People make errors all the time – it’s an aspect of being human. Errors made while using medical devices can lead to hazards which can impact patients, family members, and healthcare providers. Hazards associated with device use are a common and serious problem. Evidence from researchers suggests that the frequency and consequence of hazards resulting from medical device use error far exceed those arising from device failures. Therefore, it is essential to ensure safe and effective device use if hazards are to be controlled effectively.

FDA recognizes that most use errors with medical devices are not “inevitable human error.” Rather, they are largely influenced by device design and device labeling. OHIP seeks to promote the safe and effective use of medical devices through our Human Factors program, labeling efforts, and research activities.

Human Factors

Human Factors (HF) is a science devoted to the interaction of people and equipment. "Human Factors," "human engineering," "usability engineering," and "ergonomics" are often used interchangeably. In the field of medicine, the objective of Human Factors is to improve human performance and reduce the likelihood of use error and patient injury.

During FY 2003:

• We assisted the Center’s Office of Device Evaluation by providing several Human Factors reviews for PMA and 510(k) devices.
• We redesigned the Human Factors Website to help visitors find information about FDA's Human Factors Program. This website consolidates all human factors and use error information into one cohesive website. It gives links to key guidance documents and publications, and explains the role of human factors in the safe use of medical devices.
• We created a Human Factors Program Display to promote the Human Factors program more widely within the Agency. The display includes sections on: What is Human Factors?; Why is Human Factors Important?; What are some examples of Human Factors Problems?; and, What is FDA Doing (Human Factors program goals)?

 Labeling

Improved patient labeling on medical devices allows the patient or caregiver to better understand both instructions for use and risk-benefit information. OHIP reviews patient labeling for all new Premarket Approval (PMA) submissions and also for 510(k) and HDE submissions when CDRH's Office of Device Evaluation (ODE) determines that the patient labeling for a device is particularly important.

When patient labeling is not provided as part of a pre-market submission, OHIP reviews the application to determine if labeling would contribute to reducing use error or allow the patient to make a more informed choice concerning their healthcare. During 2003, we reviewed 102 labeling submissions. This was the eighth year that OHIP has worked with ODE to perform these reviews.

 Electronic Labeling

One important example of a new way the FDA will provide information on the products it regulates is through an electronic product label. During FY 2003, OHIP conducted usability research in best practices for the presentation of electronic labeling

On November 18, 2003 we hosted the "Medical Device Electronic Labeling Conference." The purpose of the conference was to add to our knowledge base about current best practices for conveying medical device information electronically to health care professionals, patients, and consumers. Five experts from the public and private sector presented information about research-based web design and usability guidelines, user-centered design issues, and writing style and format for web-based applications. Attendees included representatives from all the Centers. Next steps include:

• a summary report of the conference;
• a heuristic assessment of an ideal prototype of electronic labeling; and
• a usability test comparing an ideal prototype of electronic labeling to a model version of paper-based labeling presented on the web.

Use Error Model

OHIP developed a model of use errors based on real-world experiences of nurses, biomedical engineers, and home users who use a variety of medical equipment. The model was also based on known examples of use errors from literature and experience within CDRH, and a few from human factors (HF) in other industries (but which could apply to medical devices). The model proceeds from a previous projected called Prioritization and Reduction of Use Error in Devices (PROUD) 2000. It was developed with the assistance of an outside contractor who held discussion groups with visiting and traveling nurses and evaluated the results.

The current model, called UPCARE, consists of four main components: Unmet User Needs, Perception, Cognition, and Actions.

These four broad categories represent all cases of use error that have been collected and each is broken down further within the model into sub-categories. The categorizations are based on actual experiences of users and known use problems. UPCARE represents the only known descriptive model of use-errors with medical devices and was presented at the 8th Annual International Conference of Industrial Engineering Theory Applications and Practice in Las Vegas in 2003. Upon completion of this work, we will provide a source of specific and useful information for manufacturers, adverse event reporters and evaluators, reviewers of new device submissions, and device users. As such it will help guide design refinements in medical equipment and support other strategies for error-reduction. Perhaps most useful, it presents a consistent and coherent structure and vocabulary for discussing and understanding instances of medical device use error, which is currently lacking in government, industry and the user community.