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Experiences with Notified Bodies addressing EN ISO 14971:2012 Annex Zs

M

MIREGMGR

#2
We've documented how our risk compliance approach is not fully based on the standard per se, instead having several deviations including in regard to economic justification and the use of a three-factor risk analysis approach.

We weigh whether the increased benefit to an individual patient of particular risk reduction steps that can only be accomplished at greater product cost outweighs the decreased benefit to society in aggregate healthcare provided due to societal economic limits. Our view is that total societal healthcare provision is a critically important consideration, and therefore economics must be considered.

We use a three-factor risk analysis approach, including Controllability in addition to Probability and Severity. All of our products are intended for professional use and in most cases are physically and functionally simple, so incorporating the systemically provided skillset and situational awareness of professional users into our risk evaluation accomplishes two important goals:

1. It results in a much more realistic evaluation of actual risk, in terms of statistical correlation between projected risk and historical adverse-event occurrence. Our view is that risk analysis is of greatest value when it is demonstrably most accurate.

2. It significantly decreases the cost of our products for a given level of risk...or more to the point, it permits us to provide time-tested product designs to users and patients, instead of having to re-design those products in much more complex, much higher cost ways in order to incorporate risk avoidance technology into them that does not rely on the skillset and situational awareness of the professional user. The latter approach of course, even if it were marketable, would result in higher societal healthcare costs and thus less aggregate provision of healthcare.

Our most recent audit, by a major British based NB, was last October, and the above approach was again accepted without quibble.
 
#4
Thank you MIREGMGR.
Do I understand correctly that acceptance of any risk solely depends on your risk/benefit assessment? What about reducing the risk as much as possible? Was there any discussion with your NB about that topic?
 
M

MIREGMGR

#5
How do you define Controllability?
From our current procedure:

APPENDIX C – Control of Harm


Page 1 of 1

Control measures are persistent features of the manufacturing system, the product itself, its Instructions for Use and/or its labeling, that are intended to detect hazards and thus reduce risk. Control takes into account the professional training and experience of the intended clinical user.


Control Scale


Control Categories


Severity Number


Estimation of Detection / Mitigation


Uncontrolled


5

A product hazard is uncontrolled, and the harm may occur whenever the product is in use.

Partly controlled


4

A product hazard is likely to be detected by a diligent user prior to patient use, and the product removed, replaced, or used with special care. (or) A product that may occasionally have a hazard is manufactured utilizing a sampling-inspection, so that detection and elimination of the hazard is probable but not assured.

Normally Controlled


3

A product hazard is always detectable by a diligent user prior to patient use, and the product removed, replaced, or used with special care. (or) Each unit of a product is tested for the presence of a hazard, so that assuming diligent testing, all instances of that hazard will be detected and eliminated. (or) A product is manufactured using a validated process such that a hazard is improbable.

Well Controlled


2

A product is designed so that a hazard is self-preventing, such as by interfering with installation, setup or procedural preparation, or automatic self-testing. (or) A product is designed with redundant functionality or backup features that eliminate the potential for harm from an unlikely hazard. (or) A product is manufactured using a validated process such that a hazard is improbable, and separately every unit of product is tested to assure that a hazard is not present, using means that substantially eliminate the potential for testing error.

Fully Controlled


1

A product is designed either to eliminate the possibility of a hazard, or to reduce its occurrence to a negligible level as well as being always detectable, self-preventing or self-testing.
The table-formatting won't paste here and I don't have the time to prepare a jpg, but you get the idea.

Obviously this is written to fit the context of our product range and production processes.
 
M

MIREGMGR

#6
Do I understand correctly that acceptance of any risk solely depends on your risk/benefit assessment?
Yes.

What about reducing the risk as much as possible? Was there any discussion with your NB about that topic?
Yes. They understand that our chosen Essential Requirements compliance path in this regard is not (full compliance with a standard), and instead is (compliance with a standard with documented deviations and a documented rationale), and they have evaluated our deviations and our rationale and accepted them.
 
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