FDA 2011 Human Factors Draft Guidance vs. IEC 62366-1:2015

[A 2020 Amendment has been issued for IEC 62366-1]

This summary discusses the following two documents:

• Draft Guidance for Industry and Food and Drug Administration Staff-- Applying Human Factors and Usability Engineering to Optimize Medical Device Design (2011)

• ANSI/AAMI/IEC 62366-1:2015 (Medical Device--Part 1: Application of usability engineering to medical devices)

IEC 62366-1:2015 has more similarities to the FDA’s 2011 Human Factors Draft Guidance in comparison to its predecessor, IEC 62366:2014. This post identifies a couple of high-level differences that still exist between the two documents.

Information that IEC 62366-1:2015 includes and the FDA’s 2011 Human Factors Draft Guidance does not:

IEC 62366-1:2015 sets up the idea of abnormal versus normal use of a device and explains that human factors engineers should only consider what falls under the normal use spectrum.

IEC 62366-1:2015 mentions the need to take into account transport and storage of the device.

IEC 62366-1:2015 describes use error as leading to a hazardous situation in one of two ways. Either the machine causes a hazard because of a user input or user causes a hazard because of the machine’s output.

IEC 62366-1:2015 provides examples of use-related hazardous situations in an annex.

IEC 62366-1:2015 incorporates an UOUP section (User interface of unknown provenance) solely for the purpose of explaining what to do if the device was already on the market before the publication of IEC 62366-1:2015. For example, the manufacturer will need to consider post-market material such as customer complaints or instances where the product created hazards (see a detailed overview in ClariMed's 2015 HFES Medical Device Symposium presentation).

Information that FDA’s 2011 Human Factors Draft Guidance includes that IEC 62366-1:2015 does not:

FDA’s 2011 Human Factors Draft Guidance clarifies the number of test participants that should be used during Usability Validation – 15 users of each user type.

FDA’s 2011 Human Factors Draft Guidance includes, in an appendix, the necessary information to incorporate into an HFE submission to the FDA.

FDA’s 2011 Human Factors Draft Guidance gives details on how to use a task analysis in order to break down the device use process to discover hazards in a mutually exclusive and collectively exhaustive manner. To embellish upon the content in the FDA’s 2011 Human Factors Draft Guidance, ClariMed believes that identifying hazards should not involve a group of “stakeholders” brainstorming in a room. Hazard identification should be driven by perception-cognition-action analysis in which each task is individually deconstructed to identify all hazards systematically.

FDA’s 2011 Human Factors Draft Guidance explains that simple mock-ups and prototypes can be used for formative testing.

FDA’s 2011 Human Factors Draft Guidance describes the importance of recording all close calls that occur during testing because they may be indicative of problems on the user interface.

FDA’s 2011 Human Factors Draft Guidance gives examples of where to find information regarding use-related hazards with similar devices already on the market (e.g. the MAUDE database).

Minor difference between the IEC 62366-1:2015 and the FDA’s 2011 Human Factors Draft Guidance:

The IEC 62366-1:2015 talks about how long the life of the device is before it is considered unsafe to use (Section 3.6), whereas the FDA’s 2011 Human Factors Draft Guidance bases the safety cut-off line on the number of uses (an excerpt from Section 10.1.1 is shown below).

Source: FDA.gov

Conclusion

There still remains some standardization that needs to occur between the FDA and the international standards for human factors. However, overall the documents are very similar. In reviewing both documents in detail, it is clear international standards committees have been striving to align the content of the IEC 62366 standard with “state of the art” human factors practices. The similarities between these documents makes it easy to comply with the international human factors standard and FDA expectations at the same time.

References

"Draft Guidance for Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design." U.S. Food and Drug Administration: Protecting and Promoting Your Health. U.S. Department of Health and Human Services, 22 June 2011. Web. 13 Aug. 2015. .