Medical devices are complicated machines that require a lot of engineering, testing, and regulation to be made safe for patients and doctors. They can fail for a number of reasons, but the consequences can be dire for patients and their doctors.
To help medical device organizations reduce the risk of failure, failure analysis is a way of systematically identifying the potential sources of failure. According to the Barnes Firm, a Brooklyn personal injury lawyer, “failure analyses can be performed in a number of ways, but the key is to understand both the cause and the consequences of a failure. Failure analyses come in two forms: qualitative and quantitative.” Qualitative failure analyses look at a failure as a whole and attempt to understand why the failure occurred. Quantitative failure analyses look at a failure in detail and attempt to identify the root cause. Both of these methods help reduce the risk of failure in the future by identifying the potential causes, and ultimately, the root causes of failure.
Causes of Medical Device Failures
Medical device failures are often caused by issues with design, production, quality, regulation, and more. To find out which of these are the most likely causes of a failure, a failure analysis is performed.
A failure analysis can reveal the root causes of failure, and can help organizations avoid similar issues in the future. The method of failure analysis used depends on the type of device, the operator and patient population, as well as other factors.
Some examples of potential failure analysis methods include:
- Visual analysis: Operators examine the device and make observations about the device, such as how it looks, how it feels, or what it sounds like. This information helps to give context about the device and can be used to identify potential issues with the device.
- Sensory analysis: Operators are able to examine the device itself and the device-related materials, such as the device’s components, the interior of the device, and the device’s labeling.
- Functional analysis: Operators perform tests on the device and evaluate the device’s performance, including how well the device focuses, how easy it is to use, and other performance metrics.
What is a Failure Analysis?
A failure analysis is a way of systematically identifying the potential sources of failure. This helps reduce the risk of failure in the future by identifying the potential causes, and ultimately, the root causes of failure.
The most effective way to perform a failure analysis is to create an incident Analysis plan. In this plan, you identify all the areas that could involve potential failures in your medical device, such as design, production, quality, and more. You also identify all of the potential failure causes and factors that could contribute to that cause.
You also want to collect data from each of these areas, such as production logs, design models, logs from actual surgeries, or other pertinent information. You then feed this data into a software tool. The software identifies any potential issues, and you can use that information to improve your medical device.
Qualitative Failure Analysis
Qualitative failure analysis uses visual analysis to identify potential issues with a device. If a device is visually inspected, operators can identify issues with the design and make observations about the device, such as how it looks, how it feels, or what it sounds like. Operators can also identify potential issues with the materials and design, such as the device’s components, the interior of the device, or the device’s labeling. Based on these observations, operators can identify potential issues with the design and make recommendations for improvements.
Quantitative Failure Analysis
Quantitative failure analysis uses design models to identify potential issues with a device. Design models are physical representations of how a device should look, how it should operate, and how it should be manufactured. Design models are created based on the device’s intended use and the device’s user requirements. Device design models are created by engineers, who use design tools to create a representation of the device. Design models are then reviewed by different teams, such as regulatory, quality assurance, and design review teams.
Strategies to Improve Your Failure Analysis
As we’ve seen, failure analysis is a way of systematically identifying the potential sources of failure. But how do you identify potential issues so you can improve your failure analysis? There are a few key strategies you can implement to increase the effectiveness of your failure analysis.
- Build a culture of safety – When performing a failure analysis, it’s important to have a culture of safety. This means establishing a safety mindset throughout your organization. This includes building a safety culture and having a safety leadership style that focuses on safety throughout all aspects of your organization.
- Get buy-in – The best way to identify potential issues and improve your failure analysis is to get buy-in throughout your organization. This includes involving key stakeholders throughout the process, such as your Quality Management team, your regulatory team, and your design review team.
- Create an incident analysis plan – The best way to identify potential issues and improve your failure analysis is to create a plan. In this plan, you identify all the areas that could involve potential failures in your medical device, such as design, production, quality, and more. You also identify all of the potential failure causes and factors that could contribute to that cause. You also want to collect data from each of these areas, such as production logs, design models, logs from actual surgeries, or other pertinent information. You then feed this data into a software tool. The software identifies any potential issues, and you can use that information to improve your medical device.
Remain Diligent With Your Medical Devices
Medical devices are complex machines that require a lot of engineering, testing, and regulation to be made safe for patients and doctors. They can fail for a number of reasons, but the consequences can be dire for patients and their doctors.
To help medical device organizations reduce the risk of failure, failure analysis is a way of systematically identifying the potential sources of failure. Failure analyses can be performed in a number of ways, but the key is to understand both the cause and the consequences of a failure.
Qualitative failure analysis uses visual analysis to identify potential issues with a device. If a device is visually inspected, operators can identify issues with the design and make observations about the device, such as how it looks, how it feels, or what it sounds like.
Quantitative failure analysis uses design models to identify potential issues with a device. Design models are physical representations of how a device should look, how it should operate, and how it should be manufactured. Device design models are created based on the device’s intended use and the device’s user requirements.
