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Medical Device Risk Management

  • Identify risks
  • Weigh costs versus benefits
  • Eliminate unnecessary risk

risk managementRisk analysis is a structured tool for the evaluation of potential problems which could be encountered in many situations (riding in an airplane, taking a drug, or using a medical device.) Risk is everywhere, with varying likelihoods and consequences. Risk analysis is now routinely used during the design phase for medical devices to manage risk.

Risk has two components:

  1. Probability of the occurrence of harm and its frequency
  2. Impact of that harm and how severe it might be

For Example:

  • Airplane Crash – Low likelihood, high consequences
  • Car Crash – More likely, varying consequences
  • Spilling food – high likelihood, low consequences

Three rules of risk management:

  1. Benefits must exceed cost
  2. Accept no unnecessary risk
  3. Make decisions at the appropriate level in the organization

Why Perform risk analysis?

  1. It is required
  2. It could save a costs of consequences
  3. Protection from product liability.
  4. Regulatory submissions checklists (PMA and 510k) used by the FDA include risk analysis.

Who Requires Risk Management?

Risk Management helps ensure the safety of medical devices. There are many risks associated with the design & production of Medical Devices but also in their use. Risk to safety of patients, users, handlers and Regulatory Product liability must all be managed. ISO 14971 is recognized by:

  • Manufacturers must conduct and document a risk management process. ISO 13485 refers to ISO 14971 for guidance related to risk management.
  • The U.S. Food and Drug Administration (FDA)
  • The EU has made it mandatory.

PDFCompare Risk Management requirements of ISO 13485, ISO 14971, and FDA QSR-820

Risk Management Terms

Here are some of the terms discussed in ISO Guide 73:

guide 73
BUY ISO Guide 73
– Risk management vocabulary

  1. Intended Use/Purpose – Intended Use/Purpose Use of a Product, Process or Service in accordance with the specifications, instructions and information provided by the manufacturer.
  2. Harm – Physical injury or damage to health of people, or damage to property or the environment.
  3. Hazard – Potential source of Harm.
  4. Risk – Combination of the probability of occurrence of harm and the severity of harm.
  5. Residual Risk – Risk remaining after protective measures have been taken.
  6. Risk analysis – Systematical use of available information to identify hazards and to estimate the risk.
  7. Risk evaluation – Judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of society.
  8. Risk assessment – Overall process of risk analysis and risk evaluation.
  9. Risk control – The process through which decisions are reached and implemented for reducing risks to or maintaining risks within specified levels.
  10. Risk management – Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.

Risk Management Process

  1. Risk analysis
  2. Intended use/intended purpose identification
  3. Hazard identification
  4. Risk estimation (likelihood x severity)
  5. Risk management
  6. Risk evaluation
  7. Risk acceptability decisions
  8. Risk control
  9. Option analysis
  10. Implementation
  11. Residual risk evaluation/Overall risk acceptance
  12. Post-production information
  13. Post-product experience
  14. Review of risk management experience

ISO 14971 provides a framework of risk management activities as applied to medical devices. From initial analysis to risk control & evaluation, the probability and frequency of harm can be assessed, analyzed & managed.

Risk Assessment Tools

  1. Risk Matrix
  2. PHA = Preliminary Hazard Analysis
  3. FTA = Fault Tree Analysis
  4. FMEA = Failure Mode Effects Analysis
  5. HAZOP = Hazard Operability Analysis
  6. HACCP = Hazard Analysis and Critical Control Point

NOTE: Risk Management Worksheet Required for all operations or training and must be completed during planning phase Reviewed before operations/training

Applications of Risk Analysis

  1. Design
  2. Production
  3. Premarket Notifications
  4. Complaints
  5. MDR
  6. Change Control
  7. Failure Analysis
  8. and similar applications

ISO 9001 All in One Package