Risk Assessment Production Process Milling for Implantable Joints

P

phloQS

#1
Hi All,

First of all I am not sure if this is the right forum for this thread, so please admins feel free to move it.
We are producers of implantable hip joints and we use milling and turning to produce them.
During a meeting for risk assessment for a new hip joint there came up a question which no one of us could truly answer:
Are there any residual from the milling process on the surface of the joint? Of course there ist tapping fluid on it and maybe some chips. But we thought of residuals explicitly from the tool. This might be important due to biocompatibility as the tool are made of special metals which are definetely not biocompatible.
So any experts in milling here?

Thanks for your answers in advance


phloQS
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi All,

First of all I am not sure if this is the right forum for this thread, so please admins feel free to move it.
We are producers of implantable hip joints and we use milling and turning to produce them.
During a meeting for risk assessment for a new hip joint there came up a question which no one of us could truly answer:
Are there any residual from the milling process on the surface of the joint? Of course there ist tapping fluid on it and maybe some chips. But we thought of residuals explicitly from the tool. This might be important due to biocompatibility as the tool are made of special metals which are definetely not biocompatible.
So any experts in milling here?

Thanks for your answers in advance


phloQS
You could send some specimen for SEM analysis, that would tell you exactly what's there. It would help if you also provide a sample tool of each type + any documentation you have regarding its material (from its manufacturer).
 

pkost

Trusted Information Resource
#3
There is always a risk of particles transferring from one part to another....your tool wears - where do the wear particles go? the majority will drop down but some could stay on the part.

All orthopaedic implants should go through a validated cleaning process after the manufacturing process. SEM as ronen_E suggested can be used to identify particulates, XPS to identify any lubricant residuals
 
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