=
All may be used, but
some are more
practical or convincing
than others
If available,
market feed back
data is fastest,
cheapest and most
convincing
Agree your approach
with your Notified Body
before
A review of sources for risk estimates
Presentation title Date 17
ISO 14971, 5. NOTE 6
Information or data for estimating risks can be
obtained, for example, from:
a) published standards;
b) scientific technical data;
c) field data from similar medical devices already in use
including published reported incidents;
d) usability tests employing typical users;
e) clinical evidence;
f) results of appropriate investigations;
g) expert opinion; and
h) external quality assessment schemes.
D 3.2.1. Seven approaches are commonly
employed to estimate probabilities:
use of relevant historical data;
prediction of probabilities using analytical or simulation
techniques;
use of experimental data;
reliability estimates;
production data;
post-production information; or
use of expert judgment.
1. A ISO14971 compliant system will have established
links between
Risk, incl. Failure Mode: How a failure is observed
(should be searchable in e.g. a FMECA, but may not be).
- and codes for Complaints
leading again to found Technical Errors
2. Risk Analysis: Do ERRORS happen?
PMS: Complaints indicate presence of ERRORS
3. Risk Analysis: Do ERRORS lead to harm?
With what SEVERITY?
PMS: Adverse-events indicate medical consequences of
ERRORS
PMS: Complaints without Adverse Events may indicate
low severity scenarios
4. In less-than-perfect complaint handling this may
require expert judgment
(i.e. meetings between Risk and PMS people)
Review risk analysis on marketed products
Presentation title Date 18
You may end up with 2 -10 risks,
with both complaints and adverse
events.
Users will face the ERROR from
time to time.
And some will experience HARM
You have monitored these risks,
and determined that they are
acceptable.
The remaining risks:
Should as per this analysis, be
lower.
Update your risk analysis
accordingly
You may have done this to
perfection (as you should acc. to
ISO14971), or you may not
Handling the critical risks
Presentation title
Date 19
P5
P4
P3
P2
P1
S1 S2 S3 S4 S5
X
X
X X
For residual risks that are judged acceptable, the
manufacturer shall decide which residual risks to
disclose
and what information is necessary to include in the
accompanying documents (ISO14971, 6.4)
I.e. the critical risks
But may not describe all needed elements:
1. Error: What not to do (warning),
2. Resulting probability
3. Consequence (harm) and
4. Severity.
E.g. Do not press button, as this may lead to burns,
requiring healthcare intervention.
Impact
This old requirement is NOT part of Annex Z
But weaknesses if any, become clear
And may if applicable be the most costly part!
But thats another story
Critical risks in Information For Safety
Presentation title Date 20
+ +
Thanks for listening!
Presentation title Date 21