Robert North, PhD, chief scientist of Human Centered Strategies, and participant in the AAMI committee that is updating the human
interaction standards, highlights the impact of user interface design on medical device safety. In speaking for the FDA (?), he notes correctly that the, "FDA views errors during human interaction with a device as seriously as
any mechanical, electrical, software, or chemical errors that may make
a device cause patient harm." From the MD&DI story:
To understand the effect of regulation on the design-research and
early concept-testing phases, the overall process that FDA requires
must first be understood. This process is succinctly described on FDAs
Web site [here]. It cites AAMI/ANSI HE74-2001, Human Factors Design Process for Medical Devices. It further states the following:
This standard serves as a guideline for integrating human factors
engineering into the product design and development process necessary
to satisfy the FDA Quality SystemsDesign Control requirement to ensure
that the needs of the user are appropriately defined, verified and
validated. Any declaration of conformance to this standard with respect
to establishing a manufacturers standard design and development
process adequate to meet the needs of the user should be accompanied by
the following documentation at a minimum:
- Description of the process to be followed in defining the user needs to establish the device-user interface design input.
of the process to be followed in verifying that the user needs as
defined by the design input is addressed by the design output.
of the process to be followed in validating that the final design
functions in a way as to met the intended users needs.
of the risk analysis process to be followed in identifying and
assessing reasonably foreseeable risks associated with intended use.
All of these FDA requirements affect how a medical manufacturer
would structure and document design research and early concept work.
After the Improving Patient Safety through Medical Device Interoperability and High Confidence Software workshop last week in Boston, it was clear that the importance of this area grows considerably as connectivity and interoperability is added to medical devices. This, combined with the rather sorry state of embedded system software development - in both requirements gathering and product development processes - I suspect the FDA will be increasing their scrutiny in this area.