Human Factors/ Usability Studies Following IEC 62366 and the New FDA Guidance

         One of the first step in redressing the clinical underreporting data gap has already been implemented by the standards community by replacing the term User Error with Use Error. FDA defines use error as An act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. It takes the onus off the user by providing only the identification of what happened, not why it happened. It is no longer the users fault if the device causes the user to commit an error.

         Usability, and the consequences of how people interact with medical devices, are important in device design and testing, and malpractice and product liability litigation.

• Including safety alerts
• Encouragement of certain recalls
• The process of device clearance and approval

         FDA constantly strives to approve devices which are designed so that it is almost impossible for accidental usage harm to people. Still there is loads of evidence that doctors, nurses and patients make user error while using medical devices that result in patient harm. FDA and other international regulatory agencies identified that manufacturers must pay more attention to human factors at the earliest stages of product design and development, when user input can make a difference.

         Due to clinical under-reporting, the number and nature of close calls is unknown. Undefined close calls make it difficult for product design and development team to analyze and potentially correct the issue. International Electrotechnical Commission (IEC) standards call these under reported close calls Slips, Lapses, and Mistakes and most of these are device-use errors that have the potential to result in serious hazards.

• The changes to ISO 62366 standard
• The changes to (2016) FDA Guidance
• The process of conducting rigorous usability and human factors studies during
(1) the product design process (2) integrating it with the device risk analysis & design process & (3) validating the effectiveness of the studies
• Various types and methods of human factors analysis
• User error versus use error
• User profiles
• Use scenarios
• Step by step human factors program development
• Common Mistakes and how to avoid them

This webcast will be of a valuable assistance to the below audience.

• Development Engineers
• Engineering Management
• Production Management
• QA/ QC personnel
• Software developers