When to give a new Batch Number for a reworked batch ?

SGquality

Quite Involved in Discussions
As per Guide to Inspections of Medical Device Manufacturers
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114981.htm,
routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device.

Under these conditions, could anyone advise when should be change the batch number to reflect that it is a reworked batch ?

Also I understand that in medical devices, there is no reprocess but only rework, right ?
 

insect warfare

QA=Question Authority
Trusted Information Resource
As per Guide to Inspections of Medical Device Manufacturers
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114981.htm,
routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device.

Under these conditions, could anyone advise when should be change the batch number to reflect that it is a reworked batch ?
I would think that the batch number would be changed when rework actually happens. Typically, "rework" is achieved when work is performed on something and it (including its constituent parts) meets all specifications and functions according to its intended use. Repair, or in this case, "remanufacturing" happens when work is performed on something but is not conforming to specifications, ergo it may or may not function according to its intended use.

Also I understand that in medical devices, there is no reprocess but only rework, right ?
I personally don't know of any such decree in the MD world, but I would assume most consumers would prefer reworked equipment over re-manufactured, if not for liability reasons....

Brian :rolleyes:
 

somashekar

Leader
Admin
As per Guide to Inspections of Medical Device Manufacturers
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114981.htm,
routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device.

Under these conditions, could anyone advise when should be change the batch number to reflect that it is a reworked batch ?

Also I understand that in medical devices, there is no reprocess but only rework, right ?
If you have a specific quantity covered under a batch number, you keep aside all the devices requiring rework and when these quantities pile up to a batch quantity, consider them all under a new batch number. Make sure you perform an adverse effects determination before reworking and document the same (aka risk assessment of reworking)
 

yodon

Leader
Super Moderator
For the sake of discussion, let's turn the question inside out a bit. What's the reason in the first place for having batch or lot (or serial) numbers? Isn't it to support traceability? So let's say then that you pull in units from a variety of batches and do the routine maintenance (for the sake of argument, let's just say cleaning) as the OP indicates. Would you then give this disparate group of units the same batch number?

Another case to consider: in the routine maintenance, you replace a critical part (e.g., drop-in replacement yet the part itself is from a different lot from the original parts incorporated). You don't want to lose the original traceability yet you need some means to track this new part.

I guess I'm not necessarily arguing against any of the opinions expressed so far. I would like to assess how proper traceability is maintained under the various scenarios.
 
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