Professional Documents
Culture Documents
Background
Peter Bge
>20 years working with development processes within medical devices
>15 years working in ISO and IEC with
ISO14971 Risk Management,
IEC6366 Usability
IEC60601-1 Safety of electrical medical devices
Presentation title Date 3
A gruesome story,
with a happy end, starring the PMS-hero
1. Why the risk standard has been amended
2. Examining the content deviations in Annex
ZA, ZB and ZC and how this will impact
medical device and IVD manufacturers
3. Clarifying how medical device manufacturers
should adapt to meet the requirements of
the standard
4. Some open questions
Presentation title Date 4
1.
Treatment of negligible risks: A statement in - i.e. also the
manufacturer must take all risks the Risk Mgt acceptable/small ones.
into account when assessing Report may be How to demonstrate that
Sections 1 and 2 of Annex I of sufficient you have identified all risks?
the directive.
2.
Discretionary power of Update of RM How to demonstrate
manufacturers as to the Report may be that you have reduced
acceptability of risks: all risks sufficient all, potentially many
have to be reduced as far as small, risks?
possible and that
all risks combined, regardless What does combined
of any "acceptability" mean?: Add? - Fault
assessment, need to be balanced, Tree?
together with all other risks,
against the benefit of the device. Is this the right focus?
Presentation title Date 9
4.
Discretion as to whether a risk-benefit Update of RM If the Clinical Evaluation
analysis needs to take place: the Report may report is used.
manufacturer must undertake the risk- be sufficient Makes sense for injection
benefit analysis for the individual risk devices.
and the overall risk-benefit analysis Makes less sense for devices
(weighing all risks combined against the used in complex medical
benefit) in all cases. procedures: Then it is truly a
new requirement.
2. The impact of content deviations in Annex Zx
ISO 14971, 6.2: Content deviation Impact. Issues?
The manufacturer
shall use one or
more of the 6. Some think its a new
following risk Deviation as to the first risk Update of requirement.
control options in control option: RM Report How to demonstrate
the priority order Eliminate or reduce risks as far may be that youve done all?
listed: as possible (inherently safe sufficient
design and construction)"
a) inherent safety 5. Some think its a new
by design; Discretion as to the risk control Update of requirement.
options / measures: the RM Report How to demonstrate
b) protective manufacturer must apply all the may be that youve done all?
measures in the "control options" and may not sufficient
medical device stop his endeavours if the first
itself or in the or the second control option has
manufacturing reduced the risk to an
process; "acceptable level" (unless the
additional control option(s)
c) information for do(es) not improve the safety).
safety.
Presentation title Date
The question of
13
3.
are they INTOLERABLE? No.
You may therefor do a new risk ESTIMATION the rationale
=
being that the risk estimates have not been linked as close to
PMS data, as they should have been
Presentation title Date 17