Overview Risk

ISO 14971: Overview of the standard April 2, 2010
FDA Medical Device Industry Coalition
ISO 14971: Overview of

the standard
Risk Management Through Product Life

Cycle: An Educational Forum
William A. Hyman
Department of Biomedical Engineering
Texas A&M University
Medical devices
Application of risk
management to
medical devices
- 14 pages in body
- 63 pages in 10 Annexes
April 2010 2
William Hyman, Sc.D. 1

Contents
Scope
Terms and definitions
General requirements
Risk analysis
Risk evaluation
Risk control
Residual risk acceptability
Report/documentation
Post-production
April 2010 3
Contents
Scope
Terms and definitions
General requirements
Risk analysis
Risk evaluation
Risk control
Residual risk acceptability
Report/documentation
Post-production
April 2010 4

Annexes
Rationale
Overview
Identifying device characteristics that have risk
Risk concepts
Examples of hazards
Risk management plan
Techniques
In vitro
Biological hazards
Residual risk
April 2010 5
Observations on 14971
It is voluntary
It is cited and recognized by FDA
A search within FDA for ISO 14971

produces 564 items!
Its
useful application requires
knowledge and diligence
April 2010

Observations on 14971
The reasons to undertake risk
management (guided by 14971)
are that:
Reducing risk is a good thing
Compliance is also a good thing
Dont let the compliance imperative

overwhelm the risk control imperative
April 2010
Direct citations of 14971 in submitted

documents
From an MDR: risk analysis (performed

according to ISO 14971 2000
From a 510(k) Summary: risk analysis

preformed identifiedby ISO 14971and QSR
and internal procedures for risk analysis.
April 2010 8

General principles
Risk is commonly described as having two
principle components:
> Severity
if the harm occurs
> Probability
of the harm occurring
April 2010 9
A few definitions
Harm is the adverse event

Hazard is the potential cause of the harm
Note: You can detect a hazard before it
causes harm, but detecting harm means
the harm already occurred
Safety is the absence of unacceptable risks
But unacceptable to whom?
April 2010 10

General principles
Risk management is something that

you have to
actively do
It is not simply a byproduct of
general good intentions and good
engineering
April 2010 11
General principles
Risk can often not be reduced to

zerobut this is not an excuse for all
hazards and harms
There may be residual risks after
appropriate risk evaluation and
control
Residual risks must undergo
acceptance and communication
activities 12

The process part 1

Risk Analysis
Risk
Risk Evaluation Assessment
Risk Control
April 2010 13
The process part 1

Risk Analysis
Cycle! Risk
Risk Evaluation Assessment
Risk Control
April 2010 14

The process part 2

Risk Analysis
Risk Evaluation
Risk Control
Cycle!
Acceptability?
15
The process part 3

Risk Analysis
Risk Evaluation
Risk Control Risk

Management
Acceptability?
Cycle!
Repor
t
Post Production 16

A note on post production
Manufacturing deviations
Complaints and complaint handling
CAPA
Capture
Recalls
Evaluate
Act
Evaluate
April 2010 17
General requirements in 14971

(Section 3)
A formal (documented) process and plan
in place
Management commitment
Resources
Personnel
Qualified personnel
Documented results
April 2010 18

Risk analysis (Section 4)

Intended use and misuse
Risk related characteristics
Hazard identification
> known and foreseeable

Risk estimation
> systematic
> based on available and general
information
April 2010 19
Risk evaluation (Section 5)
Manufacturer determined criteria for

Risk acceptability decision making
There is not a predetermined, all purpose

acceptable level of risk
> no equation
> no regulation
April 2010 20

Risk control (Section 6) - Engineering
Elimination by (re)design
Protective measures to protect against
the risk both physical and alarms
Information (IFUs, training)
Preferably in this order!
You shouldnt try to fix a dangerous
design with a warning (if you could
have reasonably designed it out)!
April 2010 21
Risk control (Section 6) -Management
Residual risk evaluation after controls are

applied
Another round of acceptance decision making
including
Risk/benefit analysis (Section 6.5)
> an effort to make otherwise
unacceptable risks acceptable
which is potentially confusing
If accepted --- disclosure decision making
April 2010

Overall risk (Section 7) - Management
After all individual risk control

activity has been done
then decision making applied to
complete design
Note: assessing the collective risk
that results from the individual
risks is a challenging and
imprecise procedure
April 2010 23
Report (Section 8)
Review pre product release

Appropriately implemented
Overall residual risk is acceptable
Post production processes are in place
Documented
April 2010 24

Post production(Section 9)
Collect and review

Attention to previously unrecognized
risks
Attention to severity or rate of
occurrence above originally estimated
Include feedback into risk
management process itself
April 2010 25
Annexes
Rationale
Overview
Identifying device characteristics associated
with risk
Risk concepts
Examples of hazards
Techniques
In vitro
Biological hazards
Residual risk
26

Annex C Questions -examples

Intended and means of use (& user)
Materials and components
Sterile, or user sterilization
Measurements and data interpretation
Use in conjunction with
interfacing
Unwanted outputs (e.g. Noise, heat, EMI)
Susceptible to environment, forces, etc.
27
Annex C Questions (cont)

Software (& menus)
Reuse, intended and single use
Installation & use training
New manufacturing processes
Transmittal of user information
User interface issues human factors
distractions
alarms
predictable misuse
28

Note
Lists of questions, lists of hazards, check

lists, pull down menus, etc are not a
substitute for thoughtful analysis by a
knowledgeable person
The more unique/different your device is,

the less likely it is that pre-prepared lists
will be comprehensive
April 2010 29
Annexes
Rationale
Overview
with risk
Risk concepts
Examples of hazards
Techniques
In vitro
Biological hazards
Residual risk
30

Annex D Risk concepts

Probability and severity scales
Qualitative 3 and 5 level scales are shown
Severity
Catastrophic Death
Critical Permanent impairment
or life threatening
Serious Medical intervention
Minor No medical intervention
Negligible Inconvenience or
temporary
31

Probability and severity scales
Probability with verbal or numerical descriptors

14971 other
Frequent >10-3 highly likely
Probable < 10-3 and >= 10-4 will occur
Occasional < 10-4 and >=10-5 may occur
Remote < 10-5 and >=10-6 possible but unlikely
Improbable < 10-6 very unlikely
32


Scale issues
How many levels?
3? 5? 10?
Levels are often ill defined

especially probability
Often imprecise, yet precision is pretended
Tendency to be optimistic (if not cheat)
33

Matrix
Probability
Severity


Matrix
Probability
Good (more or less) Severity

Matrix Bad (more or less)
Probability


Probability

Challenging!

And the rest?
Probability

Challenging!

There is no zone that is automatically

acceptable or unacceptable
The manufacturer must have their own

decision and sign off process
April 2010 39
Analysis of Risk: Are Current Methods

Theoretically Sound?
Applying risk assessment may not give
manufacturers the answers they think
they are getting
Nataly F. Youssef and William A. Hyman
http://www.mddionline.com/article/analysis-risk-are-
current-methods-theoretically-sound
April 2010 40

Annexes
Rationale
Overview
with risk
Risk concepts
Examples of hazards
Techniques
In vitro
Biological hazards
Residual risk
41
Annex G- Risk management

techniques
Preliminary hazard analysis (PHA)
early review of potential risks and their

possible causation
early guidance on what will need to be

controlled
April 2010 42


techniques
Fault tree analysis (FTA)
> define a bad event

> identify what can lead to that event
> identify what can lead to the things
that lead to the event
> etc
April 2010 43
FTA
Bad event #1
Cause #1 Cause #2 Cause #3
Cause (a) of Cause (b) of

cause #1 cause #1
April 2010 44


techniques
Failure Modes and Effects Analysis(FMEA)
> identify a failure mode of compoent,

device, or user
> identify the effects of that failure
mode
> perform risk assessment to determine
if the effect requires action
April 2010 45

techniques
Hazard and Operability Study(HAZOP)
> similar to FMEA
> emphasis on use of system
Hazard Analysis and Critical Control Points

> similar to or uses many of the same
methods
> emphasis on processes
(e.g. manufacturing)
April 2010 46

Annexes
Rationale
Overview
with risk
Risk concepts
Examples of hazards
Techniques
In vitro
Biological hazards
Residual risk
47
Annex J- Residual risk
Communication
Audience
Method
Effectiveness
April 2010 48

SUMMARY
Risk management is a good thing
even if there wasnt an FDA
14971 is a well recognized guide to risk
management methodology
Butit is not a cook book, or a check list, or
an alternative to conscientious effort
The objective is to use it thoughtfully as
opposed to going through the motions to
meet regulatory requirements
April 2010 49
Questions?
April 2010 50

Overview Risk

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Overview Risk

Uploaded by

Copyright:

Available Formats

ISO 14971: Overview of the standard April 2, 2010

FDA Medical Device Industry Coalition

ISO 14971: Overview of

Risk Management Through Product Life

William Hyman, Sc.D. 1

William Hyman, Sc.D. 2

A search within FDA for ISO 14971

William Hyman, Sc.D. 3

Compliance is also a good thing

Dont let the compliance imperative

Direct citations of 14971 in submitted

From an MDR: risk analysis (performed

From a 510(k) Summary: risk analysis

William Hyman, Sc.D. 4

Harm is the adverse event

William Hyman, Sc.D. 5

Risk management is something that

Risk can often not be reduced to

William Hyman, Sc.D. 6

The process part 1

The process part 1

William Hyman, Sc.D. 7

The process part 2

The process part 3

Risk Control Risk

William Hyman, Sc.D. 8

A note on post production

General requirements in 14971

William Hyman, Sc.D. 9

Risk analysis (Section 4)

> known and foreseeable

Risk evaluation (Section 5)

Manufacturer determined criteria for

There is not a predetermined, all purpose

William Hyman, Sc.D. 10

Risk control (Section 6) - Engineering

Risk control (Section 6) -Management

Residual risk evaluation after controls are

William Hyman, Sc.D. 11

Overall risk (Section 7) - Management

After all individual risk control

Review pre product release

William Hyman, Sc.D. 12

Collect and review

William Hyman, Sc.D. 13

Annex C Questions -examples

Annex C Questions (cont)

William Hyman, Sc.D. 14

Lists of questions, lists of hazards, check

The more unique/different your device is,

William Hyman, Sc.D. 15

Annex D Risk concepts

Annex D Risk concepts

Probability with verbal or numerical descriptors

William Hyman, Sc.D. 16

Annex D Risk concepts

Levels are often ill defined

Often imprecise, yet precision is pretended

Tendency to be optimistic (if not cheat)

Annex D Risk concepts

William Hyman, Sc.D. 17

Annex D Risk concepts

Good (more or less) Severity

Annex D Risk concepts