marie luis murray
Starting to get Involved
Dear readers,
we have a device which is an adhesive gel that contains Chlorhexidine (CHX) at 0,12% to be applied to an injured wound. The physical barrier is created by the gel and does not allow bacteria to reach the wound. We would like to say that the CHX has antimicrobial properties and reduces risk of infection. However, the % (0,12% used) is also accepted as preservative in cosmetics for instance.
How will this device be classified? if we claim the antimicrobial properties, the device will fall within rule 14? how can we demonstrate that it is a MD and not a drug? should we present any clinical data comparing the gel with vs gel without CHX?
or if we claim that the CHX is preservative, will the device fall under rule 21?
Does ISO 1099317 apply to the CHX? is CHX considered a leachable?
many many thanks!
we have a device which is an adhesive gel that contains Chlorhexidine (CHX) at 0,12% to be applied to an injured wound. The physical barrier is created by the gel and does not allow bacteria to reach the wound. We would like to say that the CHX has antimicrobial properties and reduces risk of infection. However, the % (0,12% used) is also accepted as preservative in cosmetics for instance.
How will this device be classified? if we claim the antimicrobial properties, the device will fall within rule 14? how can we demonstrate that it is a MD and not a drug? should we present any clinical data comparing the gel with vs gel without CHX?
or if we claim that the CHX is preservative, will the device fall under rule 21?
Does ISO 1099317 apply to the CHX? is CHX considered a leachable?
many many thanks!