Making Medical Devices SAFE
   
   
 

Several human factors techniques are available to help evaluate the potential for people to commit errors when using a device.
 
 

 

Making Medical Devices SAFE

Here are four strategies for improving the safety of medical devices. We've tagged each strategy with a key word with the goal of creating a helpful mnemonic:

 

Start early. Companies that succeed in creating safer medical devices begin thinking about device safety from the earliest stages of their product concept development. Identifying safety risks early in the process gives companies more flexibility with risk management. It's much less expensive to introduce design changes early in a product's development, and design changes can almost always offer better risk mitigation than adding warnings to product packaging or changing instructions for use.

 

Attitude. Ironically, one of most effective strategies for reducing use-errors is to accept their inevitability. Once a company accepts that people will make mistakes using their device, they can start work on minimizing both the likelihood of those mistakes and their consequences should they happen.

 

Factors. Creating safer products requires knowing the factors that contribute to error: both the human factors relating to why people make errors and the design factors that make errors more or less likely to occur or more and less difficult to detect and recover from. Safer devices are designed to accommodate a human's need for consistency, and clear and timely feedback. They avoid ambiguity, memory load and unnecessary complexity.

 

Evaluate. Several human factors techniques are available to help evaluate the potential for people to commit errors when using a device. Analytic techniques, such as the Usability & Safety Bench Test, identify gaps between the cognitive, perceptual, and motor skills required to use a device safely across different use environments, and the cognitive, perceptual, and motor skills of the target user population. Empirical techniques, such as Usability Testing, can identify sources of confusion, ambiguity, and inefficiency that contribute to use errors. Still other techniques (e.g., Healthcare Failure Modes and Effect Analysis or HFMEA) can be strengthened by adding human factors expertise to the evaluation process.

 

 

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