Medical device safety system design: a systematic approach

   As technology advances, medical devices that improve disease diagnosis and the treatment of illness or injury are introduced. Many of these lifesaving medical devices perform these functions through the control and measured application of hazardous and potentially lethal energy sources such as x-rays, gamma radiation, lasers, or high-voltage electrical charge. Patients and healthcare providers depend on medical devices to perform safely and predictably in a variety of situations and environments.

   However, as medical devices become more sophisticated, they increase in complexity and their response to user inputs, environmental inputs, and component failures aren’t as predictable. Therefore, a systematic approach to device safety is essential to the successful and cost- effective development of complex medical devices.

    A well-designed safety system must implement risk controls for all of the product’s hazards. For devices that have significant risk of harm, the safety system includes elements that are fully independent of the operational elements of the system. The safety system must also have well-defined interfaces with the operational elements of the system at critical points.

This article looks at issues such as how to:

•Define safety requirements

•Address safety in the architecture

•Consider an independent safety system

•Electromechanical considerations

•Good safety system design

•Review the system architecture

The article "Medical device safety system design: a systematic approach" originally appeared in MDDI (Medical Device + Diagnostic Industry), click here to read it.

About the authors

David Warburton is the director of Systems Engineering at Foliage, Inc. (Burlington, MA);  Dan Goldman is a lead medical device system architect at the firm.

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