ISO14971 Medical Device Risk Management Course - E-Learning1. SEMOEGY LEARNING
For Medical Technology
Education, Knowledge & Information Resource
MEDICAL DEVICE RISK MANAGEMENT
Execution Level
Dr. Nealda Yusof
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APPLIED ISO 14971
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2
WELCOME TO
SEMOEGY LEARNING
3. Copyright © Semoegy Advisers & Ventures 3ISO 14971 Risk Management – Execution Level
medical technology
Education Knowledge Information
Resource
i
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
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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
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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. 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
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9. RISK VS. SAFETY
Minimizing risk levels will
correspondingly increase
safety levels.
An activity is considered
safe if its risks are
considered acceptable.
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Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution Level
1.
Safety
1.
Risk
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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
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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. 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
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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
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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.
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Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution Level
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.
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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.
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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
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
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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
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Semoegy Learning Division
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SEMOEGY LEARNING
Education | Knowledge | Information Resource
For Medical Technology
Register for this class here: bit.ly/ISO14971
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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. CONSTRUCTING A PLAN
RISK MANAGEMENT PLAN
23
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan
ISO 14971 Risk Management – Execution Level
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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
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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
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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
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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
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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. 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.
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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
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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)
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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
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ISO 14971 Risk Management – Execution Level
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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
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ISO 14971 Risk Management – Execution Level
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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. 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.
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36. STEPS & ACTION PLAN – RISK EVALUATION
Process of comparing the estimated risk
against a given risk criteria to determine
the acceptability of the risk
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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. RISK CONTROL OPTIONS
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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. 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
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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
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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
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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
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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. FAILURE MODE & EFFECTS ANALYSIS
RISK ASSESSMENT TOOLS
43
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
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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
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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
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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:
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RISK PRIORITY NUMBER – RISK RANKING
47
Scale 1 to 10Scale 1 to 10
Risk Priority Number (RPN)
Range 1 to 100
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RISK PRIORITY NUMBER – RISK RANKING
48
Scale 1 to 10Scale 1 to 10
Risk Priority Number (RPN)
Range 1 to 100
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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
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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. 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
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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
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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
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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
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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. 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
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0
1
2
3
4
5
6
7
8
9
10
11
0 1 2 3 4 5 6 7 8 9 10 11
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ISO 14971 Risk Management – Execution Level
RISK CHART - EVALUATION
57
Probability
Levels
Severity Levels
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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. 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
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ISO 14971 Risk Management – Execution LevelCopyright © Semoegy Advisers & Ventures
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
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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. Copyright © Semoegy Advisers & Ventures 62ISO 14971 Risk Management – Execution Level
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Editor's Notes Semoegy provides in training courses specialising in medical technology. We also provide information resources and best practices in easy-to-understand formats. You can already find some regulatory infographics on our website. Verification - confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. are techniques by which an effect or consequences of individual components are systematically identified and is more appropriate as the design matures.