ISO14971:2019 - Verification of implementation and effectiveness of risk control

[mithilesh]

Hi All

I am trying to implement ISO14971:2019 in our companies risk management procedure and have a question on implementation of risk control measure:

ISO 14971:2019 requires implementation of risk control measures, verification of implementation and verification of the effectiveness of those risk control measures.

Does anyone have any specific examples on how to verify implementation of risk control vs. how to verify effectiveness of the risk controls.

One example i can think of is: for a medical device such as an insulin pen injector; one of the risk control was the OD of pen system to control the dosing of the pen. The implementation of the risk control would then be the drawing and the design verification test protocol. The verification of the risk control would then be the design verification test report .

Can you guys provide other specific examples. For example..if i identify a risk control as Instruction for Use..what would be the verification of implementation and verification of effectiveness for this?

Thank you

 

[monoj mon]

.if i identify a risk control as Instruction for Use..what would be the verification of implementation and verification of effectiveness for this?

In my opinion, it would be "Usability".

 

[yodon]

@monoj mon is right - verification confirms the content is included in the IFU and validation (probably via a summative study per 62366) would validate that the instructions were understandable. Bear in mind that if you consider the content deviation from EN ISO 14971:2012 that says labeling alone cannot reduce risk, "effectiveness" is not really a consideration, you just want to be sure that you have communicated in an understandable manner.

 

[ThatSinc]

look at what the hazardous situation and harm is, and then look at what your control measure is - how can you prove that the control measure has reduced the probability of the hazardous situation or harm from occurring.

some abbreviated potentials below from previous experience;

Risk/Issue - Control Measure - VoE
Device damaged in transit - Robust shipping boxes - transit validation
Device degrades over time (fluid in a bottle) - device formulation for long shelf life / packaging size to ensure it's used in a timely manner - stability studies for life / validation on time taken for users to exhaust a bottle following opening
Skin sensitivity to device - product formulation - ISO 10993 mandated studies on sentisation etc.

@monoj mon Bear in mind that if you consider the content deviation from EN ISO 14971:2012 that says labeling alone cannot reduce risk, "effectiveness" is not really a consideration, you just want to be sure that you have communicated in an understandable manner.

I thought that this myth was debunked a long time ago?

Instructions for safety and disclosure of residual risk are two completely separate entities.

Putting a warning on a UV lamp that says "Exposure to UV may cause skin cancer" does not reduce risk. Providing an instruction that users must wear appropriate safety equipment, etc. If shown to be understood, and verified as effective through any usability studies, certainly can reduce the risk.

 

[zoneofindifference]

look at what the hazardous situation and harm is, and then look at what your control measure is - how can you prove that the control measure has reduced the probability of the hazardous situation or harm from occurring.

some abbreviated potentials below from previous experience;

Risk/Issue - Control Measure - VoE
Device damaged in transit - Robust shipping boxes - transit validation
Device degrades over time (fluid in a bottle) - device formulation for long shelf life / packaging size to ensure it's used in a timely manner - stability studies for life / validation on time taken for users to exhaust a bottle following opening
Skin sensitivity to device - product formulation - ISO 10993 mandated studies on sentisation etc.




I thought that this myth was debunked a long time ago?

Instructions for safety and disclosure of residual risk are two completely separate entities.

Putting a warning on a UV lamp that says "Exposure to UV may cause skin cancer" does not reduce risk. Providing an instruction that users must wear appropriate safety equipment, etc. If shown to be understood, and verified as effective through any usability studies, certainly can reduce the risk.

Any thoughts on whether you could point to drug product characterizations studies as either verification of implementation of a risk control measure or verification of effectiveness for a combination product?

 

[yodon]

I suppose there's a case if you are, say, mitigating overdose and the (combo) product is limited to an amount that cannot result in overdose. The design can be verified to limit the dosage to a safe amount and the characterization study might support that the limit is effective for preventing overdose.

 

[Fritz]

Hi everybody

I'm also unsure what is the "implementation of risk control" and the "verification of effectiveness of the risk controls" for an specific example.

1. Events leading to the harm: Insufficent undersized design of the prothesis to resist loadings during activities of daily living -> Fatigue fracture of the prothesis -> Fall of the patient
2. Harm: Bone fracture
3. Risk control: Pre-clinical endurance testing.
4. Implementation of the risk control: a) Standard operating procedure demanding pre-clinical endurance testing in accordance with ISO 10328. b) Work instructions how to perform testing in accordance with ISO 10328. c) A specific test description including an acceptenace criterion based on ISO 10328.
5. Verification of effectivness of the risk control: Mechanical test report that the device passed the test in accordance with ISO 10328.

Is this correct or is the mechanical test report the "Implementation of the risk control"? But what is the "Verification of effectivness of the risk control" then?

Thank you

 

[ThatSinc]

Everything you have listed there is a part of your verification of effectiveness, and ongoing production controls

The actual control measure is what you have done to ensure that the design doesn't fracture.

The clue is in the events you have listed about the part being undersized.

Your risk control measure is the dimensions of the part, your VoI is the technical drawing of the part showing the dimensions.

Your VoE is as you have everything there, the evidence that shows the part doesn't fail under the loads defined by the user and use specifications, or the standard in this case.

 

[Fritz]

Hi ThatSinc

Thanks for the explanation.

I'm asking because others might say, that the verification of effectivness of the risk control to reduce the harm (the injury of the prothesis user) can only be shown by a clinical study or post market surveillance.

Kind regards

 

[ThatSinc]

If it can only be shown by a clinical study or post market surveillance and the risk without it is unacceptable - I guess you'd better do a clinical study rather than find out it's not effective through post market surveillance.

This example seems to have it covered through the standard, if the standard has tensile strength requirements and test methods?