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UDI - Direct Marking and Reprocessing Clarification
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UDI - Direct Marking and Reprocessing Clarification
UDI - Direct Marking and Reprocessing Clarification
UDI - Direct Marking and Reprocessing Clarification
UDI - Direct Marking and Reprocessing Clarification
UDI - Direct Marking and Reprocessing Clarification
UDI - Direct Marking and Reprocessing Clarification
UDI - Direct Marking and Reprocessing Clarification
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UDI - Direct Marking and Reprocessing Clarification


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Some Related Topic Tags
21 cfr part 801 - labeling, fda (food and drug administration), labeling requirements, reprocessing, unique device identification (udi)
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  Post Number #1  
Old 22nd October 2014, 07:29 PM
Mark Meer

 
 
Total Posts: 710
Question UDI - Direct Marking and Reprocessing Clarification

FDA 21 CFR 801.45 (a) states:
"A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use."

Couple quick questions:

1. So "direct marking" is synonymous with "permanent marking", and by "permanent marking" this means some kind of etching or engraving? I presume an indelible label is inadequate?

2. What is the definition of "reprocessing"? Does it include basic cleaning or disinfecting (e.g. simple wipe-down with an alcohol swab)?

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  Post Number #2  
Old 23rd October 2014, 05:03 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,244
Re: UDI - Direct marking and reprocessing clarification

A Quick Bump!

Can someone help?

Thank you very much!!
  Post Number #3  
Old 23rd October 2014, 01:25 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: UDI - Direct marking and reprocessing clarification

Quote:
In Reply to Parent Post by Mark Meer View Post

I presume an indelible label is inadequate?
I believe the expectation is: it's the device maker's responsibility to define how the device is to be reprocessed. Any means of directly marking the device is acceptable if it will remain readable across the worst-case-foreseeable number of reprocessing procedures through the device's declared lifecycle.

Quote:
What is the definition of "reprocessing"? Does it include basic cleaning or disinfecting (e.g. simple wipe-down with an alcohol swab)?
I'm sure this is formally defined, but I don't have a reference handy at the moment. My understanding though is that "reprocessing" includes only operations that are done to the device to prepare it for safe and effective re-use, over and above ordinary cleaning and disinfecting.

Surgical instruments typically go to central sterilization for reprocessing. Some kinds of invasive scopes might be reprocessed by the using department.

Last edited by MIREGMGR; 23rd October 2014 at 01:35 PM.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #4  
Old 23rd October 2014, 02:22 PM
Mark Meer

 
 
Total Posts: 710
Re: UDI - Direct marking and reprocessing clarification

Thanks MIREGMGR.
I've been trying to track down a formal definition of reprocessing...

The FDA should really have a dedicated page devoted to definitions, which all other CFR and Guidance pages can link to. Presently, all the definitions are scattered and restated.

Also, they could certainly clarify what they mean by "permanent" because, if as you say, it's based only on device lifecycle and foreseeable reprocessing, this is definitely not my idea of "permanent".

...I blame the FDA for my confusion!
  Post Number #5  
Old 23rd October 2014, 07:32 PM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Total Posts: 258
Re: UDI - Direct marking and reprocessing clarification

Hi Mark,

1. Etching or engraving may be overstepping depending on the intended use. I like what EN 60601-1:2013 says about this. Section 7.1.3 is call Durability of markings. It requires that markings can only be removed with a tool or by lots of force, and shall be clearly legible during the expected service life during normal use. It also says that adhesive labels must not come loose or curl. Finally a cloth hand rub test is specified that involves water, ethanol and isopropyl alcohol

2. See "Reprocess" definition below from AAMI TIR 30 (2011) - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

Reprocess: To make ready for reuse a device, instrument, or piece of equipment by any or a combination of the following processes: cleaning, decontamination/disinfection, repackaging, and sterilization.

Last edited by Sam Lazzara; 24th October 2014 at 04:54 PM.
Thanks to Sam Lazzara for your informative Post and/or Attachment!
  Post Number #6  
Old 23rd October 2014, 07:44 PM
Mark Meer

 
 
Total Posts: 710
Re: UDI - Direct marking and reprocessing clarification

Thanks Sam.

I also agree that the 60601-1 marking durability description is far more comprehensive.

...But I'm more concerned with FDA interpretation of their UDI requirements.

Quote:
Reprocess: To make ready for reuse a device, instrument, or piece of equipment by any or a combination of the following processes: cleaning, decontamination/disinfection, repackaging, and sterilization.
Is this an FDA definition? If so:
- could you kindly provide a reference?
- this seems pretty all-encompassing as far as reusable medical devices are concerned. I'd think that just about all reusable medical devices have some kind of recommended cleaning instructions...

EDIT: Ah, I see that an FDA representative quote to this effect (reprocessing includes cleaning) in this thread.

Last edited by Mark Meer; 23rd October 2014 at 07:52 PM. Reason: added thread link
  Post Number #7  
Old 24th October 2014, 12:46 AM
Obama420

 
 
Total Posts: 1
Re: UDI - Direct marking and reprocessing clarification

"A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use."



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  Post Number #8  
Old 24th October 2014, 10:02 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: UDI - Direct marking and reprocessing clarification

Quote:
In Reply to Parent Post by Mark Meer View Post

I see that an FDA representative quote to this effect (reprocessing includes cleaning) in this thread.
I just investigated and responded to that Jay Crowley quote in that other thread.

http://elsmar.com/Forums/showpost.ph...99&postcount=9
Thanks to MIREGMGR for your informative Post and/or Attachment!
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