Biocompatibility evaluation for Hardware/Interface Components?

#1
Hi All,

Let's say we have a heart-lung machine that is used with a disposable part. Only the disposable part has contact to the patient. The heart-lung machine has interfaces that the user needs to touch in order to operate the machine during the procedure.

No, obviously, in the scope of ISO10993-1:2018 it says that this standard applies to medical devices that have direct or indirect contact to the patient. So the heart-lung machine would not be in scope. Furthermore it says that if the medical devcie is used for protection (e.g. gloves, masks etc) also the contact with the user's body needs to be evaluated. Again, our machine is not in scope.

Figure 1 also clearly states that ISO 10993-1 does not apply if there is np patient contact.

However: In section 5.2.2 there is a note that says:

"Some medical devices used in either sterile or non-sterile environments include components that can come into contact with a user’s ungloved hands such as human interfaces for electronic equipment (e.g. computer keyboards, dials or buttons, touch screens, SD cards, USB sticks); housings for electronic monitors or programmers that can come into contact with any intact skin (e.g. electronic devices like cell phones, tablets); or components that can come into contact with a user’s gloved hand (e.g. catheter handles).If these types of components can be shown to be made from materials in common use for other consumer products with a similar nature of contact, no further biological evaluation is needed."

How am i to understand this section? Isn't that contradictory to what the scope and figure 1 says? Do I now have to prepare a document for our heart-lung machine? If so, I am guessing it is not a full biocompatibility evaluation, but rather a list of materials used with the concluding statment that these are all "materials in common use for consumer products"? But how do i prove that?

Anybody asked themselves this question before?

Thanks a lot

Freddo
 
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#2
Freddo,

unfortunately, ISO 10993-1:2018 is not entirely consistent in defining body contact throughout the standard. You are safe if you consider both patient and any (professional) user contact in your biological evaluation report (BER).

Regarding section 5.2.2, I would recommend to directly address your NB and explore their expectations: I have seen reviewers of the very same NB having different expectations, ranging from a simple statement in the BER without further substantiation, to actually listing consumer product examples for each used (base) material.

HTH,
 
#3
Thanks for your comment.
Unfortunately (or, maybe, fortunately) its not something that comes from our NB but rather from my collegues from the hardware department that insist they need it, and my interpretation of the standard always was that we do not need it (and the NB never requested it). Then they pointed me to section 5.2.2 and i was out of arguments.... Let's hope this gets clarified in the next update of ISO 10993-1.

Regards

Freddo
 
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