Hazard

A hazard is simply defined as a "potential source of harm".

More broadly, a hazard is a designation of something that causes harm. For a hazard to cause harm, there must be a trigger event or a series of events, referred to as the hazardous situation.

For example, bacterial contamination is considered a hazard, but the existence of bacteria alone is not harmful to the device itself. A resulting hazardous situation, such as the bacteria not being properly removed before a surgical procedure, could then lead to harm (e.g., a bacterial infection).

The use of certain devices, such as ordinary crown glass lenses in eyeglasses and sunglasses, may constitute an avoidable hazard to the eye of the wearer.

Frequently Asked Questions (FAQs) Associated with Hazard

1. What are the objectives of identifying hazards (Risk Analysis)?

The analysis process aims to identify possible hazards, including user error. A comprehensive risk analysis requires creative thinking, and it is preferable to include hazards and hazardous situations that seem highly unlikely rather than omitting them.

The intent of a risk analysis is to:

• Identify possible hazards, including use error.
• Calculate risk, under normal and fault conditions.
• Determine risk acceptability.
• Reduce unacceptable risks to acceptable levels.
• Ensure changes made do not introduce new hazards.

2. When should hazard analysis be initiated?

Risk management, which includes hazard analysis, should be incorporated early in the design controls process. Integrating hazard consideration early in design decisions allows mitigation through design choices if necessary. Design validation for medical devices must include risk analysis, and performing this analysis is considered "almost always appropriate". The initial risk analysis should ideally be performed during design inputs.

3. Who should be involved in performing hazard analysis?

The risk analysis should be conducted by a cross-functional team so that all relevant perspectives can be considered. For example, personnel knowledgeable about clinical use may be best suited for analyzing intended use and foreseeable misuse, while the quality/regulatory team may focus on safety issues, as they are familiar with standards, complaints, and recalls.

4. What resources can be used to identify hazards?

Sources of information that can assist in generating a list of hazards and hazardous situations include:

• ISO 14971 Annex C, which contains a solid starting list of hazards.
• Publicly available information about similar devices already on the market.
• Device incident data (public complaint reporting data).
• Published scientific literature.
• Data from various pre-market testing and possibly clinical trial or usability testing.
• Expert consultants, provided their qualifications are documented.

5. How are hazards managed once they are identified?

Once a hazardous situation is identified, a risk estimation must be applied, which typically considers the probability of the harm occurring and the severity of the harm. If the risk is unacceptable, risk control measures are taken to reduce the risk.

ISO 14971 specifies an order for applying risk control measures, prioritizing controls that place the onus on design and manufacturing first, through "inherently safe design and manufacture". The layers of control are generally:

1. Inherently safe design and manufacture (e.g., selecting appropriate materials, ensuring sharp edges are avoided).
2. Protective features in the device or manufacturing process (e.g., safety guards, quality control checks).
3. Information for safety, including labeling, instructions for use, and user training.

6. What information is required on the FAQ page for genetic health risk assessment devices related to risks?

For over-the-counter genetic health risk assessment systems, a Frequently Asked Questions (FAQ) page must be provided that contains information specific to each variant/disease pair reported. This section must explain:

• The health condition/disease being tested.
• The purpose of the test.
• The information the test will and will not provide.
• The meaning of the result(s).
• Other risk factors that contribute to the disease.
• Appropriate follow-up procedures.
• How the results may affect the user’s family.

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