UDI (Unique Device Identification) and Reprocessing Medical Devices

[Java23]

Hi - Help Please as the Boss and I differ on the term "reprocess".

Can anyone help me out and help me to understand if / when a device is considered to be a reprocessed device.

The UDI compliance date for "reprocessed Class II" devices is September 2015. For non-reprocessed Class II devices, the date is September 2016. The device is a prescription device used in hospitals.

I am interested to learn if (880.6740) Vacuum-powered body fluid suction apparatus (vacuum regulator) is considered to be a "reprocessed" device. The instructions for use and hospital protocol is to clean the outside of the device and disinfect and/or sterilized with ETO if the device becomes contaminated. Also, there is mention not to return contaminated devices to the manufacturer for repair (user is instructed to disinfect/sterilize before returning).

I may be totally off-base however, my brain keeps telling me the device is considered "reprocessed" and I believe the due date to be Sept. 2015.

Any thoughts, comments and advice would be greatly appreciated

 

[Sam Lazzara]

I assume you are asking about this in relation to requirements for direct marking of the UDI (directly on the device itself).

The device you describe appears to be a reusable device that requires reprocessing (cleaning, disinfection, sterilization, etc.) to get it ready for subsequent uses. My opinion is that the device you are speaking about will require direct marking under the FDA UDI regulations unless you have a good (documented in the design history file) excuse for not doing it.

Class I devices that are GMP-exempt do not require a UDI (in general).
Class I devices that are not GMP-exempt require only the DI-Device Identifier portion of a UDI (they do not require a PI - Production Identifier).

?801.45 Devices that must be directly marked with a unique device identifier.

(a) In general. 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.

(b) UDI for direct marking. The UDI provided through a direct marking on a device may be:
(1) Identical to the UDI that appears on the label of the device, or
(2) A different UDI used to distinguish the unpackaged device from any device package containing the device.

(c) Form of a UDI when provided as a direct marking. When a device must bear a UDI as a direct marking, the UDI may be provided through either or both of the following:
(1) Easily readable plain-text;
(2) Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand.

(d) Exceptions. The requirement of paragraph (a) of this section shall not apply to any device that meets any of the following criteria:
(1) Any type of direct marking would interfere with the safety or effectiveness of the device;
(2) The device cannot be directly marked because it is not technologically feasible;
(3) The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use.
(4) The device has been previously marked under paragraph (a) of this section.

(e) Exception to be noted in design history file. A labeler that decides to make use of an exception under paragraph (d of this section) must document the basis of that decision in the design history file required by ?820.30(j) of this chapter.

 

[Java23]

Thanks Sam

Actually, I thought about direct marking but, was not posing the question. Now that you mention it, it makes more sense to me and should definitely be considered. Is direct marking a process whereby something is etched into the device itself? If so, I am thinking that since the outside of the device is plastic, it probably would not be technologically feasible therefore, possibly an exemption.

Greatest concern is the date that we need to comply by - 2015 or 2016. I have had a couple people tell me that we do not reprocess the device. I think they are thinking that reprocessing means us, (the company/manufacturer) doing the reprocessing.

While the company/manufacturer does not reprocess, users are instructed to clean/disinfect and sterilize when the device has become contaminated.

My assumption is that it doesn't matter who does the reprocessing - if we tell someone to clean / disinfect / sterilize, the device is considered a reprocessed device. Is my thinking wrong/off? Trying to be logical and hopefully avoid confusion of the term reprocessor... I have not found a good definition of "reprocessor" and am trying my best to convey the intent / determination of what is considered "reprocessed device".

Device is Class II USA and Class IIa EU.

Thanks Sam for your help once again You are a wealth of information!

 

[Sam Lazzara]

Ok, sorry I did not answer your real question.
This FDA webpage may be useful for you.

I can only think of three types of medical device reprocessors:
- central services departments in healthcare facilities that reprocess devices
- third party service providers
- the original manufacturer who happens to offer reprocessing services

Reprocessors are not mentioned by name in the UDI regulations.

The UDI requirements you are referring to that come into force in 2015 and 2016, are the requirements I was referring to for direct marking of reusable devices intended to be reprocessed before each use.

Compliance date is 2015-09-24 for devices that are life-supporting or life-sustaining devices that must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. ? 801.45.

Compliance date is 2016-09-24 for Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. ? 801.45.

 

[MIREGMGR]

(Response deleted by me because on reflection it wasn't substantially useful...Sam's reply above covers the issue.)

 

[Java23]

MIREGMGR - Thank you - I did see your post when I was at work and looked at it briefly - worked late and came home to open it and saw you deleted. Believe me, any response is helpful to me - and I just wanted to thank you for taking the time to respond. Much appreciated

 

[Java23]

Thank you Sam - much appreciated. Seeing as though we (manufacturer) don't "offer reprocessing services" my assumption is that we need to be ready in 2016 for Class II.

My greatest concern is that we tell the user to clean/disinfect and sterilize when necessary in our IFU and service manual. It is the instructions we give that cause me to think of "reprocessing". My brain keeps thinking that because we instruct to clean/disinfect and sterilize, we "suggest" that the reusable device should be "reprocessed". As you noted, I have confirmed that hospital protocol is to clean/disinfect the device between patient use. So, then the central services departments in healthcare facilities would be reprocessing the device.

I need to understand (and maybe reading the link you sent will help) if we tell a user or if standard hospital protocol is to clean/disinfect and/or sterilize if the device is considered to be reprocessed.

I only question this because I read another blog FAQs a while back and the question was around reprocessing. Comment was that FDA was contacted and that they would, in the near future, post more information regarding what reprocessing entails. As of yet, I have not seen an update to that FAQ however, the response listed was if a device is cleaned/processed or sterilized between patient use to consider it reprocessed.

I will read the link you sent and hopefully this will become more clear to me. Again, I thank you for your advice and help. Much appreciated

 

[Laura S]

From the FDA's "CDRH Learn" UDI hyperlink, Jay Crowley says this about "reprocessed devices", specifically in context about direct device marking.

"In the final rule we only require Direct Marking for devices that are intended to be reprocessed between patient use, so we have extended this from devices that need to be sterilized to any device that needs to be reprocessed,
that is, cleaned, disinfected, or sterilized, between each use."

From this comment, it appears to me that the definition of "reprocess" is functional and not directly tied to "where" the operation is being done to make the device fit for use for the next patient.

I hope this helps.

 

[MIREGMGR]

Because the above quote from Jay Crowley would be problematic for many makers of (non-invasive, non-fluid-path-communicating) durable devices if broadly applicable, I just called DICE (formerly DSMICA) to ask about it.

The response was that Mr. Crowley was not wearing a lawyer's hat when he wrote the comment in question, and FDA does not regard ordinary sanitary cleaning at the point of use of non-invasive, non-fluid-path-communicating devices between patient uses as "reprocessing".

 

[QM Becky]

Hi Folks! Searching the forum for thoughts and opinions on UDI Direct marking and stumbled upon this thread. Realizing the discussion is a bit dated.

In Nov 2017 the FDA FINALLY released guidance on Direct Marking (the draft was issued in June 2015). In the guidance document they reiterate that direct marking is required for products that are both:

a) intended to be used more than once, and
b) intended to be reprocessed before each use.

If either of these statements fail to apply, direct marking is not required.

They go on to define "reprocessed" as:

"device intended to be reprocessed if it is intended to undergo high-level disinfection and/or sterilization before each use or between uses. This means that devices that are only intended to be cleaned and/or to undergo lower levels of disinfection without subsequent high-level disinfection or sterilization before each use or between uses are not required to be directly marked with a UDI."

They further define "high level disinfection" as "a lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores."

For products that only need to be kept clean and whose cleaning procedures are to use mild soapy water, I would not interpret those as needing to be directly marked even if they are intended for multi-person use. (ie. blood pressure cuffs, finger sensors for BP, HR, SpO2, other monitors in a typical office - otoscopes, wt scales, thermometry modules, stethoscopes... etc). These products are all used on multiple patients and by some definitions - reprocessed. But not by the definition of "high level disinfection" presented by the FDA.

Has anyone else come across this question or implementation?

My contention is that products as those described above would NOT require direct marking.

Thoughts?