Implant Contamination - 17-4 SS Devices - Machine Shop

K

Katydid

#1
Hello All. I am working for a small medical device manufacturer (machine shop). We have been producing devices used by surgens during implant surgeries, like spreaders, clamps, inserters, etc. We are very good at preventing contamination of the typical stainless steels used for surgical devices, but we are starting to manufacture titanium and 316LVM implants. There have been many questions regarding contamination of implants, and since I am from an automotive background, I don't know any of the answers. I need help in understanding to what extent contamination is typically controlled. After I have some idea, I will address it with the customers.

Right now, we ensure we don't use brass EDM wire or copper sinkers to prevent brass/copper contamination of a titanium implant. We always start with new glass bead mediums, grinding pads, polishing equipment whenever we change over from a stainless steel to titanium implants. When we change a mill or lathe over from stainless to a titanium job, we plan to blow off all tools, and clean the chip pans, but not change coolants and other fluids.

Do we need to worry about any of these other circumstances if they are typically used for 17-4 SS devices when we go to an implant job:
Ultrasonic Cleaning Bath
Machine Coolants, Lubricants, and/or Cutting Oils
Passivation Tanks (for 316 LVM implant grade material)
Machine Tooling (drills used on a different material first)
Reground Tooling

I appreciate any input you would have to offer. I just want some understanding of normal practices before I contact the customer in the next couple of days to agree on contamination control. I have a week or two to determine the requirements prior to starting our new jobs, old jobs were on dedicated equipment.
 
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Al Rosen

Staff member
Super Moderator
#2
Katydid said:
Hello All. I am working for a small medical device manufacturer (machine shop). We have been producing devices used by surgens during implant surgeries, like spreaders, clamps, inserters, etc. We are very good at preventing contamination of the typical stainless steels used for surgical devices, but we are starting to manufacture titanium and 316LVM implants. There have been many questions regarding contamination of implants, and since I am from an automotive background, I don't know any of the answers. I need help in understanding to what extent contamination is typically controlled. After I have some idea, I will address it with the customers.

Right now, we ensure we don't use brass EDM wire or copper sinkers to prevent brass/copper contamination of a titanium implant. We always start with new glass bead mediums, grinding pads, polishing equipment whenever we change over from a stainless steel to titanium implants. When we change a mill or lathe over from stainless to a titanium job, we plan to blow off all tools, and clean the chip pans, but not change coolants and other fluids.

Do we need to worry about any of these other circumstances if they are typically used for 17-4 SS devices when we go to an implant job:
Ultrasonic Cleaning Bath
Machine Coolants, Lubricants, and/or Cutting Oils
Passivation Tanks (for 316 LVM implant grade material)
Machine Tooling (drills used on a different material first)
Reground Tooling

I appreciate any input you would have to offer. I just want some understanding of normal practices before I contact the customer in the next couple of days to agree on contamination control. I have a week or two to determine the requirements prior to starting our new jobs, old jobs were on dedicated equipment.
I'm sorry, I'm not familiar with implants, but maybe someone else will come across this now.

Does anybody have any experience in this area and can offer some advice?
 

Wes Bucey

Quite Involved in Discussions
#3
Golly. I'm sorry I missed this when it was first posted.

We ran titanium products (medical and non-medical) on a dedicated machine. Similarly, we ran all non-ferrous on dedicated machines. Our primary reason was financial, not hygiene. We were able to sell our pure scrap for much higher price than mixed scrap. Similarly, our tooling was optimized for the material.

We made bone screws as our only implants. Other medical stuff were tools or parts for instruments and machines.

I can see several sources of contamination of foreign material into the implant device which might not be removed by passivation or ultrasonic cleaning. Such contaminations would probably (not guaranteed) be removed by electropolishing.

I don't see coolant as a source of contamination which would NOT be removed by normal cleaning.

I DO see tooling (cutting, drilling, or Electronic Discharge Machines), tumbling/deburring medium, as potential sources of contamination of SS or Titanium parts. Essentially what happens is that the foreign material is welded to the base material by heat or mechanical [cold or contact] welding.

This is really a situation beyond the normal scope of the Cove (certainly beyond MY scope) and ought to be referred to a metallurgist.
 
K

Katydid

#4
Thanks!

I took quite a few courses in metallurgy in college (materials engineering), but had no experience in medical until now. I totally agree with your comments that my question is a bit too narrow, and not a perfect fit for the cove. I am glad though, to see that you are thinking along the same lines I am. Since my last posting, I did get a little more information from the customer, and this is how it panned out:

All of our implants are treated in an acid bath at the customer location prior to being coated, so my risks are somewhat reduced. We will have to control:
1) Polishing mediums
2) Grinding mediums
3) Tumbling mediums
4) Blasting mediums
5) Contamination of the ultrasonic with unauthorized cleaning agents from instrument manufacturing
6) Brief rinse out of stainless steel chips from machine and tooling prior to switching to titanium
7) Passivation is not an issue since titanium is self-passivating and we do not require this internal process for any of our implants.

I thank you for your reply. Every now and then, support from the cove helps to keep me working in the right direction. You guys are great! :thanks:
 
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