Biocompatibility evaluation for Hardware/Interface Components?

[planB]

Have also a look into

• the new FDA draft guidance "(broken link removed)", which list ABS as safe material on p.4
• ISO 10993-1:2018, section 5.2.2 (a), NOTE:

  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 [...]. 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.

Hope this helps,

 

[Kuldeep Singh]

Thanks PlanB

Are the draft documents acceptable by notify body?? Second, Document issue by FDA regulatory body, is this acceptable by EU notify body??

I am asking just because, during an audit NB rejected the biological evaluation of material which was accepted by FDA in 510(k).

 

[planB]

Kuldeep Singh,

In your biological evaluation, including your ABS material, you take _all_ relevant existing data into account. In this respect, relevant literature and relevant publications of authorities are definitely not only legitimate, but also a preferred basis for an informed documented conclusion, and might also serve as an adequate response to your NB audit finding.

Hope this help,

 

[johnwong]

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

Is there any update for the heart-lung machine if biocompatibility is needed?