Page 217 - Safety Risk Management for Medical Devices

196 Safety Risk Management for Medical Devices

24.1 POSTMARKET RISK MANAGEMENT
As stated earlier, preproduction risk management is a predictive tool, used to forecast
future Hazards and risks, while postmarket risk management is a reactive endeavor,
intended to contain and limit Harm from devices that have been released to the market.
Production and postproduction monitoring are the means by which to detect
whether a released product has harmed patients or has the potential for causing undue
harm. The result of postmarket risk management may be to hold manufactured prod-
uct from being released, or issue corrective actions, including product recalls. In cases
of imminent potential Harm to patients, it may be necessary to issue immediate infor-
mation (Customer Letter) before new Risk Controls are developed and verified.
Postmarket risk management involves understanding of: the Hazard in question,
the risk of potential Harm, size and magnitude of the patients’ vulnerability, and
countermeasures that should be taken until the product itself is addressed for correc-
tive measures.
A common tool that is used in this vein is the Health Hazard Assessment (HHA). In
the United Stated, 21 CFR part 7 requires the conduct of an evaluation of the health
hazard (actual or potential) presented by a product being recalled or considered for recall.
In Europe, MDD [4] Article 10 compels similar action. Elements of an HHA are:

• Identify the Hazard (actual or potential).
• Identify the related Harm(s), both immediate and long term.
• Identify the population at risk and whether any subpopulation is at greater
risk.
• Describe the mechanism of occurrence of the Hazard, and exposure to the
Hazard.
• Is the Hazard in question happening when the product is used under labeled
conditions?
• Is the Hazard in question previously predicted?
• Is the Hazard in question manifesting under normal or fault conditions?
• Identify conditions that would exacerbate or mitigate the risk.
• Identify the degree to which the Hazard is recognizable by the patient/user
and the feasibility of countermeasures.
• What is the likelihood of future additional risks due to the Hazard in question?
• Balance the risk of corrective action versus the risk of not taking corrective action.
Example: an implanted device may pose a greater risk than previously predicted. But
the risk of explant surgery could be greater than the risk of leaving the device in.
• Conclusion and recommended actions.

Any decision for action or inaction should be approved by appropriate personnel,
e.g., medical safety officer, and the decisions and approvals should be documented.