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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
- Introduction
- Harm
- Normal and Fault Conditions
- Hazards, Hazardous Situations, and Causes
- Examples
- Conclusion
- Next Steps
- About Us
Before diving into the best practices for conducting a risk assessment, it’s important to clarify some terminology. ISO 14971:2019 (the Standard) and TR 24971 (the Guidance) provide helpful definitions and examples, but even with that, the use of some risk elements can get confusing when you’re actually working on a risk assessment. This article pr...
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. If you ask the question “What is the patient suffer...
Clause 5.4 of the Standard says: “The manufacturer shall identify and document known and foreseeable hazards associated with the medical device based on the intended use, reasonably foreseeable misuse and the characteristics related to safety in both normal and fault conditions.” What are “normal and fault conditions”? Generally, “normal” condition...
By definition, Hazards are “a potential source of harm.” We’ve established that harms are injuries like infection, a burn, or radiation exposure. A hazard is just the source of that harm. Examples of hazards in the Guidance include: electricity, moving parts, infectious bacteria, chemicals, gases, sharp edges, high currents, temperature, and ionizi...
When working on a risk analysis, sometimes the information in a particular column may not strictly hold to the strict definitions provided in the Standard. The wording for a Hazard may include elements of the Harm or Hazardous Situation, the Hazardous Situation may read more like a Cause, and the Cause may be too specific to serve as a good lead in...
When working on a small risk assessment (<100 lines), you may be able to get away with allowing the Hazardous Situation to include some Cause language and for the Hazard to suggest the Harm – it’s small enough that reading across the line gives the team a good understanding to the risk so they can address it appropriately. But if the device is more...
With these definitions in mind, the next articles will begin to dig into the challenges of using the FMEA process to guide decisions that will improve device safety. 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...
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'.
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
Aug 9, 2020 · Introduction. 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 ...
Jan 27, 2021 · ISO 14971:2019 1 defines a harm as injury or damage to the health of people, or damage to property or the environment. It is important to note that there has been a subtle, but very important, change in the definition of harm in the current revision of ISO 14971. The concept of harm is no longer limited to physical injury to a patient or a user.
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Jan 1, 2015 · Hazards. A hazard is a potential source of harm. It is a potential source because harm can occur only when people (property or environment) are exposed to one or multiple hazards. Hazards exist with or without medical devices and do not have the property of probability.
