Page 257 - Safety Risk Management for Medical Devices

236 Safety Risk Management for Medical Devices

• Risk management is a living and an ongoing process for as long as the medical
device is in the field.
• Include in the Risk Management Plan that a person with relevant medical
knowledge will review and approve documents that evaluate Harms or risks of
Harms, e.g., Harms Assessment List, Risk Assessment and Control Table, and
benefit risk analysis.
• Good traceability is an invaluable tool for both change-impact analysis, and
determination of whether a detected field issue has a safety impact or not.
• When doing Use-Misuse Failure Modes and Effects Analysis, include in the
team people with clinical knowledge, such as doctors, nurses, or field clinical
engineers who spend time in the clinics/operating rooms and know how the
product actually gets used.
• Near misses or close calls should not be dismissed. They are gifts—a warning
without any harm. Learn from them as if they were real events.
• It is important to maintain consistency among the risk management artifacts
and the design. As designs iterate, a robust change-control and configuration-
management system helps ensure that the risk management documents remain
consistent with the actual design of the medical device.
• Risk management produces large documents that are not easy to review. When
asking people to review risk management documents, make specific requests of
them to limit the scope of their work, e.g., ask the medical/clinical person to
review the document from the medical safety perspective, while the mechanical
engineer would evaluate the mechanical aspects in the document.
• Risk management is collaborative endeavor. In addition to the normal func-
tions of R&D, manufacturing, Clinical, etc., engaging the Intended User may
provide a unique perspective and may identify risks that relate to their expected
use of the product in their specific environments.
• Even though the BXM method deploys a numerical method which lends itself
to mathematical computations, one should not be lulled into thinking that the
output of the analysis is the absolute truth. Remember that the input to the
math is still an estimation. But it is better to make many small estimates and
mathematically aggregate them, than to just make one big overall estimate.
This is similar to estimating the annual budget of a company. The CFO doesn’t
just pull a number out of thin air. He/she asks people at all levels to make esti-
mates for their budgets. Then these small estimates are gradually aggregated
until the entire company budget is determined.
• It’s important to cultivate and encourage humility in self and others. The
absence of humility, can lead to unjustified certitude or hubris. This is when
the spirit of inquiry stops and can lead to errors in risk management.
• Cultivate and encourage imagination.