Mark Meer

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#1
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)?
 

MIREGMGR

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#3
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.

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.
 
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Mark Meer

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#4
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! :notme: :lol:
 

Sam Lazzara

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#5
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.
 
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Mark Meer

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#6
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.

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.
 
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O

Obama420

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#7
"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.":bonk::notme:



_____________________
watson
 

Mark Meer

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#9
Thanks for following up on that MIREGMGR!
I totally agree with your statement that the "quote from Jay Crowley would be problematic for many makers of (non-invasive, non-fluid-path-communicating) durable devices if broadly applicable", and DICE's reply seems reasonable.

I really don't see why the 21CFR doesn't simply state something to the effect of: "UDI device markings shall maintain integrity and legibility as required by 830.20, throughout the device's stated intended use and lifecycle." That would cover reprocessing, cleaning, multiple-users...etc.

Oh well...

:topic:
A bit off topic here, but is a reply from DICE carry any authority should some 510k reviewer have a different interpretation later on? (...especially if made by phone...).
 

MIREGMGR

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#10
A bit off topic here, but is a reply from DICE carry any authority should some 510k reviewer have a different interpretation later on? (...especially if made by phone...).
Not just made by phone, but then paraphrased to you by some guy that you don't know in an Internet forum. Hey, sounds pretty authoritative to me, right?

The direct answer to your question is, depending on their seniority and their relationship with their supervisor, that 510(k) reviewers can interpret anything as they see fit. So when there's a 510(k) reviewer involved, my approach is to try to clarify every rule-interpretation as early as possible.
 

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