— James Reason, PhD, Author of Managing the Risks of Organization Accidents and Human Errors

While the healing touch of care giving is worlds apart from the operation of plant machinery or the piloting of a plane, some of the most promising patient safety initiatives underway today are based on research done in fields as far removed from medicine as these. Fundamental insights about human error and the nature of accidents learned through analysis of industrial disasters — nuclear power plant meltdowns, chemical spills, subway fires — are at the heart of a new approach to preventing medical harm. The approach shifts attention away from the fault of individuals to the larger contributing factors, often hidden and almost always out of their control.

For example, analysis of World War II Air Corps (today’s Air Force) accidents revealed that poorly designed cockpits often led pilots to make mistakes. They were highly trained personnel, but the controls before them did not take into account the effects of intense stress on their perception and cognition. The analysis led to cockpit design improvements that became the model for a new era of dramatically safer military and commercial airplanes.

This understanding reflects a science known as human factors, often linked to pioneering organizational psychologist James Reason. Human factors is a discipline devoted to studying the interaction of people and equipment and the variables that affect the outcome of the contact. It is rooted in the awareness that the successful performance of the "operator" within large systems — whether on the manufacturing floor, in military sorties, or in health care delivery — depends on an array of complex and interdependent forces. And if those forces are poorly understood and not accommodated in the design of the process or equipment, the stage is set for error and possible disaster: near misses, accidents, or even fatalities.

The science of human factors dates back to the Industrial Revolution, when enterprises sought to increase output by properly matching worker and job, person and machine. As technology advanced the focus shifted to workplace safety because of increasing hazards resulting from machines that were powerful enough to exceed users’ capabilities. High-risk industries such as nuclear power, aerospace and transportation were compelled to incorporate human factors engineering into their operations and tailor effective methodologies that could help ensure workers’ safety.

All around us are examples of the work of human factors engineers. Think about opening a door. Sometimes when you approach a door it is instantly clear what action you have to take to open it: push, pull, grab the left or right side, and so forth. Yet other times you may have no idea what to do so you might fumble a bit, and go through some trial and error. Or what about turning on a stove at a friend’s or neighbor’s house, one you have not used before. You might pause for a moment, thinking: "Does this knob turn on the front or rear burner? Which way does it turn, clockwise or counterclockwise?"

The work of human factors engineers in the product design gives us the best chance of opening the door or turning on the stove correctly. Their work is also behind subtle but ubiquitous safeguards such as the alarm that reminds us that the keys have been left in the car ignition or the headlights were left on; the lawnmower that stops moving if you let go of the handle; and the ergonomic enhancements that ease wrist pain at the computer keyboard.

Through systematic research and testing, human factors engineers gain a thorough understanding of the likely experiences surrounding the use of the equipment in development. What are the user’s capabilities — age, strength, training, and level of fatigue? What is the work environment noise level, temperature, lighting, likely distractions, social and organizational factors, supervision, and so on? Do the parts and steps involved make sense? Are the displays and knobs intuitive enough? Are the labels and instructions clear? What is the "mental workload" required — the amount of thinking and concentration exerted while using the equipment or device? The process of collecting and refining this data helps engineers design usable, effective, and safe systems.

Health care has been slow to incorporate human factors, despite the mounting complexity of care delivery systems and evidence of resulting risk to patients. This is beginning to change. For example, the medical device industry is adopting human factors methodology, in part because of its natural ties with other manufacturing industries. And of course, medical equipment pervades every sphere of care delivery, from prevention and diagnosis through treatment, monitoring, and rehabilitation. Devices include everything from bandages, stethoscopes, and needles to pacemakers, x-ray machines and brain stimulators.

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) recognizes the need for human factors knowledge in the health care industry. The regulatory group estimates that one-third of the incident reports it receives annually involve medical equipment "use error," a term referring to flawed design — inattention to human factors rather than faulty equipment or incompetent operators. Acknowledging the problem, device manufacturers have begun incorporating human factors engineering into product design.

For example, enhancements in methods of drug administration, some widespread and some in use by early adopters, show great promise in reducing medication errors.

• Anesthesia machines have been redesigned to prevent a physician from inadvertently administering the wrong gas to a patient. At one time, it was possible for the canisters of nitrous oxide (laughing gas) and oxygen to be switched, for example. Now the tubing of one cannot be attached to the opening or "connector" of the other.

• Medication systems using bar codes, pioneered by the Veterans Health Administration and recently endorsed by the US FDA, offer built-in protections that greatly reduce the risk of patients being given the wrong drug. The basic process is: a hospital’s pharmacy labels all bottles and containers with bar codes, and patients’ wristbands are also imprinted with a code showing what medicines they should get. The nurse uses a hand-held scanner to verify a match between patient and drug, enhancing the likelihood of accurate dosages and timing of medications delivered.

• The "smart" infusion pump for medications delivered intravenously stores relevant information electronically on hundreds of drugs, including standard concentrations and acceptable dosing ranges. When a nurse programs a dose into the pump, the pump sounds a warning and gives a visual readout if the rate requested is inappropriate or outside institutional limits. If necessary, the infusion is automatically prevented.

Quality-driven organizations are pushing to expand awareness and adoption of human factors throughout health care delivery. One such institution is Iowa Health System (IHS) in Des Moines, Iowa, USA. Gail Nielsen, IHS’s Patient Safety Administrator, says, "Human factors engineering touches nearly every aspect of patient care, from equipment use and the physical environment to staffing, workload, and patients’ ability to use devices prescribed by their clinicians."

Through her stewardship of safety initiatives at IHS and her leadership role in the IMPACT network initiated by the Institute for Healthcare Improvement (IHI), Nielsen sees application of this science as a strategic organizational priority. According to Nielsen, "Health care administrators and managers must make human factors engineering an integral part of their institution’s patient safety program."

For quality and risk managers taking on this challenge and focused in particular on the need to reduce medical device and equipment hazards, Nielsen suggests the following: "A good way to begin is through department discussions of what staff members have observed or experienced themselves in using medical equipment, including complex software." She says, "Unit briefings or ‘safety huddles,’ are really useful forums for initiating a program to reduce potential hazards." Nielsen recommends considering a Device Use — Safety Briefing Model that has proven valuable for IHS.

Once such discussions are underway at the department or unit level, Nielsen urges administrators to develop a formal process of sharing the Briefing feedback with the institution’s risk manager. More broadly, in addressing device use hazards, Nielsen advises managers to do the following:

• Include human factors requirements in RFPs for equipment purchases and train Materials Management and Purchasing staff on human factors engineering.
• Study the policies and procedures on human factors programs of device vendors and buying groups used by your institution and affiliate organizations.
• Incorporate human factors concepts into root cause analyses.
• Conduct device simulation drills upon receiving newly purchased equipment to seek out potential problems or user interface flaws.
• Establish a non-punitive reporting environment to facilitate employee self-reporting of device use problems or near misses.
• Train employees to look for problems as they use equipment and devices, and establish a standing reporting process for pertinent observations.
• Define and practice a formal procedure for immediately removing patients from potential harm on discovery of human factors issues.
• Develop an alert system to quickly relay hazards related to human factors engineering to front-line staff.
• Share human factors discoveries and subsequent improvements with senior management.

Nielsen recommends that all individuals with a role in care delivery — including unit staff, physicians, therapists, nurses, technologists, and administrators — keep in mind the core principles of human factors: stay focused on the user’s experience and needs; anticipate the unplanned; design for recovery; and, above all else, respect human limits.

In a 2001 editorial in the British Medical Journal, IHI’s President and CEO, Donald Berwick, MD, MPP, makes a wise comment on this adage about human limits. Berwick says, "So long as it involves humans — and thank God it does — health care will never be free of errors. But it can be free of injury."

By applying the science of human factors to health care endeavors, we gain opportunities to continually reduce errors and protect our patients and staff from injury — while still preserving the precious human touch at the heart of medicine.

Additional Information

Berwick DM. Not again! Preventing errors lies in redesign — not exhortation. British Medical Journal. 2001;322:247-248.

Sawyer D, et al. Do It By Design: An Introduction to Human Factors in Medical Devices. Washington, DC, USA: US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health; December 1996.

Kaye R, Crowley J. Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Washington, DC, USA: US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health; July 2000.

The Department of Veterans Affairs' (VA) National Center for Patient Safety Root Cause Analysis tool (see "Triggering and Triage Questions").