CDRH's Approach to Providing Human Factors Information
Dick Sawyer, PhD
Senior Human Factors Scientist
Division of Device User Programs and
Office of Communication, Education, and Radiation Programs (OCER)
Center for Devices and Radiological Health
Food and Drug Administration
The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) strongly supports the development of medical device-related information for use by industry, health professionals, lay users, and FDA personnel. Such information may be cross-cutting or may be related to a particular problem, device area, or discipline. Typically, such projects involve collaboration among CDRH, manufacturers, health professionals, and lay users. Either the information is developed jointly or the FDA develops it and asks parties and organizations both inside and outside of the agency to review drafts. Finally, CDRH conducts research studies and surveys that are detailed in reports available to the public.
Types of materials that have evolved from CDRH efforts include educational documents on a variety of medical devices and radiation-emitting products: videos on device-specific safety issues, job aids and checklists for device-user procedures, reports of CDRH research projects or surveys conducted by consultants or state agencies, standards, industry alerts, and manuals related to such subjects as labeling and good manufacturing practices. Specifically, CDRH staff have participated in the development of standards, recommendations, and guidance pertaining to electromagnetic interference, apnea monitors, software, user instructions, and various human factors issues.
Human Factors Efforts
Regarding human factors, per se, CDRH projects conducted over the last decade often have focused on job aids, lay user instructions, and training of health professionals. For example, a long-standing source of accidents has been anesthesia equipment improperly tested and set up prior to use. Therefore, in cooperation with manufacturers, the American Society of Anesthesiologists, and the Patient Safety Foundation, CDRH developed a checklist now widely used by anesthesiologists for setting up their equipment. Likewise, the agency has conducted studies on defibrillator-use problems and has produced checklists for their use. In addition, CDRH has conducted research on human factors issues related to patient use of blood glucose monitors and infusion pump operating problems. In the case of the former, a user checklist was developed in an effort lead by a national health professional organization. The conclusions of the infusion pump study have many implications for improved user training and pump design. Finally, the Center has produced a series of videotapes on hemodialysis safety in a project in which industry and health organizations participated.
Some human factors efforts have focused specifically on labeling. One substantial effort was the development of Write It Right, the widely recognized booklet on principles and procedures for designing user instructions. A parallel effort is the Human Factors Principles for Medical Device Labeling, based on CDRH research on contact lens cleaning booklets. The principles described in these documents also are embodied in other Center guidance, such as the drafted 510(k) guidance for passive patient restraints.
In addition to the aforementioned projects, many device specific and cross-cutting engineering standards developed with CDRH participation embody user-interface design and/or labeling principles, although the term, "human factors" rarely appears. Design issues related to connectors, markings, leads, controls, symbols, and machine logic (software) are woven into these documents. Currently CDRH is developing three documents having user-interface design implications: an apnea monitor standard, a performance standard for electrode lead wires, and a software review document. Among other things, the first two address monitor leads. Patients have suffered serious burns and electrocutions because health professionals and lay users have made errors easily prevented by simple protective mechanisms not conventionally provided by manufacturers. The software document, which deals to a large extent with validation issues, also has a human factors appendix that points out common device problem areas and discusses the need for human factors evaluations.
The publication of the ANSI/AAMI HE-48 Human factors and engineering guidelines and preferred practices for the design of medical devices in a sense is a watershed----the document is the first comprehensive human factors guidance related to medical devices. It brings user interface problems into focus and legitimizes the device-related concerns of health professionals who ask the question, "Was it really my fault?" with respect to device operating errors. In short, the AAMI guideline is a critical benchmark in the process of infusing human factors into medical device design.
The Center currently is working on a human factors primer, which will describe human factors problems, issues, rules-of thumb, methods, and related agency concerns. Emphasizing tangible device design issues and related incidents, the booklet will impress on manufacturers, health professionals, and Center personnel the criticality of good user-interface design and will increase their understanding of human factors. With respect to FDA concern with specific device areas, Center human factors staff have developed a priority-setting model that will be used to identify devices that deserve special human factors attention. Finally, the Center increasingly will be involved in the development of device-specific and cross-cutting human factors documents for Center personnel and manufacturers on a selective basis, as well as developing training to reinforce such information.