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Medical Device Design
Factors such as complexity of the device and the risk
associated with the device’s use should be taken into consideration when
evaluating the allocation of resources for medical device design.
Preventing Error and Promoting Ease of Use
The goal in any good HFE design is to limit the
likelihood of error, enhancing the ease of use of the device and preventing any
tampering against safeguards. As the manufacturer you design your device to
operate in a specified manner. If given the opportunity it is likely that a user
will operate the device (either knowingly or unknowingly) in a manner not
consistent with the design. The manufacturer can anticipate user intention and
in effect implement “protection” against misuse. Another inherent reason for
misuse is complexity. Opportunities for mistakes will increase with increasing
complexity of device use. Complexity encourages users to take “short cuts”
whenever possible.
Is it a regulatory requirement?
Yes, Human Factors Engineering is stated in the quality system regulation and is
something that firms (selling products in the US) must comply with. The QSR
indirectly uses catch all phrases that makes HFE consideration unavoidable.
"maintain procedures to control and verify the design of the device in order to
ensure that specified design requirements are met. Manufacturers are required to
establish and maintain procedures:
-- To ensure that the design requirements are appropriate and address the
intended use of the device, including the needs of the user and patient, and
-- For verifying and validating the device design, to ensure that devices
conform to the users needs and intended uses."
Building your HFE file
In addition to in-house brainstorming, other sources of
information are useful for input into your HFE program. For instance FDA’s MDR
database has an inexhaustible supply of incidents related to device-human
interaction failures.
Other sources of information that may be useful include FDA’s MAUDE database as
well as other hospital incident reporting systems. There are also published
standards, scientific technical data, usability tests employing typical users
(and perhaps untypical users), clinical evidence, as well as expert advice.
Using Risk Management for Human Factors Engineering
Risk management is an essential element for any Quality Management System.
Applying it systematically helps identify, understand, control and mitigate
potential HFE related hazards.
The following is a step by step analysis of how your HFE program should be
implemented.
-- The steps to managing HFE risks begins with identifying and describe
use-related hazards related to user-device interactions (see below for
recommendations on where to get information). A list should be compiled of known
risks as well as any foreseeable misuse of the device.
-- The next step is to estimate the risk associated with each hazard. This
evaluation can be either quantitative or qualitative, but should stem from the
method used in your risk management plan. This can be a time saver step since
some hazards may result in very low risks. This will effectively direct you to
the more likelihood hazards that will require more in-dept analysis and
mitigation. The decision whether the risk requires mitigation or not should be
made and recorded.
-- After estimating risk and determining that risk mitigation is required, the
next step is to develop strategies and controls to reduce the likelihood or
mitigate the consequences of use-related hazard scenarios. Strategies should
consider simplifying product use as well as safe-guarding against alarm
tampering. In essence you are “fool-proofing” use of your product.
-- After estimating various methods of risk control (there may be more than one
way to mitigate a risk) select and implement the control strategy. Sometimes the
risk can not be mitigated any further than is reasonably possible. This is the
time to determine if the risk is reasonably acceptable and outweighs the benefit
of the device.
-- The next step is to ensure that no other risks were inadvertently introduced
as a result of implementing the control. If this is the case, then the new risk
needs to be evaluated as we did for each identified hazard.
-- The product specifications (operational and function requirements) need to be
re-evaluated to ensure the control measures didn’t change anything. This step
should follow after all hazards have been mitigated – including those that
resulted from control measures. In essence you have thoroughly evaluated your
device for risks and have completed implementation of all control measures.
-- The final step is to test and validate the design use – to ensure safe and
effectiveness.
Conclusion
Human Factors Engineering is an effective way to
systematically test potential user-product interfaces. It is an off shoot from
your Quality Management System’s Risk Management policy.
Indirectly, HFE is not only an US FDA requirement but does fall under
requirements of other countries. For instance in Canada, Class II and higher
devices must under requirements of ISO 13485, follow ISO 14971 (Application of
Risk Management to Medical Devices). Human-device interfaces result in risks the
same way as other opportunities. In the end – it just makes good sense since you
are truly designing a good safe and effective product.
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