ANSI/AAMI/ISO 14971:2007 defines harm as “physical injury or damage to the health of people, or damage to property or the environment,” hazard as “potential source of harm,” and hazardous situation as a “circumstance in which people, property, or the environment are exposed to one or more hazard(s).”1 These definitions are distinct in wording. However, when used in real-world situations, confusion frequently occurs in the application of these terms. For example, one organization’s use of hazard might be interpreted as a harm, hazardous situation, failure mode, or cause by another organization. Even within the same organization, these terms sometimes are used interchangeably without distinction. Inconsistent use of these terms might not be considered a critical issue, as long as their use results in identification of all elements of risk and adequate risk control measures. However, this issue becomes critical in today’s international regulatory environment and complex healthcare system, in which more stakeholders are involved in risk management, more devices are interconnected, and the results of one risk analysis may become input to another risk analysis. This article illustrates best practices in the use of these terms and associated benefits to stakeholders, such as risk management engineers, independent reviewers (e.g., the U.S. Food and Drug Administration [FDA]), healthcare institutions (and their information technology and biomedical staff), and ultimately patients. Understanding Risk Management Terminology Although the terms in ANSI/AAMI/ISO 14971:2007 may seem simple in concept, applying them effectively in practice can be difficult. To address this issue, these terms have been mapped into a framework of risk analysis taxonomy (Figure 1). The goal is to illustrate these terms and interrelations in a logical fashion so that risk management engineers, independent reviewers, and device system integrators (e.g., hospitals) can comprehend and apply them effectively. As a result, our explanations can be summarized as follows.
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