AAMI TIR59 has just been released. It’s titled Integrating human factors into design controls. It has been developed to provide information on integrating human factors engineering/usability engineering (HFE/UE) into the design controls process for medical devices. It directly addresses the FDA requirements in 21 CFR Section 820.30 for design controls. This technical information report can assist you in creating consistent and aligned processes throughout your product development cycle.
Two important things to note about the AAMI TIR59. First, it proposes a methodology that can be integrated into existing processes. Secondly, it includes information on risk management implications at the end of each clause. And as a technical information report, the document provides recommendations only. Other solutions are entirely possible.
Additionally, IEC 62366-1 (ANSI/AAMI/IEC 62366-1:2015) mandates a Usability Engineering File. So the AAMI TIR59 also focuses on activities that overlap both sets of requirements.
The standard begins with the usual scope and definitions sections. Acronyms are also given a section as well. Next, the report reviews the integration of HFE/UE with existing design controls. Pre-design controls are also discussed.
With Section 6, clauses of the 21 CFR 820.30 are each identified and reviewed with suggestions for compliance. These TIR59 sections include the FDA 820.30(a) through 820.30(j). The final section of the publication is on post-market surveillance. Annex A is informative, and gives you specific suggestions for your HFE/UE report. These are on development, organization and content, and other considerations. A 14-item bibliography completes the document.
I find it reassuring that the human element (users) of medical device design is now getting additional attention. I have met folks whose devices contain a high degree of interactivity. They can be challenged by tasks that may seem simple for the device manufacturer but present problems when the user has deviations from a routine. I’m sure there are many other examples of issues that have occurred as our concepts of what medical devices are and do have expanded.
To get your copy of this AAMI technical information report, head to the Document Center Inc. webstore at www.document-center.com. Document Center is an authorized distributor of the AAMI standards and provides free update notification as part of your standards purchase. Here is a direct link to the order page for AAMI TIR59 for your convenience.
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