FDA continues to focus on the importance of conducting human factors studies for medical devices prior to premarket submissions with their current release of the finalized 2011 Draft Guidance on “Applying Human Factors and Usability Engineering to Medical Devices”1 and Draft Guidance on the “List of the Highest Priority Devices for Human Factors Review”.2 These were released less than a year after finalizing the Guidance on “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff”, which highlighted the criticality of applying human factors to medical devices requiring reprocessing instructions.3 The influx of recent FDA discussions and robust guidance documents are on the heels of several reports of life-threatening device user errors.
The shared goal across the industry is to ensure medical devices are safe and effective for the intended users, and these guidance documents have been updated and released by FDA to help improve device design and instructions for use to minimize user errors and potential harm.
The highest priority devices necessitating human factors review, per the FDA February 2016 Draft Guidance, include, but are not limited to: Ablation generators, Auto injectors, Automated external defibrillators, Duodenoscopes, Gastroenterology-urology endoscopic ultrasound systems, Hemodialysis and peritoneal dialysis systems, infusion pumps, Insulin delivery systems, Robotic catheter manipulation systems and surgery devices, Ventilators, and Ventricular assist devices.2 For full listing: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484097.pdf
In addition, FDA recommends conducting a risk analysis on any medical device not included in the list of highest priority to determine if there is cause for potential harm to the end users. The Office of Device Evaluation (ODE) may request human factors data for new devices or other devices not included in this list, as assessed during the pre-submission process.4 It can be difficult to predict what user errors, if any, will occur during device use; therefore, usability testing can prove to be a valid method of assessing device design or instruction deficiencies.
Human Factors studies provide validity and value to medical device regulatory submissions. Providing evidence-based research and results can help FDA better evaluate safety, effectiveness, and substantial equivalence in these medical devices that are prone to user error. FDA recommends providing a comprehensive report of the human factors data and usability engineering processes followed to substantiate the premarket submission.
Conducting human factors studies plays an integral role in the life-cycle of a medical device and operating instructions. In addition, the application of these validation procedures upfront actually proves to save time, money, and resources in the long-run
NAMSA has the expertise and experience in successfully supporting numerous medical device manufactures with human factors and usability testing, from concept to market release, including study design and protocol development, risk assessment, subject recruitment, and full study execution and analysis. Through our MRO® Approach can provide this support at each and every step in the process, including Institutional Review Board (IRB) submission requirements, 510(k) and PMA submission guidance, electronic database development, final clinical study report compilation, and statistical analyses. NAMSA has applied human factors and usability testing on several of the above mentioned “highest priority” devices and continues to receive requests for this support given the recent FDA recommendations.
Human factors studies should be conducted in a testing environment that mimics the intended use scenario as closely as possible. Participants conduct simulated use of the device according to the instructions, including any necessary protective gear, and evaluate the clarity of those instructions and usability of the process. The participants are observed during the simulation and record the participant’s adherence to each step of the process, as well as any other observations on the usability of the device. It is important to clearly define success/failure for adherence to the instructions for analyzing and reporting the data.
Figure 1. Interactions among HFE/UE considerations result in either safe and effective use or unsafe or ineffective use.1
Human factors data is a valuable component in demonstrating safe and effective use; therefore, should be considered during product development, design, and validation testing. Additionally, the data can be applied and evaluated to provide a comprehensive premarket submission.
1 U.S. Food and Drug Administration. (2011, June 21). Applying Human Factors and Usability Engineering to Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Retrieved February 03, 2016, from http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf
2 U.S. Food and Drug Administration. (2016, February 03). List of Highest Priority Devices for Human Factors Review. Draft Guidance for Industry and Food and Drug Administration Staff. Retrieved February 09, 2016, from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484097.pdf
3 U.S. Food and Drug Administration. (2015, March 17). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff. Retrieved February 09, 2016, from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf
4 Brennan, Z. (2016, February 02). Human Factors Review: FDA Outlines Highest Priority Devices. Retrieved February 09, 2016, from http://www.raps.org/Regulatory-Focus/News/2016/02/02/24233/Human-Factors-Review-FDA-Outlines-Highest-Priority-Devices/