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particular hazard. To avoid confusion, describe each risk separately and clearly. For example, when considering the hazard of selecting the wrong drug because of similar (look-alike) packaging, there is risk to the patient, risk to the staff involved and risk to the organisation. Failure to describe or define each risk clearly
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- Introduction
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One of the most challenging elements of risk analysis is the assignment of Harms and Severities to a particular hazardous situation. On the surface, describing the consequences of the sequence of actions that lead to exposure to a hazard seems pretty straight-forward: establish a set of criteria describing increasing levels of Harm (e.g., from “Neg...
One of our primary recommendations to clients with regard to conducting risk analyses is to do their homework before jumping into detailed analyses. By “homework” we mean conducting research into the type of hazards and failures (and associated harms) that can occur as a result of the use of your device. There are a variety of tools and approaches ...
When assessing the severity of harms that could occur during the use of your device, it is very important to clearly establish the “use scenarios” and “user profiles” being considered in your analysis. For example, if your device is indicated for use with the general population, your “user profile” will be defined quite broadly: e.g., from pediatri...
The last piece of the puzzle is to more clearly distinguish between harms that occur as a direct result of a hazard/hazardous situation and those that only occur following a series of subsequent events. To illustrate how these distinctions can be made, we have taken the five examples from Table E.1 in ISO 14971:2007 (Note: it’s the old version of t...
In our next article, we will continue to explore specific challenges associated with components of the FMEA process by digging into the estimation of the probability of occurrence. If you’ve missed any of our previous articles, you can look them up on here. MEDIcept … Trusted Solutions, Rapid Response …
MEDIcept Inc. is an international consulting firm specializing in medical device, IVD, and biotechnology Regulatory, Quality, and Clinical Services. Since 1996, we have worked with thousands of companies to solve their most critical FDA and ISO issues. Our integrated solutions are rooted in our direct experience and span all stages of the product l...
vi This Glossary is designed for the policymakers, prac - titioners and other stakeholders who work in the many fields that contribute to reducing the health risks and
Feb 24, 2020 · ISO 14971 provides guidance on different classes of hazards such as energy hazards, biological or chemical hazards, information hazards and functional hazards. It is helpful to make a master hazards list under different categories so you can evaluate them holistically within the scope of a given medical device.
Jul 9, 2020 · Harm is defined by the Standard as “injury or damage to the health of people, or damage to property or the environment.”. The definition used to be “physical injury” but “physical” was removed from the most recent description. The “injury or damage to the health of people” part is straight-forward.
May 27, 2022 · Communication of information relating to a patient or service used for the purposes of their care management. A manufactured digital artefact, product or service that is used for health or social care purposes. This could include a 'health IT system', 'data flow', 'information standard' or 'medical device'.
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Jan 1, 2015 · 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.
