Hazardous situation

A hazardous situation is defined as the trigger event or series of events that must occur for a hazard (a potential source of harm) to actually cause harm.

The term "hazardous situation" is central to the risk management framework, particularly under ISO 14971 for medical devices, which defines the condition that links a potential problem (hazard) to actual negative outcomes (harm).

In essence, the existence of a hazard alone is not harmful; it requires a hazardous situation to be initiated.

Example: If bacterial contamination is the hazard, the hazardous situation occurs when bacteria are not properly removed before the surgical procedure.

Frequently Asked Questions (FAQs) Associated with Hazardous Situations

The sources detail how hazardous situations are identified, analyzed, and managed throughout the product life cycle to maintain safety and compliance.

1. How does a Hazardous Situation relate to a Hazard and Harm?

In the terminology used for risk analysis:

• Hazard is the source of the potential problem (e.g., bacterial contamination).
• Hazardous Situation is the necessary precursor event that occurs, involving people, property, or the environment, leading to harm (e.g., bacteria not being removed properly before use).
• Harm is the physical injury or damage that results (e.g., a bacterial infection).

A single hazard may lead to many different hazardous situations and subsequent harms. When documenting, it can be helpful to assign a code to each hazardous situation for clear traceability later in the process.

2. How are Hazardous Situations identified?

The process of identifying hazardous situations is part of the Risk Analysis phase and requires creative thinking.

• Team Collaboration: Identification should be performed by a cross-functional team to ensure all perspectives are considered. Personnel knowledgeable about clinical use may be best suited for analyzing the intended use and foreseeable misuse of the device to identify these situations.
• Inclusivity: When conducting a thorough risk analysis, it is preferred to consider and include hazardous situations that seem highly unlikely rather than omitting them.
• Resources: Teams can consult publicly available information about similar devices already on the market, such as public complaint reporting data, which can provide ideas for unexpected hazardous situations. Annex C of ISO 14971 also provides a starting list of hazards.

3. When should the analysis of Hazardous Situations occur?

Analysis of hazardous situations should be integrated early in the design controls process.

• Early Mitigation: Considering these situations early allows manufacturers to mitigate them through design choices, if necessary.
• Design Inputs: Outputs of risk management, which include identified hazardous situations, are required to be one of the design and development inputs for the device.
• Scope: While the scope is generally broad for a new project, later in the product life cycle, the scope of analysis may be narrow if focusing only on a design or process change.

4. How are Hazardous Situations evaluated and controlled?

Once a hazardous situation is identified, a risk estimation is applied to it.

• Risk Estimation: The risk estimation process determines the overall risk index by considering both the probability of the harm occurring and the severity of the harm resulting from the hazardous situation.
• Risk Control: If the calculated risk is unacceptable, risk control measures are taken to reduce the risk of the hazardous situation occurring. The primary focus is placed on using "inherently safe design and manufacture" to minimize the foreseen hazardous situation.
• Residual Risk: After risk controls have been implemented and verified, the final step is to evaluate the residual risk that still remains for that hazardous situation.

5. How are Hazardous Situations managed Post-Production?

Ongoing management and review are crucial to capturing hazardous situations that arise once the device is in use.

• Information Review: The risk analysis team must periodically review post-production data (such as information from device users, installation/maintenance personnel, and regulatory reporting) to determine if new hazardous situations were not previously captured, or if the estimated risk level for existing hazardous situations needs to be revised.
• Escalation: Escalation triggers should be established for the immediate evaluation of risk analysis documents if concerning data is received. This process may include evaluating the hazardous situation to determine if recall efforts are required.
• HCT/P Context: For Human Cell, Tissue, or Cellular or Tissue-Based Products (HCT/Ps), procedures must control environmental conditions where conditions could reasonably be expected to cause accidental exposure of HCT/Ps to communicable disease agents. A departure from established procedures relevant to preventing risks of communicable disease transmission must be justified and recorded.

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