Taking a bit of a guess here, but when I have seen this kind of request before, its tends to be for one of two reasons:
1) there are hospitals that "sterilize" devices in disinfection/sterilizer machines, and they want to know how to set the disinfection cycles, or
2) the national standards for hospital based sterilization require a cleaning AND disinfection step first before final sterilization (I know this came up in the UK a lot a few years ago when I worked with these types of devices)
The hospital standards tend to be written thinking only of "reusable" devices and not primary sterilization of a "new" implant, which can lead to much confusion. I suspect the NB is aware of this and is trying to make sure adequate direction to the user is given. There are probably quite a few ways to deal with this if you can clarify the need.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 03-Mar-2020 13:58
From: Richard Vincins
Subject: HIgh Level Disinfection of Critical (implant) Devices
Hello Anon,
Well there can be a difference between disinfection and sterilisation - typically the Sterility Assurance Level (SAL) of 10-3 and 10-6 respectively. Though have to say I am a little confused because typically there would be no disinfection involved with an implant except maybe in the manufacturing process. When non-sterile implant devices are provided to users for further processing, typically they would do a "quick" clean or no clean, but would sterilise the implant before use. If you are talking about disinfection, this is typically in regard to device that are reprocessed and used multiple times in a procedure. As an example, implant tools could be cleaned and disinfected before the next use with a new non-sterile implant. Typically those reusable devices like endoscopes or cameras would go through a disinfection or sterilisation process before the next use. In fact, some devices can only be disinfected, i.e. through cold solutions like glutaraldehyde, because they can not be processed using heat. Though there are some cold sterilisation processes as well. The information you received from your NB sounds ccontraddictory or not quite correct - though the exact device and IFU would need to be reviewed, because maybe this is in reference to the surgical instruments/tools being used. You are right it does not make sense, because HLD and sterilisation is different. Also just a note, this also depends on national law as well as even specific hospital protocols what they require for low level disinfection, high level disinfection, and sterilisation. There is quite a bit of information out on the web discussion these three levels. And yes cleaning is also different because if something is not clean all you are doing is disinfecting large foreign matter that can be broken open later with nasty things inside.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 27-Feb-2020 15:45
From: Anonymous Member
Subject: HIgh Level Disinfection of Critical (implant) Devices
This message was posted by a user wishing to remain anonymous
Hello Colleagues
I am reaching out to ask for clarification regarding the requirement for High Level Disinfection of implant devices. If a non-sterile implant device is labeled as requiring cleaning and steam sterilization prior to use, are instructions for high level disinfection also required?
I have received an interpretation from my NB that EN ISO 17664 and MDD require an IFU for a non-sterile implant device to include validated instructions for disinfection in addition to cleaning and sterilization. However in both the standard and the directive I am seeing language like "if the medical devices is intended to be disinfected" and "information on the appropriate processes".
It doesn't make sense to me that our labeling should require high level disinfection if steam sterilization is required, so I would very much appreciate hearing insights from those in the regulatory community who have more experience with (re)processing than I do :)
Thank you in advance for your valuable device!