Wherever you are in your product development lifecycle,
Sterling can help.
Author: Dan Sterling | Date: February 7, 2018 | Updated on December 1, 2022
Medical device hazard analysis is a fundamental requirement of ISO 14971 risk management. The steps in conducting a hazard analysis entail identifying hazards from possible occurrences or “hazardous effects.” These hazardous events could stem from the environment or usability of the device from human factors. After an assessment of the possible failures in the product or “causes” included on your hazard analysis checklist, you should take steps to do a comparison of the risks’ costs to their benefits. This is known as a “top-down” approach that reviews the component of the product at the end.
In the case the cost is greater than maintaining a residual risk— you must take actions to mitigate or eliminate this risk. In the case the benefit is greater than perceived cost— you should take actions to ensure that stakeholders are aware of the residual risks that they are being exposed to during use, why they are necessary to the medical device, and how they should be handled. There are two major co-dependent factors used in determining whether the risks the medical device poses are acceptable. On one axis, there is the probability of the hazardous event’s occurrence, or the likelihood of this event happening. On the other axis, there is the evaluation of the severity of the event, or how risky the consequences are.
There are different types of hazard analysis in medical device development. The most common approaches to top-down hazard analysis include Fault Tree Analysis (FTA) and Hazard Analysis and Critical Control Point (HACCP). The two are similar in approach, but visually FTA is seen as a convenient way to estimate probabilities of frequency. At the top of the tree lies the hazardous event that poses a risk, which then branches down to various levels of factors that cause this event to happen that need to be addressed. This method is based on creating logic gates for each causation event or gates to see which are necessary to make the top-level event occur.
In the initial steps of development, it can be difficult to know specific hazardous events that might occur, but there are still high-cost baseline hazardous events that could pose risk during development that must be considered. This is useful for determining the best course of action when selecting materials, developing monitors, controls, and other design features for the product. FTA is primarily risks of various alternatives.
HACCP has a specific seven step process in structuring the hazard analysis. In addition to identification, HACCP targets critical points and limits. Once done, a specific system is established to monitor these critical control points and verify that the HACCP system is working effectively while establishing a record-keeping system.
The same perspective is applied throughout the intricacies of production to post-production of medical devices to ensure there are considerations for life threatening risks from malfunctions and misinformation. Often a risk matrix will be created with the probability of occurrence, set in relativity to severity based on the company’s risk-acceptability criteria. The result is a constantly improving and low-cost product.
At Sterling Medical Devices, we know what should be included in a hazard analysis and embed it with our human factors engineering process. To learn more about our human factors engineering, visit here.
October 7, 2013
February 18, 2021