Page 197 - Safety Risk Management for Medical Devices

176 Safety Risk Management for Medical Devices

If you desire to track the pre/post risks, the modification of the RACT template is
easy. Simply replicate columns P1 through Negl-Risk, and label them “pre.”
Alternatively, as the RACT is a living document and continues to evolve, you can
save an earlier version of the RACT as the “pre-risk,” and use the last version of the
RACT as the “post-risk.”

20.1 RISK ASSESSMENT AND CONTROL TABLE WORKFLOW

In the following sections the workflow for RACT is described. The workflow
description corresponds to the template that is provided in Appendix B—Templates.

20.1.1 Examine the Clinical Hazards List
Start by citing all the applicable Hazards from the Clinical Hazards List (CHL) in the
Hazard column. Entries in the CHL that are not applicable need to be rationalized in
the Hazard Analysis Report. If new Hazards are identified in the underlying analyses,
include them in the RACT and initiate an update to the CHL.

20.1.2 Capture End-Effects with Safety Impact
Examine the System Design Failure Modes and Effects Analysis (DFMEA), the
System Process Failure Modes and Effects Analysis (for integral Systems) (PFMEA),
and the System Use-Misuse Failure Modes and Effects Analysis (UMFMEA). Import
the End-Effects that have a Safety Impact of Y. These End-Effects go into the Hazards
column of the RACT.

20.1.3 Populate the Initial Cause and Sequence of Events columns
For the entries that are collected from the underlying Failure Modes and Effects
Analyses (FMEAs), capture the Initial Cause of Hazard and Sequence of Events from
the FMEAs and populate the RACT. It is possible that you may identify additional
initial Causes and sequences of events. Add those to the RACT.

20.1.4 Populate Hazardous Situations column
Define the Hazardous Situations. A Hazardous Situation is where persons/property/
environment are exposed to Hazards such that Harm can be experienced. For exam-
ple, an implantable defibrillator battery may experience high current discharge and
overheating. This creates a Hazardous Situation if the device is implanted in a patient.

20.1.5 Revisit the Preliminary Hazard Analysis
Revisit the Preliminary Hazard Analysis (PHA). If there is any relevant information in
the PHA that is missing from the RACT, capture it.