SEMOEGY LEARNING
For Medical Technology
Education, Knowledge & Information Resource
MEDICAL DEVICE RISK MANAGEMENT
Executi...
Copyright © Semoegy Advisers & Ventures
Copyright © Semoegy Advisers & Ventures
2
WELCOME TO
SEMOEGY LEARNING
Copyright © Semoegy Advisers & Ventures 3ISO 14971 Risk Management – Execution Level
medical technology
Education Knowledg...
Copyright © Semoegy Advisers & Ventures 4ISO 14971 Risk Management – Execution Level
Copyright © Semoegy Advisers & Ventures
Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution ...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution ...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution ...
KEY DEFINITIONS
Harm
Hazard
Hazardous Situation
Severity
Safety
8
Overview of the ISO 14971 >> The Principles
ISO 14971 Ri...
RISK VS. SAFETY
 Minimizing risk levels will
correspondingly increase
safety levels.
 An activity is considered
safe if ...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution ...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution ...
WHEN TO APPLY RISK MANAGEMENT
As early as possible in the
design phase
Build in safety features into
the design specificat...
A REGULATORY REQUIREMENT
Manufacturers must demonstrate
that all activities involved in the
design, testing, production an...
INTERNATIONAL REQUIREMENT
Jurisdiction/Standard Regulatory requirement
European Union medical device directive 93/42/EEC A...
RISK MANAGEMENT & ISO 13485
Clause in ISO 13485 Risk management requirement
Clause 7.1 – Product realisation The organizat...
Copyright © Semoegy Advisers & Ventures
A KEY REQUIREMENT OF ISO 13485
16
Risk management is a key requirement
in many act...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> The Principles >> ISO 14971 Overview
ISO 14971 Risk Ma...
RISK/BENEFIT PRINCIPLE
PRINCIPLES
18
Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle
Copyright © Semo...
RISK/BENEFIT PRINCIPLE – §6.5
Analyse the
suitability of a
medical device
to be marketed
A complex
exercise
Perceptions of...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle
ISO 14971 Ris...
Copyright © Semoegy Advisers & Ventures 21ISO 14971 Risk Management – Execution Level
Semoegy Learning Division
No. 1 Irvi...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle
ISO 14971 Ris...
CONSTRUCTING A PLAN
RISK MANAGEMENT PLAN
23
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
ISO 14...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
IMPORTANCE...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
ISO 14971 ...
Copyright © Semoegy Advisers & Ventures
WHAT TO INCLUDE IN A RISK MANAGEMENT PLAN
Scope of
activities
Baseline &
Outcomes
...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
ISO 14971 ...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
ISO 14971 ...
STEPS & ACTION PLAN – DEFINITIONS
Risk analysis
Risk estimation
Risk evaluation
Risk control
29
Overview of the ISO14971 >...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
ISO 14971 ...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk An...
Copyright © Semoegy Advisers & Ventures
STANDARDS
• ISO 60601 – EMC
• IEC 62304 – Software lifecycle
• ISO 8637 – Cardiova...
Copyright © Semoegy Advisers & Ventures
QUESTIONS TO ASSESS DEVICE-RELATED HAZARDS – ANNEX C
• Intended use
• Implanted
• ...
Copyright © Semoegy Advisers & Ventures
STEPS & ACTION PLAN – RISK ESTIMATION
Possible
consequences/severity
Probability o...
FACT-BASED RISK ESTIMATION
35
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Estimation
I...
STEPS & ACTION PLAN – RISK EVALUATION
Process of comparing the estimated risk
against a given risk criteria to determine
t...
RISK CONTROL OPTIONS
Copyright © Semoegy Advisers & Ventures 37
Overview of the ISO14971 >> Risk Management Plan >> Constr...
EXAMPLES OF RISK CONTROL MEASURES – FIGURE D.6
Product/process Devices Hazard Inherent safety
by design
Protective
measure...
VERIFICATION OF RISK REDUCTION
39
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Verification
...
Copyright © Semoegy Advisers & Ventures 40ISO 14971 Risk Management – Execution Level
Semoegy Learning Division
No. 1 Irvi...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Verific...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Verific...
FAILURE MODE & EFFECTS ANALYSIS
RISK ASSESSMENT TOOLS
43
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 149...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures 50
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Manage...
HAZARD IDENTIFICATION
No Identified Hazard Hazardous situation Hazard Type Circumstance Harm
1 Allergic reaction Prolonged...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
RISK ESTIMATION – RANKING PROBABILITIES
Hazardous situation Hazard Type Circumstance Harm Probability of
Occurrence
Severi...
Copyright © Semoegy Advisers & Ventures
0
1
2
3
4
5
6
7
8
9
10
11
0 1 2 3 4 5 6 7 8 9 10 11
Overview of the ISO14971 >> Ri...
Copyright © Semoegy Advisers & Ventures
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Managemen...
RISK ESTIMATION – RANKING PROBABILITIES
Hazard Type Circumstance Harm Probability of
Occurrence
Severity Acceptable
Known ...
ITERATIVE RISK MANAGEMENT
Highly individual to the
medical device
Full integration into the
quality management
system
60
O...
Copyright © Semoegy Advisers & Ventures 61
Risk Assessment Tools >> FMEA
Annex B
Figure B.1 – Overview of risk management
...
Copyright © Semoegy Advisers & Ventures 62ISO 14971 Risk Management – Execution Level
Semoegy Learning Division
No. 1 Irvi...
Nächste SlideShare
Wird geladen in …5
×

ISO14971 Medical Device Risk Management Course - E-Learning

3.018 Aufrufe

Veröffentlicht am

The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard. This short course is based on the current ISO 14971:2007 edition. It has been designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry. More focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects.

Take this course here: http://bit.ly/2u6aaHv

Veröffentlicht in: Gesundheitswesen
  • Als Erste(r) kommentieren

ISO14971 Medical Device Risk Management Course - E-Learning

  1. 1. SEMOEGY LEARNING For Medical Technology Education, Knowledge & Information Resource MEDICAL DEVICE RISK MANAGEMENT Execution Level Dr. Nealda Yusof Copyright © Semoegy Advisers & Ventures APPLIED ISO 14971
  2. 2. Copyright © Semoegy Advisers & Ventures Copyright © Semoegy Advisers & Ventures 2 WELCOME TO SEMOEGY LEARNING
  3. 3. Copyright © Semoegy Advisers & Ventures 3ISO 14971 Risk Management – Execution Level medical technology Education Knowledge Information Resource i
  4. 4. Copyright © Semoegy Advisers & Ventures 4ISO 14971 Risk Management – Execution Level
  5. 5. Copyright © Semoegy Advisers & Ventures Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level RISK MANAGEMENT & MEDICAL DEVICES 5 WHY IT IS CRUCIAL
  6. 6. Copyright © Semoegy Advisers & Ventures Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level IMPORTANCE TO MEDICAL DEVICES 6 2 3 QUALITY EFFICACY 1 SAFETY THE 3 PILLARS OF MEDICAL DEVICES GUIDING PRINCIPLES • Regulatory requirements • Market approval RISK REDUCTION • Hazards • Defects • Malfunction/Failure • Side effects MAXIMIZE BENEFITS • Clinical performance • Therapeutic purpose
  7. 7. Copyright © Semoegy Advisers & Ventures Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level THE TWO FACTORS OF RISK 7 The probability of occurrence of harm Severity of the harm The frequency or likelihood harm will occur The extent of its impact or consequences
  8. 8. KEY DEFINITIONS Harm Hazard Hazardous Situation Severity Safety 8 Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level Physical injury or damage to the health of people, or damage to property or the environment. Potential source of harm. Circumstance in which people, property, or the environment are exposed to one or more hazard(s). Measure of the possible consequences or impact of a hazard. Severity is one component of risk. Freedom from unacceptable risk Copyright © Semoegy Advisers & Ventures
  9. 9. RISK VS. SAFETY  Minimizing risk levels will correspondingly increase safety levels.  An activity is considered safe if its risks are considered acceptable. Copyright © Semoegy Advisers & Ventures 9 Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level 1. Safety 1. Risk
  10. 10. Copyright © Semoegy Advisers & Ventures Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level APPLICATION OF RISK MANAGEMENT 10 Design & Development Tool Post-market monitoring Communication tool As a design input Product lifecycle management Governance & compliance
  11. 11. Copyright © Semoegy Advisers & Ventures Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level A DESIGN REQUIREMENT 11 User requirements Intended use Safety requirements Technical requirements Process specifications Design details Risk reduction Integration into the design process
  12. 12. WHEN TO APPLY RISK MANAGEMENT As early as possible in the design phase Build in safety features into the design specifications Implement good project management Prevent design churn or re- working 12 Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  13. 13. A REGULATORY REQUIREMENT Manufacturers must demonstrate that all activities involved in the design, testing, production and distribution of a medical device are aimed at minimizing risks and ensuring product safety. 13 Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  14. 14. INTERNATIONAL REQUIREMENT Jurisdiction/Standard Regulatory requirement European Union medical device directive 93/42/EEC Annex I – “eliminate or reduce risks as far as possible”. ISO13485 – QMS for Medical Devices Clauses 7.1 – Product realization and in 7.3.2 – Design and development inputs. US Food and Drug Administration Quality System Regulation, section 820.30(g) requires risk analysis as part of design validation. US Food and Drug Administration Risk management requirement mentioned in the guidance for design control and process validation. Copyright © Semoegy Advisers & Ventures 14 Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level
  15. 15. RISK MANAGEMENT & ISO 13485 Clause in ISO 13485 Risk management requirement Clause 7.1 – Product realisation The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained Clause 7.3.2 – Design and development inputs Output of risk management is a design and development input. Copyright © Semoegy Advisers & Ventures 15 Overview of the ISO 14971 >> The Principles ISO 14971 Risk Management – Execution Level
  16. 16. Copyright © Semoegy Advisers & Ventures A KEY REQUIREMENT OF ISO 13485 16 Risk management is a key requirement in many activities and requirements associated with quality management systems for medical device organizations.
  17. 17. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> The Principles >> ISO 14971 Overview ISO 14971 Risk Management – Execution Level PRODUCT LIFE-CYCLE RISK MANAGEMENT (§A.2.1) 17 INITIAL CONCEPTION PRODUCTION DISTRIBUTION DECOMMISSIONING Applies to all stages of the life-cycle of a medical device Risk management does not end with the transfer of a design to production. Applies to product or process changes through the product life-cycle
  18. 18. RISK/BENEFIT PRINCIPLE PRINCIPLES 18 Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle Copyright © Semoegy Advisers & Ventures ISO 14971 Risk Management – Execution Level
  19. 19. RISK/BENEFIT PRINCIPLE – §6.5 Analyse the suitability of a medical device to be marketed A complex exercise Perceptions of risk vs. benefits depends on the context 19 Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  20. 20. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle ISO 14971 Risk Management – Execution Level PERCEIVED RISKS VS ANTICIPATED BENEFITS 20 PRINCIPLES OF BUSINESS EXCELLENCE Clinical Judgement Patient/End-user Perception AvailableInformation MarketExperience Risk vs. Benefit
  21. 21. Copyright © Semoegy Advisers & Ventures 21ISO 14971 Risk Management – Execution Level Semoegy Learning Division No. 1 Irving Place, #05-13G The Commerze@Irving Singapore 369546 SINGAPORE E-mail: global.training@semoegy.com Website: www.semoegy .com SEMOEGY LEARNING Education | Knowledge | Information Resource For Medical Technology Register for this class here: bit.ly/ISO14971
  22. 22. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle ISO 14971 Risk Management – Execution Level RISK/BENEFIT PRINCIPLE 22 One of the CENTRAL features of Risk Management SOURCES OF RISK • Technology (state of the art) • Design • Intended use • Function & performance RISK vs. BENEFIT Method of determining the acceptability of risks by ensuring that the anticipated benefits outweigh or are balanced against the risks.
  23. 23. CONSTRUCTING A PLAN RISK MANAGEMENT PLAN 23 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level Copyright © Semoegy Advisers & Ventures
  24. 24. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan IMPORTANCE OF PLANNING 24 DECISION DECISION Envision the steps and outcome Facilitate decision-making Clarify the framework and methods Efficient resource utilization Defining the budget Certainty of direction for the team Management reporting Promotes communication ISO 14971 Risk Management – Execution Level RISK MANAGEMENT TOP-LEVEL ROADMAP
  25. 25. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level PURPOSE OF A PLAN 25 Organized Approach 1 Essential for good risk management Visibility 2 Inclusion of essential elements Communication Tool 3 As an information reference for the team
  26. 26. Copyright © Semoegy Advisers & Ventures WHAT TO INCLUDE IN A RISK MANAGEMENT PLAN Scope of activities Baseline & Outcomes Responsibilities & Authorities Tasks & Tools Schedules Risk acceptability criteria Verification activities Methods for collecting data 26 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level
  27. 27. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level TIMELINE OVERVIEW & EXPECTATIONS 27 Jan 01 Hazard Identification 02 Risk Analysis 03 Risk Evaluation 04 Risk Control 05 Verification & Monitoring Feb Mar Apr May Jun Jul Aug Sep Frequency Severity FMEA Risk/Benefit Analysis 4 months
  28. 28. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level GANTT CHART 28 Activities 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Hazard Identification Risk Analysis Risk Estimation Risk Evaluation Risk Control Verification & Monitoring MilestoneA MilestoneB Responsible person Start/Stop dates Budget Resources
  29. 29. STEPS & ACTION PLAN – DEFINITIONS Risk analysis Risk estimation Risk evaluation Risk control 29 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level Systematic use of available information to identify hazards and to estimate the risk. Process used to assign values to the probability of occurrence of harm and the severity of that harm. Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk. Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels. Copyright © Semoegy Advisers & Ventures
  30. 30. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan ISO 14971 Risk Management – Execution Level STEPS & ACTION PLAN – FROM HAZARD TO CONTROL [FIG. E.1] 30 Hazard Hazardous situation Harm Severity of the harm Probability of occurrence of harm Risk Sequence of events Exposure(P1) (P2) P1xP2 Start Outcome
  31. 31. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Analysis ISO 14971 Risk Management – Execution Level STEPS & ACTION PLAN – RISK ANALYSIS 31 • Intended use, state-of-the art & performance • Standards, regulations & literature search • Information of similarly marketed devices • Adverse incident reports • Design fault • Misuse • Malfunction/Failure • Known & foreseeable hazards • Various use situations • Looking into the future • Initiating events & circumstances Normal & fault conditions • Risk analysis tools • Brainstorm with engineers • User experience studies • Conduct simulated testing Fact Finding Categorise Type Characterize • Detect • Measure • Quantify Qualitative & Quantitative Preliminary Hazard Analysis (PHA)
  32. 32. Copyright © Semoegy Advisers & Ventures STANDARDS • ISO 60601 – EMC • IEC 62304 – Software lifecycle • ISO 8637 – Cardiovascular implants and extracorporeal systems • ISO 11073 – Point-of-care medical devices • ISO 10993 – Biological evaluation of medical devices • ASTM E 1837 – Disinfection efficacy for reusable medical devices • ISO 1283 - Haemodialysers • International Standards Organisation (ISO) • American Society for Testing and Materials (ASTM) • Association of Analytical Communities (AOAC) • Association for the Advancement of Medical Instrumentation (AAMI) • International Electrotechnical Commission (IEC) • Organisation for Economic Cooperation and Development (OECD) • British Standard European Norm (BS EN) • Pharmacopeias 32 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Analysis ISO 14971 Risk Management – Execution Level
  33. 33. Copyright © Semoegy Advisers & Ventures QUESTIONS TO ASSESS DEVICE-RELATED HAZARDS – ANNEX C • Intended use • Implanted • Patient or user contact • Materials & components • Transfer of energy • Delivery of substances • Biological Materials • Re-use & processing • Sterilization controls • Modification of patient environment • Measurements • Alarm • Data storage • Dependencies • Interpretation • Use with other devices • Environmental influences • Consumables & accessories • Maintenance & calibration • Software • Shelf-life & Life-time • Delayed or long-term use • Mechanical forces • Decommissioning & disposal • Training & qualification • Information for safe use • Manufacturing process • Person with special needs 33 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Analysis ISO 14971 Risk Management – Execution Level
  34. 34. Copyright © Semoegy Advisers & Ventures STEPS & ACTION PLAN – RISK ESTIMATION Possible consequences/severity Probability of harm 34 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Estimation ISO 14971 Risk Management – Execution Level • Quantitative • Qualitative • No estimation
  35. 35. FACT-BASED RISK ESTIMATION 35 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Estimation ISO 14971 Risk Management – Execution Level • Published standards • Scientific technical data • Field data from similar medical devices already in use • Published reported incidents • Usability tests employing typical users • Clinical evidence • Results of appropriate investigations • Expert opinion • External quality assessment schemes. Copyright © Semoegy Advisers & Ventures
  36. 36. STEPS & ACTION PLAN – RISK EVALUATION Process of comparing the estimated risk against a given risk criteria to determine the acceptability of the risk Copyright © Semoegy Advisers & Ventures 36 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Evaluation ISO 14971 Risk Management – Execution Level Risk acceptability criteria Estimatedrisks Determining Acceptable Risks • Applicable standards specifying requirements • comparing levels of risk evident from medical devices already in use • Evaluate clinical data, especially for new technology • Any information regarding the state-of-the-art technology
  37. 37. RISK CONTROL OPTIONS Copyright © Semoegy Advisers & Ventures 37 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Control ISO 14971 Risk Management – Execution Level Inherent safety by design Protective measures Information for safety Design change or improvement in the device 1 2 3 Failure prevention features in the device or production process Actions or practices by patient or end-user to prevent harm Orderofpriority
  38. 38. EXAMPLES OF RISK CONTROL MEASURES – FIGURE D.6 Product/process Devices Hazard Inherent safety by design Protective measure Information for safety Single use medical device Catheter Biohazard cross- contamination Locking or destructive mechanism Single-use indication Adverse event warning Active implant Pacemaker Electric fields Material shields Attenuation filters Common hazards warning IVD medical device Blood analyser Incorrect results due to sample handling Pre-mixed single-step sample processing Implementation of controls Deviation from assigned values Software Patient data management Erroneous data High integrity coding File backup/extracti on On-screen warnings Steam sterilization Biopsy device/forceps High temperature material degradation Use thermo- resistant material Pressure and temperature recording & alarms Packaging & loading instructions 38 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Control ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  39. 39. VERIFICATION OF RISK REDUCTION 39 Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Verification ISO 14971 Risk Management – Execution Level Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Verification Copyright © Semoegy Advisers & Ventures
  40. 40. Copyright © Semoegy Advisers & Ventures 40ISO 14971 Risk Management – Execution Level Semoegy Learning Division No. 1 Irving Place, #05-13G The Commerze@Irving Singapore 369546 SINGAPORE E-mail: global.training@semoegy.com Website: www.semoegy .com SEMOEGY LEARNING Education | Knowledge | Information Resource For Medical Technology Register for this class here: bit.ly/ISO14971
  41. 41. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Verification ISO 14971 Risk Management – Execution Level EXAMPLES OF RISK CONTROL VERIFICATION 41 Risk minimized/eliminated Data Biocompatibility tests Sterilization validation Packaging validation Data supporting the effectiveness of risk control measures Material toxicity Bacterial contamination Packaging leakage Compliance with IEC 60601 EMCElectrical hazards
  42. 42. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Verification ISO 14971 Risk Management – Execution Level RELATIONSHIP OF RISK EVALUATION, RISK CONTROL & VERIFICATION 42 Risk evaluation Acceptable risk level? Risk control Verification Acceptable risk level? Risk evaluation Risk/Benefit analysis RELEASE Yes Yes No No Or Risk < benefits? Yes UNACCEPTABLE No
  43. 43. FAILURE MODE & EFFECTS ANALYSIS RISK ASSESSMENT TOOLS 43 Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level Copyright © Semoegy Advisers & Ventures
  44. 44. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level FAILURE MODE & EFFECTS ANALYSIS 44 1 2 3 Study of consequences The effect each individual component has on product safety and quality. Preventing defects Early at the development stage when changes are relatively easier and inexpensive to make. Enhancing safety Minimising the probability of occurrence of product failures. Increasing performance Due to a more robust process that eliminates or reduces corrective actions and late change crises. Systematic method Identifying and preventing product and process problems before they occur
  45. 45. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level FMEA VS ISO 14971 RISK MANAGEMENT 45 FMEA ISO 14971 Focus on harm Normal and abnormal circumstances Medical devices Difference between FMEA & ISO 14971 Focus on defects Failure situations Automotive/Generic “as far as reasonably possible”Based on RPN Risk/benefit analysisContinuous improvement
  46. 46. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level ADDITIONAL RISK PARAMETER IN FMEA 46 The probability of occurrence of harm The frequency or likelihood harm will occur Severity of harm The extent of its impact or consequences Probability of detection of harm The probability of detecting the harm before it occurs. • Occurrence (O) • Severity (S) • Detection (D) 3 Risk Parameters:
  47. 47. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level RISK PRIORITY NUMBER – RISK RANKING 47 Scale 1 to 10Scale 1 to 10 Risk Priority Number (RPN) Range 1 to 100
  48. 48. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level RISK PRIORITY NUMBER – RISK RANKING 48 Scale 1 to 10Scale 1 to 10 Risk Priority Number (RPN) Range 1 to 100
  49. 49. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level MERGING FMEA WITH ISO 14971 49 Risk management planning Hazards Hazardous situation Harm Risk evaluation Risk control Residual risk Production & post- production information Component/ process Failure mode Local/system effect Risk priority number Risk control Residual RPNFMEA Source: Gantus • Intended use • Technology • Design • Function • Misuse • Information • Clinical practice • Initiating circumstances • Behaviour • Level of training • Environment • Shelf-life • Lack of information Risk analysis & estimation Risk management according to ISO 14971 • Injury • Damage • Adverse events • Short-term & long-term • Related to the patient • And other users Comparison with • Standards • Marketed devices • Clinical data • Similar technology • Risk acceptability Verification • Testing • Statistical analysis • Validation • Risk acceptability • Risk/benefit analysis • Overall residual riskISO 14971
  50. 50. Copyright © Semoegy Advisers & Ventures 50 Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level C.2.1 What is the intended use and how is the medical device to be used? Coronary stent Non-Invasive coronary angioplasty • Wrong/inaccurate placement • Peripheral injuries • Unable to navigate tortuous pathway • Surgical complications • Fracture X-ray fluoroscopy Medical Dye Technology • Allergic reactions • Breathing problems • Bleeding • Artery blockage • Blood clots • Heart attack • Infection • Restenosis Hazard Hazard • Bleeding • Artery blockage • Blood clots • Infection • Restenosis Intended UseMaintain arterial patency Performance Hazard Function Radiation exposure Dye reaction Hazard Hazard
  51. 51. HAZARD IDENTIFICATION No Identified Hazard Hazardous situation Hazard Type Circumstance Harm 1 Allergic reaction Prolonged contact Known Abnormal Clinical complications 2 Bleeding Poor design/placement Foreseeable Abnormal Blood loss 3 Artery blockage Poor design/placement Foreseeable Abnormal Heart attack 4 Infection Inadequate product & procedural sterility Foreseeable Abnormal Death 5 Restenosis Injury/poor design or placement Known Normal High blood pressure/heart attack 6 Material toxicity Inappropriate material Foreseeable Abnormal Clinical complications 7 Foreign body reaction Inappropriate material/Immune system Known Normal Clinical complications 8 Degradation residue Inappropriate material Foreseeable Normal Clinical complications 51 Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  52. 52. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level WHAT IS RISK RANKING? 52 Assigning values to risk factors Qualitative or semi- quantitative values Categorise risks from highest to lowest values Prioritise the elimination of high risks
  53. 53. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level HOW TO PERFORM RANKING – RANKING CRITERIA 53 ISO 14971 – Table D.2, D.3, D.4, Annex D Common Terms Possible SEVERITY description Catastrophic Results in patient death Critical Results in permanent impairment or life-threatening injury Serious Results in injury or impairment requiring professional medical intervention Minor Results in temporary injury or impairment not requiring professional medical intervention Negligible Inconvenience or temporary discomfort Common Terms Possible PROBABILITY description (Semi-Quantitative) Frequent ≥ 10-3 Probable ≥ 10-4 and < 10-3 Occasional ≥ 10-5 and < 10-4 Remote ≥ 10-6 and < 10-5 Improbable < 10-6 Common Terms Possible PROBABILITY description (Qualitative) High Like to happen, often, frequent Medium Can happen but not frequently Low Unlikely to happen, rare, remote
  54. 54. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level PROBABILITY RANKING CRITERIA 54 Common Terms Possible description Rank Frequent ≥ 500 per thousand (≥ 5 in 10) 10 200 per thousand (≥ 2 in 10) 9 100 per thousand (≥ 1 in 10) 8 High 50 per thousand (≥ 1 in 20) 7 10 per thousand (≥ 1 in 100) 6 Occasional 2 per thousand (≥ 1 in 500) 5 0.5 per thousand (≥ 1 in 2,000) 4 0.1 per thousand (≥ 1 in 10,000) 3 Improbable 0.01 per thousand (≥ 1 in 100,000) 2 ≤ 0.001 per thousand (≥ 1 in 1,000,000) 1
  55. 55. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level SEVERITY RANKING CRITERIA 55 Common Terms Possible description Rank Catastrophic Results in patient death 10 Results in permanent impairment or life-threatening injury 9 Critical Results in temporary injury or impairment requiring professional medical intervention 8 Non-compliance with regulatory requirements 7 Serious Results in temporary injury or impairment not requiring professional medical intervention 6 Product recall issued 5 Minor Discomfort resulting from physiological response 4 Treatment incompatibility with no adverse response 3 Negligible Inconvenience or temporary discomfort 2 Device incompatible with some consumable models 1
  56. 56. RISK ESTIMATION – RANKING PROBABILITIES Hazardous situation Hazard Type Circumstance Harm Probability of Occurrence Severity Prolonged contact Known Abnormal Clinical complications 10 10 Poor design/placement Foreseeable Abnormal Blood loss 4 9 Poor design/placement Foreseeable Abnormal Heart attack 1 9 Inappropriate material Foreseeable Abnormal Clinical complications 3 2 Injury/poor design or placement Known Normal High blood pressure/heart attack 5 4 Inadequate product & procedural sterility Foreseeable Abnormal Death 2 10 Inappropriate handling Foreseeable Normal Clinical complications 8 4 Foreign body response Foreseeable Normal Clinical complications 1 6 56 Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  57. 57. Copyright © Semoegy Advisers & Ventures 0 1 2 3 4 5 6 7 8 9 10 11 0 1 2 3 4 5 6 7 8 9 10 11 Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level RISK CHART - EVALUATION 57 Probability Levels Severity Levels
  58. 58. Copyright © Semoegy Advisers & Ventures Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution Level DETERMINING RISK ACCEPTABILITY [N X M] MATRIX 58 Severity [N columns] Probability [M rows] 1 2 3 4 5 6 7 8 9 10 1 ACC ACC ACC ACC ACC ACC ACC ACC BOR BOR 2 ACC ACC ACC ACC ACC ACC ACC BOR BOR NACC 3 ACC ACC ACC ACC ACC ACC BOR BOR NACC NACC 4 ACC ACC ACC ACC ACC BOR BOR NACC NACC NACC 5 ACC ACC ACC ACC BOR BOR NACC NACC NACC NACC 6 ACC ACC ACC BOR BOR NACC NACC NACC NACC NACC 7 ACC ACC BOR BOR NACC NACC NACC NACC NACC NACC 8 ACC BOR BOR NACC NACC NACC NACC NACC NACC NACC 9 BOR BOR NACC NACC NACC NACC NACC NACC NACC NACC 10 BOR NACC NACC NACC NACC NACC NACC NACC NACC NACC
  59. 59. RISK ESTIMATION – RANKING PROBABILITIES Hazard Type Circumstance Harm Probability of Occurrence Severity Acceptable Known Abnormal Clinical complications 10 10 NACC Foreseeable Abnormal Blood loss 4 9 NACC Foreseeable Abnormal Heart attack 1 9 BOR Foreseeable Abnormal Clinical complications 3 2 ACC Known Normal High blood pressure/heart attack 5 4 ACC Foreseeable Abnormal Death 2 10 NACC Foreseeable Normal Clinical complications 8 4 NACC Foreseeable Normal Clinical complications 1 6 ACC 59 Overview of the ISO14971 >> Risk Assessment Tools >> FMEA ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
  60. 60. ITERATIVE RISK MANAGEMENT Highly individual to the medical device Full integration into the quality management system 60 Overview of the ISO14971 >> The Principles >> ISO 14971 Overview ISO 14971 Risk Management – Execution Level Risk evaluation Risk control Residual risk acceptability Risk management report Production & post- productio n Risk analysis Copyright © Semoegy Advisers & Ventures
  61. 61. Copyright © Semoegy Advisers & Ventures 61 Risk Assessment Tools >> FMEA Annex B Figure B.1 – Overview of risk management activities as applied to medical devices ISO 14971 Risk Management – Execution Level
  62. 62. Copyright © Semoegy Advisers & Ventures 62ISO 14971 Risk Management – Execution Level Semoegy Learning Division No. 1 Irving Place, #05-13G The Commerze@Irving Singapore 369546 SINGAPORE E-mail: global.training@semoegy.com Website: www.semoegy .com SEMOEGY LEARNING Education | Knowledge | Information Resource For Medical Technology Register for this class here: bit.ly/ISO14971

×