The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket submissions, as well final guidance from 2011 on applying human factors and usability engineering to medical devices.
FDA said it believes these device types have “clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices.”
Manufacturers should provide FDA with a report that summarizes the human factors or usability engineering processes they have followed, including any preliminary analyses and evaluations and human factors validation testing, results and conclusions, FDA says.
The list was based on knowledge obtained through Medical Device Reporting (MDRs) and recall data, and includes:
- Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, OCL)
- Anesthesia machines (e.g., BSZ)
- Artificial pancreas systems (e.g., OZO, OZP, OZQ)
- Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC )
- Automated external defibrillators
- Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels
- Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels
- Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, ONW)
- Implanted infusion pumps (e.g., LKK, MDY)
- Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
- Insulin delivery systems (e.g., LZG, OPP)
- Negative-pressure wound therapy (e.g., OKO, OMP) intended for home use
- Robotic catheter manipulation systems (e.g., DXX)
- Robotic surgery devices (e.g., NAY)
- Ventilators (e.g., CBK, NOU, ONZ)
- Ventricular assist devices (e.g., DSQ, PCK)
In addition to the draft list, FDA finalized guidance from 2011 on applying human factors and usability engineering to medical devices.
The agency said it received over 600 comments on the draft guidance, which deals mostly with design and user interface, “which were generally supportive of the draft guidance document, but requested clarification in a number of areas. The most frequent types of comments requested revisions to the language or structure of the document, or clarification on risk mitigation and human factors testing methods, user populations for testing, training of test participants, determining the appropriate sample size in human factors testing, reporting of testing results in premarket submissions, and collecting human factors data as part of a clinical study.”
In response to these comments, FDA said it revised the guidance, which supersedes guidance from 2000 entitled "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” to clarify “the points identified and restructured the information for better readability and comprehension.”
The goal of the guidance, according to FDA, is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible.
FDA said the most effective strategies to employ during device design to reduce or eliminate use-related hazards involve modifications to the device user interface, which should be logical and intuitive.
In its conclusion, FDA also outlined the ways that device manufacturers were able to save money through the use of human factors engineering (HFE) and usability engineering (UE).
“Many device manufacturers have found that the application of HFE/UE during the development of their products reduces the need for design modifications and costly updates after market introduction and offers competitive advantages,” FDA said. “With increased safety, the likelihood of your incurring expenses associated with product recalls or liability is reduced; and when HFE/UE approaches are used during the design development process, particularly if the perspective of users is taken into account, the overall ease of use and appeal of a device can simultaneously be enhanced.”
Applying Human Factors and Usability Engineering to Medical Devices
List of Highest Priority Devices for Human Factors Review