How to handle complaints after end of specified medical device life-time

[Aphel]

Dear all,

How do we have to process complaints in case a medical device is used beyond its specified liefe time?
Is it expected by regulations to document & evaluate complaints even if the customer used it device outside the specified life time?

Thanks for any comments!

BR Aphel

 

[MIREGMGR]

Is it expected by regulations to document & evaluate complaints even if the customer used it device outside the specified life time?

Yes, and report adverse events to appropriate authorities.

The significance of the device being out of lifetime...assuming that you can show that that lifetime was adequately communicated to the end user, i.e. it wasn't just marked on packaging that wasn't present at the time that the end user selected the device to use...is that "beyond lifetime" is your reason why a corrective/preventative action isn't required.

 

[somashekar]

The device lifetime is an input into the design and development process under the requirements essential for design and development. This lifetime obviously gets into your regulatory product documentation, as well as reflects into the records control.
This information is generally not available to the user, and is determined by the organization when a customer complaint is received as in your case. This however does not mean that such devices in use are NOT safe and effective any longer.
Several decisions can be taken in handling such complaints.
1. Refurbish, and assure that the device is safe and effective. Maintain records and inform customer that the device is good and refurbished but is beyond its stipulated lifetime.
2. Offer a newer version / upgraded version of the medical device (if you have) due to the complaint device being beyond estimated life time, at an agreed cost. OR be able to do the upgrade on the returned device and ensure safety and effectiveness. maintain records and keep customer informed.
3. Offer a new model device that you perhaps have introduced as a direct replacement for the customer returned device, which now is beyond estimated lifetime, and perhaps is also obsolete in your range now. The costs of repair of the returned device may not be feasible, or can no longer be supported.

 

[Aphel]

Hi!

Thank you for your responses!
The basic message for me was - YES it is necessary to treat customer complaints beyond the device lifetime as "complaint".

BR
Aphel

 

[p1stonbroke]

Also use this an an opportunity to analyze the defects which arise which may create opportunities to make the product more robust in future, or even (potentially) give it a longer life.

 

[Statistical Steven]

Hi!

Thank you for your responses!
The basic message for me was - YES it is necessary to treat customer complaints beyond the device lifetime as "complaint".

BR
Aphel

MIREGMGR said it best...it is a complaint by the definition of a complaint. But how you investigate and take action on the complaint is what you need to document and justify. Many uses know they are using a device beyond it's intended life cycle and continue to use it until it no longer functions. Many times this egregious behavior leads to a patient injury or worse a death. The manufacturer still has to file the appropriate paperwork.

Just a quick aside. If there are software controls that can render a device not usable after it's life cycle, the FDA might expect you to implement such a control. So if you determine 5000 cycles is the life cycle, you can have an electronic counter that makes the device stop working at 5000 cycles.