Hazard Analysis in Medical Devices | Risk Management

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The Importance of Hazard Analysis in ISO 14971: Defining and Mitigating Potential Sources of Harm

The hazard analysis is pivotal to your medical device’s risk management file. ISO 14971 defines a hazard as a “potential source of harm,” where a harm is injury or damage to health or property. The hazard analysis is a formal assessment of how your device could potentially harm the end user or patient in the event of device misuse or malfunction. The hazard analysis demonstrates how the manufacturer has considered and mitigated potential hazards in the product’s design.

How Hazard Analysis Differs from FMEA in Medical Device Risk Management

A Failure Mode and Effects Analysis (FMEA) is structured using a “bottom up” approach where the low-level component or process failures are evaluated to determine the effect of the failure on the device or the user and the cause of the failure to be prevented. For a Design FMEA, an example of a component failure is a gasket failing to provide proper seal against water ingress. 

Conversely, a Hazard Analysis is created using a “top down” approach where high-level failures are analyzed. Examples of high-level failures include user misuse, the product being dropped, or power loss. Like an FMEA, a diverse, cross-functional team ensures that you are considering all aspects of the product.

The Components of a Comprehensive Hazard Analysis: Biological Hazards, Misuse, Mechanical, Electrical, and Software Hazards

While this is not an exhaustive list, there are a few topics that every hazard analysis should consider:

  1. Biological Hazards
  2. Reasonably Foreseeable Misuse
  3. Mechanical Hazards
  4. Electrical Hazards

Examining Biological Safety in Medical Device Hazard Analysis

As medical devices are typically intended to come into contact with the body to perform their intended use, biological safety and biocompatibility hazards in the design must be considered. The ISO 10993 series of standards are internationally recognized to guide manufacturers in the evaluation and mitigation of biological safety hazards in medical devices. Use of these standards as part of your hazard analysis will help determine the type and level of testing required to ensure your device has minimized hazards due to irritation, sensitization, cytotoxicity, and more.

Identifying Reasonably Foreseeable Misuse in Medical Device Hazard Analysis

ISO 14971 defines reasonably foreseeable misuse as “use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.” The most common source of medical device recalls is caused by misuse of the product. The standard IEC 62366 guides medical device manufacturers on how to identify use-related hazards and implement a usability engineering process so that use-related hazards are effectively mitigated.

Understanding Electrical Hazards in Medical Device Hazard Analysis

If your device is electrically powered, then electrical hazards must be considered. The IEC 60601 series of standards are internationally recognized to guide manufacturers in the evaluation and mitigation of electrical hazards. Electrical hazards tend to result in patient harm such as electrical shock, burn, or electrical fire. Typical electrical hazards that need to be considered include:

  • Accessible electrical parts
  • Reversed polarity of connections
  • Loss of power
  • Overheating of components
  • Accuracy of controls

Implementing Hazard Analysis Mitigation Strategies: Keeping End Users Safe

Regulators around the globe expect medical device manufacturers to implement mitigation strategies to reduce the likelihood or severity of their documented hazards. Though tedious, the hazard analysis and risk management process will help keep end users safe. If you would like to leverage Simbex’s broad expertise and decades of experience to help develop your hazard analysis for your medical device, contact us.

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