Risk Analysis

Pattern Attributes

Intervention Process
Domain Medical
Work Programme SPRTMDRC
Research Area Any
Evidence Type Standard
Evidence Source Standard
Evidence Strength Hypothetical
Trigger product_domain == medical, need_risk_mgt == true

Problem

To ensure that medical devices are safe and effective, risks need to be managed. To achieve this medical device organisations should implement a risk management process. The first step of this process is to analyse risks posed by the medical device to determine if they require risk control measures to be implemented. Failure to do this can lead to unsafe and dangerous medical devices being placed on the market.

Analysis

Ensuring that medical devices are safe for use is an essential part of the development process. To ensure the safety of these devices, medical device manufactures should implement a risk management process. The first step of this process is to identify all possible risks that may arise with the medical device and to estimate the severity of harm and probability of the risk occurring. These estimations can be made based on previous experience of the risk management team and on risks of similar medical devices.

Solution

  1. Identify known or foreseeable risks in both normal and fault conditions.
  2. Estimate the severity of harm that can result from the risk in line with the risk management plan and provide justification for estimation.
  3. Estimate the probability of occurrence of the risk in line with the risk management plan and provide justification for the estimation.
  4. Document risk analysis in the risk management file and ensure traceability of each risk.

References

  1. ISO 14971 (2007) - Medical Devices - Application of risk management to medical devices, Switzerland, ISO.