often walk away from the event feeling invigorated that there are so many human factors (HF) professionals out there working to make medical technology, as well as clinical care environments, safe, effective, and satisfying.

FDA representatives from the Center for Drug Evaluation Research (CDER) and the Center for Device and Radiological Health (CDRH) attended the symposium and engaged with other attendees, sharing their perspectives during workshops, panels, and presentations.

Below are some key takeaways from FDA officials’ insights and perspectives shared at the symposium:

  • Make HF documentation usable. FDA’s HF reviewers have a tough job. They need to review HF documents for dozens of different devices each month, familiarizing themselves with each product’s intended use, users, use environments, and use-related risks, among other things. FDA’s HF reviewers sometimes feel like they’re doing a scavenger hunt, sifting through hundreds of pages of documents and following cross-references, searching for key nuggets of information and insight. Do your part to make it a little bit easier by submitting HF documentation in a format that will facilitate, rather than hinder, their review. For an HF validation protocol review, include HFE/UE report sections 2-8 (minus HF validation results), to provide HF reviewers with the necessary context to assess and comment on the protocol. For a full submission, include HF validation test data in a table that summarizes the use scenario, task and its criticality, event (e.g., use error), harm and its severity, root cause(s), and residual risk conclusion.
  • Robust use-related risk analysis continues to be pivotal. FDA reiterated the importance of conducting a thorough use-related risk analysis, including considering foreseeable misuse, identifying and analyzing known use-related problems, and revising the risk analysis in response to development activities (e.g., formative testing).
  • Manufacturers must consider, and design to mitigate against, foreseeable misuse. Speaking of foreseeable misuse, FDA provided a friendly reminder that their expectations about foreseeable misuse have remained consistent for over a decade – they consider a use-related risk analysis incomplete without considering foreseeable misuse. 
  • FDA doesn’t expect error-free devices. As indicated in the FDA’s final HF guidance for medical devices, FDA does not expect devices to be “perfect” and error-free. Rather, the expectation is that manufacturers will reduce use-related risks as much as possible and to an acceptable level. Note that the claim that “nothing further can be done, so residual risk is acceptable” might not hold water with the FDA if device has glaring design flaws that are arguably easy to address (e.g., small and/or low contrast text, unclear graphical instructions).
  • Keep up with post-market surveillance. Manufacturers have an obligation to keep tabs on what’s going on with their currently marketed products, and address any concerning adverse events. There are a variety of approaches for identifying known use-related problems with predecessor as well as comparable products, such as reviewing internal complaint logs, FDA published sources (e.g., MAUDE, MedSun, recall notices), and social media websites (which you might be surprised to learn are very informative!). If FDA has become aware of a device issue through these sources, it’s reasonable for the Agency to expect that the manufacturer will be aware as well.
  • FDA continues to engage with industry to communicate regulatory expectations. For example, FDA’s CDRH has published a guidance document to help manufacturers interpret and respond to deficiency letters most effectively. FDA is also offering a “Day 10 call,” which can occur ~10 days after a manufacturer receives an Additional Information request and provides a guaranteed opportunity to ask clarifying questions about the documented deficiencies and request for additional information.

As always, FDA representatives encouraged manufacturers to contact them or the FDA project manager via appropriate channels with any questions or to get input on a specific situation.

Emergo by UL’s Human Factors Research & Design (HFR&D) team will be presenting a webinar May 16, 2019 to further explore these issues.

Erin Davis is Managing Human Factors Specialist and Allison Strochlic is Research Director at Emergo by UL’s HFR&D division.

Additional FDA regulatory and human factors information from Emergo by UL:

  • HFE user research for medical devices and IVDs
  • Human factors analysis support for medical devices
  • Webinar: Human factors engineering for medical devices