EN ISO 14971:2012 AS FAR AS POSSIBLE

An interpretation by Surbhi Financial Technologies Pune, India

Foreword
EN ISO 14971:2012 has been harmonised on August 31, 2012 by the EU. Hence all medical device companies with CE certified products have to comply with that standard to evidence comply with ESR of MDD / AIMD / IVDD. The explanation of the changes has been explained in the Content Deviations appearing in the Annexes. However, there is confusion globally on its implementation. This is an attempt to offer an acceptable solution that is in conformity with the requirements of the 3 Directives MDD, AIMD and IVDD. The focus is on the concept of As Far As Possible since all other CDs are based on this concept. This is based on the presentation I gave at the 11th National Medical Device Conference at Ahmedabad, India on Jan 1011, 2014.
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The Concept
Annex D Para D.8 to ISO 14971 contains the concept of reducing risks as low as reasonably practicable (ALARP).
ALARP concept has an element of economic consideration.

Annex 1 Section 2 First indent require risks to be reduced as far as possible. Hence Manufacturers and NBs may not apply ALARP concept with regard to economic issues. The concept to be used is as far as possible stated in the Directive

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Let us examine it
Let us assume that we are applying the provisions of EN ISO 14971:2012 to
Prevention of people dirtying their clothes by Sitting on a bench in the park Using the As far as Possible Concept.
This is only for illustration purposes there is no claim made here that the
bench is a medical device.

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Situation: Objective:

A bench in a public park has been freshly painted. A notice is to be given to the public that comes to park that the bench has been freshly painted. Action taken: A notice of Wet Paint is placed on the bench. To avoid it flying away, tapes are applied to hold it in place.

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Nevertheless, some one will come and sit on the bench

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Alternative Risk Mitigation Action Place a bigger notice

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Alternatively Apply a paper or fabric barricade.

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The As Far As Possible requirement will force me to look at this option, as a risk mitigation action to prevent any one coming closer to the bench thereby preventing the possibility any one coming close to the freshly painted bench.

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The AFAP will then force me to evaluate the possibility of jumping over the fence or cutting through the barbed wires. Since ISO 14971 covers possible misuse and other fault conditions. Hence this structure be constructed around the freshly painted bench in the park.

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Thus

AFAP takes me through additional lengths to mitigate risk

Since economic considerations are not permitted, as per the content deviations.

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On the Other Hand

Alarms are ubiquitous in medical devices in emergency care.
Yet in the US, it has been ranked as the No.1 Health Technology Hazard by ECRI in their 2012, 2013 and 2014 Reports.
In the 2011 Report, it was the second leading health hazard.

This reflects that

Probably the RMFs are not capturing
Fatigue Decipherability Besides other issues. Hence no risk mitigation activities are being incorporated in the medical devices.
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Additionally
In October 2013, AAMI and FDA organised a summit to discuss Healthcare Technology in Non Clinical Settings. One of the challenges identified was
Design with Empathy.

This message needs to percolate in the industry. And AFAP is one possible measure to ensure Designing with Empathy.
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A remark I wish to add

I cannot help but mention that the requirement imposed by the CD# 3 is not in conformity with the requirements in MDD. The recitals to the directive provide regulatory intent in the absence of any explanation in the directive on the phrase

http://eur-lex.europa.eu/en/techleg/10.htm

Recital appearing on third page of the MDD reads as

Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to minimising or reducing risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;
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Where does that leave us?

Approach I recommend should be based on 1. Conformity with Harmonised Standards 2. Risk Benefit Analysis as required by the Directives. Since it would comply with the regulatory intent and meet the current requirements as experienced today, necessitating the evolution of EN ISO 14971:2012. This is explained further.
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Conformity with HS
Section 2 of Annex 1 of MDD requires that the medical devices should be generally regarded as state of the art. In terms of Article 5 of the MDD, MD shall presume compliance with ER in respect of devices which are in conformity with the HS. Therefore, any device that meets the requirements of the applicable HS reflects the current state of the art, and no other consideration needs to be factored into the evaluation
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Risk Benefit Analysis: MDD

Clause 1 Annex I MDD
The devices must be designed and manufactured in such a way that when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
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Risk Benefit Analysis: IVDD

Para A.1 of Annex 1 to IVDD states that any risk which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.
This has been interpreted by the EU Commission as an overall risk-benefit analysis must taken place, in any case, regardless of the application of criteria established in the management plan of the manufacturer
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Thank you
Our Contact details are
Surbhi Financial Technologies C 603 Mithras Park, Rahatani Road, Pimpale Saudagar PUNE 411027 INDIA Phone +91 98204 44331 Email ks@surbhi.co.in Page on LinkedIn http://in.linkedin.com/pub/kanwal-jit-singh/0/aa7/939/

Bringing fresh insights to add economic value, by asking the right questions.
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