Reworked DOA (Dead On Arrival) Return back to Inventory as New?

[sreenu927]

Hi All,

If DOA returns (IVD Medical Device installation-IQ failed at customer site and customer has got replacement and the IQ failed unit was sent back to Manufacturer), can this instrument be reworked and treated as brand new instrument and put back to the inventory? (And ofcourse with a deviation documented!!)

Thanks,
Sreenu

 

[Wes Bucey]

How do you handle the product that is discovered at final inspection to be nonconforming?

1. Do you scrap it?
2. Fix it (rework)?
3. If you rework, how do you handle it?
4. Does rework get put back into inventory as new (AFTER PASSING INSPECTION) or does it get sold as "remanufactured" at a discount?

It seems to me that there may be some distinction between reworking a DOA (never functioned correctly) and reworking a product that had a component fail after once working.


If there is a distinction between "rework" of a DOA and "repair" of a once functioning unit, then they should be segregated and handled differently.


Bottom line:

1. First determine WHY a product gets past final inspection to be DOA at a customer's workplace (root cause?)
2. Next determine if a simple "correction" of a product is necessary or if "corrective action" of a process is necessary.
3. THEN determine whether repaired or reworked items may be treated as new and put in inventory to be sold as new or should be segregated and sold with full disclosure of being "remanufactured."

 

[sreenu927]

Hi Wes,

Thanks for your quick response. I have checked our procedures.
For RUO instruments, we rework and sell it as refurbish instruments.
Unfortunately, our procedure didn;t tell anything of IVD, as this is the first case of IVD instrument DOA return!!

As suggested, we are already in the process of investigation.

In general, for Medical devices (including IVD instruments) what is the industry practice for DOA return? What does US FDA regulations say for such instruments?

Thanks,
Sreenu

 

[Ronen E]

In general, for Medical devices (including IVD instruments) what is the industry practice for DOA return? What does US FDA regulations say for such instruments?

I'm not sure re. IVD, but generally, for medical devices, I think FDA regulations that apply in this case are those that relate to (a) non-conforming product; and (b) customer complaints. The regulatory situation regarding "remanufacturing" or "refurbishing" of multi-use devices (actually the semi-official term is "reconditioning") is, as far as I know, complicated and vague for about the last 10 years.

 

[sreenu927]

Hi,

If we consider the complete QA inspection as IQ/OQ/PQ pass at customer site, in case it fails and the instrument is brought back to the site and reworked, can we treat this as a new instrument for sale?
Is this approach acceptable from regulatory perspective?

We are thinking that as IQ/OQ/PQ is failed and the customer didn't sign the IQ/OQ/PQ protocol that the instrument is handed over to them, hence we are assuming that the instrument is not yet "put into service" or in a way, "not distribtued" to the customer and hence no field service action is required, treating the instrument is not in the field yet!!
The instrument after necessary rework will be treated as a new instrument for sale.

IS this the correct assumption??

Thanks,
Sreenu

 

[Wes Bucey]

Hi,

If we consider the complete QA inspection as IQ/OQ/PQ pass at customer site, in case it fails and the instrument is brought back to the site and reworked, can we treat this as a new instrument for sale?
Is this approach acceptable from regulatory perspective?

We are thinking that as IQ/OQ/PQ is failed and the customer didn't sign the IQ/OQ/PQ protocol that the instrument is handed over to them, hence we are assuming that the instrument is not yet "put into service" or in a way, "not distribtued" to the customer and hence no field service action is required, treating the instrument is not in the field yet!!
The instrument after necessary rework will be treated as a new instrument for sale.

IS this the correct assumption??

Thanks,
Sreenu

The question remains WHY?

1. Why did the instrument fail? Is it an issue with a component?
2. If a component failed, WHY? (might same component fail in other devices? Is a recall necessary of devices already in the field?)
3. Was it assembled correctly? (i.e. all components OK, just botched in assembly)
4. If assembled correctly, how did it pass YOUR final inspection?
5. Why did it fail at customer? (did they execute the protocols correctly?)

So many questions and I'm thousands of miles away. Shouldn't you want the answers first yourself before putting an instrument back in the field after a minor "fix" if there is any possibility other devices may also fail and at a time when life, health, or safety could be involved instead of just at first inspection before use?

 

[Bev D]

In the US, the question of what constitutes 'used' or refurbished vs. 'new' is (to my knowledge) somewhat ambiguous and generally subjec to case law and interpretation. As a previous poster said , the FDA is less concerned with how you 'market' the product from a new or refurbished standpoint than it is with the quality of the product itself.

I have worked with my organization's legal department to disposition various situtations such as the one you describe. The rule that my organization has come to is that we not sell any product that left our physical premises (in our case our owned physical warehouses) and was subsequently returned for any reason as new. Even if we don't do anything other than retest the product to ensure that it meets requirements. This is the safest path where no definitive laws exist.

 

[Ronen E]

In the US, the question of what constitutes 'used' or refurbished vs. 'new' is (to my knowledge) somewhat ambiguous and generally subjec to case law and interpretation. As a previous poster said , the FDA is less concerned with how you 'market' the product from a new or refurbished standpoint than it is with the quality of the product itself.

I have worked with my organization's legal department to disposition various situtations such as the one you describe. The rule that my organization has come to is that we not sell any product that left our physical premises (in our case our owned physical warehouses) and was subsequently returned for any reason as new. Even if we don't do anything other than retest the product to ensure that it meets requirements. This is the safest path where no definitive laws exist.

I agree.

IQ/OQ/PQ reasoning would be (forgive my directness) just an argumentative stunt to allow reselling the unit at the lowest possible costs for the manufacturer. IMO once a unit leaves the manufacturer's established controls (leaving physical premises is a strict way of looking at it), it is fair and square distributed, and whatever consequently happens, it can't be considerd "new" any more.