Benefit - What is the definition of Benefit in ISO 14971?

[dgrainger]

Hi,

I can't find a definition in the standard!
Am I missing something?

 

[Pads38]

Am I missing something?

It is not a defined term.

So, falling back to the Oxford English Dictionary, gives:

An advantage or profit gained from something.(noun)

 

[dgrainger]

Thanks for confirming that it isn't defined.
It does make Risk/benefit analysis difficult if only one side of the equation is defined!

 

[FoGia]

I have been looking for this information as well. I found two sources of information that may help:

• FDA guidance on "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions"
• MEDDEV 2.7/1 rev 4 describes benefits as "Positive impacts of a device on the health of an individual should be meaningful (relevant for the patient) and measurable." (p.43)

It seems to me that benefits have to be best describe in a similar manner as risks (situation, probability, occurence,...).

 

[FoGia]

BTW the MDR is providing a definition:

‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

 

[Pads38]

Found this in ISO TR24791 (guidance document to 14971)

The benefit arising from a medical device is related to the likelihood and extent of improvement of health expected from its use. Benefits can be described in terms of positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or public health impact.

There is a whole section on Risk Benefit analysis. I won't post any more for copyright reasons.

 

[Marcelo]

ISO 14971 will beef up on the benefit/risk evaluation, and thus we decided we needed to include a definition of benefit.

Current draft definition is:

"3.2
benefit
positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health

Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or public health impact"

 

[dgrainger]

That's good to know.
When is it expected to be finalised?