Medical Devices - Direct vs. Indirect Body Contact - Definitions

[Arnthor]

Dear all,

I have a question.

How do you determine a component of a medical device is direct or in-direct with body contact?

I tried to look up on ISO 10993-1:2009 and its series, but not they do not have a clear definition.

Can anybody give me some examples?

Best regards,

Arnthor

 

[Stijloor]

A Quick Bump!

Can someone help Arnthor with this?

Thank you very much!

Stijloor.

 

[JeantheBigone]

How about this for an example.

Consider a device which applies ultrasound therapy. The casing for the electronics would not be considered to have direct contact. Of course you have to touch it to pick it up and move it to where you want it, but it is not considered body contact. The "wand" which is applied to the skin by the therapist wuold be considered to have direct body contact.

 

[mccsuz]

Consider also IV tubing sets. The inside of the tubing is not in DIRECT contact, but is in INDIRECT contact with the bloodstream since medication comes in contact with that surface prior to being in contact with the body. The needle or cannula that is inserted in the bloodstream is in DIRECT contact.

 

[MIREGMGR]

Surgeons' gloves have direct patient contact. Anything that the surgeon touches with his/her hands intraprocedurally has indirect patient contact, even if otherwise it does not touch the patient.