Japan Medical Device Recall Requirements

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#1
I am helping an IVD test manufacturer with their risk management. They have a product that has components that are packaged in sealed foil pouch together with a small packet of desiccant.

If the desiccant was to burst open and spill the desiccant contents on to the IVD test components in the sealed pouch, would this constitute a recall of the batch/lot under the medical device regulations in Japan?

In my opinion, there is no adverse event as there is no death or serious injury to user or patient and there is no need for reporting or recall. The only concern is that the contents of this pouch cannot be used, and the user would have to take another pouch for the test.

Any help would be greatly appreciated!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Hi,

In the risk management you have to consider also
a) that the user might still use the IVD although the desiccant has spilled (what could be the consequences?)
b) that the issue might be systematic, i.e. there's a risk that many other units are damaged.

Cheers,
Ronen.
 
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#3
Thanks for the reply. Perhaps I didn't make this as clear as it should have been. I am helping this company deal with a real situation, rather than a FMEA/ISO 14971 Risk Assessment.

Apparently, they received a batch of desiccants with a less than 0.1% rate of failure (leaking desiccant). The impact has been isolated to this one lot of product which is not yet in the field but it is with a distributor in Japan.

They are in the process of determining the impact on the test result of using a test that has had desiccant leakage.

In my opinion, if this testing indicates no impact on the test performance, then there would be no need for them to recall the lot. Would you agree?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
if this testing indicates no impact on the test performance, then there would be no need for them to recall the lot.
It depends on the strength of this indication, statistically or otherwise scientifically.

Further, the testing has to allow for a worst case scenario of the test component being contaminated with the desicant - it needs to be idiot proof.

Cheers,
Ronen.
 

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