Use of Antimicrobial Inhibitors in Medical Devices

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WisdomseekerSC

Can anyone enlighten me on the current regulations governing the use of antimicrobial agents in medical devices. We do not manufacture any drugs or antimicrobial agents but are considering incorporating them into our components for medical devices. Does this make them a combination product? What about loading of pharmaceuticals (provided by the customer) into our components? :confused: Is a certain classification of cleanroom needed?
 
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WisdomseekerSC

We are located in USA but sell to medical device manufacturers worldwide.
 
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MIREGMGR

We were told by FDA CDER last June, after a fairly extensive interaction in which we outlined some technology that we had in mind, that if a material is "antimicrobial" and its function is to protect or benefit the patient or the user, it is a drug and the product is a combination device.

If OTOH the anti-microbial functionality is justified to FDA's satisfaction as being primarily intended to protect the product itself from deterioration, and if the material is shown via testing to be non-leaching/non-migratory/non-sacrificial/not chemically interactive with the patient in the intended use, the FDA may choose to regard the product as just a device.

Also note that any such material must have an EPA pesticide registration in order to make any antimicrobial-functionality claim or statement at all. The EPA has taken big-time enforcement action against shoe makers for anti-microbial claims based on use of unregistered materials. Do a Google search on "EPA VF North Face".

And, note that other nations have differing stances. Japan, for instance, applies their standard Z2801.
 
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WisdomseekerSC

OK...I guess we will let our customers determine the functionality. What about the processing of the materials by a contract manufacturer? Any compliance issues to be aware of?:caution:
 
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MIREGMGR

I'm somewhat guessing at this point because we haven't gone there yet, and the FDA was not willing to define their enforcement stance in our discussions.

My assumption is that, much like their enforcement approach to sterilization and sterile packaging, they would regard a contract manufacturer performing a high-expertise function such as incorporation of a biologically active material into a device as co-regulatorily responsible for that aspect of the device, including its safety and effectiveness in regard to the finished device's intended and other uses.

I think the warning letter record points in that direction, mostly.
 
J

Jimmy the Brit

Can anyone enlighten me on the current regulations governing the use of antimicrobial agents in medical devices.
:2cents: Not a product type that I have experience of, but as a microbiologist my immediate thought is that materials that are anti-microbial are often cytotoxic, which could cause you grief with biocompatibility testing - I would strongly advise having a discussion with a suitable reviewer before spending lots of money on a study design you have no chance of passing.

Jimmy
 
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MIREGMGR

... materials that are anti-microbial are often cytotoxic, which could cause you grief with biocompatibility testing

In that regard, our experience so far is that it makes a lot of difference which additive vendor you are working with. I don't want to name particular suppliers or technologies, but we found one that was prepared to support us with existing third party biocompatibility data, an existing EPA registration, etc.
 
S

SteveK

As indicated, there are quite a few antimicrobial technologies out there – either incorporated into the product itself (often silver based) or a coating that bonds to the substrate (e.g. silane quaternary ammonium compounds) – also think about the stuff in your toothpaste, washing up liquid, plastic food chopping board etc - typically triclosan. These materials are commonly used in health care facilities to help prevent the spread of MRSA, E.coli etc - for example incorporated into medical textiles (e.g. drapes). There seems now to be an impetus to use them in/on medical devices. Their use in the EU is controlled by Directive 98/8/EC - placing on the market of biocidal products (adopted in 1998). Note there is a toxicity issue with (nano) silver technology – see Friends of the Earth website! FYI one of the tests used for efficacy is JIS Z2801.:2cents:
 
D

DeviceMaker

We were told by FDA CDER last June, after a fairly extensive interaction in which we outlined some technology that we had in mind, that if a material is "antimicrobial" and its function is to protect or benefit the patient or the user, it is a drug and the product is a combination device.

If OTOH the anti-microbial functionality is justified to FDA's satisfaction as being primarily intended to protect the product itself from deterioration, and if the material is shown via testing to be non-leaching/non-migratory/non-sacrificial/not chemically interactive with the patient in the intended use, the FDA may choose to regard the product as just a device.

There are many medical devices that contain antimicrobial agents that are only medical devices (not combo) - antimicrobial wound care dressings. This is guidance from FDA regarding this topic.
 

Attachments

  • 510(k) Submissions for Medical Devices that Include Antimicrobial Agents.pdf
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