Is a surgeon's marker pen a medical device?

PPcricket

Starting to get Involved
#1
I have a question with regards to the marker pen a surgeon uses in order to highlight the area he/she will operate upon....

Are these marker pens classed as Medical Devices? or can they be classed as Medical devices?

Any input into this would be greatly appreciated....thanks, P
 
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GStough

Staff member
Super Moderator
#2
http://www.fda.gov/MedicalDevices/D...nce/Overview/ClassifyYourDevice/ucm051521.htm

Here's a link to the FDA's site for determining whether or not you have a medical device.

I would not think that a surgeon's marker pen is a medical device because it isn't used/intended for use in diagnosing, treating, preventing, etc. a disease or medical condition. However, I could be wrong...

Hope the link helps. :bigwave: And welcome to the Cove! :)
 

PPcricket

Starting to get Involved
#4
I did a quick search on the web and also the link by Gidget....it seems that these marker pens are in fact 'Medical Devices' or you can justify them to be devices. I'm assuming it's dependant on the claims....I will inform my bosses!! thanks for the comments...P
 

Ajit Basrur

Staff member
Admin
#5
I did a quick search on the web and also the link by Gidget....it seems that these marker pens are in fact 'Medical Devices' or you can justify them to be devices. I'm assuming it's dependant on the claims....I will inform my bosses!! thanks for the comments...P
Hi PPcricket,

You are correct - refer Product Classification - FDA

These surgical markers are Class I medical device; under 21 CFR Sec. 878.4660
 

bio_subbu

Super Moderator
#6
Surgeons marker pen is a medical device, classified in Part 878 - GENERAL AND PLASTIC SURGERY DEVICES, Subpart E--Surgical Devices, Sec. 878.4660 Skin marker.

(a)Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Thanks and Regards
S. Subramaniam
 
J

JaxQC

#7
Regardless if it is or not, I would think you’d still have some questions that would still need answered (and the documentation as objective evidence on hand) as opposed to just grabbing any pen.
  • Non-toxic (both absorbed and Cytotoxicity (edge of wound healing).
  • How permanent is it (does antiseptic wash / various prep solutions take it off during operation prep)
  • Any ingredients in the ink that are susceptible to reaction / allergy
  • It may seem odd but also visible on all skin color variations. The goal being is that you’d want as sharp and obvious a contrast between the ink color and the various skin pigmentations in the world as possible. How you document this I have no idea but it’d be pretty important to me that it was unmistakable if I was getting an amputation.
 
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