Regulatory Update, May 2016
Sunday, May 1, 2016
Human Factors Take Center Stage in FDA Guidance Documents
In the February 3, 2016 Federal Register, the FDA issued three guidance documents on human factors engineering (one final and two draft documents). These are relevant to clinical research as medical device manufacturers conduct clinical trials to evaluate human use factors during their device development programs. Human factors/usability engineering considerations in the development of medical devices involve the three major components of the device-user system: (1) device users, (2) device use environments and (3) device user interfaces.
The intended users of a medical device should be able to use the device without making errors that could compromise medical care or patient or user safety. Device users may be clinical caregivers, other hospital workers (radiology or laboratory technologists), therapists, home care aides or the professionals who install and set up the devices and those who clean, maintain, repair or reprocess them. Intended users also may be the patients themselves, or a family member or friend who serves as a lay caregiver. The environments in which medical devices are used include a variety of conditions that would drive the user interface design. Medical devices are used in clinical or non-clinical environments, community settings or moving vehicles. A device user interface includes all points of interaction between the user and the device, including all elements of the device with which the user interacts. A device user interface might be used while the user sets up the device, uses the device or performs maintenance on the device.
The FDA writes that the critical element is the device user interface. Human factors/usability engineering is used to design the user-device interface. The user interface includes all components with which users interact while preparing the device for use (e.g., unpacking, set up, calibration), using the device, or performing maintenance (e.g., cleaning, replacing a battery, making repairs). The most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively. Specific beneficial outcomes of applying human factors/usability engineering to medical devices include:
- Easier-to-use devices.
- Safer connections between device components and accessories (e.g., power cords, leads, tubing, cartridges).
- Easier-to-read controls and displays.
- Better user understanding of the device’s status and operation.
- Better understanding of the patient’s current medical condition.
- More effective alarm signals.
- Easier device maintenance and repair.
- Reduced user reliance on user manuals.
- Reducing need for user training and retraining.
- Reduced risk of use error, adverse events and product recalls.
From a clinical trial perspective, human factors testing usually means simulated-use testing, where likely users operate the device in a controlled setting in order to ensure that problems related to use of that device can be recognized and then eliminated or least substantially mitigated through further development efforts.
The Guidance Documents
Under Docket No. FDA-2011-D-0469, the FDA made available a final guidance document titled, “Applying Human Factors and Usability Engineering to Medical Devices.” This guidance document is intended to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments. The recommendations in this guidance document are intended to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm. The FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use.
For safety-critical technologies such as medical devices, the process of eliminating or reducing design-related use problems that contribute to or cause unsafe or ineffective medical treatment is part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction should be included in risk analysis and risk management. By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device and avoiding potential device recalls.
The June 22, 2011, the draft version of this guidance netted more than 600 comments, 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.
Under Docket No. FDA-2015-D-4599, the FDA made available the draft guidance document titled, “List of Highest Priority Devices for Human Factors Review.” They are:
- Ablation generators (associated with ablation systems).
- Anesthesia machines.
- Artificial pancreas systems.
- Certain auto injectors.
- Automated external defibrillators.
- Certain duodenoscopes.
- Certain gastroenterology-urology endoscopic ultrasound systems.
- Hemodialysis and peritoneal dialysis systems.
- Infusion pumps (implanted or otherwise).
- Insulin delivery systems.
- Negative-pressure wound therapy intended for use in the home.
- Robotic catheter manipulation systems and surgery devices.
- Ventricular assist devices.
The FDA stated that these device types should have human factors data included in premarket submissions. They have clear potential for serious harm resulting from use error and having human factors data will help the FDA evaluate the safety and effectiveness and substantial equivalence of these devices. Currently, this is a draft guidance and therefore is not intended to be implemented but once the guidance is made final, the FDA will suggest that for the listed devices, manufacturers should provide the FDA with a report that provides a summary of the human factors or usability engineering processes they have followed, including any preliminary analyses and evaluations and human factors validation testing, results and conclusions.
Alternatively, manufacturers may provide a detailed rationale supporting the conclusion that human factors data are not necessary. This would be based on analysis of risk associated with users, uses, and use environments and results of that analysis would indicate that the severity of the potential harm resulting from use error is not serious. Further, for device types not on the list, the FDA will expect to see human factors data if analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm. The FDA may also decide that human factors data are needed on a case-by-case basis. In other words, this list is just a starting point.
Under Docket No. FDA-2015-D-4848, the FDA also made available a draft guidance document titled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” This document provides guidance to industry and the FDA staff on the underlying principles of human factors (HF) studies during the development of combination products, which are comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product. It describes the FDA recommendations on HF information to be provided in a combination product investigational or marketing application. It clarifies the different types of HF studies, offers recommendations for timing and sequencing of HF studies, and discusses how HF studies contribute to ensuring that combination products are safe and effective for the intended users, uses and environments. In addition, the draft guidance describes how HF studies relate to other clinical studies.
Interested parties may submit comments on final guidance documents at any time. The FDA may consider those comments for future revisions. For the draft guidance documents, to ensure that the FDA considers those comments before it begins work on the final versions, submit comments on the draft documents by May 3, 2016. Submit electronic comments at http://www.regulations.gov/. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. FDA has instructions on how to submit confidential information. If those instructions are not followed, any submitted confidential information will be made public.
The Regulatory Update is excerpted from Research Practitioner, Volume 17, Number 02, Mar.-Apr. 2016.