Page 72 - Safety Risk Management for Medical Devices

Risk Management Process 51

This together with Fault Tree Analysis constitutes the Hazard identification phase.
Additionally, the Security Risk Assessment file is examined for potential security risks
with a safety impact.
Next, the risk estimation phase is entered (see Chapter 17: Risk Estimation). This
is where all the Hazards and their causes, the corresponding Hazardous Situations and
Harms are brought together in one table called the Risk Assessment and Control
Table (RACT). Risk Controls should be applied, and risks reduced as far as possible
(in compliance with EN ISO 14971:2012 [7]). Within the RACT, the risks for each
Hazard, Hazardous Situation as well as overall, for the whole System are estimated.
The RACT is the heart of the BXM risk management process. In any ISO 14971
compliant risk-management process something like the RACT is found. It may be
called by other names, e.g., Risk Table, Risk Matrix, Risk Analysis Chart, etc.
Following the Risk Controls and risk estimation, another pass is made to investi-
gate whether it is possible to further reduce the residual risks for each Hazard or
Hazardous Situation. If possible, additional Risk Controls are implemented. Next, the
overall residual risk for the System is assessed with consideration of all the Hazards that
the System could present.
Once the overall residual risk of the System is known, a benefit risk analysis is
performed to determine whether the potential benefits of the System outweigh its
potential risks. If the benefits do not outweigh the risks, and no justification can be
made for release of the product, then the System should not be released for commer-
cial purposes. If the benefits do outweigh the risks then update the RACT with any
additional Risk Controls that were put in place since the initial RACT was produced,
and produce a Hazard Analysis Report (HAR). A HAR is a relatively large document
which embodies much of the details of the risk management process, e.g., the RACT
and the benefit risk analyses.
For submission purposes, an executive summary of the HAR is produced as input
to the Risk Management Report (RMR). While the HAR could be overwhelming
to a Regulatory reviewer due to its size and depth of detail, the RMR is a smaller
document that is designed to provide a good understanding of the risk management
work and give the Regulatory reviewer confidence that the System is safe enough for
commercial release.
The RMR is included in the Regulatory Submission. After the approval and
release of the medical device, the risk management process continues for as long of
the medical device is in the market. Periodically, the risk management work-products
are examined for potential impact due to input from production and postproduction
monitoring. Input such as complaints, trending, other field data, and even changes to
the Standard ISO 14971 [3,7] itself are considered. If any change or finding warrants
revising of the risk management work-products, the required changes are done and
the results are reflected in the RMR.