What exactly does the risk analysis process of medical device products include?

Mondo Health Updated on 2024-01-29

One of the non-clinical information of medical device registration declaration is very important"Product Risk Management Materials".It is the information formed by recording the risk management process of the product and the results of its review. This information mainly includes:Risk analysis, risk assessment, risk controlsystemWait, thenRisk AnalysisWhat exactly should be involved in the process?

Intended Use and Reasonably Foreseeable Misuse

The manufacturer should consider the specific medical deviceIntended UseDocumenting. Information that should be considered for intended use includes, for example, the intended indications, patient population, the type of body part or tissue interacting with the medical device, user characteristics, the environment in which it will be used, and how it operates. Manufacturers should also be availableReasonably foreseeable misuseDocumenting.

Identification of safety-related features

For the specific medical device under consideration, the manufacturer should identify the medical device that may affect the safety of the medical deviceQualitative and quantitative propertiesand form a document. Where appropriate, the manufacturer should specify the boundaries of these characteristics.

Identification of hazards and hazardous situations

Manufacturers should base their safety-related characteristics on intended use, reasonably foreseeable misuse, and normal and fault conditionsIdentify known and foreseeable hazards associated with medical devicesand form a document.

For each identified hazard, the manufacturer should consider and document the resulting hazard situation by considering the reasonably foreseeable sequence or combination of events capable of causing the hazardous situation.

Sequence of eventsIt can be triggered at all stages of the life cycle, e.g. during transport, storage, installation, maintenance, routine inspections, eventual decommissioning and disposal.

Risk estimation

For each identified hazard situation, the manufacturer should make use of the available information or dataEstimate the associated risks。For the probability of damage occurringCan't estimateDangerous situations,A list of possible consequences should be drawn upfor risk assessment and risk control.

It is used to determine the probability of damage occurrence and the severity of injuryQualitative or quantitative classificationshould be documented in the risk management documentation.

Information or data used to estimate risk can be obtained from:Published standards, scientific or technical studies, field materials for similar medical devices already in use(including publicly available incident reports),Usability tests conducted by typical users, clinical evidence, results of relevant studies or simulations, expert opinions, or external quality assessment protocols for in vitro diagnostic medical devicesand so on.

All of the above documents should be documented in the risk management document.

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