Japanese rule on EtO residuals in sterilized medical devices?

M

MIREGMGR

#1
We have been told that Japan has significantly tighter regulations on EtO residuals in sterile-barrier-pouched medical devices, compared to the limits imposed by ISO 10993-7 in relation to ISO 11135. We hadn't previously known that. Fortunately, our current product mix exported to Japan is well under allowed residual limits, particularly by the time it gets there, and we did not learn of this new issue via an adverse regulatory action or user complaint.

Can someone point me to information on this Japanese rule?
 
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Stijloor

Staff member
Super Moderator
#2
We have been told that Japan has significantly tighter regulations on EtO residuals in sterile-barrier-pouched medical devices, compared to the limits imposed by ISO 10993-7 in relation to ISO 11135. We hadn't previously known that. Fortunately, our current product mix exported to Japan is well under allowed residual limits, particularly by the time it gets there, and we did not learn of this new issue via an adverse regulatory action or user complaint.

Can someone point me to information on this Japanese rule?

According this book, EtO is banned in Japan.

Stijloor.
 
M

MIREGMGR

#3
According this book, EtO is banned in Japan.
Heh. Did you note the title of the book? I hardly think anyone is going to be trying to eat any of our products. :rolleyes:

I have conclusive circumstantial evidence that EtO sterilization of medical devices is not prohibited in Japan. We sell on a bulk private label basis to a number of multinational medical companies that then resell our products around the world, including in Japan in several instances. All of our sterile product, as sold worldwide, is clearly and prominently labeled "Sterile EO", the international symbol/text for EtO sterilization. In all cases, it's sold as we package and label it...no re-packaging or re-labeling is done. (We have multiple business and regulatory ways of knowing this, and verifying it.) Sterile application technique requires that the product be in its unopened pouch all the way to the point of application, and the personnel doing the application are most often quite highly educated and trained medical personnel...different ones at every hospital or other procedural site, of course.

It seems implausible that we could have been shipping product for many years, that has been used by thousands of such individuals in Japan, and yet no one had ever read the label and discovered that they were working with a device that was sterilized in a (supposedly) prohibited manner.

I am looking for help on this matter, but it does need to be medical-device-knowledgable help. :D
 
M

MIREGMGR

#5
Thank you for trying. I may have to contact a Japanese consulate, or perhaps check with the US Commerce Department.
 

Stijloor

Staff member
Super Moderator
#6
Thank you for trying. I may have to contact a Japanese consulate, or perhaps check with the US Commerce Department.
You're welcome.

Be patient. There are a lot of good people here at The Cove Forums that know a heck of a lot more about medical devices and applicable (international) regulations than I do.

Stijloor.
 

Doug Tropf

Quite Involved in Discussions
#7
If you do a search of forum threads using "Japanese medical device sterilization" as the search topic you will find some threads that might be of some help.
 
G

Gert Sorensen

#8
We have been told that Japan has significantly tighter regulations on EtO residuals in sterile-barrier-pouched medical devices, compared to the limits imposed by ISO 10993-7 in relation to ISO 11135. We hadn't previously known that. Fortunately, our current product mix exported to Japan is well under allowed residual limits, particularly by the time it gets there, and we did not learn of this new issue via an adverse regulatory action or user complaint.

Can someone point me to information on this Japanese rule?
Hi MIREGMGR,

Took a while, but I did find someone in my network who knows a little about these things. Here goes:

You should contact NAMSA (they have a Japanese branch). They know about Biocompatibility testing, and in particular the japanese requirements as specified in the Japanese Pharmacopee.

The requirements to sterile products are listed in the Japanese Pharmacopee, and the japanese version of 10993-1. It appears that one of the differences are that the bouillons (broths) that needs to be used are tested for longer periods and against higher demands.

Anyway, the recommandation was to make sure that you get in touch with someone who really knows the japanese situation. Any deviation from their requirements can result in a prolonged process with the regulatory authorities in Japan.

:bigwave:
 
M

MIREGMGR

#9
Actually we contacted our registrar (BSI), which arranged internationally for a translation to be done since apparently there is no official English language version of that particular Japanese rule. I'd post it here, but (1) it's lengthy and (2) I believe BSI considers the translation to be proprietary to their clients only, since there must have been some costs to them in the rather extensive international email chain that it took them to accomplish the task.

Also, they've asked us to meaning-check the translation to make sure that they don't have any situations where a term has two disparate meanings and the wrong one inadvertently was chosen, and we haven't formally reported back to them on that yet.

The bottom line for us is that for devices with no patient contact, there is no residuals requirement; and for devices of greater than 80 grams mass that have only short-term (<24 hr) unbroken-skin external contact with adults, the requirement is comparable to 10993-7; but for lesser-mass devices the requirements are tighter, and for all devices that have pediatric contact or invasive/semi-invasive functionality, the requirements are much tighter.
 
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