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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
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2
WELCOME TO
SEMOEGY LEARNING
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medical technology
Education Knowledge Information
Resource
i
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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
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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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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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
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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
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
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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
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
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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Overview of the ISO 14971 >> The Principles
ISO 14971 Risk Management – Execution Level
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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
RISK/BENEFIT PRINCIPLE
PRINCIPLES
18
Overview of the ISO14971 >> The Principles >> Risk/Benefit Principle
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ISO 14971 Risk Management – Execution Level
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
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.
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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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
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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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
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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
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Analysis
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
Overview of the ISO14971 >> Risk Management Plan >> Constructing a Plan >> Risk Analysis
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
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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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
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
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
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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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
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
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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
FAILURE MODE & EFFECTS ANALYSIS
RISK ASSESSMENT TOOLS
43
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Management – Execution Level
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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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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
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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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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
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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
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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
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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
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
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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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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
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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
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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
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
Overview of the ISO14971 >> Risk Assessment Tools >> FMEA
ISO 14971 Risk Management – Execution Level
RISK CHART - EVALUATION
57
Probability
Levels
Severity Levels
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
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
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
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
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

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ISO14971 Medical Device Risk Management Course - E-Learning

  • 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. Copyright © Semoegy Advisers & Ventures Copyright © Semoegy Advisers & Ventures 2 WELCOME TO SEMOEGY LEARNING
  • 3. Copyright © Semoegy Advisers & Ventures 3ISO 14971 Risk Management – Execution Level medical technology Education Knowledge Information Resource i
  • 4. Copyright © Semoegy Advisers & Ventures 4ISO 14971 Risk Management – Execution Level
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 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

Editor's Notes

  1. 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.
  2. Verification - confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
  3. are techniques by which an effect or consequences of individual components are systematically identified and is more appropriate as the design matures.