SGS Global PowerPoint Template - · PDF file© SGS SA 2013 ALL RIGHTS RESERVED: Tuesday 9 December 2014 Risk management according to EN ISO14971:2012 3 WHAT IS RISK MANAGEMENT

1 © SGS SA 2013 ALL RIGHTS RESERVED: Tuesday 9 December 2014 Risk management according to EN ISO14971:2012

EN ISO14971:2012 Risk management for Medical Devices

GET YOUR MEDICAL DEVICES TO MARKET

FASTER WHEN YOU KNOW THE WAY

Tuesday 9 December 2014

Seminar MDProject

Bart Mersseman

SGS: Notified Body Medical Devices

Product Manager Medical Devices

SGS Belgium NV Noorderlaan 87

B-2030 - Antwerp - Belgium

Phone: +32 (0)3 545 48 60

E-mail : [email protected]


What is risk management


WHAT IS RISK MANAGEMENT

Decision making process relating to safety of a medical device

throughout the design, development and product lifecycle

The safety of the patients, user and handlers at the centre of the

process.

Safety: safe (technical /clinical safety) and performant (therapeutic /

diagnostic safety)

EN ISO14971:2012

risk management

systematic application of management policies,

procedures and practices to the tasks of

• analysing,

• evaluating,

• controlling and

• monitoring risk


Why risk management


WHY RISK MANAGEMENT

Business

Product liability

Regulatory

Risk to safety of patients, users, handlers


WHY? SAFETY AND PERFORMANCE

Safety and performance:

E.g. MDD:

Not doing what is claimed

Not safe during life-time

…

E.g. misdiagnoses

imperfect sensitivity due to

flaw in design (and design controls)

flaw during manufacture

flaw during transport

…

Or inherently imperfect sensitivity


WHY? REGULATORY

Regulatory requirements: Essential requirements:

Medical Device Directive 93/42/EEC + amendments


WHY? REGULATORY

Regulatory requirements: Technical documentation:

Medical Device Directive 93/42/EEC + amendments


WHY? REGULATORY

Regulatory requirements: Quality Management system

Harmonised standard EN ISO 13485:2012 - Medical Devices

Quality Management Systems Requirements for Regulatory Purposes

Clause 7.1 requires, “…risk management throughout

product realization.”

In addition, “Records arising from risk management shall be

maintained”.

The standard cross references ISO 14971 for guidance related to

risk management.

Clause 7.3.2 states that design and development inputs

include risk management outputs


WHY? PRODUCT LIABILITY

Product liability:

The liability of any or all parties along the chain of

manufacture/distribution of any product for damage caused

by the product:

Component manufacturers

Assembling manufacturer

Wholesaler

Distributor

Retail store owner (in OTC and non-medical products)


WHY? PRODUCT LIABILITY

Product Liability a Serious Issue?

(US Market)

They generate more $1-million plus verdicts than any other type of

personal injury suits except malpractice.

29% of all verdicts are returned with judgments of $1 million or more.

Defendants loose 56% of all cases which go to trial.

=> but also in Europe more and more cases


WHY? BUSINESS

Concept Feasability Design Pilot Base Buisness

Cost ofChange

€ 100 € 1.000 € 10.000 € 100.000 € 1.000.000

€ 100 € 1.000 € 10.000

€ 100.000

€ 1.000.000

€ 0

€ 200.000

€ 400.000

€ 600.000

€ 800.000

€ 1.000.000

€ 1.200.000

Cost of Change


WHY? SUMMING UP….

You have to do it….

It is one of the first things a Notified Body or an Authority (Competent

Authority in Europe, FDA in USA, Health Canada, …) will ask for!

Required by law

Appears on regulatory submission checklists

Will help define testing that should be done to prove the safety of your

device

Helps to eliminate costs e.g. associated with recalls and redesign

Offers a measure of protection from liability

It is just the right thing to do…


How will we apply risk

management


HOW? RISK MANAGEMENT: EN ISO

14971:2012

Definition: An iterative process of assessing a

product’s benefit / risk balance

Goal: Developing and implementing tools to

minimize risk while preserving its benefit

Timing: Should be done through product’s lifecycle


HOW? RISK MANAGEMENT: EN ISO

14971:2012

Term Definition Clause ISO14971

Harm Physical injury or damage to the health of people, or

damage to property or the environment

(a) 2.2

Hazard Potential source of harm (a) 2.3

Hazardous situation Circumstance in which people, property, or the

environment are exposed to one or more hazard(s)

(a) 2.4

Risk Combination of the probability of occurrence of harm

and the severity of that harm

(a) 2.16

Risk control process in which decisions are made and measures

implemented by which risks are reduced to, or

maintained within specified levels

(a) 2.19

Safety Freedom from unacceptable risk (a) 2.24

Disclosure of residual

risks

Information in the accompanying documents on risks

remaining after all risk control measures have been

taken

(b) 5.1

Information for safety Instructions of what actions to take or to avoid in order

to prevent a hazardous situation from occurring

(b) 5.2


HOW? RISK MANAGEMENT: EN ISO 14971:2012



Harmonised standard EN ISO 14971:2012:

Application of risk management to medical devices

Process to identify hazards

Estimate and evaluate and control the risks

Monitor the effectiveness of the controls

Applicable to all stages

Systematic framework



The results of risk management influence product

realization processes:

nature and extent of purchasing controls

influencing supplier approval activities,

providing important design inputs,

serving as criteria for evaluating design outputs,

establishing the need for design change, and

helping to determine production and process control

requirements, and monitoring and measurement

devices controls, as well as acceptance activities.



Output of risk management activities can influence

decisions and activities :

management review decisions,

personnel training,

infrastructure,

monitoring and measurement,

handling of nonconforming product, and

corrective and preventive actions.



Risk:

Design and product related: risk analysis is

required/described in many harmonised technical

standards e.g. EN IEC 60601

Process related: risk management is a requirement of

harmonised standard EN ISO13485 (§7.1)

Risk management is integral part of the whole quality

system.

Risk management file: ‘living’ documents (updates

required)




EN ISO 14971:2012

CHANGING OR MORE STRICT REQUIREMENTS

EN ISO 14971:2012

identical to ISO 14971:2007 but includes annexes Z that show

how it meets the essential requirements in MDD 93/42/EEC

Harmonised since 30th August 2012

“Consensus Paper for the Interpretation and Application of

Annexes Z in EN ISO 14971: 2012 (draft)”

1. Treatment of negligible risks

Document:

• identify known and foreseeable hazards

• estimate the risk for each hazardous situation identified

• the risk control measures for each individual risk




Pro

bab

ilit

y o

f O

ccu

rren

ce

9 I N T O L E R -

8 A B L E

7

6 A R E G -

5 F I O N

4 A

3 B P

2 A

1 R

1 2 3 4 5 6 7 8 9

Severity

Intolerable

Region

As Low As

Reasonably

Practicable

Region

(ALARP)

Reduced as far

as possible

(AFAP)

Broadly

Acceptable

Region (BAR)

April 2001 Tony C. Chan


2. Discretionary power of manufacturers as to the

acceptability of risks:

• all risks have to be reduced as far as possible (AFAP)

• all risks combined, regardless of any "acceptability"

assessment, need to be balanced, together with all other

risks, against the benefit of the device.



2.

• As far as possible: AFAP

• Acceptability: death or serious deterioration of health is

unlikely

Geharmoniseerde normen

Internationale normen

historical data, best medical practice and state of the art

Further risk control measures do not improve the safety

If a reduction to an acceptable level

cannot be achieved, a risk-benefit analysis

must demonstrate that the residual risk is

outweighed by the medical benefit

as explained further



3. "as far as possible (AFAP) “: as low as reasonably practicable

(ALARP) not acceptable with regard to economic considerations.

• the [Essential Requirements require risks to be reduced "as far as possible"

without there being room for economic considerations.

•

=> safety of the product must not be traded off against business perspectives.

=> For transparency the manufacturer must document the end-point criteria of

risk reduction based on his risk policy.



4. A) risk-benefit analysis for the individual risk

B) overall risk-benefit analysis => In any case the manufacturer shall

perform an overall risk-benefit analysis considering all individual risks to provide

a rationale for overall risk acceptance.

(weighing all risks combined

against the benefit)



4. Example

A) risk-benefit analysis for the individual risk

B) overall risk-benefit analysis



5. all the "control options" and not stop if the first or the second

control option has reduced the risk to an "acceptable level“

=> the manufacturer shall document the control options in the priority order



6. inherently safe design and construction

Example: electrode

6. Information of the users influencing the residual risk : (adding a

label or a warning/information in the IFU).

=> The manufacturer shall not claim a reduction to the probability of

harm when disclosing residual risk.



6. inherently safe design and construction



EN ISO14971:2012 Risk management for Medical Devices

GET YOUR MEDICAL DEVICES TO MARKET

FASTER WHEN YOU KNOW THE WAY

Tuesday 9 December 2014

Seminar MDProject

Bart Mersseman

SGS: Notified Body Medical Devices

Product Manager Medical Devices

SGS Belgium NV Noorderlaan 87

B-2030 - Antwerp - Belgium

Phone: +32 (0)3 545 48 60

E-mail : [email protected]

Documents

SGS Global PowerPoint Template - · PDF file© SGS SA 2013 ALL RIGHTS RESERVED: Tuesday 9 December 2014 Risk management according to EN ISO14971:2012 3 WHAT IS RISK MANAGEMENT