Drug and Medical Device Risk Assessments

The US Food and Drug Administration (FDA) states that proactive risk assessments should be employed to help identify potential use-related errors and to remedy any safety concerns prior to a product reaching the market. FDA recommends the use of failure mode and effects analysis (FMEA) and simulated use testing (human factors testing) as tools to support conducting a risk assessment of a product.

Engagement Description

Med Safety Board’s risk assessments are typically used to evaluate a unique aspect of a product, such as a change in presentation, special use requirements, or a new device design, and are conducted in the development or pre-market stage before submission to regulatory agencies for marketing approval or clearance.

Using aspects of FMEA, Med Safety Board can help companies identify where in the use process an error could occur and how to mitigate associated risks.

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Failure Mode and Effects Analysis – FMEA

Failure mode and effects analysis is a risk assessment method based on the simultaneous analysis of failure modes, their consequences, and their associated risk factors. The FMEA process seeks to uncover design flaws in such a way that may predict and limit the consequence of human error. It assumes that no matter how knowledgeable or careful a practitioner or individual is, errors are possible or likely due to certain product-related factors. FMEA examines a given process, identifies possible or likely errors, and gauges their level of impact. The goal of FMEA is to simulate the environment in which the product will be used in order to bring problem areas to the surface. Where errors are considered likely, suggested actions are provided.

Human Factors & Usability Testing

FDA requires human factors studies for all medication-related devices. As an accompaniment to its risk assessment process, Med Safety Board’s team of experts, including human factors engineers, can offer human factors and usability testing in a simulated use-case environment. MSB medical error databases and best practice training provide unique value as an accompaniment to human factors training and device evaluation.

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