Device deficiencies (~complaint) discovered during a clinical trial

[shimonv]

The following text is from the the ISO 14155, section 7.4.3:

7.4.3 Device deficiencies
All device deficiencies of an investigational device shall be documented throughout the clinical investigation and managed by the sponsor in accordance with written procedures for the control of a non-conforming product. The sponsor shall take, where applicable, appropriate corrective and preventive actions to protect the safety of subjects, users, and other persons. Device deficiencies of the comparator, if applicable, shall be documented.

And so comes the question:
Do you use the complaint handling procedure to log device deficiencies? If not, how else do you manage it?
It seems to me that following the complaint investigation process per ISO 13485 is a bit more than necessary.

Thanks,
Shimon

 

[Zero_yield]

Not my area of expertise, but I did a little digging. The company I work for handles it per our Complaints / Nonconformance procedures, per the standard.

Maybe to help clarify, does ISO 14155 use the same terminology for "investigational device" as the FDA?

Investigational Device Exemption (IDE)

 

[shimonv]

The terminology of ISO 14155 and FDA IDE are not quite the same.
I suspect the common practice for handling device deficiencies is through the complaint system, but I'm curious to know who handles them differently and how does that work.

 

[John C. Abnet]

The terminology of ISO 14155 and FDA IDE are not quite the same.
I suspect the common practice for handling device deficiencies is through the complaint system, but I'm curious to know who handles them differently and how does that work.

In my experience, a same/common system so as not to fragment information/confuse users. Then, within that system, a way to toggle data into different categories for the purpose of data mining and managing. For example....ALL logged events use a common discrete identifier such as...


22-0001
22-0002
22-0003
2-2-0004
etc..etc...

As each event is entered the user can/must then select a specific toggle/category.. For example,...
22-0002 may have "injury toggled to indicate that nonconforming event is an operator health/safety issue.
22-0003 may have "customer reject" toggled to indicate that this is a customer complaint.
22-0003 may have "information only" to show that no corrective action is required, unless investigation proves otherwise, ...

...etc..et.c..

Hope this helps.

Be well.